Efferalgan Forte

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If, in adults, pain does not subside after 5 days, and fever after 3 days, or if, in adolescents, pain or fever does not subside after 3 days, or if the patient feels worse, they should contact a 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 elevated 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. The medicine is intended for use in adults and adolescents with a body weight over 50 kg (over 15 years of age).

2. Important information before taking Efferalgan Forte

When not to take Efferalgan Forte:

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

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 taken into account when taking other medicines containing paracetamol (including prescription and over-the-counter medicines), so as not to take 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 within one to two days after paracetamol overdose, with maximum severity usually occurring within 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,
• anorexia, bulimia, or wasting of the body,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration of the body,
• hypovolemia (reduced blood volume).

You should not consume alcohol during treatment or take medicines containing alcohol.
During long-term (over 3 months) use of painkillers in patients with chronic headaches, when taken every other day or more frequently, medication-overuse headache (MOH) may develop or worsen. MOH should not be treated by increasing the dose. In such cases, in agreement with the doctor, you should stop taking painkillers.

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 alter the effect of the following medicines or the use of the following medicines may alter the effect of concomitantly used Efferalgan Forte:

• MAO inhibitors - it is contraindicated to use them concomitantly with MAO inhibitors and within 2 weeks after the end of treatment with these medicines due to the possibility of excitement and high fever.
• Medicines containing salicylamide (a painkiller 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 (mainly used 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). Caution should be exercised when used concomitantly.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when used concomitantly with these medicines.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• Oral anticoagulants - concomitant use of paracetamol with anticoagulant medicines 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 and for one week after discontinuation of paracetamol.
• Phenytoin (a medicine used in epilepsy) - concomitant administration 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 medicine used in gout) - it causes a decrease in paracetamol excretion. During concomitant use with paracetamol, the doctor will consider reducing the dose of paracetamol.
• Flucloxacillin - caution should be exercised when using flucloxacillin concomitantly with paracetamol due to the increased risk of developing a disorder related to 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 the doctor orders a test for uric acid or blood sugar.

Using Efferalgan Forte with alcohol

During treatment, you should not consume alcohol or take medicines containing alcohol, due to the increased risk of toxic liver damage.

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 duration.
Paracetamol may be used during breastfeeding only with the doctor's consent and in individual cases. Caution should be exercised during treatment while breastfeeding.
If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of taking the medicine, you should consult a doctor.
There are no available, sufficient data to demonstrate the effect of paracetamol on 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 (E 420), and sodium benzoate (E 211)

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 (E 420). Sorbitol (E 420) 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.
Sorbitol (E 420) may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan Forte contains 120 mg of 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 directed by a doctor, pharmacist, or nurse. If you have any doubts, you should consult a 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, for a total of no more than 3 effervescent tablets (3 g of paracetamol). However, in 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 patients 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,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration.

Method of administration
Oral administration.
The effervescent tablet should be dissolved in a glass of water and the prepared solution should be drunk. Do not chew or swallow the tablets.
Frequency of administration
To prevent periodic exacerbations of pain or fever, the interval between doses should be 6 hours and should never be less than 4 hours.
Duration of treatment
In adults, do not use the medicine without a doctor's recommendation for more than 5 days in case of pain and more than 3 days in case of fever. In adolescents, never use the medicine for more than 3 days.

Taking a higher than recommended dose of Efferalgan Forte

In case of taking too high a dose or accidentally taking Efferalgan Forte, you should contact a doctor for appropriate advice.
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have alcoholic disease, liver disease, 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 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 been no more than an hour since ingestion and contact a doctor immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water.
You should seek medical advice immediately.
Rare cases of acute pancreatitis have been observed.

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 a 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:
common: in less than 1 in 100 but more than 1 in 1,000 patients,
rare: in less than 1 in 1,000 but more than 1 in 10,000 patients,
very rare: in less than 1 in 10,000 patients,
not known: frequency cannot be estimated from the available data.
Rare: lowering of blood pressure.
Very rare: tachycardia, nausea, vomiting, renal colic, necrosis of renal papillae, acute renal failure.
Not known: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of deep layers of skin and subcutaneous tissue); diarrhea, abdominal pain; increased liver transaminase activity; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count); rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Very rare, requiring discontinuation of treatment, cases of hypersensitivity reactions (skin redness, dyspnea, bronchospasm, excessive sweating) have been reported.

Reporting side effects

If you experience any side effects, including any side effects 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, website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help provide more information on the safety of this 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.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 docusate, 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 effervescent tablets, 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
979, Avenue des Pyrénées
47520 Le Passage, France
UPSA
304, Av. Dr. Jean Bru
47000 Agen, 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 Spain, the country of export:933416.10

Parallel import authorization number: 67/24

Date of leaflet approval: 19.02.2024

[Information about the trademark]