Efferalgan

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information in a foreign language.
EFFERALGAN (EFFERALGANMED)
500 mg, effervescent tablets
Paracetamolum
EFFERALGAN and EFFERALGANMED are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If in adults pain persists beyond 5 days, or cold and flu symptoms or fever beyond 3 days; in children and adolescents, if pain, cold and flu symptoms, or fever persist beyond 3 days, or if the patient feels worse, consult a doctor.

Table of Contents

1. What Efferalgan is and what it is used for
2. Important information 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 is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature occurring during illness, but does not lower normal body temperature.
Paracetamol irritates the gastric mucosa to a lesser extent than salicylates.
Indications for use:

• Pain of various origins (headache, toothache, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Symptomatic treatment of influenza-like and common cold conditions.
• Fever.

2. Important information before using Efferalgan

When not to use Efferalgan

• if the patient has a known allergy (hypersensitivity) to paracetamol or any of the other ingredients of Efferalgan,
• in children with body weight less than 17 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active, decompensated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase deficiency,
• if the patient is being treated with MAO inhibitors (medicines used e.g. for depression) and within 14 days after stopping such treatment,

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• when used concomitantly with analgesics having agonist-antagonist activity: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

• Efferalgan contains paracetamol and should be used taking into account the simultaneous intake of other medicines containing paracetamol (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3).
• Doses higher than recommended should not be used. Use of doses exceeding the recommended ones carries a risk of severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring after 3–4 days.
• Paracetamol may cause severe skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. If skin reactions occur, the patient should inform a doctor and discontinue use of the medicine immediately in case of skin rash or any other sign of hypersensitivity.

Consult a doctor before using Efferalgan if the patient has any of the following conditions:

• liver function disorders, including Gilbert’s syndrome (familial hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcohol-related disease or excessive alcohol consumption (ingestion of 3 or more alcoholic drinks daily),
• anorexia, bulimia, or physical wasting,
• prolonged malnutrition,
• low glutathione reserves in the liver due to e.g. eating disorders, cystic fibrosis, HIV infection, fasting or cachexia, sepsis,
• dehydration,
• hypovolemia (reduced circulating blood volume).

In case of overdose or accidental ingestion of the medicine, consult a doctor immediately.
The patient should inform the doctor about using this medicine if the doctor orders tests for blood uric acid or blood glucose levels.
Efferalgan and other medicines
Tell your doctor about all medicines you have recently taken, including those available without a prescription.
Concomitant use of Efferalgan may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan taken simultaneously:

• MAO inhibitors – should not be used together with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of developing excitation and high fever.
• Medicines containing salicylamide (an analgesic also used in feverish conditions) – concomitant use prolongs paracetamol elimination time.
• Medicines increasing hepatic metabolism – concomitant use of paracetamol with drugs such as St. John’s wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used (see “Use of doses higher than recommended of Efferalgan” in section 3). Caution is advised during concomitant use.
• Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised during concomitant use with these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of kidney function disorders.

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• Oral anticoagulants – concomitant use of paracetamol with coumarin-type anticoagulants, including warfarin, may lead to slight changes in INR values. In such cases, the doctor may increase the frequency of INR monitoring during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. High doses and/or prolonged use of paracetamol should be avoided during phenytoin treatment. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces paracetamol elimination. During concomitant use with paracetamol, the doctor may consider reducing the paracetamol dose.

Use of Efferalgan with alcohol
Do not drink alcohol or take medicines containing alcohol while using this medicine due to increased risk of toxic liver damage. The risk of liver damage is particularly high in fasting individuals and those who regularly consume alcohol.
Pregnancy, breastfeeding and effects on fertility
Efferalgan may be given to pregnant women if necessary. The lowest effective dose providing adequate pain relief or fever reduction should be used, and the medicine should be taken for the shortest possible duration.
If pain is not relieved or fever does not subside, or if more frequent dosing becomes necessary, consult a doctor.
There are insufficient data available to determine whether paracetamol affects fertility.
Driving and operating machinery
Efferalgan does not affect psychomotor performance. There are no contraindications to driving or operating machinery.
Efferalgan contains sodium, sodium benzoate, and sorbitol
Due to the sodium content of 412.4 mg (17.9 mEq) per effervescent tablet, this should be taken into account in patients with impaired kidney function and in patients controlling sodium intake in their diet.
The medicine contains 60.606 mg of sodium benzoate in each tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Efferalgan

The tablet should be dissolved in a glass of water and taken orally. Do not chew or swallow the undissolved tablet.
The dose is determined based on the patient's body weight.
The recommended dose of Efferalgan is:
Adults and adolescents with body weight above 50 kg (aged over 15 years)
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight every 4 to 6 hours. The maximum daily dose of paracetamol is 75 mg/kg body weight/day, not exceeding a total of 4 g paracetamol per day.
The recommended single dose of Efferalgan is 500 mg or 1 g paracetamol (one or two effervescent tablets), every 4 to 6 hours, up to a maximum of 3 g paracetamol, i.e. 6 effervescent tablets per day.
However, in the case of severe pain, the daily dose may be increased to the maximum daily dose of 4 g paracetamol, i.e. 8 effervescent tablets per day. There must always be at least a 4-hour interval between doses.

