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Finasteride 1 Mg Tablets

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ASANDOZ

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride 1 mg Film-coated Tablets

Finasteride


Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Finasteride is and what it used for

2.    Before you take Finasteride

3.    How to take Finasteride

4.    Possible side effects

5.    How to store Finasteride

6.    Further information


1.    WHAT FINASTERIDE IS AND WHAT IT IS USED FOR

Finasteride is used to treat early forms of male

pattern hair loss (also called androgenetic alopecia).

2.    BEFOREYOUTAKE FINASTERIDE

Do not take Finasteride tablets if you

•    are allergic (hypersensitive) to finasteride or any of the other ingredients in Finasteride tablets (see section 6)

•    are a woman

Check with your doctor or pharmacist before taking Finasteride tablets if you

•    have difficulty emptying your bladder completely or a greatly reduced flow of urine.

Your doctor should examine you before you start taking Finasteride tablets to exclude other obstructions in the urinary tract.


Taking other medicines

Finasteride tablets can normally be taken with other medicines. Please ask your doctor or pharmacist before you take other medicines at the same time or if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Special precautions

Finasteride tablets are only intended for men. Finasteride should not be used in children under the age of 18.

Pregnancy

Women who are pregnant or may become pregnant should not handle broken or crushed Finasteride tablets. If finasteride is absorbed through the skin or taken by mouth by a woman pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which prevents contact with finasteride provided the tablets are not broken or crushed.

If your sexual partner is or may possibly be pregnant, you must avoid exposing her to your semen, which could contain a small amount of the drug by using a condom. If you think a pregnant woman has come into contact with finasteride, you should consult a doctor.

Driving and using machines

There is no evidence to suggest that Finasteride tablets affect the ability to drive or use machines.

Important information about some of the ingredients of Finasteride Tablets

Finasteride tablets contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Blood tests

Finasteride tablets can affect a blood test called PSA. If you have a PSA test done, tell your doctor you are taking Finasteride tablets.


3. HOWTOTAKE FINASTERIDE

Always take Finasteride tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Usual dose is

1 mg (1 tablet) daily. The tablet should be swallowed whole and should not be broken or crushed. It may be taken with or without food.

If you stop taking Finasteride tablets

Although an improvement is often noticed after a short time, it may be necessary to continue the treatment for at least 6 months. Do not alter the dose or stop treatment without asking your doctor.

If you take more Finasteride tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.


You should promptly report to your doctor any changes in your breast tissue such as lumps,pain or nipple discharge as these may be signs of a serious condition, such as breast cancer.

5. HOWTO STORE FINASTERIDE

Keep out of reach and sight of children.

Do not use Finasteride tablets after the expiry date which is stated on the blister, carton or bottle after‘Expiry date:'. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.



If you forget to take Finasteride tablets

Do not take a double dose to make up for a forgotten tablet. Just take the next one when it is due.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Finasteride tablets can cause side effects, although not everybody gets them.

Stop taking Finasteride tablets and contact your doctor immediately if you develop any of the following symptoms of an allergic reaction:

swelling of the face, tongue or lips or urticaria (itchy skin rash).

Please tell your doctor or pharmacist if you

notice any of the following effects or any side effects not listed.

Uncommon (occur in less than 1 in 100 users): reduced sex drive, difficulty ejaculating, reduced amount of ejaculatory fluid, depressed mood Not known (frequency cannot be estimated from the available data): Allergic reactions, including rash, itching, urticaria (itchy skin rash) and swelling of the lips and face; irregular heartbeat; elevated liver enzymes; breast tenderness and enlargement; testicular pain; infertility.

The following undesirable effects have been reported in post-marketing use: breast tenderness and enlargement; and testicular pain, persistence of erectile dysfunction after discontinuation of treatment with Finasteride 1 mg; male breast cancer.


6. FURTHER INFORMATION

What Finasteride tablets contain

•    the active substance is finasteride 1 mg

•    the other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, lauroyl macrogolglycerides, sodium starch glycollate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172) and macrogol 600.

What Finasteride tablets look like and contents of the pack

Finasteride 1 mg Film-coated Tablets are round, biconvex reddish-brown tablets, with the markings‘F1' They are supplied in:

Blister packs containing 28 tablets Plastic bottles containing 28 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Actavis hf, Reykjavikurvegur78,

IS-220 Hafnarfjordur, Iceland.

This leaflet was last approved in 07/2011 (to be

amended after approval).


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