PROSCAR Film-coated tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
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
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: