Efferalgan

Package leaflet: Information for the user

Efferalgan adults 1000 mg effervescent tablets, forest fruits flavour

paracetamol
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before taking Efferalgan
3. How to take Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which works by relieving pain (analgesic) and reducing fever (antipyretic).
Efferalgan is used in adults and adolescents over 15 years of age for:

• the treatment of symptoms of feverish conditions
• the symptomatic treatment of mild to moderate pain
• the symptomatic treatment of joint pain (arthritic pain).

Consult a doctor if the person taking the medicine does not feel better or feels worse.

2. What you should know before using Efferalgan

Do not use Efferalgan
if the person taking the medicine:

• is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol) or to any of the other ingredients of this medicine (listed in section 6);
• is under 15 years of age (see section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before using Efferalgan.
During treatment with Efferalgan, inform your doctor immediately if:

• you chronically consume alcohol. Alcohol consumption during treatment is not recommended.
• you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite)
• you suffer from bulimia (an eating disorder in which a person ingests excessive amounts of food and then resorts to various methods to eliminate it in order not to gain weight)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning skin due to chronic illness)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced blood volume circulating in the body)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish discoloration of the skin and eyes)
• you suffer from severe liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that induce liver enzymes (increase the activity of the liver)
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body; its deficiency may cause hemolytic anemia)
• you suffer from hemolytic anemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• you are experiencing prolonged fasting
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause severe skin reactions which can be fatal. The use of Efferalgan must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or for prolonged periods
The use of high or prolonged doses of this medicine may cause serious liver disorders and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache may increase or worsen headache, especially if taken frequently and repeatedly. In such cases, medical advice should be sought.
Children and adolescents
This medicine may be given to adolescents aged over 15 years (see section “How to use Efferalgan”).
Other medicines and Efferalgan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if the person taking the medicine is also taking:

• other medicines containing paracetamol, because serious adverse effects may occur if paracetamol is taken in high doses
• coumarin anticoagulants including warfarin (medicines that delay blood clotting): in this case, your doctor will perform more frequent monitoring of INR values (the time it takes for blood to clot)
• medicines or substances that induce liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic)
  • cimetidine (a medicine used in the treatment of stomach ulcers)
  • antiepileptic medicines such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of the following medicines with Efferalgan requires extreme caution and should only be done under strict medical supervision:

• probenecid, a medicine used to treat hyperuricemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise you to reduce the dose of Efferalgan
• salicylamide (an analgesic and antipyretic medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid disturbances (called high anion gap metabolic acidosis) requiring urgent treatment (see section 2)
• chloramphenicol (an antibiotic), as it may increase the risk of possible adverse effects
• medicines that delay gastric emptying (such as anticholinergics), as these medicines delay the effect of Efferalgan
• zidovudine (a medicine used to treat HIV).

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, note that administration of paracetamol may interfere with the measurement of serum uric acid levels (uricemia) and blood glucose levels (glycemia).
Efferalgan and alcohol
Use Efferalgan with caution if the person taking the medicine chronically consumes alcohol, as there is a risk of toxicity (see sections “Warnings and precautions” and “If you use more Efferalgan than you should”).
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If necessary, Efferalgan may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible duration.
Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rash has been reported in breastfed infants. However, paracetamol administration is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.
Driving and using machines
Efferalgan does not affect the ability to drive or use machinery.
Efferalgan contains sodium, lactose, sorbitol (E420), sodium benzoate (E211), and aspartame (E951)

• This medicine contains 369.85 mg of sodium (a main component of table salt) per tablet. This corresponds to approximately 18% of the maximum daily intake recommended in an adult's diet. Talk to your doctor or pharmacist if you need one or more doses per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

• This medicine contains sorbitol (252.2 mg of sorbitol per tablet, equivalent to 252.2 mg/4628 mg). Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine.

• This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, consult them before taking this medicine.

• This medicine contains 120 mg of sodium benzoate per tablet, equivalent to 120 mg/4628 mg.

• This medicine contains 39 mg of aspartame per tablet, equivalent to 39 mg/4628 mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to use Efferalgan

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medications you are taking (with or without prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you use more Efferalgan than you should).

Adults
The recommended dose is 1 tablet per administration, repeated if necessary, respecting an interval of at least 6–8 hours between doses, without exceeding 3 tablets per day.
In the case of more intense pain, the administration may be repeated after an interval of at least 4 hours.

Use in children and adolescents
Adolescents over 15 years of age
The recommended dose is 1 tablet per administration, repeated if necessary, respecting an interval of at least 6–8 hours between doses, without exceeding 3 tablets per day.
In the case of more intense pain, the administration may be repeated after an interval of at least 4 hours.
It is important to take Efferalgan at regular intervals to avoid fluctuations in pain and/or fever levels. The interval between administrations must be at least 4 hours.

Maximum recommended dosage
The maximum dose is 3 g of paracetamol per day.

Patients with kidney disease
If the person taking the medicine suffers from kidney disease, the interval between doses should be adjusted according to creatinine clearance (an index used to monitor kidney function):

• creatinine clearance between 10 and 50 ml/min: the interval between doses should be at least 6 hours, and the maximum daily dose should not exceed 3 g;
• creatinine clearance less than 10 ml/min: the interval between doses should be at least 8 hours, and the maximum daily dose should not exceed 2 g.

Patients with liver disease
If the person taking the medicine suffers from reduced liver function, the dose should be reduced or the interval between administrations prolonged.
The maximum dose should not exceed 2 tablets per day in the following cases: adult patients weighing less than 50 kg, liver disease (hepatopathy), Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.

Elderly
In elderly patients, dose adjustment is usually not required unless the patient also suffers from other diseases requiring such adjustment (see sections “Patients with kidney disease” and “Patients with liver disease”).

Instructions for use
For oral use.
Completely dissolve the tablet in a glass of water. Do not chew or swallow the tablet whole.

If you use more Efferalgan than you should
In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially if the person taking the medicine:

• has liver disease
• abuses alcohol
• suffers from chronic malnutrition
• is taking medicines or substances that stimulate liver enzymes (increase liver activity).

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

• nausea
• vomiting
• anorexia (lack or reduction of appetite)
• pallor
• malaise
• diaphoresis (excessive sweating).

After paracetamol overdose, the following have been observed:

• sudden inability of the kidneys to function properly (acute kidney injury),
• a condition in which small blood clots form in the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation),
• rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to altered blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Symptoms of liver damage peak after 3–4 days.

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.

If you forget to take Efferalgan
Do not take a double dose to make up for the missed dose.

