Efferalgan forte

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
EFFERALGAN FORTE (DAFALGAN 1 g)
1 g, effervescent tablets
Paracetamolum
EFFERALGAN FORTE and DAFALGAN 1 g are different trade names for the same medicine.
Please read this leaflet carefully 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.

• Keep this leaflet, so 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If in adults pain persists for more than 5 days or fever for more than 3 days, and in adolescents if pain or fever persists for more than 3 days, or if the patient feels worse, consult a doctor.

Table of contents

1. What Efferalgan Forte is and what it is 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 pack and other information

1. What Efferalgan Forte is and what it is used for

Efferalgan Forte is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature occurring during illness, but does not lower normal body temperature.
Paracetamol irritates the gastric mucosa to a lesser extent than salicylates.
Indications:

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgias, and others).
• Fever.

2. Important information before using Efferalgan Forte

When not to use Efferalgan Forte

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in individuals with body weight less than 50 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active, decompensated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase deficiency,
• if the patient is being treated with MAO inhibitors (medicines used e.g. for depression) and within 14 days after stopping such treatment,

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• when used concomitantly with analgesics having agonist-antagonist activity: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions
Before starting to use Efferalgan Forte, discuss this with your doctor, pharmacist or nurse.
Due to the content of 1 g paracetamol per effervescent tablet, Efferalgan Forte should not be used in children and adolescents under 15 years of age.
Efferalgan Forte contains paracetamol and should be used taking into account the simultaneous intake of other medicines containing paracetamol (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3).
Do not use doses higher than recommended. Using higher than recommended doses poses a risk of severe liver damage. Symptoms of liver injury usually appear one to two days after paracetamol overdose, with maximum severity typically occurring on days 3–4.
Paracetamol may cause serious skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor about any skin reactions and discontinue use of the medicine if a skin rash or any other sign of hypersensitivity occurs.
Consult a doctor before using Efferalgan Forte if the patient has any of the following conditions:

• liver function disorders, including Gilbert’s syndrome (hereditary hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic disease, excessive alcohol consumption (drinking 3 or more alcoholic drinks daily),
• anorexia, bulimia or physical wasting,
• prolonged malnutrition,
• low glutathione reserves in the liver due to, for example, eating disorders, cystic fibrosis, HIV infection, fasting or wasting, sepsis,
• dehydration,
• hypovolemia (reduced circulating blood volume).

Efferalgan Forte and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Concurrent use of Efferalgan Forte may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan Forte taken simultaneously:

• MAO inhibitors – do not use concurrently with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of excitation and high fever.
• Medicines containing salicylamide (an analgesic also used in fever) – concurrent use prolongs the elimination time of paracetamol.
• Medicines increasing hepatic metabolism – concurrent use of paracetamol with medicines such as St. John’s wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used (see “Use of doses higher than recommended of Efferalgan Forte” in section 3). Caution is advised during concomitant use.

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• Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised during concomitant use with these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.
• Oral anticoagulants – concurrent 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 INR monitoring during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. During phenytoin treatment, avoid high and/or long-term use of paracetamol. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces the excretion of paracetamol. During concomitant use with paracetamol, the doctor may consider reducing the paracetamol dose.
• Flucloxacillin – caution is advised when using flucloxacillin simultaneously with paracetamol due to increased risk of developing blood and body fluid disorders (metabolic acidosis with high anion gap), especially in patients with risk factors for glutathione deficiency such as severe kidney dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with 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 levels.
Use of Efferalgan Forte with alcohol
Do not drink alcohol or take medicines containing alcohol while using this medicine, due to increased risk of toxic liver damage. The risk of liver damage is particularly high in fasting individuals and those who regularly consume alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Efferalgan Forte may be administered to pregnant women if necessary. Use the lowest effective dose sufficient to relieve pain or reduce fever, and take the medicine for the shortest possible duration.
If pain is not relieved or fever does not subside, or if increased frequency of dosing becomes necessary, consult a doctor.
There are insufficient data available to determine whether paracetamol affects fertility.
Driving and operating machinery
Efferalgan Forte does not affect psychomotor performance. There are no contraindications to driving vehicles or operating machinery.
Efferalgan Forte contains sodium, sorbitol and sodium benzoate
Each effervescent tablet contains 567 mg of sodium (main component of table salt). This corresponds to 28% of the maximum recommended daily sodium intake in the adult diet. Patients, especially those monitoring dietary sodium intake, who take 1 or more effervescent tablets daily over a long period, should consult their doctor or pharmacist.
Each effervescent tablet contains 252 mg of sorbitol. Sorbitol is a source of fructose. If intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient’s body cannot break down fructose) has been diagnosed in the patient (or their child), the patient should consult a doctor before taking the medicine or giving it to a child.
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Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan Forte 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 used this medicine during pregnancy.