Children and adolescents with body weight up to 50 kg
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight, preferably every 6 to 8 hours. The maximum daily dose of paracetamol is 60 mg/kg body weight/day.
For children with body weight from 17 to 25 kg (aged 6 to 8 years), the single dose is 250 mg paracetamol (half an effervescent tablet). If necessary, the dose may be repeated every 6 hours. Do not administer more than 1 g paracetamol per day (2 effervescent tablets).
For children with body weight from 25 to 33 kg (aged 8 to 10 years), the single dose is 250 mg (half an effervescent tablet). If necessary, the dose may be repeated every 4 to 6 hours. Do not administer more than 1.5 g paracetamol per day (3 effervescent tablets).
For children with body weight from 33 to 50 kg (aged 10 to 15 years), the single dose is 500 mg (one effervescent tablet). If necessary, the dose may be repeated every 6 hours. Do not administer more than 2 g paracetamol per day (4 effervescent tablets).
The approximate age range according to body weight is provided only as a guideline.

Frequency of administration
Regular administration of the medicine helps prevent periodic intensification of pain or fever:

• In children, regular intervals between doses should be maintained both during the day and at night.
• In adults, the interval between doses must not be less than 4 hours.

Elderly patients
There is no need to modify the dose.

Patients with impaired renal function
In patients with impaired renal function, the recommended single dose is 500 mg (1 effervescent tablet), and the minimum interval between doses should follow the scheme below:
Creatinine clearance Interval between doses
CrCl ≥50 ml/min 4 hours
CrCl 10–50 ml/min 6 hours
CrCl <10 ml/min 8 hours

Patients with impaired liver function
In patients with impaired liver function, the dose should be reduced or the intervals between doses extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight/day (should not exceed 2 g/day):

• Adults with body weight below 50 kg,
• Chronic or compensated active liver disease, especially mild to moderate liver insufficiency, Gilbert’s syndrome (familial non-haemolytic hyperbilirubinaemia),
• Chronic alcohol-related disease,
• Prolonged malnutrition,
• Dehydration.

Duration of treatment
In adults, do not use Efferalgan for longer than 5 days for pain, or longer than 3 days for cold, flu, or fever, without medical advice. In children and adolescents, never use the medicine for longer than 3 days.

Use of a higher than recommended dose of Efferalgan
If an overdose of Efferalgan has been taken, contact a doctor immediately for appropriate advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with alcohol-related disease, liver disorders, and patients taking drugs that induce liver enzymes, as these individuals have an increased risk of liver damage.
Overdose may cause symptoms within a few to several hours, such as: nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage may already be developing, later manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
In any case where this medicine has been taken in a single dose of 10 tablets (5 g paracetamol) or more, vomiting should be induced if less than one hour has passed since ingestion, and immediate medical advice must be sought. Administration of 60–100 g of activated charcoal orally, preferably mixed with water, is recommended. Immediate medical advice should be sought.

Missed dose of Efferalgan
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Efferalgan can cause adverse reactions, although not everyone experiences them.
If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

The frequency of the adverse reactions listed below is defined as follows:
Rare: in less than 1 in 1,000 but more than 1 in 10,000 treated patients.
Very rare: in less than 1 in 10,000 treated patients.

Rare: malaise, hypotension (low blood pressure), increased hepatic aminotransferase activity.
Very rare: hypersensitivity reactions, tachycardia, diarrhoea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count), decrease or increase in INR values (blood coagulation index).

Very rare, treatment-requiring cases of hypersensitivity reactions have been reported: skin redness, rash, erythema or urticaria, angioedema (swelling of deep skin layers and subcutaneous tissue), dyspnoea, bronchospasm, excessive sweating, hypotension up to symptoms of anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include dyspnoea, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "tightness", dizziness, significant weakness, up to loss of consciousness; in severe cases may be life-threatening), as well as Quincke's edema, severe skin reactions: acute generalized pustular rash over the entire body or blisters and erosions on the skin, in the mouth, eyes, and genital organs, accompanied by fever and joint pain, or rupturing giant blisters, extensive erosions on the skin, shedding of large epidermal sheets, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Efferalgan

No special storage instructions are required.
Keep the medicine out of sight and reach of children.
Do not use Efferalgan after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of 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 substance is paracetamol. One effervescent tablet contains 500 mg of paracetamol.
Other components of the medicine are: sodium benzoate, sodium carbonate, citric acid, sorbitol,
sodium bicarbonate, sodium saccharin, sodium docusate, povidone.

What Efferalgan looks like and contents of the pack
Effervescent tablet
Pack:
Pack containing 4, 8 or 16 effervescent tablets in Al/PE foil blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in France, country of export:
UPSA SAS
3 Rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturers:
UPSA SAS
979, avenue des Pyrénées
47520 Le Passage
France
UPSA SAS
304, avenue du Docteur Jean Bru
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47000 Agen, France

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Marketing authorisation number in France, country of export: 325 699-3
34009 325 699 3 9
325 700-1
34009 325 700 1 0
Parallel import authorisation number: 30/17
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