If you stop using Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If the person taking this medicine experiences any of the following side effects, STOP treatment with this
medicine and contact the doctor immediately:

• skin reactions which may present as:
  • urticaria (appearance of itchy skin welts)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (appearance of red spots on the skin with a "target" appearance, associated with itching)
  • purpura (appearance of purple-colored skin patches of varying sizes)
  • Stevens-Johnson syndrome (a severe form of polymorphic erythema)
  • epidermal necrolysis (severe skin lesion characterized by redness, blistering, and areas of skin detachment and death)
  • generalized acute exanthematous pustulosis (eruption of hundreds of superficial pustules spread throughout the body)
  • drug-induced fixed eruption (skin rash of red/violet color)
• allergic reactions which may present as:
  • laryngeal edema (swelling of the throat)
  • angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • anaphylactic reaction (severe allergic reaction), including hypotension (low blood pressure)
  • hypersensitivity
  • anaphylactic shock (severe allergic reaction)
  • bronchospasm (excessive and prolonged contraction of airway muscles causing breathing difficulties)

Additionally, the following side effects may occur, for which there are insufficient data available
to determine frequency:

• thrombocytopenia (reduced number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
• anemia (reduced hemoglobin in the blood, the substance that carries oxygen)
• diarrhea
• abdominal pain
• gastrointestinal reactions
• abnormal liver function
• hepatitis (inflammation of the liver)
• changes in INR (a value used to express the time it takes for blood to clot)
• increased liver enzymes
• headache
• dizziness
• hypotension (low blood pressure)
• acute renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in urine)
• anuria (cessation or reduction of urine production by the kidneys)
• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness using paracetamol (see section 2), frequency not known (frequency cannot be determined from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the tube and the carton after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store in the original packaging to protect the medicine from moisture.

6. Package Contents and Other Information

What Efferalgan Contains

• The active substance is: paracetamol. Each tablet contains 1000 mg of paracetamol.
• The other components are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E420), sodium docusate, povidone, sodium benzoate (E211), lactose, aspartame (E951), potassium acesulfame, berry flavor (see section "Efferalgan contains sodium, lactose, sorbitol (E420), sodium benzoate (E211) and aspartame (E951)").

Description of the Appearance of Efferalgan and Contents of the Package
White effervescent tablets, packaged in a box containing 2 tubes with 8 tablets each.

Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome

Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France

Package leaflet: information for the user

Efferalgan 80 mg suppositories, infants 150 mg suppositories, children 300 mg suppositories

paracetamol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before using Efferalgan
3. How to use Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which works by relieving pain (analgesic) and reducing fever (antipyretic).
Efferalgan is used in children with a body weight equal to or greater than 4 kg for:

• the treatment of symptoms of feverish conditions,
• the symptomatic treatment of mild to moderate pain.

Consult a doctor if the person taking the medicine does not feel better or feels worse.

2. What you need to know before using Efferalgan

Do not use Efferalgan
if the person taking the medicine:

• is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), or to any of the other ingredients of this medicine (listed in section 6)
• is allergic to soy or peanuts.

Warnings and precautions
Use with caution and consult your doctor or pharmacist before using Efferalgan. During treatment with
Efferalgan, inform your doctor immediately if:

• you chronically consume alcohol. Alcohol consumption during treatment is not recommended
• you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite)
• you suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it to avoid gaining weight)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic diseases)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced volume of circulating blood)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish discoloration of the skin and eyes)
• you suffer from severe liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that stimulate liver enzymes (increase the activity of the liver)
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body; deficiency may cause hemolytic anemia)
• you suffer from hemolytic anemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• prolonged fasting
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause serious skin reactions which can be fatal. The use of Efferalgan must be discontinued at the first appearance of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or for prolonged periods
The use of high or prolonged doses of this medicine may cause severe liver damage and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurring, may increase or worsen headache. In such cases, medical advice should be sought.
Children
This medicine can be given to children with a body weight equal to or greater than 4 kg (see section 3 “How to use Efferalgan”).
Other medicines and Efferalgan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription.
In particular, inform your doctor if the person taking the medicine is taking:

• other medicines containing paracetamol, because serious adverse effects may occur if paracetamol is taken in high doses;
• coumarin anticoagulants including warfarin (medicines that delay blood clotting): in this case, your doctor will perform more frequent monitoring of INR values (the time taken for blood to clot);
• medicines or substances that stimulate liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic);
  • cimetidine (a medicine used in the treatment of stomach ulcers);
  • antiepileptics such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of these medicines together with Efferalgan requires extreme caution and must be carried out only under strict medical supervision.

• probenecid, a medicine used to treat hyperuricemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise reducing the dose of Efferalgan
• salicylamide (a pain-relieving and fever-reducing medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) which must be treated urgently (see section 2).
• chloramphenicol (an antibiotic): may increase the risk of possible adverse effects
• medicines that slow gastric emptying, such as anticholinergics: these medicines delay the effect of Efferalgan.
• zidovudine (a medicine for the treatment of HIV).

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, note that administration of
paracetamol may interfere with the measurement of uric acid levels (uricemia) and blood sugar levels (glycemia).
Efferalgan and alcohol
Use Efferalgan with caution if the person taking the medicine chronically consumes alcohol, as there is a risk
of poisoning (see sections “Warnings and precautions” and “If you take more Efferalgan than you should”).
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If necessary, Efferalgan may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, for the shortest possible duration. Contact your doctor if pain and/or fever do not subside or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rash has been reported in breastfed infants. However, paracetamol administration is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.
Driving and using machines
Efferalgan does not impair the ability to drive vehicles or operate machinery.

3. How to use Efferalgan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Administration of suppositories is not recommended in case of diarrhoea.
To avoid the risk of overdose, check that other medicines being taken (with or without prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you use more Efferalgan than you should).
For children, it is essential to follow the dose based on their body weight. The weight-to-age correlation shown in the table below is only approximate; therefore, always consider the child's weight:
Efferalgan 80 mg suppositories for infants

Efferalgan for early infancy 150 mg suppositories

Efferalgan children 300 mg suppositories

It is important to use Efferalgan at regular intervals to avoid fluctuations in pain and/or fever levels.
In children, the interval between doses should preferably be at least 6 hours.

Patients with kidney disease
If the person taking the medicine suffers from kidney disease, the interval between doses must be at least 8 hours.

Instructions for use
Rectal use.

If you use more Efferalgan than you should
In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially if the person taking the medicine:

• suffers from liver disease
• abuses alcohol
• suffers from chronic malnutrition
• is taking medicines or substances that stimulate liver enzymes (increase liver activity).

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

• nausea
• vomiting
• anoressia (loss or reduced appetite)
• pallor
• malaise
• diaforesis (excessive sweating).

