Package leaflet: Information for the user

EFFERAMOL 1000 mg effervescent tablets

paracetamol
Generic medicine
Read this leaflet carefully before taking 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 effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Efferamol is and what it is used for
What you need to know before taking Efferamol
How to take Efferamol
Possible side effects
How to store Efferamol
Contents of the pack and other information

1. What Efferamol is and what it is used for

Efferamol contains paracetamol, which acts to relieve pain and reduce fever.
Efferamol is used in adults and adolescents over the age of 15 for the symptomatic treatment
of various types of pain (for example, headache, joint pain, stiff neck, backache, toothache, menstrual pain, minor surgical procedures).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Efferamol

Do not take Efferamol

if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
if you are under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Efferamol.
In particular, inform your doctor:

if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause a blood disorder);
if you suffer from haemolytic anaemia (destruction of red blood cells);
if you have liver diseases that reduce liver function (mild/moderate hepatic insufficiency, Gilbert's syndrome, severe hepatocellular insufficiency, acute hepatitis) or if you are receiving concomitant treatment with medicines that affect liver function;
if you have reduced kidney function (mild/moderate renal insufficiency);
if you are receiving concomitant treatment with any other medicine (see "Other medicines and Efferamol"). Use with caution in cases of chronic alcoholism, excessive alcohol consumption (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.

During treatment with Efferamol, always keep in mind that:

before taking any other medicine, you must check that it does not contain the same active ingredient, because if paracetamol is taken in high doses, serious adverse reactions may occur. Always inform your doctor before taking any other medicine (see "Other medicines and Efferamol").

During treatment with Efferamol, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or 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 in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine may cause liver disorders (hepatopathy) and even severe alterations affecting the kidneys and blood.
Before taking this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.
Children and adolescents
Do not give Efferamol to children and adolescents under 15 years of age (see section "Do not take Efferamol").
Other medicines and Efferamol
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, inform your doctor if you are taking:

medicines containing paracetamol. During treatment with paracetamol, before taking any other medicine check that it does not contain paracetamol, because if paracetamol is taken in high doses, serious adverse effects may occur;
medicines that slow gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of Efferamol;
medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of Efferamol;
cholestyramine (a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
chloramphenicol (an antibiotic), as it may increase the risk of adverse effects;
rifampicin (an antibiotic);
cimetidine (a medicine used in the treatment of stomach ulcers);
antiepileptics (medicines used to treat epilepsy), e.g. glutethimide, phenobarbital, carbamazepine;
zidovudine (a medicine for the treatment of HIV);
oral anticoagulants (medicines used to make blood less thick). In case of high-dose paracetamol treatment (4 g daily for at least 4 days), take Efferamol only under strict medical supervision;
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) that require urgent treatment (see section 2). 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 uric acid and blood glucose levels.

Efferamol and alcohol
Take Efferamol with caution and only under strict medical supervision if you abuse alcohol (see section "Warnings and precautions").
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Efferamol 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 decrease or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if clearly necessary and under medical supervision.
Driving and using machines
Efferamol does not affect the ability to drive or use machinery.
Efferamol contains sodium, sorbitol and benzoate
Sodium: this medicine contains 498.21 mg of sodium (the main component of table salt) per tablet. This corresponds to 25.5% of the maximum daily dietary intake recommended for an adult. Talk to your doctor or pharmacist if you need to take more than the recommended doses daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Sorbitol: this medicine contains 563 mg of sorbitol per tablet, equivalent to 24 mg/kg/day considering the maximum daily dose of 3 tablets/day. Sorbitol is a source of fructose. 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, talk to your doctor before taking this medicine.
Benzoate: this medicine contains 50 mg of sodium benzoate per tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to take Efferamol

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and adolescents over 15 years of age
The recommended dose is 1 effervescent tablet up to 3 times a day.
The interval between doses should not be less than four hours.
Dissolve the effervescent tablets in a glass of water.
Renal impairment
In case of renal impairment, the dose should be reduced:

creatinine clearance below 10–50 ml/min: 500 mg every 6 hours
creatinine clearance below 10 ml/min: 500 mg every 8 hours.

Use in children
Efferamol must not be used in children under 15 years of age.
If you take more Efferamol than you should
In case of accidental overdose of Efferamol, stop taking it immediately and contact your doctor or go to the nearest hospital.
Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that may generally appear within the first 12–48 hours include:

loss of appetite (anorexia), nausea and vomiting, followed by a marked deterioration in general condition;
changes in blood laboratory values (increased blood bilirubin, lactic dehydrogenase, liver transaminase levels, decreased blood prothrombin levels);
liver damage which may lead to coma and death.
Treatment
The doctor will provide appropriate supportive therapy depending on the nature and severity of the symptoms.

There is a risk of poisoning, especially in patients with liver disease, chronic alcoholism, chronic malnutrition, and in patients receiving enzyme inducers. In
these cases, overdose may be fatal.
If you forget to take Efferamol
Do not take a double dose to make up for the missed dose.
If you stop taking Efferamol
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.
If you experience any of the following side effects, STOP taking this medicine and contact your doctor
immediately:

allergic reactions such as:
- skin rashes with skin irritation (erythema) and redness of the skin accompanied by itching (urticaria)
- swelling of the throat (laryngeal oedema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).

Additionally, patients taking this medicine may experience the following side effects with unknown frequency
(frequency cannot be estimated from the available data):

decrease in the number of platelets in the blood (thrombocytopenia)
decrease in the number of white blood cells in the blood (leucopenia/agranulocytosis)
reduction in haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia)
dizziness
stomach and intestinal disturbances
abnormal liver function
inflammation of the liver (hepatitis)
red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
rapid reduction in kidney function (acute renal failure)
inflammation of the kidneys (interstitial nephritis)
blood in the urine (haematuria)
cessation or reduction in urine production (anuria)
severe condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.
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 Efferamol

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 label after "Exp.".
The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, unopened packaging, correctly stored.
After first opening the tube, the product should be used within 3 months (only for tube packaging).
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 Efferamol contains
The active substance is paracetamol.
Each effervescent tablet contains 1000 mg of paracetamol.
The other components are: sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, sorbitol,
sodium docusate, sodium benzoate, simethicone, orange flavour, sucralose.

Description of the appearance of Efferamol and contents of the pack
White to off-white, round effervescent tablets.
Efferamol is available in:
Carton containing 12 effervescent tablets in blister packs
Carton containing 12 effervescent tablets in a bottle

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM) – Italy

MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy