GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Theophylline Extended-release Capsules 100mg
B. Theophylline Extended-release Capsules 200mg
C. Theophylline Extended-release Capsules 300mg
D. Theophylline Extended-release Capsules 400mg
B. Theophylline Extended-release Capsules 200mg
C. Theophylline Extended-release Capsules 300mg
D. Theophylline Extended-release Capsules 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Theophylline Extended-release Capsules 100mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………100mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells.
B. Theophylline Prolonged-Release Capsules 200mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline ………200mg
Excipients……………………………………………………q.s
Approved colours used in capsule shells.
C. Theophylline Prolonged-Release Capsules 300mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………300mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells.
D. Theophylline Prolonged-Release Capsules 400mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………….400mg
Excipients…………………………………………………………...q.s
Approved colours used in capsule shells.
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………100mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells.
B. Theophylline Prolonged-Release Capsules 200mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline ………200mg
Excipients……………………………………………………q.s
Approved colours used in capsule shells.
C. Theophylline Prolonged-Release Capsules 300mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………300mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells.
D. Theophylline Prolonged-Release Capsules 400mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………….400mg
Excipients…………………………………………………………...q.s
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Theophylline Extended-release Capsules 400mg Technical Specification:
| Product Name: | Theophylline Extended-release Capsules |
| Brand Name: | Generic |
| Strength: | (100mg), (200mg), (300mg), (400mg) |
| Dosage Form: | Capsules (Hard-gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Asthmatic |
| Indication: | Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Theophylline Extended-release Capsules 100mg
- Theophylline Extended-release Capsules 200mg
- Theophylline Extended-release Capsules 300mg
- Theophylline Extended-release Capsules 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Theophylline Extended-release Capsules 100mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………100mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells.
- Theophylline Prolonged-Release Capsules 200mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline ………200mg
Excipients……………………………………………………q.s
Approved colours used in capsule shells. - Theophylline Prolonged-Release Capsules 300mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………300mg
Excipients……………………………………………………….q.s
Approved colours used in capsule shells. - Theophylline Prolonged-Release Capsules 400mg
Each Hard-gelatin Capsule contains:
Theophylline USP
Equivalent to Anhydrous Theophylline …………….400mg
Excipients……………………………………………………………q.s
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
