Efferalgan Forte

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

EFFERALGAN FORTE (DAFALGAN 1 g)

1 g, effervescent tablets

Paracetamol
EFFERALGAN FORTE and DAFALGAN 1 g are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking 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, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If the pain does not subside in adults after 5 days, and the fever after 3 days, or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Efferalgan Forte and what is it used for
• 2. Important information before taking Efferalgan Forte
• 3. How to take Efferalgan Forte
• 4. Possible side effects
• 5. How to store Efferalgan Forte
• 6. Contents of the packaging and other information

1. What is Efferalgan Forte and what is it used for

Efferalgan Forte is a pain-relieving and antipyretic medicine. It lowers elevated body temperature that occurs during illness, without lowering normal temperature.
Paracetamol irritates the stomach lining less than salicylates.
Indications for use:

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Fever.

2. Important information before taking Efferalgan Forte

When not to take Efferalgan Forte

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in individuals with a body weight of less than 50 kg,
• in pregnant women in the first trimester,
• if the patient has severe liver failure or active uncompensated liver disease,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase,
• if the patient is being treated with MAO inhibitors (drugs used, among others, in depression) and for 14 days after the end of treatment,

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• in the case of concomitant use with pain-relieving drugs with agonist-antagonist action: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

Before starting treatment with Efferalgan Forte, you should discuss it with your doctor, pharmacist, or nurse.
Due to the content of 1 g of paracetamol in 1 effervescent tablet of Efferalgan Forte, it is not used in children and adolescents under 15 years of age.
Efferalgan Forte contains paracetamol and should be used taking into account the concomitant use of other paracetamol-containing medicines (including those available on prescription or without a prescription), so as not to exceed the recommended daily dose (see section 3).
You should not take higher doses than recommended. Taking higher doses than recommended carries the risk of very severe liver damage. Symptoms of liver damage usually appear 1 to 2 days after paracetamol overdose, with maximum severity usually 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 can be fatal. You should inform your doctor about skin reactions and stop taking the medicine if a skin rash or any other sign of hypersensitivity occurs.
You should consult your doctor before taking Efferalgan Forte if you have any of the following conditions:

• liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic disease, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, or wasting of the body,
• long-term malnutrition,
• low glutathione reserves in the liver associated with, for example, appetite disorders, cystic fibrosis, HIV infection, in fasting or wasting patients, with sepsis,
• dehydration,
• hypovolemia (reduced circulating blood volume).

Efferalgan Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Efferalgan Forte may change the action of the following medicines or the use of the following medicines may change the action of Efferalgan Forte:

• MAO inhibitors - you should not take them concomitantly with MAO inhibitors and for 2 weeks after the end of treatment with these medicines due to the possibility of excitement and high fever.
• Drugs containing salicylamide (a pain-relieving drug, also used in febrile conditions) - concomitant use prolongs the elimination time of paracetamol.
• Drugs that increase liver metabolism - concomitant use of paracetamol and drugs such as St. John's wort, antiepileptic drugs, barbiturates (drugs used mainly in epilepsy), rifampicin (a drug used in tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol (see "Using a higher dose of Efferalgan Forte than recommended" in section 3). Caution should be exercised when using them concomitantly.

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• Isoniazid (a drug used in tuberculosis) and zidovudine (an antiviral drug used in HIV infection) - caution should be exercised when using them concomitantly.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• Oral anticoagulant drugs - concomitant use of paracetamol with anticoagulant drugs from the coumarin group, including warfarin, may lead to slight changes in INR values. In such cases, the doctor will increase the frequency of monitoring INR values during concomitant use, as well as for a week after discontinuation of paracetamol.
• Phenytoin (a drug used in epilepsy) - concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, you should avoid high and/or prolonged doses of paracetamol. These patients should be constantly monitored for signs of liver damage.
• Probenecid (a drug used in gout) - it causes a decrease in paracetamol excretion. During concomitant use with paracetamol, the doctor will consider reducing the paracetamol dose.
• Flucloxacillin - caution should be exercised when using flucloxacillin concomitantly with paracetamol due to the increased risk of developing a disorder affecting blood and body fluids (metabolic acidosis with a large anion gap), especially in patients with risk factors for glutathione deficiency, such as severe kidney function disorders, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with a large anion gap is a serious disease that requires urgent treatment.

You should inform your doctor about the use of this medicine if your doctor prescribes a test for uric acid or blood sugar.

Using Efferalgan Forte with alcohol

While taking this medicine, you should not drink alcohol or take medicines containing alcohol, due to the increased risk of toxic liver damage. Particular risk of liver damage exists in individuals who are fasting and regularly drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Efferalgan Forte can be given to pregnant women if necessary. You should use the lowest effective dose for the shortest possible time.
If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, you should consult your doctor.
There are no available, sufficient data to indicate whether paracetamol affects fertility.

Driving and using machines

Efferalgan Forte does not affect psychophysical fitness. There are no contraindications to driving vehicles and operating machines.

