Finasteride 5 Mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information foryou.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor, your pharmacist or nurse.
• This medicine has been prescribed foryou 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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. Howto take Finasteride
4. Possible side effects
5. Howto store Finasteride
6. Contents of the pack and other information
2. Before you take Finasteride
1. What Finasteride is and what it is used for
Finasteride is a film-coated tablet that contains 5 mg of finasteride as active ingredient. Finasteride belongs to a group of medicines called '5-alpha reductase inhibitors'. These medicines affect metabolism of testosterone (male hormone).
Your doctor has prescribed Finasteride because you have a condition known as benign prostatic hyperplasia (BPH). BPH is a benign enlargement of the prostate gland that is common in men afterage 50.
Your prostate gland (located near your bladder) has become bigger and is making it more difficult for you to pass urine. You may have symptoms such as a need to urinate often, especially at night, a feeling that you must urinate right away, difficulty in starting to urinate, a weak or interrupted urinary stream, or a feeling that you cannot empty your bladder completely.
It works by shrinking the enlarged prostate gland in men. Finasteride may reduce your risk of developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.
BPH develops over a long period of time. Some patients show early improvement in symptoms, but you may need to take Finasteride for at least 6 months to see whether it improves yoursymptoms.
Do not take Finasteride
• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
Finasteride is prescribed only for men. Women and children should not take Finasteride.
Women who are or may potentially be pregnant must not use Finasteride. They should also not handle crushed or broken tablets of Finasteride (see Pregnancy and Breastfeeding).
Tell your doctor about any medical problems you have or have had, and aboutany allergies.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Finasteride.
Finasteride is for the treatment of BPH in men only.
Finasteride can affect a blood test called PSA (prostate-specific antigen). If you have a PSA test done, tell your doctorthatyou are taking Finasteride.
Finasteride contains lactose. If you are intolerant to any sugars, please inform your doctor before you take this medicine.
Other medicines and Finasteride
Finasteride usually does not interfere with other medicines. However, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Finasteride with food, drinkand alcohol
Finasteride can be taken with or without food.
Pregnancy, breast-feeding and fertility
Women should not handle crushed or broken tablets of Finasteride when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential riskto a male foetus.
It is not known whether finasteride is excreted in human milk.
Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
If the active ingredient in Finasteride is absorbed after oral use or through the skin by women who are pregnant with a male baby, it may cause abnormalities in the sexual organs of the baby. If a woman who is pregnant comes into contact with the active ingredient in Finasteride, a doctor should be consulted.
5. Howto store Finasteride
Keep this medicine out ofthe sight and reach of children.
This medicinal product does not require any special storage conditions. Store in the original package.
If your sexual partner is or may potentially be pregnant, Do not use thjs medicine afterthe ■ date that js stated
you should avoid her exposure to your semen, which may on the carton The ; date refers to the ,ast d of that
contain a residual quantity ofthe drug. month
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no data to suggest that Finasteride affects the ability to drive or use machines.
Finasteride contains lactose
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 ofthe pack and other information
3. How to take Finasteride
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet daily.
If you take more Finasteride than you should
If you take too many tablets, contact your doctor immediately.
What Finasteride contains
Each film-coated tablet contains 5 mg of finasteride.
The other ingredients are:
Nucleus
Lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type A), starch pregelatinised (maize), docusate sodium, yellow iron oxide (E172) and magnesium stearate.
Coating
OPADRY Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol 400) and indigotine (E132).
What Finasteride looks like and contents ofthe pack
Film-coated tablets blue and round.
If you forget to take Finasteride
Try to take Finasteride as your doctor prescribed. However if you miss a dose, do not take an extra one. Just take the next tablet as usual.
4. Possible side effects
Like all medicines, this medicine can cause unintended or unwanted effects, although not everybody gets them.
The following side effects are among those reported for finasteride:
• decrease in the amount of semen released in the ejaculation, impotence (difficulty in having an erection, problems with ejaculation
• less desire to have sex
• palpitation
• skin rash, itching and hives, swelling of the lips and face
• increase in liverenzymes
• breast swelling or tenderness
• testicular pain
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.
Finasteride tablets are available as 5 mg tablets in blister packs of 10,15,28,30,50,60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE30PA
UK
Manufacturer:
West Pharma Produgoes Especialidades Farmaceuticas, S.A.
Rua Joao de Deus, n° 11, Venda Nova
2700 - 486Amadora
Portugal
This medicinal product is authorised in the Member States ofthe EEA under the following names:
Germany:
Italy:
Portugal:
United Kingdom:
Finasterid Tecnimede 5 mg Filmtabletten Finasteride TecniGen Finasterida Furima Finasteride
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
This leaflet was last revised in August 2013