FINASTERIDE IPSOPHARMA

Patient Information Leaflet

Finasteride Ipso Pharma 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Finasteride Ipso Pharma is and what it is used for
2. What you need to know before taking Finasteride Ipso Pharma
3. How to take Finasteride Ipso Pharma
4. Possible side effects
5. How to store Finasteride Ipso Pharma
6. Contents of the pack and other information

1. What Finasteride Ipso Pharma is and what it is used for

Finasteride Ipso Pharma 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.
Finasteride Ipso Pharma is indicated for the treatment and management of benign prostatic hyperplasia (BPH), also known as prostate enlargement, a condition characterized by a benign enlargement of the prostate.
Finasteride Ipso Pharma improves urinary flow and symptoms associated with BPH.

2. What you need to know before taking Finasteride Ipso Pharma

Finasteride Ipso Pharma is intended exclusively for male patients.
Do not take Finasteride Ipso Pharma

• 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;
• if you are a pregnant woman or suspect you may be pregnant (see also section “Pregnancy and breastfeeding”);
• if you are a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Ipso Pharma.
Although benign prostatic hyperplasia (BPH) is not a malignant tumour and cannot become one, both conditions may coexist. Only your doctor can assess 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 and/or a significantly reduced urine flow. Inform your doctor if you have been taking finasteride for 6 months or longer and 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 Finasteride Ipso Pharma. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.

Children and adolescents
Finasteride Ipso Pharma is not indicated for paediatric use, as safety and efficacy in children have not been established.

Other medicines and Finasteride Ipso Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No clinically significant interactions have been identified between Finasteride Ipso Pharma and other medicines. In particular, no significant interactions have been observed 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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Finasteride Ipso Pharma is for male use only and must not be taken by women (see also section 2 “Do not take Finasteride Ipso Pharma”).
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 Finasteride Ipso Pharma (see section “Do not take Finasteride Ipso Pharma”).
Additionally, women must not handle crushed or broken Finasteride Ipso Pharma tablets, as the active ingredient in the tablets may be absorbed through the skin and could interfere with the normal development of a male fetus.
Intact Finasteride Ipso Pharma 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 breast milk. However, women must not take Finasteride Ipso Pharma.

Driving and using machines
There are no data suggesting that finasteride impairs the ability to drive vehicles or operate machinery.

Finasteride Ipso Pharma contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Finasteride Ipso Pharma

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 per day, which can be taken regardless of meals.
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 Finasteride Ipso Pharma.
Your doctor may prescribe Finasteride Ipso Pharma together with another medicine, doxazosin, to help improve control of benign prostatic hyperplasia.

Use in patients with renal impairment
Dose adjustment is not required.

Use in elderly patients
Dose adjustment is not required, although finasteride is eliminated in slightly lower amounts in patients over 70 years of age.

If you take more Finasteride Ipso Pharma than you should
If you accidentally take an excessive dose of Finasteride Ipso Pharma, contact your doctor immediately or go to the nearest hospital.
No adverse effects have been reported in patients who have taken high doses of Finasteride Ipso Pharma for periods up to three months.

If you forget to take Finasteride Ipso Pharma
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, continue as prescribed. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Finasteride Ipso Pharma
Do not change the dose or stop treatment without informing your doctor.

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.

The most common side effects are impotence (inability to achieve an erection) and reduced sexual desire.
These side effects occur during the initial phase of treatment and resolve in most patients during the course of therapy.

Stop treatment with Finasteride Ipso Pharma and contact your doctor immediately if you experience any of the following:

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

The following side effects may occur with Finasteride Ipso Pharma:

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

• decreased libido (reduced sexual desire);
• impotence (inability to achieve an erection);
• decreased semen volume (reduction 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)

• allergic reactions, swelling of the lips, tongue, throat and face (angioedema);
• anxiety;
• depression;
• persistent reduction in sexual desire after stopping treatment;
• suicidal thoughts;
• palpitations (rapid and/or irregular heartbeat);
• increased liver enzymes;
• itching, hives;
• testicular pain;
• erectile dysfunction, which may persist after stopping treatment;
• male infertility and/or poor semen quality, which normalizes or improves after stopping treatment;
• presence of blood in semen;
• breast cancer in men.

The safety and tolerability profiles of finasteride and doxazosin alone or in combination are comparable, but the frequency of ejaculation disorders is the sum of those observed with finasteride alone and doxazosin alone.
The side effects that occurred more frequently when finasteride was administered concomitantly with doxazosin were: lack of energy, drop in blood pressure upon standing, dizziness, and ejaculation disorders.

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 https://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 Finasteride Ipso Pharma

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, unopened packaging stored correctly.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride Ipso Pharma 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, macrogol, indigo carmine lake (E132), talc.
Description of the appearance of Finasteride Ipso Pharma and package contents
Blue, shield-shaped film-coated tablets, in packs of 15 and 30 tablets in opaque PVC/PE/PVDC and aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Ipso Pharma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) – Italy
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) – Italy