Following paracetamol overdose, the following have been observed:

• sudden inability of the kidneys to function properly (acute kidney injury),
• a condition in which small blood clots form in the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation),
• rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to abnormal blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Symptoms of liver damage peak after 3–4 days.

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.

If you forget to give your child Efferalgan
Do not use a double dose to make up for the forgotten dose.

If you stop treatment with Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking this medicine and contact your doctor immediately if you experience any of the following side effects:

• skin reactions which may include:
  • itching
  • urticaria (appearance of itchy, raised welts on the skin)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (appearance of red, target-like skin lesions associated with itching)
  • purpura (appearance of purple-colored skin patches of varying sizes)
  • Stevens-Johnson syndrome (a severe form of erythema multiforme)
  • epidermal necrolysis (a serious skin disease characterized by redness, blistering lesions, and areas of skin detachment and death)
  • generalized acute exanthematous pustulosis (eruption of hundreds of superficial pustules spread over the entire body)
  • drug-induced fixed eruption (skin rash appearing as red/violet-colored patches)
• allergic reactions which may include:
  • laryngeal edema (swelling of the throat)
  • angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • anaphylactic reaction (severe allergic reaction), including hypotension (low blood pressure)
  • hypersensitivity
  • anaphylactic shock (severe allergic reaction)
  • bronchospasm (excessive and prolonged contraction of airway muscles causing breathing difficulties).

In addition, the following side effects may occur, for which insufficient data are available to determine their frequency:

• thrombocytopenia (reduced number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
• anemia (reduced hemoglobin in the blood, the substance that carries oxygen)
• diarrhea
• abdominal pain
• stomach and intestinal disturbances
• abnormal liver function
• hepatitis (inflammation of the liver)
• INR alteration (a value used to express the time taken for blood to clot)
• increased liver enzymes
• headache
• dizziness
• acute renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidneys)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a severe illness using paracetamol (see section 2), frequency not known (frequency cannot be determined from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the blisters and the outer packaging after Exp. The
expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efferalgan contains
Efferalgan infants 80 mg suppositories

• The active substance is: paracetamol. Each suppository contains 80 mg of paracetamol.
• The other components are: solid semisynthetic glycerides, including lecithin derived from soybean oil.

Efferalgan young children 150 mg suppositories

• The active substance is: paracetamol. Each suppository contains 150 mg of paracetamol.
• The other components are: solid semisynthetic glycerides, including lecithin derived from soybean oil.

Efferalgan children 300 mg suppositories

• The active substance is: paracetamol. Each suppository contains 300 mg of paracetamol.
• The other components are: solid semisynthetic glycerides, including lecithin derived from soybean oil.

Description of the appearance of Efferalgan and contents of the pack
White suppositories, packed in polyvinyl chloride/polyethylene blisters, in a carton box containing 10 suppositories.
Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome
Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France

Package leaflet: information for the user

Efferalgan 500 mg tablets

paracetamol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before using Efferalgan
3. How to use Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which acts by relieving pain (analgesic) and reducing fever (antipyretic).
Efferalgan is used in adults, adolescents, and children with a body weight above 26 kg for:

• the treatment of symptoms associated with feverish conditions
• the symptomatic treatment of mild to moderate pain.

Consult a doctor if the person taking the medicine does not feel better or feels worse after 3 days of treatment.

2. What you need to know before using Efferalgan

Do not use Efferalgan

• if the person taking the medicine is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Use with caution and consult your doctor or pharmacist before using Efferalgan. During treatment with
Efferalgan, inform your doctor immediately if:

• you chronically consume alcohol. Alcohol intake during treatment is not recommended.
• you suffer from anorexia (eating disorder characterized by lack or reduction of appetite)
• you suffer from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it to avoid weight gain)
• you suffer from cachexia (condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic diseases)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced blood volume circulating in the body)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish discoloration of the skin and eyes)
• you suffer from severe liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that stimulate liver enzymes (increase the activity of the liver)
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, deficiency of which may cause hemolytic anemia)
• you suffer from hemolytic anemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• prolonged fasting
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause serious skin reactions which can be fatal. The use of Efferalgan must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or for prolonged periods
The use of high or prolonged doses of this medicine may cause serious liver damage and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurring, may increase or worsen the headache. In such cases, medical advice should be sought.
Children and adolescents
This medicine can be given to children with body weight above 26 kg and to adolescents (see section 3 "How to use Efferalgan").
Other medicines and Efferalgan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, inform your doctor if the person taking the medicine is using:

• other medicines containing paracetamol, because serious adverse effects may occur if paracetamol is taken at high doses;
• anticoagulants, coumarins including warfarin (medicines that delay blood coagulation): in this case, your doctor will perform stricter monitoring of INR values (the time taken by blood to clot)
• medicines or substances that stimulate liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic)
  • cimetidine (a medicine used in the treatment of stomach ulcer)
  • antiepileptics such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol. The use of these medicines with Efferalgan requires extreme caution and must be carried out only under strict medical supervision.
• probenecid, a medicine used to treat hyperuricemia (high concentration of uric acid in the blood) and gout (joint inflammation due to deposition of uric acid): in this case, your doctor will advise reducing the doses of Efferalgan
• salicylamide (a pain-relieving and fever-reducing medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) which must be treated urgently (see section 2),
• chloramphenicol (an antibiotic): may increase the risk of possible adverse effects
• medicines that delay gastric emptying, such as anticholinergics: these medicines delay the effect of Efferalgan.
• zidovudine (a medicine for the treatment of HIV).

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that administration of
paracetamol may interfere with the measurement of uricemia (level of uric acid in the blood) and
glycemia (level of sugar in the blood).
Efferalgan with alcohol
Use Efferalgan with caution if the person taking the medicine chronically consumes alcohol, as there is a risk
of intoxication (see sections "Warnings and precautions" and "If you take more Efferalgan than you should").
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If necessary, Efferalgan may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not subside or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rash has been reported in breastfed infants. However, administration of paracetamol is considered compatible with breastfeeding. Paracetamol in breastfeeding women should nevertheless be used with caution.
Driving and using machines
Efferalgan does not affect the ability to drive or operate machinery.
This medicine contains:

• less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free";
• traces of fructose, glucose, and sucrose (contained in croscarmellose sodium): if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Efferalgan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you take more Efferalgan than you should).
Adults
The recommended dose is 1 tablet per dose, which may be repeated if necessary after an interval of at least 4 hours, without exceeding 6 tablets per day.
In the case of more intense pain, 2 tablets may be taken per dose, up to a maximum of 3 times daily, always respecting an interval of at least 4 hours between doses.
Use in children and adolescents
For children, it is essential to follow the dose based on their body weight. The weight-to-age correlation shown in the table below is only approximate; therefore, consider the child's actual weight:

It is important to take Efferalgan at regular intervals to avoid fluctuations in pain and/or fever levels.

