Efferalgan forte

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

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

Contents of the leaflet:

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 an analgesic and antipyretic medicine. It reduces elevated body temperature associated with 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, neuralgia, 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 below 50 kg,
• in women during the first trimester of pregnancy,
• in patients with severe hepatic insufficiency or active, decompensated liver disease,
• in patients with glucose-6-phosphate dehydrogenase deficiency,
• in patients being treated with MAO inhibitors (medicines used e.g. in depression) and within 14 days after discontinuation of such treatment,
• when used concomitantly with mixed agonist-antagonist analgesics: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions
Before starting to use Efferalgan Forte, discuss it 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 with caution considering 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. Use of doses exceeding the recommended may result in a risk of severe liver damage. Symptoms of liver injury usually appear one to two days after paracetamol overdose, with maximum severity typically occurring around 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 if skin reactions occur and discontinue use of the medicine immediately if a skin rash or any other sign of hypersensitivity develops.
Consult your doctor before using Efferalgan Forte if the patient has any of the following conditions:

• liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcohol-related disease or excessive alcohol consumption (ingestion of 3 or more alcoholic drinks daily),
• anorexia, bulimia, or physical wasting,
• prolonged malnutrition,
• low glutathione reserves in the liver due to e.g. eating disorders, cystic fibrosis, HIV infection, in fasting or wasted patients, or in sepsis,
• dehydration,
• hypovolemia (reduced circulating blood volume).

Efferalgan Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Concomitant use of Efferalgan Forte may alter the effect of the following medicines, or the use of these medicines may alter the effect of Efferalgan Forte:

• MAO inhibitors – do not use concomitantly with MAO inhibitors or within 2 weeks after discontinuation of such treatment due to the risk of excitation and high fever.
• Medicines containing salicylamide (an analgesic also used in fever) – concomitant use prolongs the elimination time of paracetamol.
• Medicines enhancing hepatic metabolism – concomitant 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.
• Isoniazid (used in tuberculosis) and zidovudine (an antiviral agent used in HIV infection) – caution is advised during concomitant use 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 coumarin-type anticoagulants, including warfarin, may lead to minor changes in INR values. In such cases, the doctor may increase the frequency of INR monitoring during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. During phenytoin treatment, avoid high and/or prolonged doses of paracetamol. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces paracetamol elimination. During concomitant use with paracetamol, the doctor may consider reducing the paracetamol dose.
• Flucloxacillin – caution is advised when using flucloxacillin concomitantly with paracetamol due to increased risk of developing blood and body fluid disorders (metabolic acidosis with a high anion gap), particularly in patients with risk factors for glutathione deficiency such as severe kidney dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with a high anion gap is a serious condition requiring urgent treatment.

Inform your doctor that you are using this medicine if your doctor orders tests for blood 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 effects on fertility
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.
Efferalgan Forte may be administered to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and use the medicine for the shortest possible duration.
If pain is not relieved or fever does not subside, or if increased dosing frequency becomes necessary, consult a doctor.
There are insufficient available data to determine whether paracetamol affects fertility.
Driving and operating machinery
Efferalgan Forte does not affect psychomotor performance. There are no contraindications to driving or operating machinery.
Efferalgan Forte contains sodium, sorbitol, and sodium benzoate
Each effervescent tablet contains 567 mg of sodium (the main component of table salt), equivalent to 28% of the maximum recommended daily dietary sodium intake for adults. Patients, especially those monitoring their dietary sodium intake, who take 1 or more effervescent tablets daily over a prolonged period, should consult their doctor or pharmacist.
Each effervescent tablet contains 252 mg of sorbitol. Sorbitol is a source of fructose. If fructose intolerance 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. 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 used 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 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 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
In 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 impaired renal function, as reduced doses are required in these patients. Efferalgan Forte 500 mg effervescent tablets are available for use.

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 insufficiency, Gilbert's syndrome (familial non-haemolytic hyperbilirubinaemia),
• Chronic alcohol-related disease,
• Prolonged malnutrition (low glutathione reserves in the liver),
• Dehydration.

Method of administration
Oral use.
The tablet should be dissolved in a glass of water and the resulting solution drunk. Do not chew or swallow the tablets.

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, do not use the medicine for longer than 3 days.

Use of a higher than recommended dose of Efferalgan Forte
If an overdose is taken or the medicine is taken by mistake, contact a doctor immediately for appropriate advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, patients with alcohol-related disease, liver diseases, and patients taking medicines that induce liver enzymes, as these patients are at 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, vomiting should be induced if less than one hour has passed since ingestion, and immediate medical advice should be sought. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water. Immediate medical advice must be sought.

Missed dose of Efferalgan Forte
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, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The frequency of occurrence of the adverse 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, 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), decrease or increase in INR values (blood coagulation index).

Very rare cases of hypersensitivity reactions requiring discontinuation of treatment 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 swelling, skin itching and redness, headache, feeling of "tightness", dizziness, significant weakness, up to loss of consciousness; in severe cases may be life-threatening) and Quincke's edema, severe skin reactions: acute generalized pustular rash over the entire body or blisters and erosions on the skin, in the oral cavity, eyes and genital organs, fever and joint pain, or rupturing giant blisters, extensive skin erosions, shedding of large epidermal sheets, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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, e-mail: https://smz.ezdrowie.gov.pl.
Reporting of adverse effects allows the collection of further information on the safety of the medicine.

5. How to store Efferalgan Forte

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the carton. 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. Such measures 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 ingredients 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: 8 effervescent tablets in an Al/PE foil pack, inside a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Spain, country of export:
UPSA SAS
3, Rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer:
UPSA
304, Av. Dr Jean Bru
47000 Agen
France
UPSA
979, Avenue des Pyrénées
47520 Le Passage
France
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorization Number in Spain, country of export: 671990.9
866947.9
Parallel Import Authorization Number: 84/23