FINASTERIDE ALTER 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Finasteride Alter 5 mg film-coated tablets EFG

Read 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Finasteride Alter and what is it used for
2. What you need to know before you take Finasteride Alter
3. How to take Finasteride Alter
4. Possible side effects
5. Storing Finasteride Alter
6. Contents of the pack and further information

1. What is Finasteride Alter and what is it used for

Finasteride is a 5-alpha reductase inhibitor that reduces the size of an enlarged prostate.

Your doctor has prescribed Finasteride Alter because you are suffering from a condition called benign prostatic hyperplasia (BPH). Your prostate, a gland located near the urinary bladder that produces a fluid in which sperm are transported, has increased in size and is making it difficult to urinate.

Finasteride Alter reduces the size of the enlarged prostate and relieves urinary symptoms: the need to urinate frequently, pain while urinating, weak urine flow, and the feeling that the bladder is not completely empty. Finasteride Alter reduces the need for surgical intervention.

2. What you need to know before you take Finasteride Alter

Do not take Finasteride Alter

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6)
• The disorder for which Finasteride Alter is prescribed only occurs in men, so it should not be taken by women or children.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Finasteride Alter

• Tell your doctor about your current and past medical problems and any allergies you suffer from.
• Finasteride Alter is only intended for the treatment of BPH in males. Women should not use Finasteride Alter when they are or may be pregnant, nor should they be exposed to this medicine by handling crushed or broken tablets. If the active ingredient of Finasteride Alter is absorbed after oral use or through the skin by a woman who is pregnant with a male fetus, the fetus may be born with abnormalities in its sexual organs. If a pregnant woman comes into contact with the active ingredient of Finasteride Alter, she should consult her doctor. The tablets of Finasteride Alter are film-coated and this will prevent contact with the active ingredient during normal handling, provided the tablets are not crushed or broken. If you have any doubts, ask your doctor.

If your sexual partner is or may be pregnant, you should avoid exposing her to your semen as it may contain minimal amounts of the drug.

• BPH develops over a long period of time. Sometimes the symptoms improve quickly, but you may need to take Finasteride Alter for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, therapy with Finasteride Alter may reduce the risk of not being able to urinate and therefore the need for surgery. You should see your doctor regularly for check-ups and to assess your progress.

• Although BPH is not cancer and does not cause cancer, both conditions can exist at the same time. Only a doctor can evaluate your symptoms and their possible causes.

• Finasteride Alter may decrease the levels of prostate-specific antigen (PSA, a substance in the body that increases when the prostate grows and can cause obstruction). If you have had a PSA test, tell your doctor that you are taking Finasteride Alter.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Alter. If you experience any of these symptoms, talk to your doctor as soon as possible.

Children and adolescents

Finasteride Alter is not indicated in women or children.

Other medicines and Finasteride Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Finasteride Alter is not expected to interact with other medicines.

Taking Finasteride Alter with food and drinks

Take one Finasteride Alter tablet a day, with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride Alter is for use in males only.

Finasteride Alter is not indicated in women.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Finasteride Alter is unlikely to affect your ability to drive or use machines.

Finasteride Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Finasteride Alter

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Finasteride Alter is a medicine that is taken orally. Take one Finasteride Alter tablet a day, with or without food.

Remember that your prostate took many years to grow enough to cause symptoms. Finasteride Alter will only be able to treat your symptoms and control the disease if you continue taking it long-term.

Your doctor may prescribe Finasteride Alter together with another medicine, called doxazosin, to help you better control your BPH.

If you think the effect of Finasteride Alter is too strong or too weak, tell your doctor or pharmacist.

If you take more Finasteride Alter than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Finasteride Alter

If you forget to take a dose, do not take an extra dose; just take the next tablet as usual.

Do not take a double dose to make up for forgotten doses.

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 following side effects may happen with this medicine:

Allergic reactions

Stop taking this medicine and see your doctor immediately if you have any of the following symptoms:

• swelling of the lips, face, tongue, or throat, difficulty swallowing and breathing, hives (angioedema)
• skin rash, itching, lumps under the skin (hives)

Other side effects may include:

• being unable to have an erection (impotence)
• having less desire to have sex
• having problems with ejaculation, for example, a decrease in the amount of semen released during sex. This decrease in semen does not seem to affect normal sexual function.

These side effects may disappear after a while if you continue taking this medicine. If not, they usually disappear when you stop taking Finasteride Alter.

Other side effects reported in men are:

• Breast tenderness or swelling
• Palpitations (feeling heartbeats)
• Changes in liver function, which can be seen in a blood test
• Testicular pain
• Being unable to have an erection that can continue after stopping treatment
• Male infertility and/or poor semen quality. There have been reports of improvement in semen quality after stopping treatment.
• Depression
• Anxiety
• Decreased sex drive that can last after stopping treatment
• Ejaculation problems that can last after stopping the medicine.

You should tell your doctor immediately about any changes in breast tissue, such as lumps, pain, enlargement, or nipple discharge, as these can be signs of a serious disease, such as breast cancer.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Finasteride Alter

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Alter

• The active substance is finasteride. Each tablet contains 5 mg of finasteride.
• The other ingredients are:

Core: Lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl cellulose (type A) (from potato), polysorbate 80 (E433), magnesium stearate.

Coating: Hypromellose, triacetin, titanium dioxide (E171), and indigo carmine (E132, indigo carmine).

Appearance and packaging

Finasteride Alter is presented in the form of tablets. The tablets are round and blue. Each pack contains 28 tablets in Al/PVC blisters.

Marketing authorisation holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet:May 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/