• In children, the interval between doses should preferably be at least 6 hours.
• In adults and adolescents, the interval between doses should be at least 4 hours.

Recommended maximum dosage
In adults and adolescents weighing more than 40 kg, the maximum dose is 3 g of paracetamol per day.

Patients with kidney disease
If the patient has a kidney disease, the dosing interval should be adjusted according to creatinine clearance (an index used to monitor kidney function):

• Creatinine clearance between 10 and 50 ml/min: the dosing interval should be at least 6 hours and the maximum daily dose should not exceed 3 g.
• Creatinine clearance less than 10 ml/min: the dosing interval should be at least 8 hours and the maximum daily dose should not exceed 2 g.

Patients with liver disease
If the patient has impaired liver function, the dose should be reduced or the dosing interval prolonged.
The maximum dose should not exceed 4 tablets per day in the following cases: adult patients weighing less than 50 kg, hepatic disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.

Elderly patients
In elderly patients, dose adjustment is usually not required unless the patient also suffers from other diseases requiring such adjustment (see sections “Patients with kidney disease” and “Patients with liver disease”).

Duration of treatment
Do not use Efferalgan for more than 3 consecutive days without consulting a doctor.

Instructions for use
For oral use.
Swallow the tablet whole with a glass of water.

If you take more Efferalgan than you should
In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and may lead to death, especially if the patient:

• Suffers from liver disease
• Abuses alcohol
• Suffers from chronic malnutrition
• Is taking medicines or substances that stimulate liver enzymes (increase liver activity).

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

• Nausea
• Vomiting
• Anorexia (lack of or reduced appetite)
• Pallor
• Malaise
• Diaphoresis (excessive sweating)

After paracetamol overdose, the following have been observed:

• Sudden inability of the kidneys to function properly (acute kidney injury)
• A condition in which small blood clots form in the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation)
• Rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to altered results in certain blood tests (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconscious state), or death.
Symptoms of liver damage peak after 3–4 days.

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of symptoms.

If you forget to take Efferalgan
Do not take a double dose to make up for the missed dose.

If you stop taking Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following side effects, STOP taking this medicine immediately and contact your doctor without delay:

• Skin reactions which may include:
  • urticaria (appearance of itchy skin welts)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (appearance of red spots on the skin with a "target-like" appearance, associated with itching)
  • Stevens-Johnson syndrome (a severe form of polymorphic erythema)
  • epidermal necrolysis (a serious skin disease characterized by redness, blistering, skin detachment and skin death)
  • generalized exanthematous pustulosis (an eruption of hundreds of superficial pustules spread over the entire body)
  • fixed drug eruption (a red/violaceous skin rash)
• Allergic reactions which may include:
  • laryngeal edema (swelling of the throat)
  • angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • anaphylactic reaction (severe allergic reaction) including hypotension (low blood pressure)
  • hypersensitivity
  • anaphylactic shock (severe allergic reaction)
  • bronchospasm (excessive and prolonged contraction of the airway muscles causing breathing difficulties).

Additionally, the following side effects may occur, for which insufficient data are available to determine frequency:

• thrombocytopenia (reduced number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
• anaemia (reduced haemoglobin in the blood, the substance that carries oxygen)
• diarrhoea
• abdominal pain
• stomach and intestinal disturbances
• abnormal liver function
• hepatitis (inflammation of the liver)
• changes in INR (a value used to measure blood clotting time)
• increased liver enzymes
• headache
• dizziness
• acute renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• haematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidneys)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2), frequency not known (frequency cannot be estimated from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efferalgan contains

• The active substance is: paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: hypromellose, povidone, sodium croscarmellose, microcrystalline cellulose, glyceryl behenate, magnesium stearate.

Description of the appearance of Efferalgan and package contents
White, round tablets, packed in aluminium/PVC blisters, in a box containing 16 or 30 tablets.
Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome
Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France

Package leaflet: Information for the user

Efferalgan 500 mg effervescent tablets

paracetamol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If any adverse reaction occurs, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days of treatment.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before taking Efferalgan
3. How to take Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Package contents and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which acts to relieve pain (analgesic) and reduce fever (antipyretic).
Efferalgan is used in adults, adolescents, and children with a body weight above 26 kg (approximately 8 years of age and older) for:

• the treatment of symptoms of feverish conditions
• the symptomatic treatment of mild to moderate pain.

Consult your doctor if the person taking the medicine does not feel better or feels worse after 3 days of treatment.

2. What you should know before using Efferalgan

Do not use Efferalgan

• if the person taking the medicine is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Use with caution and consult your doctor or pharmacist before using Efferalgan.
During treatment with Efferalgan, inform your doctor immediately if:

• you are a chronic alcohol user. Alcohol consumption during treatment is not recommended.
• you suffer from anorexia (an eating disorder characterized by lack or reduced appetite)
• you suffer from bulimia (an eating disorder in which a person consumes excessive amounts of food and then uses various methods to eliminate it to avoid weight gain)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic diseases)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced volume of circulating blood)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish discoloration of the skin and eyes)
• you suffer from serious liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that stimulate liver enzymes (increase liver activity)
• you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body; deficiency may cause haemolytic anaemia)
• you suffer from haemolytic anaemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• prolonged fasting
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause severe skin reactions which may be fatal. Use of Efferalgan must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.

Use of high doses and/or for prolonged periods
Prolonged or high-dose use of this medicine may cause serious liver damage and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurrent, may increase or worsen headache. In such cases, medical advice should be sought.

Children and adolescents
This medicine may be given to children with a body weight above 26 kg and to adolescents (see section 3 “How to use Efferalgan”).

Other medicines and Efferalgan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without prescription.

In particular, inform your doctor if the person taking the medicine is also taking:

• other medicines containing paracetamol, because serious adverse effects may occur if paracetamol is taken in high doses
• anticoagulants, coumarins including warfarin (medicines that delay blood clotting): in this case, your doctor will perform stricter monitoring of INR values (the time taken for blood to clot)
• medicines or substances that stimulate liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic)
  • cimetidine (a medicine used in the treatment of stomach ulcers)
  • antiepileptics such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of these medicines together with Efferalgan requires extreme caution and must only be done under strict medical supervision.

• probenecid, a medicine used to treat hyperuricaemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise reducing the dose of Efferalgan
• salicylamide (an analgesic and antipyretic medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) requiring urgent treatment (see section 2)
• chloramphenicol (an antibiotic): may increase the risk of possible adverse effects
• medicines that slow gastric emptying, such as anticholinergics: these medicines delay the effect of Efferalgan
• zidovudine (a medicine for the treatment of HIV)

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, be aware that administration of paracetamol may interfere with the measurement of uric acid levels (uricemia) and blood glucose levels (glycemia).

