Efferalgan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

EFFERALGAN

500 mg, effervescent tablets

Paracetamol

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 directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If pain does not improve in adults after 5 days, or if symptoms of cold and flu or fever persist after 3 days, and in children and adolescents if pain, symptoms of cold and flu, or fever do not improve after 3 days, or if the patient's condition worsens, they should consult 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 properties. It reduces elevated body temperature that occurs during illness, without lowering normal body temperature. Paracetamol is less irritating to the stomach lining 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.

2. Important information before taking Efferalgan

When not to take Efferalgan

• in children with a body weight of less than 17 kg,
• in women during the first trimester of pregnancy,
• in the case of concomitant use with painkillers with agonist-antagonist action: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

Before starting treatment with Efferalgan, the patient should discuss it with their doctor, pharmacist, or nurse.

Efferalgan contains paracetamol and should be used taking into account the concomitant use of other medicines containing paracetamol (including those available on prescription or over-the-counter), so as not to exceed the recommended daily dose (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. The patient should inform their doctor about skin reactions and stop taking the medicine in case of skin rash or any other sign of hypersensitivity.

The patient should consult their doctor before taking Efferalgan if they have any of the following conditions:

• liver function disorders, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic liver disease, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, or body wasting,
• prolonged malnutrition,
• low glutathione reserves in the liver associated with, for example, appetite disorders, cystic fibrosis, HIV infection, in patients who are starving or wasting, with sepsis,
• dehydration,
• hypovolemia (reduced blood volume).

Efferalgan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Concomitant use of Efferalgan may alter the effects of the following medicines or the use of the following medicines may alter the effects of Efferalgan:

• MAO inhibitors - should not be used 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 painkiller also used in febrile conditions) - concomitant use prolongs the elimination of paracetamol.
• Medicines that increase liver metabolism - concomitant 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 "Using a higher dose of Efferalgan than recommended" in section 3). Caution should be exercised when using concomitantly.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when using concomitantly with these medicines.
• Non-steroidal 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 may increase the frequency of monitoring INR values during concomitant use, as well as for a week after discontinuing 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, large doses of paracetamol and (or) long-term doses of paracetamol should be avoided. Patients should be constantly monitored for signs of liver damage.
• Probenecid (a medicine used in gout) - reduces the excretion of paracetamol. When used concomitantly 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 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.

The patient should inform their doctor about the use of this medicine if the doctor prescribes a test for uric acid or blood sugar.

Using Efferalgan with alcohol

While taking this medicine, the patient 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 individuals who are starving and regularly drink alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Efferalgan can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time.

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, the patient should consult their doctor.

There is no sufficient data to indicate whether paracetamol affects 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 412.4 mg of sodium (the main component of table salt). This corresponds to 21% of the maximum recommended daily dose of sodium in the diet for adults. If the patient takes 1 or more effervescent tablets per day for a long time, they should consult their doctor or pharmacist, especially if they are controlling their sodium intake.

Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body does not break down fructose), they should consult 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, 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

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 old)

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 the case of severe pain, the daily dose can be increased to a maximum of 4 g of paracetamol (8 effervescent tablets per day). The patient 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 old): 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 old): 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 old): the single dose is 500 mg (one effervescent tablet), which can be repeated every 6 hours if necessary. Do not take 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 schedule:

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 Efferalgan 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 adults with a body weight below 50 kg,
• in chronic or compensated active liver disease, especially mild to moderate liver failure,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholic liver disease,
• prolonged malnutrition,
• dehydration.

Method of administration

Oral administration. The 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

Regular use of the medicine allows for the prevention of periodic exacerbations of pain or fever:

• in children, a regular interval should be maintained 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 for 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.

Taking a higher dose of Efferalgan than recommended

In case of taking too high a dose or accidentally taking Efferalgan, the patient should contact their doctor for advice.

Overdose is particularly dangerous in the elderly, small children, patients who are malnourished, have liver disease, and patients taking medicines that induce liver enzymes, as these individuals are at 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 10 tablets (5 g of paracetamol) or more, the patient should induce vomiting if it has been less than an hour since ingestion and immediately contact their doctor. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. The patient should seek medical advice immediately.

Missing a dose of Efferalgan

Do not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Efferalgan 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), decreased or increased INR (blood clotting factor) values.

Very rare, treatment-requiring cases of hypersensitivity reactions have been reported:

skin redness, 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, skin itching and 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 entire body or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or bursting giant blisters, extensive skin erosions, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

phone: +48 (22) 49 21 301

fax: +48 (22) 49 21 309

website: https://smz.ezdrowie.gov.pl.

By reporting side effects, more information can be gathered on the safety of the 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. The patient should ask their 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:

The packaging contains 8 or 16 effervescent tablets in soft Al/LDPE blisters in a cardboard box.

To obtain more detailed information, the patient 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

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Spanish authorization number: 933564.9

Parallel import authorization number: 111/23

Date of leaflet approval: 12.06.2023

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