Finasteride (proscar)

• Used to treat benign prostatic hyperplasia (BPH)
• Relieves urinary symptoms caused by BPH
• Intended solely for use in men
• Swallow whole

Finasteride 5 mg contains the active substance finasteride. Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors, also known as androgen antagonists. These types of medicines work by decreasing the production of sex hormones.

Finasteride 5 mg is used to treat men with an enlarged prostate gland (benign prostatic hyperplasia, BPH). This medicine:

• Reduces the enlarged prostate.
• Improves urine flow and other symptoms of BPH.
• Reduces the risk of suddenly being unable to urinate (acute urinary retention).
• Reduces the chance of having to undergo surgery.

Finasteride 5 mg is intended for use in men only.

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

Dosage

The recommended dose is one Finasteride 5-mg tablet daily, taken with or without food. The tablets should be swallowed whole and should not be chewed or crushed.

Alcohol/driving

Finasteride does not affect your reaction time. There are no dietary restrictions with this medicine.

If you take more or less Finasteride 5 mg than you should

If you take more Finasteride than you should, or if a child has taken this medicine by accident, please notify your doctor or pharmacist immediately.

If you forget to take a dose of Finasteride, you can take it as soon as you remember unless it is almost time for the next dose, in which case you should continue with your medication as prescribed. Never take a double dose to make up for the forgotten one.

Always consult your doctor before stopping the treatment. In most cases, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.

Finasteride 5 mg is not suitable for everyone. Do not take this medicine if:

• You are allergic to the active ingredient or to any of the other ingredients in this medicine which are listed at the end of this leaflet under 'What Finasteride contains'.
• You are a woman or child (see section 'Pregnancy and breastfeeding').

When should this medicine be used with extreme caution?

Talk to your doctor or pharmacist before taking Finasteride 5 mg if:

• Your sexual partner is or may potentially be pregnant, in which case you should avoid exposing her to your semen (by using a condom). Your semen could contain a tiny amount of the medicine and may affect the normal development of the baby’s sex organs.
• You are having a PSA test. This medicine may affect the results of PSA (prostate-specific antigen) tests.
• You have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract.

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

Pregnancy and breastfeeding

Finasteride should not be used in women. Use of finasteride in pregnant women can affect the normal development of a male baby.

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.

If a pregnant woman is exposed to Finasteride 5 mg, immediately consult a doctor.

The tablets are film coated, which prevents contact with finasteride provided the tablets are not broken or crushed.

Always consult a doctor or pharmacist before taking this medicine.

Other medicines and Finasteride 5 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that do not require a prescription.

Finasteride 5 mg does not usually affect other medicines or side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Finasteride 5 mg and see your doctor immediately if you get one or more of the following allergic reactions: swelling of the face or lips, or itchy skin rash or lumps under your skin (hives).

Other side effects of Finasteride 5 mg include:

Common (may affect up to 10 in 100 people):

• Sexual problems such as impotence and loss of libido. These side effects generally occur at the beginning of treatment and are usually only temporary and will disappear after a while if you continue taking Finasteride 5 mg.
• A decrease in the amount of semen released during sex.

Less common (may affect up to 10 in 1,000 people):

• Skin rash.
• Ejaculation problems.
• Breast swelling or tenderness.

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

• Palpitations.
• Itch (pruritus), itchy skin rash and or lumps (hives or urticaria).
• Allergic reactions such as swelling of the face and lips.
• Elevated liver enzymes.
• Pain in your testicles.

Breast cancer has been reported with this medicine. Tell your doctor immediately if you notice any of the symptoms described in section 'When should this medicine be used with extreme caution?'.

Consult a doctor if the side effects are persistent, or if you experience side effects that are not listed on the package leaflet.

The active substance is 5 mg finasteride per tablet. The other ingredients are:

Tablet core:

• Sodium lauryl sulfate
• Pregelatinised maize starch
• Lactose monohydrate
• Microcrystalline cellulose (E460)
• Sodium starch glycolate (type A)
• Magnesium stearate (E572)

Film coating:

Sepifilm:

• Hypromellose (E464)
• Microcrystalline cellulose
• Macrogol 8 stearate type I

The manufacturers of Finasteride CF 5 mg are:

Kern Pharma S.L. Venus 72
08228 Terassa-Barcelona
Spain

STADA Arzneimittel AG Stadastr. 2-18
61118 Bad Vilbel
Germany

Centrafarm Services B.V. Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

PharmaCoDane Aps Marielundvej 46 A
2730 Herlev
Denmark

STADA Production Ireland Waterford Road
Clonmel, Co. Tipperary
Ireland

Orion Cooperation Orion Pharma PO Box 65
02101 Espoo
Finland

Aliud Pharma GmbH & Co. KG Gottlieb-Daimler-Str. 19
89150 Laichingen
Germany

Haupt Pharma Münster GmbH Schleebrüggenkamp 15
48159 Münster
Germany

Read the package leaflet before use. The official package leaflet of Finasteride CF 5 mg is available for download here.