Finasteride 1 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Finasteride 1 mg Film-Coated Tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Finasteride 1 mg Film-Coated Tablets is and what it is used for
2. What you need to know before you take Finasteride 1 mg Film-Coated Tablets
3. How to take Finasteride 1 mg Film-Coated Tablets
4. Possible side effects
5. How to store Finasteride 1 mg Film-Coated Tablets
6. Contents of the pack and other information
1. What Finasteride 1 mg Film-Coated Tablets is and what it is used for
• Finasteride belongs to a group of medicines called testosterone 5- alpha reductase inhibitors.
• Finasteride is used in the treatment of men with male pattern hair loss (androgenetic alopecia), to increase hair growth and prevent hair loss.
2. What you need to know before you take Finasteride 1 mg Film-Coated Tablets Do not take Finasteride if you:
• are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine
• are taking Finasteride tablets or any other 5- alpha reductase inhibitors to treat an enlarged prostate The tablets must not be taken by women or children. The condition for which Finasteride is prescribed only occurs in men.
Warnings and precautions
Tell your doctor before you start to take this medicine if you:
• are to have a blood test called prostate-specific antigen (PSA) as Finasteride may affect the test results.
• notice any changes in your breast tissue such as lumps, pain, and enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.
Other medicine and Finasteride
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
• Finasteride is only intended for men.
• If the drug is absorbed by a pregnant woman carrying a male baby, the development of the baby’s sex organs may be affected. Therefore women who are pregnant, think they may be pregnant or may become pregnant should:
- not handle broken or crushed tablets (the whole tablets are film-coated to stop contact with the medicine during normal use).
- avoid exposure to their partners semen (e.g. by use of a condom), as the drug is present in semen.
• If a pregnant woman does come into contact with Finasteride, a doctor should be consulted. Driving and using machines
Finasteride is not expected to/known to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Finasteride
Patients who are intolerant to lactose should note that Finasteride tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Finasteride 1 mg Film-Coated Tablets
Always use Finasteride as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults (including the elderly):
One 1 mg tablet per day.
The tablets should be taken with a glass of water and can be taken with or without food.
Treatment may need to be continued for 3 to 6 months before you notice any increase in hair growth.
Use in Children: Finasteride is not recommended for use in Children If you take more Finasteride than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Finasteride
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Finasteride
Do not stop taking your medicine without talking to your doctor first. If the treatment is stopped then you are likely to lose the hair that you have gained within the next 9-12 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, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of your lips, tongue, throat and face.
Uncommon: may affect up to 1 in 100 people
• depressed mood
• difficulty having an erection after discontinuation of treatment
• decrease in sex drive after discontinuation of treatment.
• problems with ejaculation after discontinuation of treatment
Not known: frequency cannot be estimated from the available data
• Palpitation (a thumping heartbeat)
• Abnormal liver function test results (increased liver enzyme levels)
• Pain in the testes
• Infertility
• Breast swelling or tenderness
Tell your doctor or pharmacist if any of the side effects get serious, or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 1 mg Film-Coated Tablets
Keep this medicine out of the sight and reach of children. Store in the original package. Do not use
Finasteride after the expiry date that is stated on the outer packaging. The expiry date refers to the last day
of that month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Finasteride 1mg Film-Coated Tablets contain:
• The active ingredient is finasteride.
• The other ingredients are lactose monohydrate, pregelatinised starch, sodium laurilsulfate, sodium starch glycolate (type A), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).
What Finasteride 1mg Film-Coated Tablets look like and the contents of the pack
• Finasteride 1 mg Film-Coated tablets are brown and round in shape. The tablets are marked with “FNT1” on one side and plain on the other.
• The product is available in pack sizes of 7, 28, 30, 50 (hospital packs), 84, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: July 2015 PL 00289/0825
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