3. How to use Efferalgan Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, 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 (b.w.) every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg b.w. The total daily dose of paracetamol must not exceed 4 g.

Recommended dose:
Adults and adolescents with body weight above 50 kg (aged over 15 years)
The recommended single dose of Efferalgan Forte is 1 effervescent tablet (1 g paracetamol), every 4 to 6 hours, up to 3 times daily, not exceeding 3 effervescent tablets (3 g paracetamol) in total. However, in the case of severe pain, the dose may be increased to the maximum daily dose of 4 g paracetamol (4 effervescent tablets). There must always be at least a 4-hour interval between doses.

Elderly patients
There is no need to modify the dose.

Patients with renal function impairment
For patients with impaired renal function, the recommended single dose is 500 mg, and the minimum interval between doses should follow the scheme below:

| 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 renal function impairment, as reduced doses are required in these patients. Efferalgan 500 mg effervescent tablets are available for such cases.

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

• adults with 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 alcohol-related disease,
• prolonged malnutrition (low glutathione reserves in the liver),
• dehydration.

Method of administration
Oral use.
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Dissolve the tablet in a glass of water and drink the prepared solution. Do not chew or swallow the tablets whole.

Frequency of use
Regular use of the medicine helps prevent periodic exacerbations of pain or fever.
The interval between doses should be 6 hours and must in no case be shorter than 4 hours.

Duration of use
In adults, do not use this medicine for longer than 5 days without medical advice, or for fever for longer than 3 days. In adolescents, never use the medicine for longer than 3 days.

Use of a higher than recommended dose of Efferalgan Forte
If an excessive dose is taken or Efferalgan Forte is taken by mistake, contact a doctor immediately for appropriate advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with alcohol-related disease, liver disorders, and patients taking drugs that induce liver enzymes, as these patients have an increased risk of liver damage.
Overdose may cause symptoms within a few to several 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, manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.

In any case of single intake of 5 g or more of paracetamol, induce vomiting if less than one hour has passed since ingestion, and contact a doctor immediately. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water. Seek immediate medical advice.

Missed dose of Efferalgan Forte
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions 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, hypotension (low blood pressure), increased liver aminotransferase activity.

Very rare: hypersensitivity reactions, tachycardia, diarrhoea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of white blood cell), decreased or increased INR values (blood coagulation index).

Very rare, treatment-requiring cases of hypersensitivity reactions have been reported: skin redness, rash, erythema or urticaria, angioedema (swelling of deep skin layers and subcutaneous tissue), dyspnoea, bronchospasm, excessive sweating, hypotension up to symptoms of anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: dyspnoea, laryngeal and pharyngeal oedema, skin itching and redness, headache, sensation of "tightness", dizziness, significant weakness, up to loss of consciousness; in severe cases may be life-threatening), as well as Quincke's oedema, severe skin reactions: acute generalized pustular rash over the entire body or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing giant blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Efferalgan Forte

Store below 25°C.
Keep the medicine out of sight and reach of children.
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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Efferalgan Forte contains

• The active substance is paracetamol. Each effervescent tablet contains 1 g of paracetamol.
• Other components of the medicine are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium lauryl sulfate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan Forte looks like and contents of the pack
Effervescent tablet
Pack: Al/PE foil containing 8 tablets, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Portugal, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
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Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Portugal, country of export: 3852183
Parallel Import Licence Number: 317/22
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