- Approval Id
- 191733a4793f5a83
- Drug Name
- SPEDIFEN 400 SACHET 400 MG/SACHET
- Product Name
- SPEDIFEN 400 SACHET 400 MG/SACHET
- Approval Number
- SIN10707P
- Approval Date
- 1999-01-25
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GRANULE, FOR SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
<strong>Adults:</strong><br>
2–4 sachets/day according to medical advice.<br>
The maximum daily dose should not exceed 1600 mg.<br>
The administration should be taken during or after meals.<br>
In elderly the posology must be carefully assessed by the physician since a reduction of the above mentioned dosage may be needed.<br>
The content of each sachet must be dissolved in a glass of water (50–100 ml) and immediately taken.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
For symptomatic relief of pain: such as headache including migraine, toothache, dysmenorrhoea, sign and symptom of rheumatoid arthritis.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Patients who have previously shown hypersensitivity to the components of the drug. Patients with active peptic ulceration or a history of peptic ulceration; active gastrointestinal bleeding; active cerebrovascular bleeding; ulcerative colitis; hemorrhagic diathesis; severe hepatic and/or renal impairment. Severe heart failure (NYHA IV). Since cross reactivity, between aspirin and other non-steroidal anti-inflammatory drugs have been reported, SPEDIFEN® is contraindicated in patients in whom aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) have induced allergic reactions such as asthma, rhinitis, nasal polyps, angioedema. Patients with systemic lupus erythematosus and with collagen diseases must consult the physician before using SPEDIFEN®. SPEDFEN® contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria. The use of ibuprofen during pregnancy and lactation should be avoided.</p>
- 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
