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PROSCAR Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

PROSCAR 5mg film-coated Tablets (finasteride).

Qualitative and quantitative composition

Each tablet contains 5 mg of finasteride.

Pharmaceutical form

Blue-coloured, apple-shaped, film-coated tablets marked Proscar on one side and MSD 72 on the other.

Therapeutic indications

Proscar is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to: Cause regression of the enlarged prostate, improve urinary flow and improve ...

Posology and method of administration

The recommended adult dose is one 5 mg tablet daily, with or without food. Proscar can be administered alone or in combination with the alpha-blocker doxazosin (see section 5.1 Pharmacodynamic properties ...

Contraindications

Proscar is not indicated for use in women or children. Proscar is contraindicated in the following: Hypersensitivity to any component of this product. Pregnancy Use in women when they are or may potentially ...

Special warnings and precautions for use

General To avoid obstructive complications it is important that patients with large residual urine and/or heavily decreased urinary flow are carefully controlled. The possibility of surgery should be an ...

Interaction with other medicinal products and other forms of interaction

No drug interactions of clinical importance have been identified. Finasteride is metabolized primarily via, but does not appear to affect significantly, the cytochrome P450 3A4 system. Although the risk ...

Pregnancy and lactation

Pregnancy Proscar is contra-indicated in women when they are or may potentially be pregnant (see 4.3 Contraindications). Because of the ability of Type II 5 α-reductase inhibitors to inhibit conversion ...

Effects on ability to drive and use machines

There are no data to suggest that Proscar affects the ability to drive or use machines.

Undesirable effects

The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients. The ...

Overdose

No specific treatment of overdosage with Proscar is recommended. Patients have received single doses of Proscar up to 400 mg and multiple doses of Proscar up to 80 mg/day for up to three months without ...

Pharmacodynamic properties

Finasteride is a competitive inhibitor of human 5 α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia ...

Pharmacokinetic properties

After an oral dose of <sup>14</sup>C-finasteride in man, 39% of the dose was excreted in the urine in the form of metabolites (virtually no unchanged drug was excreted in the urine), and 57% of total dose ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and carcinogenic potential. Reproduction toxicology studies in male rats have ...

List of excipients

Cellulose, Microcrystalline (E460) Docusate sodium Lactose monohydrate Magnesium stearate (E572) Pregelatinised maize starch Sodium starch glycollate Type A Yellow iron oxide (E172) Hydroxypropylcellulose ...

Incompatibilities

None reported.

Shelf life

Shelf life: Three years.

Special precautions for storage

Do not store above 30°C. Store in the original package.

Nature and contents of container

Opaque PVC/PE/PVDC blisters lidded with aluminium foil; packs of 28 tablets.

Special precautions for disposal and other handling

Women should not handle crushed or broken Proscar Tablets when they are or may potentially be pregnant (see 'Contra-indications, Pregnancy and lactation, Exposure to finasteride risk to male foetus). ...

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Marketing authorization number(s)

PL 0025/0279

Date of first authorization / renewal of the authorization

July 1997

Date of revision of the text

19 June 2018

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