Finasteride 5 Mg Film-Coated Tablets
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Finasteride
Read all of this leaflet carefully before you start taking 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. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Finasteride 5 mg is and what it is used for
2. What you need to know before you take Finasteride 5 mg
3. How to take Finasteride 5 mg
4. Possible side effects
5. How to store Finasteride 5 mg
6. Contents of the pack and other information
1. What Finasteride 5 mg is and what it is used for
Finasteride 5 mg belongs to a group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.
Finasteride 5 mg is used in the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia - BPH). It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery.
2. What you need to know before you take Finasteride 5 mg Do not take Finasteride 5 mg
- if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6)
- if you are a woman (see also under "Pregnancy, breast-feeding and fertility")
- if you are a child.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride 5 mg
- if 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.
- if you have a reduced liver function. The finasteride plasma level may be increased in these patients.
A clinical examination (including digital rectal examination) and a determination of prostate-specific-antigen (PSA) in serum should be carried out prior initiating therapy with finasteride and during treatment.
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.
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.
Children
Finasteride 5 mg should not be given to children.
Other medicines and Finasteride 5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No significant drug interactions have been identified.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before handling this medicine.
Finasteride 5 mg is only intended for men.
When the patient’s sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue treatment with finasteride.
Women who are pregnant or may become pregnant should not handle broken or crushed Finasteride 5 mg 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.
Driving and using machines
There are no data which suggest that Finasteride 5 mg affects the ability to drive or use machines.
Finasteride 5 mg 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 5 mg
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 1 tablet daily (equivalent to 5 mg finasteride).
The film-coated tablets can either be taken on an empty stomach or with a meal. The film-coated tablets should be swallowed whole and should not be divided or crushed.
Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.
Your doctor will tell you how long you should continue to take Finasteride 5 mg Do not interrupt treatment early or the symptoms may come back.
Patients with impaired liver function
There is no experience of the use of Finasteride 5 mg in patients with restricted liver function (see also „ Warnings and precautions “).
Patients with impaired kidney function
No dosage adjustment is required. The use of Finasteride 5 mg in patients who have to undergo haemodialysis has not been investigated to date.
Elderly patients
No dosage adjustment is required.
Please speak to your doctor or pharmacist if you feel that the effect of Finasteride 5 mg is too strong or too weak.
If you take more Finasteride 5 mg than you should
If you take more Finasteride 5 mg than you should or if children have been taken medicine by accident please notify your doctor immediately.
If you forget to take Finasteride 5 mg
If you forget to take a dose of Finasteride 5 mg, 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. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are impotence and decreased sexual drive. These effects normally occur at the start of treatment but do not usually last long in the majority of patients if treatment continues.
Common (may affect more than 1 in 100 people)
- decreased or reduced sexual drive
- impotence, reduced volume of semen.
Uncommon (may affect up to 1 in 1000 people)
- rash
- ejaculation disorder, breast tenderness, breast enlargement.
Very rare (may affect up to 1 in 10,000 people)
- breast secretion, breast nodules.
Not known (frequency cannot be estimated from the available data)
- hypersensitivity reactions including swelling of the lips and face
- feeling tired
- heart racing
- increased hepatic enzymes
- itching, nettle rash
- testicular pain.
In addition, male breast cancer has been reported (see also under "Warnings and precautions”). Finasteride may affect the result of PSA-laboratory test.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Finasteride 5 mg
Keep this medicine out of the sight and reach of children.
Do not store above 30°C
Do not use this medicine after the expiry date which is stated on the container and the outer packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other Information
What Finasteride 5 mg contains:
• The active substance is finasteride. One film-coated tablet contains 5 mg finasteride.
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, pregelatinised starch (maize), povidone K30, sodium starch glycolate (type A), magnesium stearate, sodium laurilsulfate. The tablet coating contains Opadry blue, hypromellose (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, indigo carmine aluminium lake (E132)
What finasteride 5 mg looks like and the contents of the pack:
Finasteride 5 mg tablets are are blue, capsule shaped tablets, with the inscription “FNT5” on one side. Blister packs PVC/PVDC/Aluminium: 15, 28, 30, 50, 50x1, 98, 100, 100x1 tablets.
Bottles (HDPE): 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany.
This medicinal product is authorised in the Member States of the EEA under the following names:
FI Finasterid ratiopharm 5 mg tabletti, kalvapaallysteinen
SE Finasterid ratiopharm 5 mg tabletti, filmdragerad
NO Finasterid ratiopharm 5 mg tabletter, filmdrasjerte
NL Finasteride ratiopharm 5 mg, filmomhulde tabletten LU Finasterid-ratiopharm 5 mg Filmtabletten
PL Finasterid-ratiopharm
DE Finasterid-ratiopharm 5 mg Filmtabletten
IT Finasteride ratiopharm 5 mg compresse rivestite confilm
DK Finasterid ratiopharm
FR Finasteride ratiopharm 5 mg, comprime pellicule
UK Finasteride 5mg Tablets