Finasteride Sandoz

Finasteride Sandoz

finasteride

Manufacturer:

Sandoz

Distributor:

Zuellig
Full Prescribing Info
Contents
Finasteride.
Description
Finasteride Sandoz contains the following exipients: Tablet Core: Lactose monohydrate, microcrystalline cellulose, pregelatinised starch, lauroyl macrogol glyceride, sodium starch glycolate (type A) and magnesium stearate. Tablet Coating: Hypromellose, titanium dioxide (E171), red and yellow iron oxide (E172) and macrogol 6000.
Action
Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a particular hormone called dihydrotestosterone (DHT). Dihydrotestosterone contributes to shortening of the growth phase of the hair and to thinning of the hair.
In the scalp, Finasteride Sandoz specifically lowers the levels of DHT by blocking an enzyme (type II 5-α reductase) that converts testosterone to DHT. Only men with mild to moderate, but not complete hair loss or bitemporal recession can expect to benefit from the use of Finasteride Sandoz. In most of the men treated with Finasteride Sandoz for 5 years, the progression of hair loss was slowed, and at least 1/2 of these men also had some kind of improved hair growth.
Indications/Uses
Treatment of androgenetic alopecia (male pattern hair loss) in male 18-41 years.
Dosage/Direction for Use
Usual Dose: 1 tablet daily. Do not change the dose or discontinue treatment without informing physician.
Finasteride Sandoz does not work any quicker or better if it is taken >1 daily. To achieve increased hair thickness or decreased hair loss, it has to be taken daily for ≥3-6 months. Assess whether the treatment with Finasteride Sandoz has benefited the patient. No change in normal hair care routine is needed during treatment with Finasteride Sandoz.
Consult the physician or pharmacist if the effect of Finasteride Sandoz is too weak or too strong.
Missed Dose: Do not take a double dose to make up for a forgotten dose. Continue the treatment at the usual dose at the next scheduled time.
Discontinuation of Treatment: In order to maintain the benefit of treatment, continuous use of Finasteride Sandoz is recommended. If treatment is discontinued, any increased hair thickness gained during treatment will probably be lost within 9-12 months.
Administration: The tablets should be swallowed whole with some water (eg, 1 glass of water). It must not be crushed or divided. Finasteride Sandoz can be taken with or without food.
Overdosage
If the patient has taken too many tablets, contact the physician or hospital for advice.
Contraindications
Hypersensitivity to finasteride or to any of the other excipients of Finasteride Sandoz.
Finasteride is for use in men only and should not be taken by women or children (<18 years). It has also been found to be ineffective in the treatment of hair loss (androgenetic alopecia) in women in clinical studies.
Finasteride should not be taken by men who are taking other medicinal product containing finasteride, or any other 5α-reductase inhibitor for benign prostatic hyperplasia or any other condition.
Use in pregnancy & lactation: Finasteride Sandoz must not be taken by women. Women who are or may potentially be pregnant must not handle finasteride, especially if broken or crushed. If finasteride is absorbed through the skin or taken by mouth by women pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which helps to prevent contact with finasteride provided the tablets are not broken or crushed.
When the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (eg, by use of a condom) or discontinue treatment with finasteride.
Ask the physician or pharmacist for advice before taking any medicine.
Special Precautions
Finasteride can affect a blood test called prostate–specific-antigen (PSA). When having blood tests to check prostate gland, inform the physician if taking finasteride.
Determination of PSA in serum should be carried out prior to initiating therapy with finasteride and during treatment.
Finasteride may increase the risk of high-grade prostate cancer. It is not approved for the prevention of prostate cancer.
Post-marketing cases of male breast cancer have been reported with the use of finasteride.
Excipients: Finasteride Sandoz contains lactose. If the patient has intolerance to some sugars, consult the physician before taking it.
Effects on the Ability to Drive or Operate Machinery: There is no data to suggest that Finasteride Sandoz affects the ability to drive and use machines.
Use in children: Finasteride Sandoz is not recommended in children <18 years.
Adverse Reactions
Like all medicines, Finasteride Sandoz can cause adverse reactions, although not everybody gets them.
Potential adverse reactions of Finasteride Sandoz are generally mild and temporary in nature.
The adverse reactions have usually been temporary with continued treatment or disappeared when treatment is stopped.
Uncommon (Occur in <1 in 100 Users but >1 in 1,000 Users): Decreased sex drive; depressed mood; difficulty having an erection; problems with ejaculation eg, decrease in the amount of semen released.
Frequency Unknown (The Frequency Cannot be Estimated from the Available Data): Allergic reactions eg, rash, itching, lumps under the skin (hives) and swelling of the lips and face; breast swelling or tenderness; pain in the testicles; fast heart beat (palpitation); persistent difficulty having an erection after discontinuation of treatment.
Infertility has been reported in men who took finasteride for long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted. Increased hepatic enzymes
The following have been reported in post-marketing use: Persistence of erectile dysfunction after discontinuation of treatment with Finasteride Sandoz; male breast cancer.
Promptly inform the physician of any changes in the breast tissue eg, lumps, pain or nipple discharge. These may be signs of a serious condition eg, breast cancer.
Discontinue Finasteride Sandoz treatment if any of the symptoms occurs: Swelling of the face, tongue or throat; difficulty in swallowing; lumps under the skin (hives); breathing difficulties.
Reproductive System: Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorder, ejaculation disorders and orgasm disorders; make infertility and/or poor seminal quality (normalisation or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.
If any of the adverse reactions gets serious, or any adverse reactions not listed is noticed, consult the physician or pharmacist.
Drug Interactions
Finasteride Sandoz does not usually interfere with other medicines.
Inform the physician or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Caution For Usage
Instructions for Disposal: Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measure will help to protect the environment.
ATC Classification
D11AX10 - finasteride ; Belongs to the class of other dermatologicals.
Presentation/Packing
FC tab 1 mg (reddish-brown, round, biconvex, stamped "F1" on one side) x 28's.
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