Efferalgan

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Efferalgan, 500 mg, effervescent tablets

Paracetamol

You should carefully read the contents of the leaflet 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 a doctor, pharmacist, or nurse.

• You should keep this leaflet so that 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 pain does not improve in adults after 5 days, and symptoms of cold and flu or fever after 3 days, or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Efferalgan and what is it 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 packaging and other information

1. What is Efferalgan and what is it used for

Efferalgan is a medicine with analgesic and antipyretic effects. It lowers elevated body temperature. Paracetamol is less irritating to the gastric mucosa than salicylates.

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Symptomatic treatment of flu-like conditions and colds.
• Fever.

The medicine is intended for use in adults, adolescents, and children with a body weight of more than 17 kg (i.e., from about 6 years of age).

2. Important information before taking Efferalgan

When not to take Efferalgan

• if the patient is hypersensitive to paracetamol, propacetamol hydrochloride (a precursor to paracetamol), or any of the other ingredients of this medicine (listed in section 6),
• in children with a body weight of less than 17 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active liver disease that is not compensated,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase,
• if the patient is being treated with MAO inhibitors (medicines used, among other things, in depression) and for 14 days after the end of treatment.

Warnings and precautions

Before starting to take Efferalgan, you should discuss it with your doctor, pharmacist, or nurse.

Efferalgan contains paracetamol and should be taken with consideration of concurrent use of other medicines containing paracetamol (including prescription and over-the-counter medicines) to avoid taking a daily dose greater than recommended (see section 3).

Do 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 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 cachexia,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration,
• hypovolemia (reduced circulating blood volume).

Do not consume alcohol during treatment or take medicines containing alcohol, due to the increased risk of toxic liver damage.

During long-term (more than 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 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.

Concurrent use of Efferalgan may change the effect of the following medicines or the use of the following medicines may change the effect of concurrently used Efferalgan:

• MAO inhibitors - it is contraindicated to use them concurrently with 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 febrile conditions) - concurrent use prolongs the elimination time of paracetamol.
• Medicines that increase liver metabolism - concurrent use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines 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" in section 3). Caution should be exercised when using them concurrently.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when using them concurrently.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - concurrent use increases the risk of kidney function disorders.
• Oral anticoagulants - concurrent 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 may increase the frequency of INR monitoring during concurrent use and for one week after discontinuation of paracetamol.
• Phenytoin (a medicine used in epilepsy) - concurrent administration may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, you should avoid high doses of paracetamol and (or) long-term administration 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 elimination. During concurrent use with paracetamol, the doctor will consider reducing the paracetamol dose.
• Flucloxacillin - caution should be exercised when using flucloxacillin concurrently 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 the doctor prescribes a test for uric acid or blood sugar.

Using Efferalgan 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 can be given to pregnant women if necessary. You should use the smallest recommended dose that effectively relieves pain or reduces fever and take the medicine for the shortest possible time and as infrequently as possible.

Paracetamol may be used during breastfeeding only with the doctor's consent and in individual cases. Caution should be exercised when using the medicine during lactation.

If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of administration, you should consult a doctor.

There is no available, sufficient data to demonstrate the effect of paracetamol on fertility.

Driving and using machines

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

Efferalgan contains sodium, sorbitol (E 420), and sodium benzoate (E 211)

Each effervescent tablet contains 412 mg of sodium (the main component of common salt). This corresponds to 21% 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 300 mg of sorbitol (E 420). 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.

Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Efferalgan 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 used this medicine during pregnancy.

3. How to take Efferalgan

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

The dose is determined based on the patient's body weight. The approximate age corresponding to a given body weight is provided only as a guide.

The recommended single dose of paracetamol is 10 to 15 mg/kg body weight, every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg body weight. 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 is 500 mg or 1 g of paracetamol (one or two effervescent tablets), every 4 to 6 hours, for a total of no more than 3 g of paracetamol (6 effervescent tablets per day). However, in cases of severe pain, the daily dose can be increased to a maximum dose of 4 g of paracetamol (8 effervescent tablets per day). You should always maintain at least a 4-hour interval between doses.

Children and adolescents with a 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, with a maximum daily dose of 60 mg/kg body weight per day.

Children with a body weight from 17 to 25 kg (from 6 to 8 years of age): the single dose is 250 mg of paracetamol (half an effervescent tablet). If necessary, the dose can be repeated every 6 hours. Do not take more than 1 g of paracetamol per day (2 effervescent tablets).

Children with a body weight from 25 to 33 kg (from 8 to 10 years of age): the single dose is 250 mg (half an effervescent tablet). If necessary, the dose can be repeated every 4-6 hours. Do not take more than 1.5 g of paracetamol per day (3 effervescent tablets).

Children with a body weight from 33 to 50 kg (from 10 to 15 years of age): the single dose is 500 mg (one effervescent tablet), which can be repeated every 6 hours if necessary, and no more than 2 g of paracetamol per day (4 effervescent tablets).

Elderly patients

There is no need to modify the dose.

Patients with kidney function disorders

The recommended single dose is 500 mg (1 effervescent tablet), 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< p>

8 hours

Patients with liver function disorders

In patients with liver function disorders, the dose of the medicine should be reduced or the intervals between doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight per 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:

• in children, you should maintain a regular interval between doses both during the day and at night,
• in adults, the interval between doses should not be less than 4 hours.

Duration of treatment

In adults, do not take the medicine without a doctor's recommendation for more than 5 days in case of pain, and more than 3 days in case of cold and flu or fever. In children and adolescents, never take the medicine for more than 3 days.

Using a higher than recommended dose of Efferalgan

In case of taking too large a dose or accidental ingestion of Efferalgan, you should contact a doctor to receive appropriate advice.

Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have 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 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 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 reported.

Missing a dose of Efferalgan

Do 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:

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,

unknown: frequency cannot be estimated from the available data.

Rare: decreased blood pressure.

Very rare: tachycardia; nausea, vomiting; renal colic, renal papillary necrosis, acute renal failure,

Unknown: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of the deep layers of the 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 withdrawal 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

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 contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 500 mg 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 looks like and what the packaging contains

Effervescent tablet.

Packaging: soft blisters Al/LDPE, containing 8 or 16 effervescent tablets, in a cardboard box.

For more detailed information, you should contact the marketing authorization holder or 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

Spanish export authorization number:933564.9

Parallel import authorization number:68/24

Date of leaflet approval: 19.02.2024

[Information about the trademark]