Benalgin (Tablets) Instructions for Use

Marketing Authorization Holder

Balkanpharma-Dupnitsa, AD (Bulgaria)

ATC Code

N02BB52 (Metamizole sodium in combination with other drugs, excluding psycholeptics)

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Metamizole sodium (Rec.INN registered WHO)

Thiamine (Rec.INN registered WHO)

Dosage Form

Benalgin

Tablets 500 mg+50 mg+38.75 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat, white color, with a dividing line on one side.

Auxiliary substances : gelatin – 4 mg, wheat starch – 11 mg, microcrystalline cellulose – 45.75 mg, colloidal silicon dioxide – 2.5 mg, talc – 12 mg, magnesium stearate – 6 mg.

10 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Remedy for the relief of acute respiratory disease and “common cold” symptoms (non-narcotic analgesic + decongestant + vitamin)

Indications

• Symptomatic treatment of mild to moderate pain of various origins, including headache, toothache, musculoskeletal pain, and dysmenorrhea (menstrual pain).
• Reduction of fever (as an antipyretic) when other therapeutic measures are not effective.
• As part of the complex therapy for acute respiratory infections and the ” common cold” to alleviate associated symptoms such as pain and malaise.

The use of Benalgin should be for the shortest duration necessary to relieve symptoms, and it is not intended for long-term or prophylactic use without medical supervision.

Contraindications

• Hypersensitivity to metamizole sodium, other pyrazolone derivatives (e.g., phenylbutazone, propyphenazone), caffeine, thiamine, or any of the excipients listed in the composition.
• History of agranulocytosis or myelosuppression after previous use of metamizole or pyrazolone derivatives.
• History of blood dyscrasias such as aplastic anemia, neutropenia, or leukopenia.
• Hepatic porphyria or severe hepatic impairment.
• Severe renal impairment.
• Third trimester of pregnancy and during lactation.
• Concomitant use with other medications known to cause bone marrow suppression, such as certain chemotherapeutic agents.
• Children and adolescents under 15 years of age due to the risk of severe adverse reactions.

Benalgin is also contraindicated in patients with a history of bronchospasm induced by analgesics, particularly aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Dosage Regimen

The dosage must be individualized based on the severity of pain, fever, and the patient’s response. The lowest effective dose for the shortest possible duration should be used.

Adults and adolescents over 15 years of age: The usual dose is one tablet, 1 to 3 times a day. The tablets should be swallowed whole with a sufficient amount of liquid (e.g., a glass of water).

The maximum single dose is one tablet.The maximum daily dose should not exceed three tablets. The interval between doses should be at least 4-6 hours. Treatment should not be continued for more than 3 to 5 days for pain or 2 to 3 days for fever without medical review. If symptoms persist or worsen, a physician must be consulted.

Special Populations: For elderly patients and those with impaired renal or hepatic function, the dosage should be reduced or the dosing interval extended due to potentially reduced elimination of the active substances. A doctor should determine the appropriate dose for these patient groups. Benalgin is not recommended for use in children under 15 years of age.

Adverse Reactions

Adverse reactions are listed by system organ class and frequency. Frequency is defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:Agranulocytosis is a serious and potentially life-threatening reaction associated with metamizole. Its frequency is considered Not known. Symptoms may include sudden onset of fever, chills, sore throat, mouth ulcers, or infections. If these symptoms occur, the medication must be stopped immediately, and a doctor consulted. Other rare reactions include leukopenia, thrombocytopenia, and aplastic anemia.

Immune system disorders: Rarely, anaphylactic/anaphylactoid reactions including shock may occur. Uncommon reactions include allergic reactions such as skin rash, urticaria, and angioedema. Bronchospasm may occur, particularly in patients with a history of asthma.

Nervous system disorders: Common: Dizziness. Uncommon: Headache. The caffeine component may cause nervousness, restlessness, palpitations, or insomnia in some individuals, especially with high doses.

Cardiac disorders: Rarely, tachycardia and arrhythmias may occur, potentially related to the caffeine content.

Vascular disorders: A pronounced drop in blood pressure ( hypotension) may occur, particularly with intravenous use, but is also possible with high oral doses.

Gastrointestinal disorders: Uncommon: nausea, vomiting, abdominal pain.

Hepatobiliary disorders: Very rare: hepatitis.

Skin and subcutaneous tissue disorders: Uncommon: skin rash, urticaria. Rare: more severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported.

Renal and urinary disorders: Very rare: renal impairment including interstitial nephritis and acute renal failure. Discoloration of urine (reddish) may occur due to a metabolite of metamizole and is harmless.

If any adverse reaction becomes severe or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Drug Interactions

Concomitant use of Benalgin with other medications requires caution due to potential interactions. Inform your physician about all medicines you are taking, including prescription, over-the-counter, and herbal products.

Enhanced Myelosuppression: Concomitant use with other drugs that can suppress bone marrow function (e.g., cytostatic agents, chloramphenicol, phenylbutazone) may increase the risk of agranulocytosis and other blood dyscrasias. This combination is generally contraindicated.

Sedatives and CNS Depressants: Metamizole may potentiate the effects of sedatives (e.g., benzodiazepines) and tricyclic antidepressants.

Hypotensive Agents: Metamizole may enhance the effect of antihypertensive drugs (e.g., beta-blockers, diuretics, ACE inhibitors), potentially leading to a pronounced drop in blood pressure.

Cyclosporine: Metamizole may decrease the blood levels of cyclosporine, reducing its immunosuppressive efficacy. This requires close monitoring of cyclosporine levels.

Oral Anticoagulants (Warfarin, Acenocoumarol): Metamizole may potentiate the effect of coumarin derivatives, increasing the risk of bleeding. More frequent monitoring of INR is recommended if used concomitantly.

Cholestyramine: May reduce the absorption and efficacy of metamizole.

Caffeine-Related Interactions: The caffeine component may interact with other stimulants (e.g., theophylline), potentially increasing the risk of central nervous system and cardiovascular side effects. Conversely, drugs that inhibit caffeine metabolism (e.g., cimetidine, disulfiram, fluoroquinolone antibiotics) can increase caffeine levels and its associated effects.

Alcohol: Concurrent use with alcohol is not recommended as it may increase the risk of adverse effects, particularly gastrointestinal irritation and central nervous system depression.

Overdose

Symptoms: Symptoms of overdose are primarily related to the effects of metamizole sodium and caffeine. Overdose with metamizole may lead to nausea, vomiting, abdominal pain, severe hypotension, tachycardia, drowsiness, confusion, delirium, convulsions, and coma. Renal and hepatic toxicity may also occur. Due to the caffeine content, symptoms may also include restlessness, anxiety, tremor, palpitations, and arrhythmias. In severe cases, symptoms of agranulocytosis may develop several days after the overdose.

Management: There is no specific antidote for Benalgin overdose. Treatment is supportive and symptomatic. Gastric lavage or administration of activated charcoal may be considered if performed soon after ingestion. Monitoring of vital signs, electrolyte balance, and hematological parameters (complete blood count) is essential for several weeks. In case of severe hypotension, volume replacement and administration of vasopressors may be necessary. Hemodialysis may be considered in severe intoxication due to the dialyzability of metamizole metabolites. In case of suspected overdose, immediate medical attention should be sought, and the patient should be taken to a hospital.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.