Efferalgo: detailed information

Patient Information Leaflet

Efferalgo 500 mg effervescent granules

Paracetamol
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
Talk to your doctor if you do not notice improvement or if your symptoms worsen after 3 days in case of fever or 5 days in case of pain.

Contents of this leaflet

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

1. What Efferalgo is and what it is used for

Pharmacotherapeutic category: OTHER ANALGESICS AND ANTIPYRETICS: ANILIDES - ATC Code: N02BE01
This medicinal product contains paracetamol: an analgesic (relieves pain) and antipyretic (reduces fever).
It is indicated for the symptomatic treatment of mild to moderate pain and/or fever.
This formulation is indicated for adults, adolescents and children weighing more than 27 kg (from approximately 8 years of age). Read the "Dosage" section of the package leaflet carefully.
For children weighing less than 27 kg (under approximately 8 years of age), other paracetamol-containing formulations are available: please consult your doctor or pharmacist.

2. What you need to know before taking Efferalgo

Do not take Efferalgo

if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking Efferalgo
In case of overdose or accidental ingestion of too high a dose, contact your doctor immediately.
This medicine contains paracetamol. Other medicines also contain paracetamol.
Check that you are not taking other medicines containing paracetamol, including those obtained without
prescription.
Do not combine them together, so as not to exceed the recommended daily dose (see section 3 “How to take
Efferalgo”).

If pain persists for more than 5 days, or if fever lasts longer than 3 days, or if the effect is insufficient, or if any other symptoms occur, do not continue treatment without consulting your doctor. In case of acute fever, signs of secondary infection, or persistent disturbances, you must consult a doctor.
Prolonged, incorrect, and/or high-dose use of this medicine in patients with chronic headache may cause headache or worsening of existing headache. Do not increase the dose of painkillers; instead, consult your doctor.

Tell your doctor or pharmacist before taking this medicine if any of the following conditions apply to you:

if you are an adult and weigh less than 50 kg,
in case of mild to moderate impairment of liver function,
in case of kidney impairment,
in case of Gilbert's syndrome (familial non-haemolytic jaundice),
in case of chronic alcoholism,
if you are taking Efferalgo together with other medicines that impair liver function,
in case of glucose-6-phosphate dehydrogenase deficiency,
in case of haemolytic anaemia,
if you suffer from nutritional disorders [chronic malnutrition (low hepatic glutathione reserves), anorexia or cachexia (significant weight loss), fasting],
if you are dehydrated (excessive loss of body fluids),
in case of acute viral hepatitis or if this condition is diagnosed during treatment with Efferalgo. Inform your doctor, as treatment with Efferalgo may need to be discontinued.

During treatment with Efferalgo, inform your doctor immediately if:
If 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.
IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.
Children and adolescents
In children and adolescents treated with paracetamol, combining it with another antipyretic medicine is not justified, except in cases of inefficacy. In case of persistent fever, you must consult a doctor.
This medicine contains a red fruit flavouring that may be attractive to children. Keep this medicine out of sight and reach of children.
Other medicines and Efferalgo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes medicines obtained without a prescription.
Medicines that may affect the effects of Efferalgo:

probenecid (a medicine used to treat gout). A reduction in the dose of Efferalgo may be necessary, as probenecid increases serum levels of paracetamol,
phenobarbital, phenytoin, carbamazepine, primidone (medicines used to treat epilepsy), and rifampicin (a medicine used to treat tuberculosis). Simultaneous use of these medicines with paracetamol may cause liver damage,
AZT (zidovudine, a medicine used to treat HIV infections). Concurrent use of paracetamol and AZT increases the risk of reduced white blood cells (neutropenia). Therefore, Efferalgo should be used together with zidovudine only under medical supervision,
metoclopramide (a medicine used to treat nausea) and other medicines that accelerate gastric emptying. These may speed up the absorption and onset of effect of Efferalgo,
medicines that slow down stomach emptying. These may delay the absorption and onset of effect of Efferalgo,
cholestyramine (a medicine used to reduce elevated serum lipid levels). This may reduce the absorption and onset of effect of Efferalgo. Therefore, do not take cholestyramine within one hour after administration of paracetamol,
oral anticoagulants, particularly warfarin (medicines to thin the blood). Repeated use of paracetamol for more than one week increases the tendency to bleed. Therefore, long-term administration of paracetamol should occur under medical supervision. Occasional use of paracetamol does not significantly affect bleeding tendency,
acetylsalicylic acid and salicylamide (medicines for pain and fever) and chloramphenicol (an antibiotic). The dosage of acetylsalicylic acid, salicylamide, and chloramphenicol may need to be reduced by a doctor,
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that require urgent treatment (see section 2).

