Package Insert: Information for the Patient

Finasteride Alter 5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Finasterida is a 5-alpha reductase inhibitor that reduces the enlargement of the prostate.

Your doctor has prescribed Finasterida Alter because you suffer 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 makes it difficult to urinate.

Finasterida Alter reduces the size of the enlarged prostate and alleviates urinary symptoms: frequent need to urinate, pain while urinating, weak urine stream, sensation that the bladder has not been fully emptied. Finasterida Alter reduces the need for surgical intervention.

Do not take Finasterida Alter

• if you are allergic to finasteride or any of the other ingredients in this medication (listed in section 6)
• since the condition for which Finasterida Alter is prescribed only occurs in men, women and children should not take it.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Alter

• Inform your doctor of your current and past medical conditions and any allergies you may have.
• Finasterida Alter is only intended for the treatment of BPH in males. Women should not use Finasterida Alter when pregnant or could be pregnant, nor should they be exposed to this medication by handling crushed or broken tablets. If the active ingredient of Finasterida Alter is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of Finasterida Alter, she should consult her doctor. Finasterida Alter tablets are coated, which will prevent contact with the active ingredient during normal handling, as long as the tablets are not crushed or broken. If you have any doubts, ask your doctor.

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

• BPH develops over a long period of time. Sometimes symptoms improve right away, but you may need to take Finasterida Alter for at least six months to see if your symptoms improve. Although you may not feel any improvement or change in symptoms, Finasterida Alter therapy may reduce the risk of not being able to urinate and therefore the need for surgery. You should visit your doctor regularly so that he can perform periodic check-ups and evaluate 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.

• Finasterida Alter may decrease levels of the 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 Finasterida Alter.

Mood changes and depression

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

Children and adolescents

Finasterida Alter is not indicated for women or children.

Other medications and Finasterida Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Finasterida Alter usually does not interact with other medications.

Finasterida Alter with food and drinks

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

Pregnancy, breastfeeding, and fertility

Finasterida Alter is for exclusive use in males.

Finasterida Alter is not indicated for women.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Finasterida Alter should not affect your ability to drive or operate machinery.

Finasterida Alter contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Finasterida Alter is an oral medication. Take one Finasterida Alter tablet per day, with or without food.

Remember that your prostate took many years to grow enough to cause symptoms. Finasterida Alter will only treat your symptoms and control the disease if you continue to take it over the long term.

Your doctor may prescribe Finasterida Alter along with another medication, called doxazosina, to help you better control your BPH.

If you estimate that the action of Finasterida Alter is too strong or too weak, inform your doctor or pharmacist.

If you take more Finasterida Alter than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Finasterida Alter

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

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine:

Allergic reactions

Stop taking this medicine and seek medical attention immediately if you experience 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 (rash)

Other side effects may include:

• Being unable to achieve an erection (impotence)
• Having a reduced desire to engage in sexual activity
• Experiencing problems with ejaculation, for example, a decrease in the amount of semen released during sexual activity. This decrease in semen volume does not appear to affect normal sexual function.

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

Other side effects reported in men are:

• Swelling or tenderness of the breasts
• Palpitations (feeling the heartbeat)
• Changes in liver function, which can be seen in a blood test
• Testicular pain
• Impotence that may persist after treatment is discontinued
• Male infertility and/or poor semen quality. Cases of improved semen quality have been reported after stopping treatment.
• Depression
• Anxiety
• Reduced sexual desire that may persist after treatment is discontinued
• Problems with ejaculation that may persist after stopping the medicine.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasterida Alter

• The active ingredient is finasteride. Each tablet contains 5 mg of finasteride.
• The other components are:

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

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

Appearance of the product and contents of the packaging

Finasterida Alter is presented in the form of tablets. The tablets are round and blue in color. Each package contains 28 tablets in an Al/PVC blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last review of this leaflet:May 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/