Efferalgan Forte contains sodium, sorbitol, and sodium benzoate

Each effervescent tablet contains 567 mg of sodium (the main component of table salt). This corresponds to 28% of the maximum recommended daily dose of sodium in the diet for adults. If you take 1 or more effervescent tablets per day for a long time, patients, especially those controlling sodium intake in their diet, should contact their doctor or pharmacist.
Each effervescent tablet contains 252 mg of sorbitol. Sorbitol is a source of fructose. If it has been previously determined that the patient (or their child) has intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the patient's body does not break down fructose), the patient should contact their doctor before taking the medicine or giving it to their child.
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Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan Forte contains sodium benzoate, which may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life) whose mothers took this medicine during pregnancy.

3. How to take Efferalgan Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, you should consult your doctor, pharmacist, or nurse.
The dose is determined based on the patient's body weight. The recommended single dose of paracetamol is 10 to 15 mg/kg body weight (bw) every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg bw.
The total daily dose of paracetamol should not exceed 4 g.
The recommended dose is:
Adults and adolescents with a body weight over 50 kg (over 15 years of age)
The recommended single dose of Efferalgan Forte is 1 effervescent tablet (1 g of paracetamol), every 4 to 6 hours, up to 3 times a day, in total not more than 3 effervescent tablets (3 g of paracetamol). However, in the case of severe pain, the dose can be increased to a maximum daily dose of 4 g of paracetamol (4 effervescent tablets). You should always maintain at least a 4-hour interval between doses.
Elderly patients
There is no need to modify the dose.
Patients with kidney function disorders
The recommended single dose is 500 mg, and the minimum interval between doses should be in accordance with the following scheme:
Creatinine clearance
Interval between doses
CrCl ≥ 50 ml/min
4 hours
CrCl 10-50 ml/min
6 hours
CrCl <10 ml min
8 hours
Efferalgan Forte should not be used in patients with kidney function disorders, as reduced doses are used in these patients. Efferalgan, 500 mg effervescent tablets, have been approved for marketing.
Patients with liver function disorders
In patients with liver function disorders, the dose of Efferalgan Forte should be reduced or the intervals between doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg bw/day (should not exceed 2 g/day):

• in adults with a body weight of less than 50 kg,
• chronic or compensated active liver disease, especially mild to moderate liver failure, Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholic disease,
• long-term malnutrition (low glutathione reserves in the liver),
• dehydration.

Method of administration
Oral administration.
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The tablet should be dissolved in a glass of water and the prepared solution should be drunk. You should not chew or swallow the tablets.
Frequency of administration
Regular use of the medicine allows you to prevent periodic exacerbations of pain or fever.
Interval between doses
The interval between doses should be 6 hours and in no case less than 4 hours.
Duration of treatment
In adults, the medicine should not be used without a doctor's recommendation for more than 5 days, and in the case of fever, for more than 3 days. In adolescents, the medicine should never be used for more than 3 days.

Using a higher dose of Efferalgan Forte than recommended

In case of taking too high a dose or accidental ingestion of Efferalgan Forte, you should contact your doctor for appropriate advice.
Overdose is particularly dangerous in the elderly, small children, patients who are malnourished for a long time, with alcoholic disease, liver disease, and patients taking drugs that induce liver enzymes, as these patients have an increased risk of liver damage.
Overdose of the medicine may cause, within a few to several hours, symptoms such as:
nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the fact that liver damage is beginning to develop, manifested by abdominal distension, return of nausea, and jaundice.
In every case of taking this medicine in a single dose of 5 g of paracetamol or more, you should induce vomiting if it has not been more than an hour since ingestion and contact your doctor immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. You should seek medical advice immediately.

Missing a dose of Efferalgan Forte

You should not take a double dose to make up for a missed dose.
In case of any further doubts regarding the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects listed below is defined as follows:
rare: in less than 1 in 1,000, but in more than 1 in 10,000 treated patients
very rare: in less than 1 in 10,000 treated patients.
Rare: malaise, decreased blood pressure, increased liver transaminase activity.
Very rare: hypersensitivity reactions, tachycardia, diarrhea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), decrease or increase in INR values (blood coagulation factor).
Very rare, requiring withdrawal of treatment, cases of hypersensitivity reactions have been reported:
redness of the skin, rash, flushing, or urticaria, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), dyspnea, bronchospasm, excessive sweating, decreased blood pressure up to symptoms of anaphylactic shock (caused by a severe systemic allergic reaction, its symptoms include: dyspnea, swelling of the larynx and throat, itching of the skin and its redness,
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headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness;
in severe cases, it can be life-threatening) and Quincke's edema, severe skin reactions: acute generalized exanthematous pustulosis on the entire body or blisters and erosions on the skin, in the mouth, eyes, and genital organs, fever and joint pain or bursting giant blisters, extensive erosions on the skin, shedding of large skin flakes, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Efferalgan Forte

Store in a temperature below 25°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Efferalgan Forte contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 1 g of paracetamol.
• The other ingredients of the medicine are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan Forte looks like and what the packaging contains

Effervescent tablet
Packaging: Al/PE foil containing 8 tablets, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

UPSA SAS, 3 rue Joseph Monier, 92500 Rueil-Malmaison, France

Manufacturer:

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

Parallel importer:

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

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portuguese marketing authorization number, country of export: 3852183
3851987

Parallel import authorization number: 317/22 Date of approval of the leaflet: 25.08.2022

[Information about the trademark]
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