Effect of taking Efferalgo on laboratory tests:
If your doctor prescribes a test for blood uric acid levels or blood glucose, inform them that you are taking this medicine.
Efferalgo with food, drinks and alcohol
Alcohol consumption is not recommended during treatment.
No food or milk interaction studies have been conducted.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Efferalgo can be used during pregnancy and breastfeeding. You should use the lowest possible dose that relieves pain and/or fever, and 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.
Paracetamol may affect fertility in women; this effect is reversible after stopping treatment.
Driving and using machines
Paracetamol does not affect, or affects only negligibly, the ability to drive or use machinery.
Efferalgo contains sodium benzoate (E211), traces of benzyl alcohol and sodium.
This medicine contains 14 mg of sodium benzoate (E211) per sachet.
This medicine contains traces of benzyl alcohol per sachet.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and may cause side effects (metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.

3. How to take Efferalgo

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

The lowest effective dose for the shortest possible duration of treatment should generally be used.

Use in children and adolescents

Efferalgo is indicated in adults, adolescents, and children weighing more than 27 kg (from approximately 8 years of age onwards).

In children and adolescents, a weight-based dosage must be observed, and accordingly, an appropriate formulation should be selected. The ages provided are for indicative purposes only and relate to body weight.

The maximum daily dose of paracetamol is 60 mg/kg/day, without exceeding the maximum number of sachets indicated in the following table:

| Body weight (approximate age) | Dose per administration | Interval between 2 doses | Maximum daily dose | |-------------------------------|-------------------------|--------------------------|--------------------| | 27 kg to <41 kg
(8 to <10 years) | 500 mg paracetamol
(1 sachet) | 6 hours | 27 kg to <34 kg:
1,500 mg paracetamol per day
(3 sachets)

34 kg to <41 kg:
2,000 mg paracetamol per day
(4 sachets) | | 41 kg to <50 kg
(10 to ≤15 years) | 500 mg paracetamol
(1 sachet) | Minimum 4 hours | 41 kg to <46 kg:
2,500 mg paracetamol per day
(5 sachets)

46 kg to <50 kg:
3,000 mg paracetamol per day
(6 sachets) | | ≥50 kg (>15 years) | 500 mg to 1,000 mg paracetamol
(1 to 2 sachets) | Minimum 4 hours | 3,000 mg paracetamol per day
(6 sachets) |

A higher dose will not provide additional pain relief but may have serious consequences for the liver.

Children weighing less than 27 kg (8 years of age or younger): since the dosage for this age group is not suitable, other dosage forms of this medicine should be used.

Warning: To avoid the risk of overdose, check whether paracetamol is included in the composition of other medicinal products, including those available without a prescription. Respect the recommended maximum doses.

Consult your doctor or pharmacist if you think that the effect of Efferalgo is too strong or too weak.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.

Adults with body weight below 50 kg, chronic malnutrition, dehydration, elderly patients: consult your doctor or pharmacist.

Mild to moderate hepatic impairment, Gilbert's syndrome (familial non-haemolytic jaundice), and chronic alcoholism: do not exceed 2,000 mg of paracetamol (2 g) per day.

Renal impairment: dosage must be adjusted according to the degree of renal impairment.

Method of administration

For oral use only. Take the granules directly in the mouth onto the tongue and swallow without water. The granules must not be chewed.

Duration of treatment

Unless otherwise directed by the doctor, treatment duration is limited to:

up to 5 days for pain,
up to 3 days for fever.

If pain persists for more than 5 days or fever lasts longer than 3 days, do not continue treatment without consulting your doctor.

Prolonged or frequent use is not recommended. Long-term use, unless under medical supervision, may be harmful.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.

If you take more Efferalgo than you should

Stop treatment immediately and contact your doctor or emergency medical services immediately.

An overdose can be fatal.

The main symptoms of poisoning appearing within the first 24 hours are: nausea, vomiting, loss of appetite, pallor, malaise, sweating, and abdominal pain.

After paracetamol overdose, the following events have been observed:

Acute kidney failure (inability of the kidneys to function properly),
A condition in which small blood clots develop in the bloodstream, blocking small blood vessels,
Rare cases of inflammation of the pancreas (causing abdominal and back pain).

