Package leaflet: Information for the patient

Prostide 5 mg film-coated tablets

finasteride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prostide is and what it is used for
What you need to know before taking Prostide
How to take Prostide
Possible side effects
How to store Prostide
Contents of the pack and other information

1. What Prostide is and what it is used for

Prostide contains the active substance finasteride, which belongs to a group of medicines called
5α-reductase inhibitors, which work by reducing the size of the prostate gland in men.
Prostide is indicated for the treatment and control of benign prostatic hyperplasia (BPH), also known
as benign prostatic hypertrophy, characterized by a benign enlargement of the prostate gland.
Prostide improves urinary flow and symptoms associated with BPH.

2. What you need to know before taking Prostide

Do not take Prostide

if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6);
if you are a woman or a child;
if you are a pregnant woman or suspect you may be pregnant (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Prostide.
Although benign prostatic hyperplasia (BPH) is not a malignant tumour and cannot become one, both conditions may coexist. Only your doctor can evaluate your symptoms, possible causes and the appropriate treatment for you.
Inform your doctor:

if you have or have had any medical conditions, diseases or allergies;
if you have difficulty completely emptying your bladder or a significant reduction in urine flow.

Inform your doctor if you have been taking finasteride for 6 months or longer and if you need to undergo blood tests to determine your PSA levels (a marker for possible prostate cancer), as finasteride may affect the results of this test.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Prostide. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
Prostide is not indicated for paediatric use, as its safety and efficacy in children have not been established.
Other medicines and Prostide
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Prostide and other medicines have been identified. In particular, there are NO interactions with the following medicines:

propranolol (used to treat high blood pressure and angina, characterised by a feeling of tightness in the chest);
digoxin (used to treat heart rhythm problems);
glibenclamide (used to lower blood sugar levels);
warfarin (used to prevent blood clots);
theophylline (used to treat asthma);
phenazone (used to treat inflammation).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If your sexual partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, as it may contain a small amount of the medicine.
Women who are pregnant or suspect they may be pregnant must not take Prostide (see section "Do not take Prostide"). Furthermore, they should not handle crushed or broken Prostide tablets, as the active ingredient in the tablets may be absorbed through the skin and interfere with the normal development of a male fetus.
Intact Prostide tablets have a coating that prevents contact with the active ingredient during normal handling, provided the tablets are not crushed or broken.
Breastfeeding
It is not known whether finasteride is excreted in human milk; however, women should not take Prostide.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Prostide contains lactose
Prostide contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Prostide contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Prostide

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 5 mg tablet daily, which can be taken regardless of
meals.
Your doctor may prescribe Prostide together with another medicine, doxazosin, used to
improve the management of benign prostatic hyperplasia.
Although improvement is often observed after a short period, treatment may need to be continued for at least six months. Your doctor will advise you on how long to take Prostide.
Use in patients with renal impairment
If you have reduced kidney function (renal insufficiency), no dose adjustment of
Prostide is required.
Use in elderly patients
If you are elderly, no dose adjustment of Prostide is necessary, although finasteride is eliminated to a lesser extent in patients over 70 years of age.
If you take more Prostide than you should
If you accidentally take an excessive dose of Prostide, contact your doctor immediately or go to the nearest hospital.
No adverse effects have been reported in patients who have taken high doses of Prostide for periods up to three months.
If you forget to take Prostide
Do not take a double dose to make up for a missed dose.
If you stop taking Prostide
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Erectile dysfunction and decreased sexual desire are the most common adverse reactions. These
adverse reactions occur during the initial phase of treatment and resolve in most patients during the
course of therapy.

Common side effects (may affect up to 1 in 10 people)

decreased semen volume
impotence
decreased sexual desire

Uncommon side effects (may affect up to 1 in 100 people)

skin rash
ejaculation disorders
breast tenderness
breast enlargement

Side effects with unknown frequency (frequency cannot be estimated from the available data)

irregular heartbeat
hypersensitivity reactions such as itching, hives, and swelling (angioedema) of various body parts including lips, tongue, throat, and face
increased transaminases (enzymes indicating possible liver damage)
testicular pain
presence of blood in semen
erectile dysfunction, which may persist after discontinuation of finasteride
male infertility and/or poor semen quality, which normalizes or improves after stopping finasteride
male breast cancer
depression
persistent reduction in sexual desire after stopping treatment
persistent ejaculation problems after stopping treatment
anxiety
suicidal thoughts

Diagnostic tests:
If you need to have blood tests to determine PSA levels (an indicator of possible prostate cancer), be aware that finasteride may alter the results of this test.
Immediately report to your doctor any changes in breast tissue (mammary gland), such as lumps, pain, enlargement of breast tissue in males, or nipple discharge, as these may be signs of a serious condition such as male breast cancer.
Stop treatment with Prostide and contact your doctor immediately if you experience any of the following symptoms of angioedema:

swelling of the face, tongue, or throat
difficulty swallowing
hives
difficulty breathing

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prostide

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prostide contains

The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other components are monohydrate lactose, pregelatinized starch, sodium starch glycolate, sodium docusate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, E 132 indigo carmine on hydrated aluminum oxide.

Description of the appearance of Prostide and contents of the pack
Film-coated tablets of 5 mg (packs of 15 and 30 tablets).
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany