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Document: leaflet MAH GENERIC_PL 04569-0898 change

• leaflet MAH BRAND_PLPI 33532-0464
• leaflet MAH GENERIC_PL 04569-0898
• leaflet MAH GENERIC_PL 08553-0251

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FINASTERIDE 1 mg FILM-COATED TABLETS

(finasteride)

What is in this leaflet:

1.    What Finasteride is and what it is used for

2.    What you need to know before you take Finasteride

3.    How to take Finasteride

4.    Possible side effects

5.    How to store Finasteride

6.    Contents of the pack and other information.

1.    What Finasteride is and what it is used for

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. It can be used to treat male pattern hair loss in men.

Your doctor has prescribed Finasteride 1 mg Tablets because you have male pattern hair loss (also known as androgenetic alopecia). Finasteride 1 mg Tablets prevent further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Finasteride 1 mg Tablets.

Finasteride 1 mg Tablets block an important enzyme (Type II 5a-reductase), which is involved in the regulation of the hair follicle. In the scalp, Finasteride 1 mg Tablets specifically lower the levels of DHT, a major cause of male pattern hair loss. In this way, Finasteride 1 mg Tablets help to reverse the balding process and prevent further hair loss.

2.    What you need to know before you take Finasteride Do not take Finasteride:

if you are allergic (hypersensitive) to finasteride or any of

the other ingredients of Finasteride

if you are a child or adolescent.

if you are female (see 'Pregnancy and breast-feeding').

Finasteride 1 mg Tablets have been found to be

ineffective in the treatment of hair loss (androgenetic

alopecia) in women in clinical studies.

if you are already taking finasteride or any other

5a-reductase inhibitor for benign prostatic hyperplasia

(BPH) or any other condition.

Warnings and precautions

Determination of prostate-specific-antigen (PSA) in serum should be carried out prior to initiating therapy with finasteride and during treatment.

Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment.

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

Children and adolescents

Do not give this medicine to children aged less than 18 years

Other medicines and Finasteride

Finasteride does not usually interfere with other medicines. But tell your doctor or pharmacist if you are taking any other medicines including those obtained without a prescription.

No information is available on the use of Finasteride 1 mg Tablets together with topical (applied to the skin) minoxidil in male pattern hair loss. The combination is not recommended.

Taking Finasteride with food and drink

Finasteride can be taken with or without food.

Pregnancy

Finasteride 1 mg Tablets are only intended for men. It can affect the normal development of a male baby's sex organs. Crushed or broken tablets should not be handled by a pregnant woman because of the risk of Finasteride being absorbed. Finasteride has been found in the semen of men taking finasteride. If your sexual partner is pregnant, you must use a condom to avoid exposing her to your semen, which may contain finasteride. If you have any questions, ask your doctor.

Breast-feeding

Finasteride is not prescribed for women. It is not known if it can pass into breast milk.

Driving and using machines

Finasteride should not affect your ability to drive or use machines.

Important information about some of the ingredients of Finasteride

Finasteride contains lactose monohydrate.

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

3. How to take Finasteride

Always take Finasteride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Date: 29 SEP 2014

The recommended dose is:

Adults

Swallow one tablet daily, with or without food.

It may take six months before some patients notice an improvement. Long-term use is recommended. If treatment is stopped, the beneficial effect starts to disappear after 6 months and completely disappears after 9-12 months.

Taking more than one tablet a day will not make your medicine work better.

Patients with impaired liver function

There is no experience of the use of Finasteride 1 mg Tablets in patients with impaired liver function.

Patients with impaired kidney function

No dosage adjustment is required in patients with impaired kidney function.

If you take more Finasteride than you should

If you take more Finasteride than you should tell your doctor or go to your nearest hospital emergency department. Take the container and any remaining tablets with you.

If you forget to take Finasteride

If you forget to take Finasteride do not double the dose to make up for a forgotten dose. Take the next dose on time.

If you stop taking Finasteride

If you stop taking Finasteride you are likely to lose the hair you have gained within the following 12 months.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side-effects

Like all medicines, Finasteride can cause side effects, although not everybody gets them. The side effects have usually been temporary with continued treatment or disappeared when treatment is stopped.

The following side effects are important and will require immediate action if you experience them.

Stop taking Finasteride 1 mg Tablets and talk to your doctor immediately if you have any of the following symptoms:

•    swelling of your face, tongue or throat

•    difficulty swallowing

•    lumps under your skin (hives)

•    breathing difficulties

The following other side effects have been reported:

Uncommon (may affect up to 1 in 100 people):

•    decreased sexual drive

•    erectile dysfunction

_ • decreased volume of ejaculation

•    depressed mood

■Isl¹

Not known (frequency cannot be estimated from the available data):

•    allergic reactions, such as rash, itching, lumps under your skin (hives) and swelling of lips and face

•    pain in the testicles

•    fast heartbeat

•    persistent difficulty having an erection after discontinuation of treatment

•    infertility has been reported in men who took finasteride for a 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.

•    Changes in the way your liver is working, which can be shown by a blood test

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride

Keep out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Store in the original package to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Finasteride contains

•    The active substance is Finasteride. One film-coated tablet contains 1mg of Finasteride

•    The other ingredients are docusate sodium, magnesium stearate, microcrystalline cellulose, lactose monohydrate, pregelatinised maize starch, sodium starch glycollate, povidone. The tablet coating contains red and yellow iron oxides (E172), titanium dioxide (E171), hypromellose, talc and hydroxypropylcellulose.

What Finasteride looks like and contents of the pack

Your medicine comes as a brown coated tablet available in PVC/Aluminium blister packs of 7, 14, 28, 30, 60, 84, 90 and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in September 2014    412028

Date: 29 SEP 2014