If you forget to take Efferalgo

Do not take a double dose to make up for the forgotten dose.

If you have any doubts about the use of 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.

Rare side effects: may affect up to 1 in 1,000 people

Skin redness, rash, urticaria. Treatment must be stopped immediately, the doctor must be informed, and you must never take any medicine containing paracetamol again.
Pinpoint spots of blood on the skin (purpura). Treatment must be stopped immediately; consult your doctor before taking any medicine containing paracetamol.
Diarrhoea, abdominal pain.

Very rare side effects: may affect up to 1 in 10,000 people

Severe skin reactions. Treatment must be stopped immediately, the doctor must be informed, and you must never take any medicine containing paracetamol again.
Biological changes requiring blood tests: liver function disorders, abnormally low levels of certain white blood cells or blood cells such as platelets, which may cause nosebleeds or bleeding gums. In such cases, consult a doctor.

Frequency not known: frequency cannot be estimated from the available data

Redness or allergic reactions with sudden swelling of the face and neck, or sudden malaise with a drop in blood pressure. Treatment must be stopped immediately, the doctor must be informed, and you must never take any medicine containing paracetamol again.
Excessive (and prolonged) contraction of the airway muscles causing breathing difficulties.
Increased liver enzymes.
Reddish-purple skin lesion recurring in the same area.
Serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a severe illness who are using paracetamol (see section 2).

Reporting of side effects
If you experience 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Efferalgo contains
The active substance is paracetamol.
Each sachet contains 500 mg of paracetamol.
The other components are: basic butyl methacrylate copolymer, 30% polyacrylate dispersion, hydrophobic colloidal silica, mannitol (E421), crospovidone, sodium benzoate (E211), sucralose (E955), [red fruit flavour] (contains traces of benzyl alcohol).

Description of the appearance of Efferalgo and contents of the pack
Granules in a sachet.
White or almost white to pale yellow powder.
Efferalgo is available in packs containing 8, 10, 16 or 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
UPSA SAS, 3, rue Joseph Monier, 92500, Rueil Malmaison, France represented in Italy by:
UPSA ITALY S.R.L., Viale Luca Gaurico 91/93 – Roma

Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, 47520 Le Passage, France
UPSA S.A.S., Avenue du Docteur Jean Bru 304, 47000 Agen, France

This medicinal product is authorized in the European Economic Area countries under the following names:

Belgium:
Dafalgan Instant fruits rouges 500 mg / Dafalgan Instant rode vruchten 500 mg / Dafalgan Instant Beerengeschmak 500 mg
Dafalgan Instant agrume 500 mg / Dafalgan Instant agrum 500 mg / Dafalgan Instant Zitrusfrüchte 500 mg

Bulgaria:
Фервекс ДИРЕКТ малина 500 mg

France:
EFFERALGANSTIX FRAMBOISE 500 mg
EFFERALGANSTIX PAMPLEMOUSSE 500 mg

Greece:
DEPON InSticks® grapefruit, 500 mg
DEPON InSticks® red berry, 500 mg

Italy:
Efferalgo 500 mg

Luxembourg:
Dafalgan Instant fruits rouges 500 mg / Dafalgan Instant rode vruchten 500 mg / Dafalgan Instant Beerengeschmak 500 mg
Dafalgan Instant agrume 500 mg / Dafalgan Instant agrum 500 mg / Dafalgan Instant Zitrusfrüchte 500 mg

Poland:
FERVEX ból i gorączka INSTANT 500 mg

Romania:
Fervex Durere și Febră INSTANT 500 mg

HEALTH ADVICE

WHAT TO DO IN CASE OF FEVER:
Normal body temperature varies from person to person and ranges between 36.5°C and 37.5°C. An increase in temperature above 38°C may be considered fever, but medical treatment for fever is not recommended below 38.5°C.
This medicine is indicated for adults, adolescents and children weighing more than 27 kg (from approximately 8 years of age).
If symptoms caused by fever are too bothersome, you may take this medicine containing paracetamol, following the recommended dosage.
You can improve the effectiveness of the treatment by doing the following:

keep yourself uncovered,
drink regularly to avoid the risk of dehydration,
avoid staying in an overheated environment.

With this medicine, fever should rapidly decrease.
However:

if unusual symptoms appear,
if fever lasts more than 3 days or worsens,
if headache becomes severe or vomiting occurs,

SEEK IMMEDIATE MEDICAL ADVICE.

WHAT TO DO IN CASE OF PAIN:
The intensity of pain perception and the ability to tolerate it vary from person to person.

If there is no improvement after 5 days of treatment,
if the pain is severe, unexpected and sudden in onset (particularly strong chest pain) and/or recurs regularly,
if it is accompanied by other symptoms such as general malaise, fever, unusual swelling in the painful area, or reduced limb strength,
if it wakes you up at night, SEEK IMMEDIATE MEDICAL ADVICE.

Patient information leaflet

Efferalgo 1000 mg effervescent granules in sachet

Paracetamol
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Efferalgo is and what it is used for

Pharmacotherapeutic category: OTHER ANALGESICS AND ANTIPYRETICS: ANILIDES – ATC Code: N02BE01
This medicinal product contains paracetamol: an analgesic (relieves pain) and antipyretic (reduces fever).
It is indicated for the symptomatic treatment of mild to moderate pain and/or fever.
This formulation is indicated for adults and adolescents weighing 50 kg or more (from 15 years of age).
Carefully read the "Dosage" section of the package leaflet.
For children weighing less than 50 kg (aged approximately 15 years or younger), other paracetamol-based formulations are available: consult your doctor or pharmacist for advice.

2. What you need to know before taking EFFERALGO

Do not take Efferalgo

if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking Efferalgo
In case of overdose or accidental ingestion of too high a dose, consult your doctor immediately.
This medicine contains paracetamol. Other medicines also contain paracetamol.
Check that you are not taking other medicines containing paracetamol, including those obtained without
a prescription.
Do not combine them, so as not to exceed the recommended daily dose (see section 3 “How to take Efferalgo”).

If pain persists for more than 5 days, or if fever lasts longer than 3 days, or if the effect is insufficient, or if any other symptoms occur, do not continue treatment without consulting your doctor. In case of acute fever, signs of secondary infection, or persistent disturbances, you must consult a doctor.
Prolonged, incorrect, and/or high-dose use of this medicine in patients with chronic headache may cause headache or worsening of headache. Do not increase the dose of painkillers, but seek advice from your doctor.

Inform your doctor or pharmacist before taking this medicine if any of the following conditions apply to you:

if you are an adult and weigh less than 50 kg,
in case of mild to moderate impairment of liver function,
in case of kidney impairment,
in case of Gilbert's syndrome (non-haemolytic familial jaundice),
in case of chronic alcoholism,
if you are taking Efferalgo together with other medicines that impair liver function,
in case of glucose-6-phosphate dehydrogenase deficiency,
in case of haemolytic anaemia,
if you suffer from nutritional disorders [chronic malnutrition (low hepatic glutathione reserves), anorexia or cachexia (significant weight loss), fasting],
if you are dehydrated (excessive loss of body fluids),
in case of acute viral hepatitis or if this condition is diagnosed during treatment with Efferalgo. Inform your doctor, as treatment with Efferalgo may be discontinued by the doctor.

During treatment with Efferalgo, inform your doctor immediately if:
If you suffer from serious illnesses, including severe kidney 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 fluids) has been reported when paracetamol is used at regular doses for a prolonged period 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.
IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.
Children and adolescents
In children and adolescents treated with paracetamol, combination with another antipyretic medicine is not justified, except in cases of inefficacy. In case of persistent fever, it is necessary to consult the doctor.
Other medicines and Efferalgo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes medicines obtained without a prescription.
Medicines that may affect the effects of Efferalgo:

probenecid (a medicine used to treat gout). A reduction in the dose of Efferalgo may be necessary, as probenecid increases serum levels of paracetamol,
phenobarbital, phenytoin, carbamazepine, primidone (medicines used to treat epilepsy) and rifampicin (a medicine used to treat tuberculosis). Simultaneous use of these medicines and paracetamol may cause liver damage,
AZT (zidovudine, a medicine used to treat HIV infections). Simultaneous use of paracetamol and AZT increases the tendency to reduced white blood cells (neutropenia). Therefore, Efferalgo should be used together with zidovudine only under medical advice,
metoclopramide (a medicine used to treat nausea) and other medicines that accelerate gastric emptying. These may accelerate the absorption and onset of effect of Efferalgo,
medicines that slow down stomach emptying. These may delay the absorption and onset of effect of Efferalgo,
colestyramine (a medicine used to reduce elevated serum lipid levels). This may reduce the absorption and onset of effect of Efferalgo. Therefore, do not take colestyramine within one hour after administration of paracetamol,
oral anticoagulants, particularly warfarin (medicines to thin the blood). Repeated use of paracetamol for more than one week increases the tendency to bleeding. Therefore, long-term administration of paracetamol should be under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency,
acetylsalicylic acid and salicylamide (medicines for the treatment of pain and fever) and chloramphenicol (an antibiotic). The dosage of acetylsalicylic acid, salicylamide and chloramphenicol may need to be reduced by a doctor,
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that require urgent treatment (see section 2).

