Finasteride 5mg Tablets
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"GBR 72B-7073-APIL " IPatient Information Leaflet
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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 Tablets are and what they are used for
2. Before you take Finasteride Tablets
3. Special precautions
4. How to take Finasteride Tablets
5. Possible side effects
6. if ow to store Finasteride Tablets
7. Further information
1. What Finasteride Tablets are and what they are used for
Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.
Finasteride is used in the treatment and control of benign (not cancerous) enlargement of the prostate.
2. Before you take Finasteride Tablets Do not take Finasteride Tablets if you
• are allergic (hypersensitive) to finasteride or any of the other ingredients in Finasteride Tablets (see section 7);
• are a woman;
• are a child as finasteride tablets are not recommended for children.
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;
• haveliver problems.
Finasteride Tablets can normally be taken with other medicines. However, 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.
3. Special precautions
Breast-feeding
This medicinaFproduct is only intended for men. It is not known if finasteride is excreted in breast milk.
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 potentially be pregnant, you should avoid exposing her to your semen, which could contain a tiny amount of the drug. If you think a pregnant woman has come into contact with finasteride, you should consult a doctor.
□riving and using machines
There is no evidence to suggest that Finasteride Tablets affect the ability to drive or use machines.
Sugar intolerance
Finasteride Tablets contain lactose monohydrate. If you do not tolerate some types of sugar, contact your doctor before you take 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.
4. How to take Finasteride Tablets
Always take Finasteride Tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The usual dose is 1 tablet daily.
The tablet should be swallowed whole and should not be broken or crushed. It may be taken with or without food.
lit 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 ithe dose or stop treatment without asking your doctor.
If you take more Finasteride Tablets than you should
lit 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.
I 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.
5. Possible side effects
Like all medicines, Finasteride Tablets can cause side effects, although not everybody gets them.
The most frequent side effects are impotence (inability to obtain an erection) and reduced libido (decreased sex drive). These effects usually occur at the beginning of the treatment and in most patients are short-term.
Other side effects that may occur have been listed by body systems and frequency.
The frequencies are defined as:
Very common (occur in more than 1 in 10 patients), common (occur in less than 1 in 10 but more than 1 in 100 patients), uncommon (occur in less than 1 in 100 but more than 1 in 1,000 patients), rare (occur in less than 1 in 1,000 but more than 1 in 10,000 patients), very rare (occur in less than 1 in 10,000 patients, including isolated reports).
Reproductive system and breast disorders Common: Impotence (inability to obtain an erection).
Uncommon: Ejaculation disorder, breast tenderness, breast enlargement. Not known: Testicular pain.
Very rare: Breast secretion, breast nodules.
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.
Cardiac disorder
Not known: Palpitation (abnormal heartbeat).
Psychiatric
Common: Reduced libido (decreased sex drive).
Nervous system disorders Somnolence (drowsiness).
Hepatobiliary disorders
Not known: Increased hepatic enzymes (liver enzymes of which levels are assessed via blood test).
Immune system disorders
Not known: Hypersensitivity (allergic) reactions including swelling of the face and lips.
Investigations
Common: Decreased volume of ejaculate.
Skin and subcutaneous tissue disorders Uncommon: Rash.
Not known: Pruritis (itching), urticaria (hives).
Stop taking this product and contact your doctor immediately if you develop any of the following symptoms: swelling of the face, tongue or lips, difficulty swallowing or urticaria and difficulty breathing.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If possible note what you experienced and when it started and how long it lasted. 6. How to store Finasteride Tablets
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
There are no special storage precautions.
Use before the expiry date which is stated on the package. The expiry date refers to the last day of that month.
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.
7. Further information
What Finasteride Tablets contain
The active substance (the ingredients which makes the medicine work) is finasteride 5 mg.
The other ingredients are lactose monohydrate, cellulose microcrystalline, pregelatinised starch, lauroyl macrogolglycerides, sodium starch glycolate (type A), magnesium stearate. The film coating contains hypromellose, macrogol 6000, titanium dioxide (£171) and indigo carmine fake (E132).
What Finasteride Tablets look like and contents of the pack
The tablets are film-coated, blue, round, biconvex.
They are supplied in:
Blister packs containing 12 28,30 or 56 tablets.
Plastic bottles containing 50, 75 or 100 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder
Waymade PLC, trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex. SS14 3FR.
The Manufacturer Responsible for Release is:
Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex. SS14 3FR.
This leaflet was last approved in June 2010
