Stopadol Forte 1000 mg 10 sachets

Stopadol Forte 1000 mg 10 sachets

Stopadol Forte, 1000 mg, 10 sachets.

Composition:

Each sachet contains:
Paracetamol — 1 g.
Excipients: sodium bicarbonate, anhydrous citric acid, sodium carbonate, aspartame, sodium saccharin, orange flavor, absolute ethanol.

Product Description:

Analgesic and antipyretic medicine.
Paracetamol provides pain relief and fever reduction primarily through inhibition of prostaglandin synthesis in the central nervous system and modulation of the hypothalamic thermoregulatory center.
It promotes peripheral vasodilation, sweating, and heat loss.

Indications for Use:

Symptomatic treatment of moderate pain (musculoskeletal pain, osteoarthritis, rheumatoid arthritis, headache, toothache, dysmenorrhea).
Febrile conditions.

Method of Administration and Dosage:

• Adults and children over 15 years: 1 sachet (1 g paracetamol) dissolved in a glass of water, 3–4 times daily.
• Minimum interval between doses: 4 hours. Maximum daily dose: 4 g (4 sachets).
• Severe renal impairment (creatinine clearance <10 ml/min): interval between doses at least 8 hours.
• Hepatic impairment: contraindicated.
• Elderly patients: reduce dose by 25% due to prolonged half‑life.
• Chronic alcoholics: maximum 2 g/day.
• Oral administration: dissolve contents in half a glass of water, allow effervescence to subside before intake.

Contraindications:

Hypersensitivity to paracetamol or excipients.
Liver disease or viral hepatitis (risk of hepatotoxicity).

Precautions:

• Contains aspartame (source of phenylalanine) — contraindicated in phenylketonuria.
• Use cautiously in patients with anemia, heart or lung disease, renal impairment.
• Possible bronchospasm in aspirin‑sensitive asthmatics (cross‑reaction).
• Reassess clinical condition if pain persists >10 days or fever >3 days.
• Drug interactions: oral anticoagulants (warfarin, acenocoumarol), alcohol, anticonvulsants (phenytoin, phenobarbital, primidone), chloramphenicol, estrogens, loop diuretics, isoniazid, lamotrigine, probenecid, propranolol, rifampicin, anticholinergics, zidovudine.

Adverse Reactions / Side Effects:

Rare: hypersensitivity reactions, elevated liver enzymes, hepatotoxicity (jaundice), hypoglycemia.
Hematologic: thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia.
Hypotension, sterile pyuria.

Pregnancy and Lactation:

Pregnancy: large data sets show no fetal toxicity or congenital defects. Use only when clinically necessary, at the lowest effective dose, for the shortest duration.
Lactation: no adverse effects reported.

Storage Conditions:

Store at temperatures not exceeding 30 °C, in a dry place.
Keep out of reach of children.

Packaging:

Carton box containing 10 aluminum sachets (each 4.16 g powder) and a leaflet.