Gofen 400 soft capsules 400 mg, 60 pcs

Indication

Gofen 400 soft capsules are indicated for the symptomatic treatment of headache, dental pain, menstrual pain and fever.

Composition

Active ingredient: ibuprofen.
One soft capsule contains 400 mg ibuprofen.

Excipients: polyethylene glycol 600, potassium hydroxide, purified water.
Capsule shell: gelatin, sorbitol non-crystallising solution (E420), purified water.

Contraindications

• Hypersensitivity to ibuprofen or any component of the product.
• Bronchospasm, asthma, rhinitis or skin reactions associated with acetylsalicylic acid or other NSAIDs.
• History of gastrointestinal bleeding or perforation after NSAID use.
• Active peptic ulcer disease or history of recurrent ulcers/bleeding (two or more distinct episodes).
• Severe renal, cardiac, or hepatic failure.
• Concurrent use with other NSAIDs, including selective COX-2 inhibitors.

Dosage and Administration

Recommended for adults and children over 12 years of age.

Initial dose: 1–2 soft capsules (200–400 mg). If necessary, repeat 1–2 capsules (200–400 mg) every 4–6 hours. Do not take more than 6 capsules in 24 hours. Maximum daily dose: 1200 mg.

Take capsules with food, swallow whole with water. Elderly patients do not normally require dose adjustment.

If symptoms persist for more than 3 days, consult a physician to confirm the diagnosis and adjust treatment.

Special Precautions

Pregnancy

During the first and second trimesters, ibuprofen should be used only if the clinician judges the expected benefit to the mother outweighs the potential risk to the fetus. Ibuprofen is contraindicated in the third trimester.

Children

Contraindicated in children under 12 years.

Driving and Operating Machinery

Short-term use does not affect, or has negligible effect on, the ability to drive or operate machines.

Overdose

Symptoms may include nausea, vomiting, abdominal pain, headache, dizziness, drowsiness, nystagmus, visual disturbances, tinnitus, and rarely hypotension, metabolic acidosis, renal failure, and loss of consciousness.

Treatment is symptomatic and supportive and aims to maintain vital functions until recovery. Gastric lavage and oral activated charcoal are recommended within 1 hour after ingestion of a potentially toxic dose (over 400 mg/kg). There is no specific antidote.

Side Effects

General and immune system: Uncommon severe hypersensitivity reactions (angioedema, facial/tongue/larynx swelling, dyspnea, tachycardia, hypotension, anaphylactic shock), aseptic meningitis. Exacerbation of asthma and bronchospasm may occur.

Interactions

• Digoxin: plasma levels of both drugs may increase.
• Corticosteroids: increased risk of gastrointestinal bleeding or ulceration.
• Antithrombotic agents: increased risk of gastrointestinal bleeding.
• Anticoagulants (e.g., warfarin): NSAIDs may potentiate anticoagulant effects.
• Antiplatelet agents and SSRIs: concomitant use may increase the risk of gastrointestinal bleeding.

Storage

Store at temperatures not exceeding 25 °C in the original packaging. Keep out of the reach of children.

Shelf life: 2 years.