Efferalgan

Leaflet accompanying the packaging: patient information

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

Efferalgan (Efferalgan 150 mg), 150 mg, suppositories

Paracetamol
Efferalgan and Efferalgan 150 mg are different trade names for the same medicine.

Read the leaflet carefully 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your 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 pack 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
occurring during illness, without lowering normal temperature.
Indications for use:

• fever,
• symptomatic treatment of flu-like and cold conditions,
• pains of various origins.

2. Important information before taking Efferalgan

When not to take Efferalgan

• if you are allergic to paracetamol, propacetamol hydrochloride (a precursor to paracetamol) or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver failure or active, uncompensated liver disease,
• if you have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), which may lead to hemolytic anemia,
• if you are being treated with MAO inhibitors (medicines used, among others, in depression) and for 14 days after stopping treatment,
• if you have recently had proctitis, proctocolitis, or rectal bleeding.

The medicine contains soybean oil. Do not take if you are hypersensitive to peanuts or soy.

Warnings and precautions

Before starting to take Efferalgan, discuss it with your doctor, pharmacist, or nurse.
Efferalgan contains paracetamol. To avoid overdose, check if other medicines (including those prescribed and over-the-counter) you are taking contain paracetamol.
Overdose can lead to severe liver damage and death.
When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with the duration of treatment, frequency of use, and dose of the medicine.
If a child is taking a paracetamol dose of 60 mg/kg body weight/day, other antipyretic medicines may be considered only if the effect is insufficient.
Do not take higher doses than recommended. Taking higher doses of paracetamol than recommended carries the risk of severe liver damage.
Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.
Tell your doctor if you experience skin reactions.
Consult your doctor before taking Efferalgan if you have any of the following conditions:

• liver failure, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• severe kidney failure,
• alcoholic disease,
• eating disorders: anorexia, bulimia, or cachexia,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration,
• reduced blood volume.

During long-term (more than 3 months) use of painkillers in patients with chronic headache, 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 your doctor, you should stop taking painkillers.

Efferalgan and other medicines

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.
Taking Efferalgan at the same time may change the effect of the following medicines or taking the following medicines may change the effect of Efferalgan taken at the same time:
MAO inhibitors (a group of medicines used in the treatment of depression) – should not be taken at the same time as 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 painkiller also used in feverish conditions) – concurrent use may prolong the elimination of paracetamol.
Enzyme-inducing substances – caution should be exercised when taking paracetamol and medicines that increase liver metabolism, such as antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (a medicine used in tuberculosis), and isoniazid (a medicine used in tuberculosis). This may lead to liver damage, even when taking the recommended doses of paracetamol (see "Taking a higher dose of Efferalgan than recommended" in section 3).
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 minor changes in INR values. In such cases, your doctor will increase the frequency of monitoring INR values during concurrent use and for one week after stopping paracetamol.
Phenytoin (a medicine used in epilepsy) – concurrent administration may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or long-term doses of paracetamol. Your doctor should examine these patients for signs of hepatotoxicity.
Probenecid (a medicine used in gout) – reduces the excretion of paracetamol. When taking this medicine with probenecid, your doctor should consider reducing the dose of paracetamol.
Flucloxacillin – caution should be exercised when taking flucloxacillin at the same time as 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.
Tell your doctor if you are taking this medicine if your doctor orders a test for uric acid or blood sugar.

Taking Efferalgan with alcohol

Do not drink alcohol due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is not intended for adults (see section 3).
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Other medicines containing paracetamol as the active substance, intended for adults, have been approved.
Paracetamol can be given to pregnant women if necessary. Use the lowest possible dose that relieves pain or reduces fever and take the medicine for as short a time as possible.
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, consult your doctor.
This medicine may be used during breastfeeding only with the doctor's consent and in individual cases.
There is no sufficient data to determine whether paracetamol affects fertility.

Driving and using machines

The medicine does not affect psychomotor performance. There are no contraindications to driving vehicles and operating machinery.

3. How to take Efferalgan

Take this medicine always exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If you are not sure, ask your doctor, pharmacist, or nurse.
In children, follow the dosage according to body weight, so choose an Efferalgan medicine with the appropriate strength. The approximate age corresponding to a given body weight is given only as a guide.
In children, the recommended single dose of paracetamol is about 15 mg/kg body weight. If necessary, it can be given up to 4 times a day, but not more often than every 6 hours. The recommended maximum daily dose of paracetamol is about 60 mg/kg body weight.
Efferalgan suppositories, 150 mg, are intended for children with a body weight of 10 to 15 kg (approximately 24 months to 3 years).
The recommended single dose is 1 suppository (150 mg of paracetamol). If necessary, the dose can be repeated, but not more often than every 6 hours. Do not take more than 4 suppositories per day (the maximum daily dose of paracetamol is 600 mg).
Patients with kidney function disorders
In patients with severe kidney function disorders, the minimum interval between doses should be in accordance with the following schedule:
Creatinine clearance
Interval between doses
CrCl ≥ 10 ml/min
6 hours
CrCl <10 ml min
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/day (should not exceed 2 g/day):

• in adults with a body weight below 50 kg,
• chronic or compensated active liver disease, 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
Rectal administration. It is not recommended to use suppositories in children with diarrhea.
Frequency of administration
Due to the possibility of local irritating effects, it is not recommended to use suppositories more than 4 times a day.
Regular administration of the medicine allows preventing periodic exacerbations of pain or fever.
In children, maintain equal 6-hour intervals between doses, both during the day and at night.
Duration of treatment
The duration of suppository use should be as short as possible. Without consulting a doctor, do not take this medicine for more than 3 days.

Taking a higher dose of Efferalgan than recommended

If you take a higher dose than recommended, contact your doctor immediately, even if you do not experience any symptoms, as this may lead to life-threatening liver damage.
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have liver disease, or are 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 developing, manifested by abdominal distension, return of nausea, and jaundice.
Rare cases of acute pancreatitis have been observed.

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 taking this medicine, 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 unknown: the frequency cannot be estimated from the available data.
Unknown: increased liver enzyme activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), diarrhea, abdominal pain; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count); skin redness, rash, flushing, or urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
*Very rare, treatment-discontinuation-requiring cases of hypersensitivity reactions (dyspnea, bronchospasm, excessive sweating) have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not take 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Efferalgan contains

The active substance of the medicine is paracetamol. Each suppository contains 150 mg of paracetamol.
The other ingredients are solid fat with additives, including lecithin derived from soybean oil.

What Efferalgan looks like and contents of the pack

Suppository.
Packaging: 2 PVC/PE blisters, in a cardboard box, containing 5 suppositories each.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, 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 Bulgaria, the country of export:20020146

Parallel import authorization number: 256/24

Date of leaflet approval: 25.06.2024

[Information about the trademark]