- Approval Id
- 5da3bdbcff30d017
- Drug Name
- Spedifen Film Coated Tablet 400mg
- Product Name
- Spedifen Film Coated Tablet 400mg
- Approval Number
- SIN14169P
- Approval Date
- 2012-06-21
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **Dosage and administration**
Adults: 400 mg tablets: 2–4/day according to medical advice. The maximum daily dose should not exceed 1600 mg.
In the treatment of elderly patients, the posology should be carefully established by the doctor, who has to consider a possible reduction in the above mentioned dosages.
The tablet should be swallowed with some water.
- Route Of Administration
- ORAL
- Indication Info
- **Indication**
For symptomatic relief of pain such as headache including migraine, toothache, and dysmenorrhoea.
- Contraindications
- **Contraindications**
Patients who have previously shown hypersensitivity to the drug or to any of the excipients. Patients with active peptic ulceration or a history of peptic ulceration; active gastro intestinal bleeding; active cerebrovascular bleeding; ulcerative colitis, hemorrhagic diathesis; severe hepatic and/or renal impairment. Severe heart failure (NYHA III–IV). Third trimester of pregnancy. Since cross reactivity, between acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) has been reported, SPEDIFEN is contraindicated in patients in whom aspirin and other NSAIDs induced allergic reactions such as asthma, urticaria, rhinitis, nasal polyps, angioedema. Patients with systemic lupus erythematosus and with collagen diseases must consult the physician before use SPEDIFEN.
- Atc Code
- M01AE01
- Atc Item Name
- ibuprofen
- Pharma Manufacturer Name
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Company Detail Path
- /organization/united-italian-trading-corporation-private-limited
