EFFERALGAN 1 g Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
   1. 1 g, effervescent tablets
   2. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Efferalgan Forte and what is it used for
4. Important information before taking Efferalgan Forte
   1. When not to take Efferalgan Forte:
   2. Warnings and precautions
   3. Efferalgan Forte and other medicines
   4. Using Efferalgan Forte with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Efferalgan Forte contains sodium, sorbitol, and sodium benzoate
5. How to take Efferalgan Forte
   1. Using a higher dose of Efferalgan Forte than recommended
   2. Missing a dose of Efferalgan Forte
6. Possible side effects
   1. Reporting side effects
7. How to store Efferalgan Forte
8. Contents of the pack and other information
   1. What Efferalgan Forte contains
   2. What Efferalgan Forte looks like and contents of the pack
   3. Marketing authorization holder in Spain, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Efferalgan Forte(Efferalgan 1 g)

1 g, effervescent tablets

Paracetamol
Efferalgan Forte and Efferalgan 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 directed 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 additional information, you should consult a 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 pain does not improve in adults after 5 days, or fever after 3 days, and in adolescents if 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 pack 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 reduces elevated body temperature that occurs during illness, without lowering normal body temperature.
Paracetamol is less irritating to the stomach lining 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 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 stopping treatment,
• in the case of concomitant use with analgesic medicines 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 medicines containing paracetamol (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 you experience a skin rash or any other sign of an allergic reaction.
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,
• prolonged 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 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:

• MAO inhibitors - you should not take them concomitantly with MAO inhibitors and for 2 weeks after stopping 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 elimination 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 "Using a higher dose of Efferalgan Forte than recommended" in section 3). You should exercise caution when using them concomitantly.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - you should exercise caution when using them concomitantly.
• 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, as well as for a week after stopping 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 large and/or long-term 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 elimination. When used concomitantly with paracetamol, your doctor will consider reducing the paracetamol dose.
• Flucloxacillin - you should exercise caution 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 the 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 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 pain is not relieved or fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, you should consult your doctor.
There is no available, sufficient data to indicate whether paracetamol affects fertility.

Driving and using machines

Efferalgan Forte does not affect psychophysical abilities. 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 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 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 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 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 Forte, 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 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,
• prolonged 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, 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 much of the medicine or accidental ingestion of 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, with alcoholic disease, liver diseases, and patients taking medicines that induce liver enzymes, as these patients have an increased risk of liver damage.
Overdose of the medicine may cause symptoms such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve 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 been less 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.
If you have any further doubts about 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 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 index).
Very rare, requiring discontinuation 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, 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 whole body or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or bursting giant blisters, extensive erosions on the skin, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this 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, e-mail: 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.
There are no special recommendations for storage.
You should not use this medicine after the expiry date stated on the carton. 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 pack 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 docusate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan Forte looks like and contents of the pack

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

Marketing authorization holder in Spain, the country of export:

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

Manufacturer:

UPSA
304, Av. Dr Jean Bru
47000 Agen
France
UPSA
979, Avenue des Pyrénées
47520 Le Passage
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 671990.9

• 866947.9

Parallel import authorization number: 84/23
Date of leaflet approval: 17.05.2023
[Information about the trademark]