Effect of taking Efferalgo on laboratory tests:
If your doctor prescribes a test for blood uric acid levels or blood glucose, inform them that you are taking this medicine.
Efferalgo with food, drinks and alcohol
Alcohol consumption is not recommended during treatment.
No food or milk interaction studies have been conducted.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Efferalgo can be used during pregnancy and breastfeeding. You should use the lowest possible dose that reduces pain and/or fever, and for the shortest possible duration. Contact your doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently.
Paracetamol may possibly impair fertility in women; this effect is reversible after discontinuation of treatment.
Driving and using machines
Paracetamol does not affect, or affects only negligibly, the ability to drive and use machines.
Efferalgo contains sodium benzoate (E211), traces of benzyl alcohol and sodium.
This medicine contains 27 mg of sodium benzoate (E211) per sachet.
This medicine contains traces of benzyl alcohol per sachet.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and may cause side effects (metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, essentially 'sodium-free'.

3. How to take Efferalgo

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. If you are unsure, consult your doctor or pharmacist.

Dosage

The lowest effective dose for the shortest possible duration of treatment should generally be used.

EFFERALGO IS INDICATED IN ADULTS AND ADOLESCENTS weighing 50 kg or more (from approximately 15 years of age).

Warning: this formulation contains 1,000 mg of paracetamol (1 g) per sachet; do NOT take 2 sachets together.

| Body weight (approximate age) | Dose per administration | Minimum interval between doses | Maximum daily dose | |-------------------------------|--------------------------|-------------------------------|--------------------| | ≥ 50 kg (>15 years) | 1,000 mg paracetamol (1 sachet) | At least 4 hours | 3,000 mg paracetamol per day (3 sachets) |

A higher dose will not provide additional pain relief but may cause serious liver damage.

Adolescents weighing less than 50 kg (15 years of age or younger): since the dosage for this age group is not suitable, other dosage forms of this medicine should be used.

Warning: to avoid the risk of overdose, check whether paracetamol is included in the composition of other medicines, including those available without a prescription. Respect the maximum recommended doses.

Consult your doctor or pharmacist if you feel that the effect of EFFERALGO is too strong or too weak.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.

Adults with body weight below 50 kg, chronic malnutrition, dehydration, elderly: seek advice from your doctor or pharmacist.

Mild to moderate hepatic insufficiency, Gilbert's syndrome (non-haemolytic familial jaundice), and chronic alcoholism: do not exceed 2,000 mg of paracetamol (2 g) per day.

Renal impairment: dosage must be adjusted according to the degree of renal impairment.

Method of administration

For oral use only. Take the granules directly in the mouth, placing them on the tongue, and swallow without water. Do not chew the granules.

Duration of treatment

Unless otherwise directed by your doctor, treatment duration is limited to:

Up to 5 days for pain,
Up to 3 days for fever.

If pain persists for more than 5 days or fever lasts longer than 3 days, do not continue treatment without consulting your doctor. Prolonged or frequent use is not recommended. Long-term use, unless under medical supervision, may be harmful.

IF YOU HAVE ANY DOUBTS, CONSULT YOUR DOCTOR OR PHARMACIST.

If you take more Efferalgo than you should

Stop taking the medicine immediately and contact your doctor or emergency medical services immediately.

An overdose can be fatal.

The main symptoms of poisoning appearing within the first 24 hours are: nausea, vomiting, loss of appetite, pallor, malaise, sweating, and abdominal pain.

After paracetamol overdose, the following events have been observed:

Acute kidney failure (inability of the kidneys to function properly),
A condition in which small blood clots develop in the bloodstream, blocking small blood vessels,
Rare cases of inflammation of the pancreas (causing abdominal and back pain).

If you forget to take Efferalgo

Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use 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.

