Finasteride 5mg Tablets
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1. Trade Name of the Medicinal Product
Proscar Tablets Finasteride 5mg Tablets
2. Qualitative and Quantitative Composition
Finasteride 5mg
3. Pharmaceutical Form
Coated tablet
Clinical Particulars
4.1. Therapeutic Indications As per UK PL No: 00025/0279
4.2. Posology and Method of Administration
As per UK PL No: 00025/0279
4.3. Contra-indications
As per UK PL No: 00025/0279
4.4. Special Warnings and Precautions for Use
As per UK PL No: 00025/0279
4.5. Interactions with other Medicaments and other forms of Interaction
As per UK PL No: 00025/0279
4.6. Pregnancy and Lactation
As per UK PL No: 00025/0279
4.7. Effects on Ability to Drive and Use Machines
As per UK PL No: 00025/0279
4.8. Undesirable Effects
As per UK PL No: 00025/0279
4.9. Overdose
As per UK PL No: 00025/0279
Pharmacological Properties
5.1. Pharmacodynamic Properties As per UK PL No: 00025/0279
5.2. Pharmacokinetic Properties
As per UK PL No: 00025/0279
5.3. Preclinical Safety Data
Not stated.
Pharmaceutical Particulars
6.1. List of Excipients
As per ECMA No: 748772 issued by Spain
6.2. Incompatibilities
As per UK PL No 00025/0279
Shelf Life
6.3.
None stated.
6.4. Special Precautions for Storage
Store in a dry place in a closed container, protected from light, crushed or broken tablets should not be handled by women who are or may become pregnant.
6.5. Nature and Contents of Container
Blister strips in a printed carton.
Pack size: 28
6.6. Instruction for Use/Handling
None stated.
Administrative Data
7. Marketing Authorisation Holder
Chemilines Limited Unit 18, Fleetway West Business Park, 14 -16 Wadsworth Road Perivale
Middlesex UB6 7LD
8. Marketing Authorisation Number
PLPI 08747/0121
9. Date of First Authorisation/Renewal of Authorisation
28 July 1995
10. Date of (Partial) Revision of the Text
None stated.