Finasteride 5mg Film Coated Tablets
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PHARMACEUTICALS
PACKAGE LEAFLET: INFORMATION FOR THE USER Finasteride 5 mg 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 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 is and what it is used for
2. Before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Further information
1. WHAT FINASTERIDE S AND WHAT IT IS USED FOR
Finasteride belongs to the 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 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.
3. HOW TO TAKE FINASTERIDE
Always take Finasteride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The usual dose is one Finasteride 5 mg 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 "Take special care with Finasteride 5 mg")
Patients with impaired kidney function
No dosage adjustment is required (see "Adults"). 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 (see "Adults").
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 than you should or if children have been taken medicine by accident please notify your doctor or pharmacist immediately.
If you forget to take Finasteride
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Very Common: Common:
Uncommon:
Rare:
Very rare:
Frequency not known:
2. BEFORE YOU TAKE FINASTERIDE Do not take Finasteride
- if you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride
- if you are a woman (see also under „Pregnancy and breast-feeding")
- if you are a child.
Take special care with Finasteride
- 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 PSA test (test used to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride can affect the blood levels of the substance being tested, PSA.
- 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.
Consult your doctor if any of the above applies to you now or in the past.
Taking other medicines
No significant drug interactions have been identified.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Finasteride with food and drink
Finasteride can be taken with or without food.
Pregnancy and breast-feeding
Finasteride is only intended for men.
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.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
As far as is known Finasteride has no influence on the ability to drive or operate machinery.
Important information about some of the ingredients of Finasteride
This medicinal product 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.
Like all medicines, Finasteride can cause side effects, although not everybody gets them.
For the assessment of side effects, the following descriptions of frequency have been used:
occur in more than 1 of 10 patients occur in more than 1 in 100 patients occur in less than 1 in 100 patients occur in less than 1 in 1000 patients occur in less than 1 in 10 000 patients cannot be estimated from existing data.
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.
Stop taking Finasteride and contact your doctor immediately if you develop any of the following symptoms: swelling of the face, tongue or face, difficulty swallowing or urticaria (hives) and difficulty breathing.
Heart disorders
Frequency not known: palpitations (feeling your heartbeat)
Reproductive system and breast disorders
Common: impotence, decreased sexual drive, reduced volume of semen.
Uncommon: ejaculation disorder, tenderness or enlargement of the male breasts
Frequency not known: testicular pain
Irritations of the skin/allergic reactions
Uncommon: rash
Frequency not known: itching, urticaria (hives)
General
Frequency not known: changes in the way your liver is working, which can be
shown by a blood test.
Finasteride may affect the result of a PSA-laboratory test.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain or nipple discharge as these may be signs of a serious condition, such as breast cancer.
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.
LO
5. HOW TO STORE FINASTERIDE
Keep out of the reach and sight of children.
Do not use Finasteride after the expiry date, which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use Finasteride if you notice visible signs of deterioration.
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 What Finasteride contains
- The active substance is finasteride. Each film-coated tablet contains 5mg of finasteride.
- The other ingredients are:
lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type A), starch pregelatinised (maize), docusate sodium, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, indigo carmine aluminium lake (E132), iron oxide yellow (E172).
What Finasteride looks like and contents of the pack
Film coated tablet.
Blue coloured, circular, biconvex, beveled edged film-coated tablet debossed with’E’ on one side and ‘61’ on the other side.
Finasteride 5 mg is available in PVC/PE/PVdC-aluminium foil blister packs containing 10, 14, 15, 20, 28, 30, 45, 50, 60, 90, 98, 100 or 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
Pfizer Service Company bvba,
10 Hoge Wei, B-1930 Zaventum, Belgium,
or
Pfizer PGM,
Zone Industrielle, 29 Route des Industries, 37530 Poce Sur Cisse, France.