Efferalgan Forte

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! 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 medicine.

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 advised by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If in adults the pain does not improve after 5 days, and the fever after 3 days, or in adolescents the pain or fever does not improve after 3 days, or if you feel worse, you should contact your 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 medicine with analgesic and antipyretic effects. It lowers the elevated body temperature that occurs during illness, without lowering normal body temperature.
Paracetamol, to a lesser extent than salicylates, irritates the gastric mucosa.
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 you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in people with a body weight of less than 50 kg,
• in women during the first trimester of pregnancy,
• if you have severe liver failure or active, uncontrolled liver disease,
• if you have a deficiency of glucose-6-phosphate dehydrogenase,
• if you are being treated with MAO inhibitors (medicines used, among others, in depression) and for 14 days after the end of treatment,
• in the case of concomitant use with analgesic medicines with agonist-antagonist action: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

Before starting to take 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 medicines containing paracetamol (including those available on prescription or without a prescription), so as not to use a daily dose greater than recommended (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 the occurrence of skin reactions and stop taking the medicine in case of skin rash or any other symptom of hypersensitivity.
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, disorders of appetite, cystic fibrosis, HIV infection, in patients who are starving or wasting, with sepsis,
• dehydration of the body,
• hypovolemia (reduced blood volume).

Efferalgan Forte and other medicines

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

• MAO inhibitors - you should not take them at the same time as MAO inhibitors and for 2 weeks after the end of treatment with these medicines, due to the possibility of excitement and high fever.
• Medicines containing salicylamide (a pain reliever also used in feverish conditions) - concomitant use prolongs the excretion time of paracetamol.
• Medicines that increase liver metabolism - concomitant use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (a medicine used in tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol (see "Use of a higher than recommended dose of Efferalgan Forte" in section 3). You should exercise caution when using them together.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - you should exercise caution when using them together.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• Oral anticoagulant medicines - concomitant use of paracetamol with anticoagulant medicines from the coumarin group, including warfarin, may lead to slight changes in INR values. In such cases, your doctor will increase the frequency of monitoring INR values during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (a medicine 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. Patients should be constantly monitored for signs of liver damage.
• Probenecid (a medicine used in gout) - it causes a decrease in paracetamol excretion. When used concomitantly with paracetamol, your doctor will consider reducing the dose of paracetamol.
• Flucloxacillin - you should exercise caution when using flucloxacillin at the same time as paracetamol, due to the increased risk of developing a disorder affecting the 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 orders a test for uric acid or blood sugar.

Using Efferalgan Forte with alcohol

While taking the medicine, you should not drink alcohol or take medicines containing alcohol, due to the increased risk of toxic liver damage. There is a particular risk of liver damage in people who are starving and regularly drink 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 that relieves pain or reduces fever and take the medicine for the shortest possible time.
If the pain is not relieved or the fever does not decrease, 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 (E 420), and sodium benzoate (E 211)

Each effervescent tablet contains 567 mg of sodium (the main component of common 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 their sodium intake, should contact their doctor or pharmacist.
Each effervescent tablet contains 252 mg of sorbitol (E 420). Sorbitol (E 420) is a source of fructose.
If you have previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the patient's body does not break down fructose), you should contact your doctor before taking the medicine or giving it to your child.
Sorbitol (E 420) may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan Forte contains sodium benzoate (E 211), 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 advised by your doctor, pharmacist, or nurse. If you have any doubts, you should ask 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 keep 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.

• in adults with a body weight below 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.
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 use
Regular use of the medicine allows you to prevent periodic exacerbations of pain or fever.
Interval between doses should be 6 hours and in no case less than 4 hours.
Duration of use
In adults, do not use the medicine without a doctor's recommendation for more than 5 days, and in the case of fever, for more than 3 days. In adolescents, never use the medicine for more than 3 days.

Using a higher than recommended dose of Efferalgan Forte

In the event of taking too much of the medicine or accidentally taking Efferalgan Forte, you should contact your doctor for advice.
Overdose is particularly dangerous in the elderly, small children, patients who are malnourished for a long time, those with alcoholic disease, liver disease, and patients taking medicines that induce liver enzymes, as these individuals 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 disappear 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 without delay.

Missing a dose of Efferalgan Forte

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should ask 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 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, treatment-requiring cases of hypersensitivity reactions have been reported:
skin redness, 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, skin itching and redness, 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 all over the body or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever and joint pain or bursting giant blisters, extensive skin erosions, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell 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 the medicine.

5. How to store Efferalgan Forte

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
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 are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium lauryl sulfate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan Forte looks like and what the packaging contains

Effervescent tablet.
Packaging: soft Al/PE blisters 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Portugal, the country of export:3851987
3852084
3852183
3852282

Parallel import authorization number: 250/23

Date of leaflet approval: 31.10.2023

[Information about the trademark]