Finasteride 1mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Finasteride 1mg Film-coated Tablets
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 get 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 1mg Tablets are and what they are used for
2. Before you take Finasteride 1mg Tablets
3. How to take Finasteride 1mg Tablets
4. Possible side effects
5. How to store Finasteride 1mg Tablets
6. Further information
1. What Finasteride 1mg Tablets are and what they are used for
Your doctor has prescribed these tablets because you have the early stages of male hair loss, which is also known as androgenetic alopecia (AGA). Finasteride 1mg Tablets are used to prevent hair loss and to encourage hair growth in men.
The active substance (which makes this medicine work) is finasteride. Finasteride is a type of medicine called a 5-alpha-reductase inhibitor.
2. Before you take Finasteride 1mg Tablets
Do not take Finasteride 1mg Tablets if you
- are allergic to finasteride or any of the other ingredients in these tablets, listed in Section 6.
- are a woman.
Check with your doctor before taking Finasteride 1mg tablets
• if you have a lot of difficulty passing urine (water)
• if you suffer from liver problems
• Finasteride can affect a blood test called PSA. If you need a PSA test, you should tell the doctor that you are taking finasteride.
Taking other medicines
Finasteride 1mg Tablets do not usually interfere with other medicines. However you should tell your doctor or pharmacist about any other medicines that you are taking, including any you have bought without a prescription.
Pregnancy
Women must not use Finasteride Tablets.
Finasteride can pass though the skin, therefore the tablets are film coated to prevent contact with finasteride. Women who are or might become pregnant should not handle crushed or broken Finasteride tablets. If finasteride is absorbed through the skin by a woman who is pregnant with a male foetus, the normal development of the baby’s sex organs may be affected.
If your sexual partner is or could be pregnant, you must avoid exposing her to your semen, which could contain a small amount of finasteride — for example by using a condom during sexual activity.
If you think a pregnant woman has come into contact with finasteride, you should consult a doctor.
Driving and using machines
Driving and using machinery is not known to be affected by this medicine.
Sugar content
This medicine contains a type of sugar called lactose, so if your doctor has told you that you have an intolerance to sugars, do not take the tablets.
3. How to take Finasteride 1mg Tablets
Finasteride 1mg Tablets are for oral use and are for men only.
Always take your medicine exactly as your doctor has told you and according to the instructions printed on the label of the pack. If you are not sure, check with your doctor or pharmacist.
Adults: The usual dose is one tablet every day with or without food.
The tablets should be swallowed whole and must not be crushed or divided.
Children: Finasteride 1mg Tablets must not be used in children.
Elderly patients or those with kidney disorders: Usually no dose adjustment is needed and the same dose as for other adults should be used.
If you take more Finasteride 1mg Tablets than you should
If you take more than the recommended number of tablets, contact your doctor or pharmacist for advice straight away. No side effects have been reported under these circumstances.
If you forget to take Finasteride 1mg Tablets
Take the forgotten tablet when you remember, then take your next tablet as usual the following day.
Do not take a double dose to make up for the missed dose.
Length of treatment
Generally it takes three to six months of treatment before you will stop losing your hair. Continued treatment is required to prevent hair loss from returning. If you stop treatment, hair loss will return after 6 months and will be as it was before by 9-12 months.
4. Possible side effects
Like all medicines, Finasteride 1mg Tablets can cause side effects, although not everybody gets them. 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.
Uncommon: (occurs in more than 1 in 1,000 but less than 1 in 100 patients): Reduced desire to have sex, difficulty having an erection, ejaculation problems such as a decreased amount of semen.
Frequency unknown: fast heart beat, tenderness and enlargement of the male breasts, difficulty having erection after stopping treatment, swelling or pain in the testicles, elevated liver enzymes and allergic reactions such as skin rashes, itching, hives or swelling of the face and lips. Taking Finasteride 1mg Tablets for a long time may increase your risk of infertility.
If you have any of these side effects, they get worse or if you notice any side effects not listed, please tell your doctor or pharmacist.
5. How to store
Keep your Finasteride 1mg Tablets in a safe place out of the reach and sight of children.
Do not take this medicine after the expiry date which is stated on the blister.
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.
6. Further information
Each tablet contains 1mg of the active ingredient finasteride. The other ingredients are lactose monohydrate, cellulose microcrystalline (E460), starch pregelatinised, sodium starch glycolate (Type A), magnesium stearate (E470b), docusate sodium, hypromellose (E464), titanium dioxide (E171), macrogol and red and yellow iron oxides (E172). The sodium content of each tablet is 3.85mg.
Finasteride 1mg Tablets are light-brown, film-coated tablets with the following markings: ‘FIN’ on one side and ‘1’ on the other side. The tablets are in blister packs containing 14, 28 or 98 tablets.
Marketing Authorisation Holder and Manufacturer (also EU batch release site)
Dr Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK Tel: +44 (0) 1482 860228; Fax: +44 (0) 1482 872042
This medicine is authorised in Member States of the EEA under the following names:
UK: Finasteride 1mg film-coated Tablets (PL 08553/0251)
Spain: Finasterida 1mg Aphar Comprimidos Recubiertos EFG Italy: Finasteride Reddy’s 1mg compresse rivestite con film Bulgaria: ENYDE 1mg, ^>HAMnpaHa TaSAeTKa Romania: ENYDE 1mg, comprimate filmat
This leaflet was last approved on 07/2010 Component code: © Dr. Reddy’s Laboratories (UK) Ltd