Efferalgan

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Efferalgan (Efferalgan 150 mg), 150 mg, suppositories
Paracetamolum
Efferalgan and Efferalgan 150 mg are different trade names of the same medicinal product.
Please read carefully the information in this 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
the doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Efferalgan is and what it is used for
2. Important information before using Efferalgan
3. How to use Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature occurring during illness, but does not lower normal body temperature.
Indications:

• fever,
• symptomatic treatment of influenza-like conditions and colds,
• pain of various origins.

2. Important information before using Efferalgan

When not to use Efferalgan

• 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),
• if the patient has severe hepatic insufficiency or active, decompensated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may lead to haemolytic anaemia,
• if the patient is being treated with MAO inhibitors (medicines used, among others, for depression) and within 14 days after stopping such treatment,
• in patients who have recently had inflammation of the anus, rectum, or rectal bleeding.

This medicine contains soya oil. Do not use if known hypersensitivity to peanuts or soya has been diagnosed.

Warnings and precautions

Before starting to use Efferalgan, discuss it with your doctor, pharmacist, or nurse.

Efferalgan contains paracetamol. To avoid overdose, check whether other medicines (including those prescribed and available without prescription) taken by the patient contain paracetamol. Overdose may 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 duration of treatment, frequency of administration, and dose.

If a child is receiving a dose of paracetamol of 60 mg/kg body weight/day, consider using other antipyretic medicines only if the effect is insufficient.

Do not use doses higher than recommended. Using paracetamol doses higher than recommended carries a risk of severe liver damage.

Paracetamol may cause severe skin reactions such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal.

Inform your doctor if skin reactions occur.

Consult your doctor before using Efferalgan if the patient has any of the following conditions:

• liver insufficiency, including Gilbert's syndrome (familial hyperbilirubinaemia),
• severe renal insufficiency,
• alcohol-related disease,
• eating disorders: anorexia, bulimia, or cachexia,
• chronic undernutrition (low glutathione reserves in the liver),
• dehydration,
• reduced circulating blood volume.

Prolonged (over 3 months) use of painkillers in patients with chronic headache, taken on two or more days per week or more frequently, may lead to the development or worsening of headache. Medication-overuse headache (MOH) should not be treated by increasing the dose. In such cases, in consultation with a doctor, painkillers should be discontinued.

Efferalgan and other medicines

Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Concomitant use of Efferalgan may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan taken simultaneously:

MAO inhibitors (a group of medicines used in the treatment of depression) – do not use simultaneously with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of developing excitation and high fever.

Medicines containing salicylamide (an analgesic used also in febrile conditions) – concomitant use may prolong the elimination time of paracetamol.

Substances inducing enzymes – caution is required when using paracetamol together with medicines increasing hepatic metabolism, such as antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (used in tuberculosis), and isoniazid (used in tuberculosis). This may lead to liver damage, even when recommended doses of paracetamol are used (see section "Use of doses higher than recommended for Efferalgan" in section 3).

Non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of renal function disorders.

Oral anticoagulants – concomitant use of paracetamol with coumarin anticoagulants, 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 use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or long-term use of paracetamol. These patients should be monitored by a doctor for signs of hepatotoxicity.

Probenecid (a medicine used in gout) – reduces the elimination of paracetamol. When using this medicine together with probenecid, the doctor should consider reducing the dose of paracetamol.

Flucloxacillin – caution is required when using flucloxacillin simultaneously with paracetamol due to an increased risk of developing a blood and body fluid disorder (metabolic acidosis with a high anion gap), especially in patients with risk factors for glutathione deficiency, such as: severe renal dysfunction, sepsis, undernutrition, and chronic alcoholism. Metabolic acidosis with a high anion gap is a serious condition requiring urgent treatment.

Inform your doctor about using this medicine if your doctor orders tests for uric acid or blood glucose.

Use of 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Other paracetamol-containing medicines have been authorised for adult use.

Paracetamol may be given to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and take the medicine for the shortest possible time.

If pain is not relieved or fever does not subside, or if increased frequency of dosing becomes necessary, consult a doctor.

This medicine may be used during breastfeeding only with a doctor's approval and in individual cases.

There are insufficient available data to indicate whether paracetamol affects fertility.

Driving and operating machinery

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

3. How to use Efferalgan

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
In children, dosing should be based on body weight; therefore, select the Efferalgan preparation of appropriate strength. The approximate age corresponding to a given body weight is provided for guidance only.
In children, the recommended single dose of paracetamol is approximately 15 mg/kg body weight (b.w.). This dose may be repeated up to 4 times daily, no more frequently than every 6 hours. The recommended maximum daily dose of paracetamol is approximately 60 mg/kg b.w.
Efferalgan suppositories 150 mg are intended for children weighing 10 to 15 kg (approximately 24 months to 3 years of age).
The recommended single dose is 1 suppository (150 mg paracetamol). The dose may be repeated if necessary, no more frequently than every 6 hours. Do not use more than 4 suppositories per day (maximum daily dose of paracetamol is 600 mg).

Patients with impaired renal function
In patients with severe renal impairment, the minimum interval between doses should follow the scheme below:

| Creatinine clearance | Dosing interval | |----------------------|-----------------| | CrCl ≥ 10 ml/min | 6 hours | | CrCl < 10 ml/min | 8 hours |

Patients with impaired hepatic function
In patients with impaired liver function, the dose should be reduced or the dosing intervals extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg b.w./day (and should not exceed 2 g/day):

• Adults weighing less than 50 kg,
• Chronic or compensated active liver disease, mild to moderate hepatic insufficiency,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• Chronic alcohol-related liver disease,
• Chronic malnutrition (low hepatic glutathione reserves),
• Dehydration.

Method of administration
Rectal administration. Suppositories are not recommended in children with diarrhoea.

Frequency of administration
Due to the potential for local irritant effects, suppositories should not be used more than 4 times daily.
Regular administration helps prevent periodic exacerbations of pain or fever.
In children, maintain regular 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. Do not use this medicine for longer than 3 days without consulting a doctor.

Overdose of Efferalgan
In case of overdose, contact a doctor immediately, even if no symptoms are present, as life-threatening liver damage may occur.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with alcohol-related liver disease, pre-existing liver disorders, and patients taking drugs that induce hepatic enzymes, as these patients are at increased risk of liver damage.
Overdose may cause symptoms appearing within several to several dozen hours, such as: nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, even though liver damage may already be developing, presenting as upper abdominal discomfort, recurrence of nausea, and jaundice.
Rare cases of acute pancreatitis have been observed.

Missed dose of Efferalgan
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, 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 occurrence of the side effects listed below is defined as:
Not known: frequency cannot be estimated from the available data.
Not known: increased liver aminotransferase activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of deep layers of skin and subcutaneous tissue), diarrhoea, abdominal pain; thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type of white blood cell); skin redness, rash, erythema or urticaria, purpura, acute generalised exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
*Very rare cases of hypersensitivity reactions requiring discontinuation of treatment (dyspnoea, bronchospasm, excessive sweating) have been reported.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Efferalgan

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Following this advice helps protect the environment.

6. Contents of the packaging and other information

What Efferalgan contains
The active substance is paracetamol. Each suppository contains 150 mg of paracetamol.
Other components: hard fat with additives, including lecithin derived from soybean oil.

What Efferalgan looks like and contents of the packaging
Suppository.
Packaging: 2 PVC/PE blisters in a cardboard box, each containing 5 suppositories.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Bulgaria, 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, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Bulgaria, country of export: 20020146
Parallel Import Authorisation Number: 256/24