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Proscar 5mg Tablets

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Product Summary

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.