Efferalgan and alcohol
Use Efferalgan with caution if the person taking the medicine is a chronic alcohol user, as there is a risk of toxicity (see sections “Warnings and precautions” and “If you take more Efferalgan than you should”).
Alcohol consumption during treatment is not recommended.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If necessary, Efferalgan may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rash has been reported in breastfed infants. However, administration of paracetamol is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.

Driving and using machines
Efferalgan does not affect the ability to drive or use machinery.

Efferalgan 500 mg effervescent tablets contain sorbitol (E420), sodium benzoate (E211), sodium, fructose, glucose, and sucrose in the flavouring.
This medicine contains 126 mg of sorbitol (E420) per effervescent tablet.
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
Sorbitol may cause gastrointestinal disturbances and a mild laxative effect.
This medicine contains 50 mg of sodium benzoate (E211) per effervescent tablet. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
This medicine contains 0.96 mg of fructose per effervescent tablet. If your doctor has told you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.
This medicine contains 197 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to approximately 10% of the recommended maximum daily dietary intake for an adult. In individuals on a low-salt diet or those following a salt-restricted diet, it should be taken into account that one effervescent tablet contains 197 mg of sodium, which must be included in the daily intake. This should be considered in patients requiring sodium restriction.

3. How to use Efferalgan

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you take more Efferalgan than you should).
Adults
The recommended dose is 1 tablet per dose, which may be repeated if necessary after an interval of at least 4 hours, without exceeding 6 tablets per day.
In the case of more intense pain, two tablets may be taken at a time, up to a maximum of 3 times per day, always respecting an interval of at least 4 hours between doses.
Use in children and adolescents
For children, it is essential to follow the dose based on their body weight. The table below provides an approximate correlation between weight and age; therefore, consider the child's weight:

It is important to take Efferalgan at regular intervals to prevent fluctuations in pain and/or fever levels.

• In children, the interval between doses should preferably be at least 6 hours.
• In adults and adolescents, the interval between doses should be at least 4 hours.

Recommended maximum dosage
In adults and adolescents weighing more than 40 kg, the maximum dose is 3 g of paracetamol per day.
Patients with kidney disease
If the patient has a kidney disease, the dosing interval should be adjusted according to creatinine clearance (a parameter used to monitor kidney function):

• Creatinine clearance between 10 and 50 ml/min: the dosing interval should be at least 6 hours and the maximum daily dose should not exceed 3 g.
• Creatinine clearance below 10 ml/min: the dosing interval should be at least 8 hours and the maximum daily dose should not exceed 2 g.
  Patients with liver disease
  If the patient has impaired liver function, the dose should be reduced or the dosing interval prolonged.
  The maximum dose should not exceed 4 tablets per day in the following cases: adult patients weighing less than 50 kg, liver disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.
  Elderly patients
  In elderly patients, dose adjustment is usually not required, unless the patient also suffers from other diseases requiring such adjustment (see sections “Patients with kidney disease” and “Patients with liver disease”).
  Duration of treatment
  Do not use Efferalgan for more than 3 consecutive days without consulting a doctor.
  Instructions for use
  For oral use.
  Completely dissolve the tablet in a glass of water. Do not chew or swallow the tablet whole.
  The score line is not intended for dividing the tablet.
  If you take more Efferalgan than you should
  In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
  Taking an excessive dose of paracetamol increases the risk of poisoning and can be fatal, especially if the patient:

• has liver disease
• abuses alcohol
• suffers from chronic malnutrition
• is taking medicines or substances that induce liver enzymes (substances that increase liver activity).

Symptoms
Following accidental ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

• nausea
• vomiting
• anorexia (loss or reduced appetite)
• pallor
• malaise
• diaphoresis (excessive sweating).

After paracetamol overdose, the following have been observed:

• sudden inability of the kidneys to function properly (acute kidney injury),
• a condition in which small blood clots form throughout the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation),
• rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to abnormal blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Symptoms of liver damage peak after 3–4 days.
Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.
If you forget to take Efferalgan
Do not take a double dose to make up for the missed dose.
If you stop treatment with Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the person taking this medicine experiences any of the following side effects, STOP treatment with this
medicine immediately and contact a doctor immediately:

• skin reactions which may include
  • urticaria (appearance of itchy skin rashes or hives)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (red skin patches with a "target-like" appearance, associated with itching)
  • purpura (appearance of purplish skin patches of various sizes)
  • Stevens-Johnson syndrome (a severe form of erythema multiforme)
  • toxic epidermal necrolysis (a serious skin condition characterized by redness, blistering, skin detachment and skin death)
  • acute generalized exanthematous pustulosis (an eruption of hundreds of superficial pustules spread over the entire body)
  • fixed drug eruption (a skin rash with red or violet-colored patches)
• allergic reactions which may include
  • laryngeal edema (swelling of the throat)
  • angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • anaphylactic reaction (a severe allergic reaction), including hypotension (low blood pressure)
  • hypersensitivity
  • anaphylactic shock (a severe allergic reaction)
  • bronchospasm (excessive and prolonged contraction of airway muscles causing breathing difficulties).

Additionally, the following side effects may occur, for which insufficient data are available to determine frequency:

• thrombocytopenia (reduced number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
• anaemia (reduced haemoglobin in the blood, the substance that carries oxygen)
• diarrhoea
• abdominal pain
• gastrointestinal reactions
• abnormal liver function
• hepatitis (inflammation of the liver)
• changes in INR (a value used to express the time it takes for blood to clot)
• increased liver enzymes
• headache
• dizziness
• acute renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• haematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidneys)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious underlying illness who are using paracetamol (see section 2), frequency not known (frequency cannot be determined from available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the strip and carton following Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efferalgan contains

• The active substance is: paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: anhydrous citric acid, sodium carbonate anhydrous, sodium hydrogen carbonate, sorbitol (E420), sodium saccharin, sodium docusate, povidone, sodium benzoate (E211), grapefruit and orange flavour (containing fructose, glucose, sucrose).

Description of the appearance of Efferalgan and pack contents
Flat tablet, white to slightly off-white in colour, with bevelled edges and a break line, which causes an effervescent reaction when dissolved in water.
The break line is not intended to divide the tablet into equal parts.
The tablets are packaged in aluminium/polyethylene strips, in boxes containing 16 or 20 tablets.
Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome
Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France

Package leaflet: information for the user

Efferalgan adults 1000 mg effervescent tablets, adults 1000 mg film-coated tablets

paracetamol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before taking Efferalgan
3. How to take Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which works by relieving pain (analgesic) and reducing fever (antipyretic).
Efferalgan is used in adults and adolescents over 15 years of age for:

• the treatment of symptoms of feverish conditions,
• the symptomatic treatment of mild to moderate pain,
• the symptomatic treatment of joint pain (arthritic pain).

