Package leaflet: Information for the user

RIDESTIN 5 mg film-coated tablets

Finasteride
Generic medicine
Please 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 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What RIDESTIN is and what it is used for

RIDESTIN contains the active substance finasteride, which belongs to a group of medicines called 5α-reductase inhibitors.
RIDESTIN is used to treat and control benign enlargement of the prostate ( benign prostatic hyperplasia - BPH ). This medicine works by reducing the size of the enlarged prostate gland in men, improving urinary flow and symptoms caused by BPH.

2. What you need to know before taking RIDESTIN

RIDESTIN is intended for male patients only.
Do not take RIDESTIN

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 (see also section “Pregnancy and breastfeeding”).
If you are a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIDESTIN.
Inform your doctor:

if you have a significant amount of residual urine in the bladder after urination and/or severely reduced urinary flow, as you should be carefully monitored for possible narrowing of the urinary tract. In such cases, your doctor may consider the possibility of surgical intervention.
if you have or have had any diseases, medical conditions or allergies.

BPH is not cancer and does not lead to cancer, but both conditions may be present at the same time.
Before starting treatment with finasteride 5 mg, and periodically during treatment, your doctor will likely perform some simple tests to check whether you have prostate cancer. These tests include digital rectal examination and a blood test to determine the level of prostate-specific antigen (PSA). Your doctor will evaluate your symptoms and their possible causes. If in doubt, ask your doctor for further information.
RIDESTIN may alter PSA levels in the blood (a test used to detect prostate cancer). If you need to undergo this test, inform your doctor or nurse if you have been taking finasteride for 6 months or longer.
If your sexual partner is pregnant or could be pregnant, you must avoid exposing her to finasteride. Avoid exposing her to your semen, as it may contain small amounts of the drug (see section “Pregnancy and breastfeeding”).
Mood changes and depression
Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts, have been reported in patients treated with Ridestin. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
RIDESTIN is not indicated for pediatric use, as safety and efficacy in children have not been established.
Other medicines and RIDESTIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
RIDESTIN generally does not interfere with other medicines. No clinically significant pharmacological interactions have been identified with the following medicines:

propranolol (used to treat high blood pressure and angina pectoris);
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
RIDESTIN is for male use only and must not be taken by women (see also section 2 “Do not take RIDESTIN”).
Pregnancy
Pregnant women or women who suspect they might be pregnant must not handle RIDESTIN tablets, especially if they are broken or crushed. If finasteride, the active substance in RIDESTIN, is taken orally or absorbed through the skin by a woman carrying a male fetus, it may interfere with the normal development of the baby’s genital organs.
If your partner is pregnant or suspects she might be pregnant, avoid exposing her to your semen, as it may contain a small amount of the medicine.
RIDESTIN tablets are coated, which prevents contact with the active substance during normal handling, provided the tablets are not broken or crushed.
Breastfeeding
It is not known whether finasteride is excreted in human milk; however, if you are a woman, you must not take RIDESTIN.
Driving and using machines
There are no data suggesting that RIDESTIN impairs the ability to drive or operate machinery.
RIDESTIN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
RIDESTIN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RIDESTIN

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet containing 5 mg of finasteride taken orally once
daily. The tablets can be taken with or without food. The tablet must be swallowed
whole and must not be divided or crushed (see section Pregnancy and breast-feeding).
Although improvements may be observed in a short time, treatment for at least six months
may be necessary to determine whether a favourable response has been achieved. Your doctor will
indicate how long you should take RIDESTIN.
Your doctor may prescribe RIDESTIN together with another medicine called doxazosin, to improve
the management of benign prostatic hyperplasia.
Use in patients with impaired renal function
No dose adjustment is required.
Use in the elderly
No dose adjustment is required.
If you take more RIDESTIN than you should
If you have accidentally taken more tablets than prescribed, contact your doctor immediately or go
to the nearest hospital.
Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80
mg/day for three months without adverse effects.
No specific treatment is recommended in case of finasteride overdose.
If you forget to take RIDESTIN
If you have forgotten to take a dose, take it as soon as you remember, unless it is almost time to take the
next dose; in this case, continue as prescribed. Do not take a double dose to make up for a missed tablet.
If you stop taking RIDESTIN
Do not change the dose or stop treatment without informing your doctor.
If you have any doubts 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 experiences them.
The most common side effects are impotence (inability to achieve an erection) and reduced sexual desire. These side effects usually occur during the initial phase of treatment and resolve in most patients during the course of therapy.
The following side effects may occur with RIDESTIN:

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

decreased sexual desire;
impotence (inability to achieve an erection);
reduced ejaculate volume (decrease in the amount of semen released during sexual intercourse).

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

skin rash;
ejaculation disorders;
breast enlargement;
breast tenderness.

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

palpitations (fast and/or irregular heartbeat);
increased liver enzymes;
hypersensitivity reactions such as itching, urticaria, and swelling (angioedema) in various parts of the body including lips, tongue, throat, and face;
testicular pain;
presence of blood in semen;
erectile dysfunction, which may persist after discontinuation of finasteride;
male infertility and/or poor semen quality, which normalize or improve after stopping finasteride;
male breast cancer;
depression;
decreased libido even 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 (a marker for possible prostate cancer), be aware that finasteride may alter the results of this test.
The safety and tolerability of finasteride and doxazosin, either alone or in combination, are comparable; however, the frequency of ejaculation disorders is the sum of those observed with finasteride alone and doxazosin alone.
The side effects occurring more frequently when finasteride is administered together with doxazosin are: lack of energy, drop in blood pressure upon standing, dizziness, and ejaculation disorders.
When measuring levels of prostate-specific antigen (PSA), it should be noted that PSA values are reduced by approximately half during treatment with finasteride (see section 2 “Warnings and precautions”).
Stop treatment with RIDESTIN and contact your doctor immediately if you experience any of the following symptoms of angioedema:

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

Promptly inform your doctor of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition such as male breast cancer.
Following the instructions provided in this leaflet may reduce the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 RIDESTIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The expiry date refers to the product in its original packaging, properly stored.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What RIDESTIN contains
The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium
starch glycolate, magnesium stearate, sodium lauryl sulfate, yellow iron oxide (E172).
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, polyethylene glycol, indigo carmine lake (E132), talc.
Description of the appearance of RIDESTIN and pack contents
Film-coated tablets available in blister packs containing 15 tablets.
Film-coated tablets available in blister packs containing 30 tablets.
Film-coated tablets available in blister packs containing 60 tablets.
Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)