Rare side effects: may affect up to 1 in 1,000 people

Skin redness, rash, urticaria. Treatment must be stopped immediately, the doctor must be informed and you must never take any medicine containing paracetamol again.
Pinpoint bleeding spots on the skin (purpura). Treatment must be stopped immediately, and you must consult your doctor before taking any medicine containing paracetamol.
Diarrhoea, abdominal pain.

Very rare side effects: may affect up to 1 in 10,000 people

Severe skin reactions. Treatment must be stopped immediately, the doctor must be informed and you must never take any medicine containing paracetamol again.
Biological changes requiring blood tests: liver function disorders, abnormally low levels of certain white blood cells or blood cells such as platelets, which may cause nosebleeds or bleeding gums. In this case, consult a doctor.

Frequency not known: frequency cannot be estimated from the available data

Redness or allergic reactions with sudden swelling of the face and neck, or sudden malaise with low blood pressure. Treatment must be stopped immediately, the doctor must be informed and you must never take any medicine containing paracetamol again.
Excessive (and prolonged) contraction of the airway muscles causing breathing difficulties.
Increased liver enzymes.
Reddish-purple skin lesion recurring in the same area.
Serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

Reporting of side effects

If you experience 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgo

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

6. Package contents and other information

What Efferalgo contains
The active substance is paracetamol.
Each sachet contains 1,000 mg of paracetamol.
The other components are:
Basic butyl methacrylate copolymer, 30% polyacrylate dispersion, hydrophobic colloidal silica,
mannitol (E421), crospovidone, sodium benzoate (E211), sucralose (E955), red fruit flavour (contains
traces of benzyl alcohol).

Description of the appearance of EFFERALGO and contents of the pack
Granules in a sachet.
White or almost white to pale yellow powder.
Efferalgo is available in packs containing 8, 10, 16 or 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
UPSA SAS, 3, rue Joseph Monier, 92500, Rueil Malmaison, France represented in Italy by:
UPSA ITALY S.R.L., Viale Luca Gaurico 91/93 – Rome

Manufacturers
UPSA S.A.S., 979, Avenue des Pyrénées, 47520 Le Passage, France
UPSA S.A.S., Avenue du Docteur Jean Bru 304, 47000 Agen, France

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium:
Dafalgan Instant Forte red fruits 1 g / Dafalgan Instant Forte rode vruchten 1 g / Dafalgan Instant Forte Beerengeschmak 1 g
Bulgaria:
Фервекс ДИРЕКТ малина 1000 mg
France:
EFFERALGAN FRAMBOISESTIX 1000 mg
Greece:
DEPON InSticks® Maximum red berry 1000 mg
Italy:
Efferalgo 1000 mg
Luxembourg:
Dafalgan Instant Forte fruits rouges 1 g / Dafalgan Instant Forte rode vruchten 1 g / Dafalgan Instant Forte Beerengeschmak 1 g
Poland:
FERVEX ból i gorączka INSTANT FORTE 1000 mg
Romania:
Fervex Durere și Febră INSTANT Forte 1000 mg

HEALTH ADVICE

WHAT TO DO IN CASE OF FEVER:
Normal body temperature varies from person to person and ranges between 36.5 °C and 37.5 °C. A temperature increase above 38 °C may be considered fever, but medical treatment of fever is not recommended below 38.5 °C.
This medicine is indicated for adults and adolescents weighing 50 kg or more (from approximately 15 years of age).
If symptoms caused by fever are too bothersome, you may take this medicine containing paracetamol, respecting the recommended dosage.
You can improve the effectiveness of treatment with the following measures:

remain uncovered,
drink regularly to avoid the risk of dehydration,
avoid staying in an overly warm environment.

With this medicine, fever should decrease rapidly.
However:

if unusual symptoms appear,
if fever lasts more than 3 days or worsens,
if headache becomes severe or vomiting occurs, SEEK IMMEDIATE MEDICAL ADVICE.

WHAT TO DO IN CASE OF PAIN:
The intensity of pain perception and the ability to tolerate it vary from person to person.

If there is no improvement after 5 days of treatment,
if the pain is severe, unexpected and sudden (especially severe chest pain) and/or recurs regularly,
if it is accompanied by other symptoms such as general malaise, fever, unusual swelling in the painful area, or reduced strength in a limb,
if it wakes you up at night, SEEK IMMEDIATE MEDICAL ADVICE.