Consult your doctor if the person taking the medicine does not feel better or feels worse.

2. What you need to know before using Efferalgan

Do not use Efferalgan
if the person taking the medicine:

• is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol) or to any of the other ingredients of this medicine (listed in section 6);
• is under 15 years of age (see section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before using Efferalgan.
During treatment with Efferalgan, inform your doctor immediately if:

• you are a chronic alcohol user. Alcohol consumption during treatment is not recommended.
• you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite)
• you suffer from bulimia (an eating disorder in which a person consumes excessive amounts of food and then uses various methods to eliminate it to avoid weight gain)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic illness)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced blood volume circulating in the body)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish skin and eyes)
• you suffer from severe liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that stimulate liver enzymes (increase liver activity)
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body; deficiency may cause haemolytic anaemia)
• you suffer from haemolytic anaemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• you are experiencing prolonged fasting
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and fluid composition) has been reported when paracetamol is used regularly at high doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause severe skin reactions which can be fatal. The use of Efferalgan must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or for prolonged periods
Using high or prolonged doses of this medicine may cause serious liver disorders and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurrent, may increase or worsen the headache. In such cases, medical advice should be sought.
Children and adolescents
This medicine may be given to adolescents aged over 15 years (see section “How to use Efferalgan”).
Other medicines and Efferalgan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if the person taking the medicine is using:

• other medicines containing paracetamol, since taking paracetamol in high doses may lead to serious adverse effects
• coumarin anticoagulants including warfarin (medicines that delay blood clotting): in this case, your doctor will perform more frequent monitoring of INR values (the time taken for blood to clot)
• medicines or substances that stimulate liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic)
  • cimetidine (a medicine used in the treatment of stomach ulcers)
  • antiepileptics such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of these medicines together with Efferalgan requires extreme caution and should only be done under strict medical supervision:

• probenecid, a medicine used to treat hyperuricaemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise reducing the dose of Efferalgan
• salicylamide (a pain-relieving and fever-reducing medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) requiring urgent treatment (see section 2)
• chloramphenicol (an antibiotic), as it may increase the risk of possible adverse effects
• medicines that slow gastric emptying (such as anticholinergics), as these medicines delay the effect of Efferalgan
• zidovudine (a medicine for the treatment of HIV).

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, note that administration of paracetamol may interfere with the measurement of uric acid levels (uricaemia) and blood sugar levels (glycaemia).
Efferalgan and alcohol
Use Efferalgan with caution if the person taking the medicine is a chronic alcohol user, as there is a risk of toxicity (see sections “Warnings and precautions” and “If you take more Efferalgan than you should”).
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If necessary, Efferalgan can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible duration.
Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rashes have been reported in breastfed infants. However, paracetamol administration is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.
Driving and using machines
Efferalgan does not affect the ability to drive or operate machinery.

Effervescent tablets
Efferalgan adult effervescent tablets contain sodium, sorbitol (E420), fructose, and sodium benzoate (E211)

• This medicine contains 394 mg of sodium (a main component of table salt) per effervescent tablet. This corresponds to approximately 20% of the maximum recommended daily dietary intake for an adult. Speak with your doctor or pharmacist if you need one or more doses daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.
• This medicine contains 252.2 mg of sorbitol per effervescent tablet, equivalent to 252.2 mg/3725 mg. Sorbitol is a source of fructose.
• This medicine contains 1.93 mg of fructose per effervescent tablet, as a component of grapefruit and orange flavouring. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• This medicine contains 100 mg of sodium benzoate per effervescent tablet, equivalent to 100 mg/3725 mg.

Efferalgan adult film-coated tablets contain sorbitol (E420), fructose, glucose, and sucrose
One film-coated tablet contains:

• less than 1 mmol of sodium, i.e., essentially “sodium-free”.
• approximately 0.2 mg of sorbitol (contained in the film coating); traces of fructose (contained in croscarmellose sodium);
• glucose (contained in the film coating and croscarmellose sodium) and sucrose (contained in croscarmellose sodium): if your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to use Efferalgan

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without a prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you take more Efferalgan than you should).

Adults
The recommended dose is 1 tablet per dose, repeated if necessary, allowing at least 6–8 hours between doses, without exceeding 3 tablets per day.
In case of more intense pain, the dose may be repeated every 4 hours.

Use in children and adolescents
Adolescents over 15 years of age
The recommended dose is 1 tablet per dose, repeated if necessary, allowing at least 6–8 hours between doses, without exceeding 3 tablets per day.
In case of more intense pain, the dose may be repeated every 4 hours.
It is important to take Efferalgan at regular intervals to avoid fluctuations in pain and/or fever levels. The interval between doses must be at least 4 hours.

Maximum recommended dosage
The maximum daily dose is 3 g of paracetamol.

Patients with kidney disease
If the patient suffers from kidney disease, the dosing interval should be adjusted according to creatinine clearance (an index used to monitor kidney function):

• creatinine clearance between 10 and 50 ml/min: the dosing interval should be at least 6 hours and the maximum daily dose must not exceed 3 g;
• creatinine clearance below 10 ml/min: the dosing interval should be at least 8 hours and the maximum daily dose must not exceed 2 g.

Patients with liver disease
If the patient suffers from reduced liver function, the dose should be reduced or the dosing interval prolonged.
The maximum dose must not exceed 4 tablets per day in the following cases: adult patients weighing less than 50 kg, liver disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.

Elderly patients
In elderly patients, dose adjustment is usually not required unless the patient also suffers from other diseases requiring such adjustment (see sections “Patients with kidney disease” and “Patients with liver disease”).

Instructions for use
For oral use.
Effervescent tablets
Completely dissolve the effervescent tablet in a glass of water. Do not chew or swallow the tablet whole.
Film-coated tablets
Swallow the tablet whole with a glass of water.

If you take more Efferalgan than you should
In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially if the patient:

• has liver disease
• abuses alcohol
• suffers from chronic malnutrition
• is taking medicines or substances that stimulate liver enzymes (increase liver metabolism).

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

• nausea
• vomiting
• anorexia (loss or reduction of appetite)
• pallor
• malaise
• diaphoresis (excessive sweating).

After paracetamol overdose, the following have been observed:

• sudden inability of the kidneys to function properly (acute kidney injury),
• condition in which small blood clots form in the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation),
• rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to abnormal blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Symptoms of liver damage peak after 3–4 days.
Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.

If you forget to take Efferalgan
Do not take a double dose to make up for the missed dose.

If you stop using Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking this medicine and contact your doctor immediately if you experience any of the following side effects:

• Skin reactions which may include:

  • urticaria (appearance of itchy skin wheals)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (appearance of red spots on the skin with a "target-like" appearance associated with itching)
  • purpura (appearance of purple-colored skin patches of varying sizes)
  • Stevens-Johnson syndrome (a severe form of polymorphic erythema)
  • epidermal necrolysis (a severe skin lesion characterized by redness, blistering and areas of skin detachment and death)
  • acute generalized exanthematous pustulosis (eruption of hundreds of superficial pustules diffusely spread over the entire body)
  • fixed drug eruption (skin rash of red/violet color)

• Allergic reactions which may include:

  • laryngeal edema (swelling of the throat)
  • angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • anaphylactic reaction (severe allergic reaction), including hypotension (low blood pressure)
  • hypersensitivity
  • anaphylactic shock (severe allergic reaction)
  • bronchospasm (excessive and prolonged contraction of airway muscles causing breathing difficulties)

Additionally, the following side effects may occur, for which insufficient data are available to determine their frequency:

• thrombocytopenia (reduced number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
• anemia (reduced hemoglobin in the blood, the substance that carries oxygen)
• diarrhea
• abdominal pain
• stomach and intestinal disturbances
• abnormal liver function
• hepatitis (inflammation of the liver)
• INR alteration (a value used to express the time taken for blood to clot)
• increased liver enzymes
• headache
• dizziness
• hypotension (low blood pressure)
• acute renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in urine)
• anuria (cessation or reduction in urine production by the kidneys)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a severe illness using paracetamol (see section 2), frequency not known (frequency cannot be estimated from the available data).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister or strip and on the carton after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efferalgan contains
Effervescent tablets

• The active substance is: paracetamol. Each tablet contains 1000 mg of paracetamol.
• Other components: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sorbitol (E420), sodium docusate, povidone, sodium benzoate (E211), sodium saccharin, grapefruit and orange flavour (containing fructose).

Film-coated tablets

• The active substance is: paracetamol. Each tablet contains 1000 mg of paracetamol.
• Other components: hydroxypropylcellulose, sodium croscarmellose (containing glucose, fructose and sucrose), colloidal anhydrous silica, glyceryl behenate, magnesium stearate, film-coating agent

(medium-chain triglycerides, polydextrose, calcium carbonate, hypromellose, which in turn contains glucose, fructose and sucrose).

Description of the appearance of Efferalgan and the contents of the pack
Effervescent tablets
White, round effervescent tablets with grapefruit and orange flavour, packed in aluminium/polyethylene strips in cardboard boxes containing 16 or 20 tablets.

Film-coated tablets
White, elliptical film-coated tablets, packed in aluminium/PVC blisters in a box containing 16 tablets.

Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome

Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France

Package leaflet: information for the user

EFFERALGAN 330 mg effervescent tablets with Vitamin C

paracetamol/ascorbic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days of treatment.

Contents of this leaflet

1. What Efferalgan is and what it is used for
2. What you need to know before using Efferalgan
3. How to use Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan contains the active substance paracetamol, which acts to relieve pain (analgesic) and reduce fever (antipyretic).
Efferalgan is used in adults, adolescents and children weighing more than 26 kg for:

• the treatment of symptoms associated with fever,
• the symptomatic treatment of mild to moderate pain.

Consult a doctor if the person taking the medicine does not feel better or feels worse after 3 days of treatment.

2. What you need to know before using Efferalgan

Do not use Efferalgan

• if the person taking the medicine is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Use with caution and consult your doctor or pharmacist before using Efferalgan.
During treatment with Efferalgan, inform your doctor immediately if:

• you chronically consume alcohol. Alcohol consumption during treatment is not recommended
• you suffer from anorexia (an eating disorder characterized by lack or reduced appetite)
• you suffer from bulimia (an eating disorder in which a person ingests excessive amounts of food and then resorts to various methods to eliminate it to avoid gaining weight)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic diseases)
• you suffer from chronic malnutrition
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced volume of circulating blood)
• you have mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish skin and eyes)
• you suffer from severe liver problems
• you have acute hepatitis (acute inflammation of the liver)
• you are taking medicines that stimulate liver enzymes (increase liver activity)
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body; its deficiency may cause hemolytic anemia)
• you suffer from hemolytic anemia (a disease caused by destruction of certain blood cells, red blood cells)
• you suffer from renal insufficiency (kidney disease)
• prolonged fasting
• you suffer from iron metabolism disorders (conditions related to deficiency, accumulation, or improper distribution of iron in the body, such as hemochromatosis, sideroblastic anemia, and thalassemia)
• you are predisposed to urinary stone formation
• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.

Paracetamol may cause severe skin reactions which may be fatal. The use of Efferalgan must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or prolonged use
Using high or prolonged doses of this medicine may cause serious liver damage and serious adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver function, kidney function, and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurrent, may increase or worsen the headache. In such cases, medical advice should be sought.
Children and adolescents
This medicine can be given to children weighing more than 26 kg and to adolescents (see section 3 “How to use Efferalgan”).
Other medicines and Efferalgan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if the person taking the medicine is also taking:

• other medicines containing paracetamol, because taking paracetamol in high doses may lead to serious adverse effects
• anticoagulants, coumarins including warfarin (medicines that delay blood coagulation): in this case, your doctor will perform more frequent monitoring of INR values (the time taken for blood to clot)
• medicines that stimulate liver enzymes (increase liver activity), for example:
  • rifampicin (an antibiotic);
  • cimetidine (a medicine used in the treatment of stomach ulcers);
  • antiepileptics such as glutethimide, phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy). In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of these medicines with Efferalgan requires extreme caution and should only be done under strict medical supervision.

• probenecid, a medicine used to treat hyperuricemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise reducing the dose of Efferalgan;
• salicylamide (an analgesic and antipyretic medicine)
• flucloxacillin (an antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) which requires urgent treatment (see section 2)
• chloramphenicol (an antibiotic): may increase the risk of possible adverse effects
• medicines that slow gastric emptying, such as anticholinergics: these medicines delay the effect of Efferalgan.
• zidovudine (a medicine for the treatment of HIV)
• deferoxamine (a medicine used in cases of iron poisoning)

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, be aware that administration of paracetamol may interfere with the measurement of serum uric acid levels (uricemia) and blood glucose levels (glycemia).
Efferalgan with alcohol
Use Efferalgan with caution if the person taking it chronically consumes alcohol, as there is a risk of toxicity (see sections “Warnings and precautions” and “If you use more Efferalgan than you should”).
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Because there is limited data on high doses of vitamin C during pregnancy and breastfeeding, the use of this medicine during pregnancy and breastfeeding is not recommended unless under medical supervision.
Pregnancy
If necessary, Efferalgan may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible duration. Contact your doctor if pain and/or fever do not subside, or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Vitamin C also passes into breast milk. Skin rash has been reported in breastfed infants. However, administration of paracetamol is considered compatible with breastfeeding. Paracetamol should nevertheless be used with caution in breastfeeding women.
Driving and using machines
Efferalgan does not affect the ability to drive or use machinery.
Efferalgan contains sodium, sorbitol (E420), and sodium benzoate (E211)

• This medicine contains 329.530 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 15% of the maximum recommended daily dietary intake for an adult. Speak with your doctor or pharmacist if you have been advised to follow a low-sodium diet.
• This medicine contains 300 mg of sorbitol per effervescent tablet, equivalent to 300 mg/2955 mg. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
• This medicine contains 50 mg of sodium benzoate per effervescent tablet, equivalent to 50 mg/2955 mg.

3. How to use Efferalgan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without a prescription) do not contain paracetamol.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you use more Efferalgan than you should).
Adults
The recommended dose is 1 or 2 effervescent tablets per dose, which may be repeated if necessary after an interval of at least 4 hours, without exceeding 9 tablets per day.
Use in children and adolescents
In children, it is essential to follow the dose based on their body weight. The weight-to-age correlation shown in the table below is only approximate; therefore, consider the weight:

It is important to take Efferalgan at regular intervals to avoid fluctuations in pain and/or fever levels.

• In children, the interval between doses should preferably be at least 6 hours.
• In adults and adolescents, the interval between doses should be at least 4 hours.

Recommended maximum dosage
In adults and adolescents weighing more than 40 kg, the maximum dose is 3 g of paracetamol per day.
Patients with kidney disease
If the patient has a kidney disease, the dosing interval should be adjusted according to creatinine clearance (an index used to monitor kidney function):

• Creatinine clearance between 10 and 50 ml/min: the dosing interval should be at least 6 hours and the maximum daily dose must not exceed 3 g.
• Creatinine clearance below 10 ml/min: the dosing interval should be at least 8 hours and the maximum daily dose must not exceed 2 g.

Patients with liver disease
If the patient has impaired liver function, the dose should be reduced or the dosing interval prolonged.
The maximum dose must not exceed 6 tablets per day in the following cases: adult patients weighing less than 50 kg, liver disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.
Elderly patients
In elderly patients, dose adjustment is usually not required unless the patient also suffers from other diseases requiring such adjustment (see sections “Patients with kidney disease” and “Patients with liver disease”).
Duration of treatment
Do not use Efferalgan for more than 3 consecutive days without consulting a doctor.
Instructions for use
For oral use.
Completely dissolve the effervescent tablet in a glass of water and drink immediately. Do not chew or swallow the tablet whole. Avoid taking the medicine late in the day.
If you take more Efferalgan than you should
In case of accidental ingestion/overdose of Efferalgan, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and can be fatal, especially if the patient:

• has liver disease,
• abuses alcohol,
• suffers from chronic malnutrition,
• is taking medicines or substances that stimulate liver enzymes (increasing liver activity).

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms appearing within the first 24 hours may include:

• nausea
• vomiting
• anorexia (loss or reduced appetite)
• pallor
• malaise
• diaphoresis (excessive sweating).

Following paracetamol overdose, the following have been observed:

• sudden inability of the kidneys to function properly (acute kidney injury),
• a condition in which small blood clots form within the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation),
• rare cases of acute pancreatitis, an inflammation of the pancreas.

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to altered blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Symptoms of liver damage peak after 3–4 days.
Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.
If you forget to take Efferalgan
Do not take a double dose to make up for the missed dose.
If you stop treatment with Efferalgan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
STOP taking this medicine and contact your doctor immediately if you experience any of the following side effects:

• skin reactions which may include:
  • urticaria (appearance of itchy skin rashes or hives)
  • skin rash
  • erythema (redness of the skin)
  • erythema multiforme (appearance of red spots on the skin with a "target" appearance, associated with itching)
  • purpura (appearance of purple-coloured skin patches of varying sizes)
  • Stevens-Johnson syndrome (a severe form of polymorphic erythema)
  • toxic epidermal necrolysis (a serious skin disease characterized by redness, blistering, skin detachment and skin death)
  • generalized acute exanthematous pustulosis (widespread eruption of hundreds of superficial pustules over the entire body)
  • fixed drug eruption (skin rash with red or purple-coloured lesions)
• allergic reactions which may include:
  • laryngeal edema (swelling of the throat)
• angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
• anaphylactic reaction (severe allergic reaction) including hypotension (low blood pressure)
• hypersensitivity
• anaphylactic shock (severe allergic reaction)
• bronchospasm (excessive and prolonged contraction of the airway muscles causing breathing difficulties)

In addition, the following side effects may occur, for which there are insufficient data available to determine frequency:

• thrombocytopenia (decreased number of platelets in the blood)
• leucopenia/agranulocytosis/neutropenia (decreased number of white blood cells in the blood)
• anaemia (decreased haemoglobin in the blood, the substance that carries oxygen)
• diarrhoea
• abdominal pain
• stomach and intestinal disturbances
• abnormal liver function
• hepatitis (inflammation of the liver)
• changes in INR (a value used to measure the time it takes for blood to clot)
• increased liver enzymes
• headache
• dizziness
• acute kidney failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• haematuria (blood in the urine)
• anuria (cessation or reduction in urine production by the kidneys)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2), frequency not known (frequency cannot be estimated from the available data).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
Store this medicine in the original packaging and at a temperature not exceeding 25°C. Keep the
container tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the tube and the carton after Exp. The expiry date refers to the last day of that month.
After first opening the container, the medicine should be used within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Efferalgan contains

• The active substances are: paracetamol and ascorbic acid. Each effervescent tablet contains 330 mg of paracetamol and 200 mg of ascorbic acid.
• The other components are: potassium hydrogen carbonate, sodium hydrogen carbonate, sorbitol (E420), citric acid, sodium benzoate (E211), sodium docusate, povidone [see section "**Efferalgan contains sodium, sorbitol (E420) and sodium benzoate (E211)"].

Description of the appearance of Efferalgan and contents of the pack
White effervescent tablets, packaged in polypropylene tubes, in a carton containing 2 tubes of
10 tablets each.
Marketing Authorization Holder
UPSA S.A.S. - Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 9/11 - Rome
Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, Le Passage, France
or
UPSA S.A.S., Avenue du Docteur Jean Bru 304, Agen, France