Finedor

Package leaflet: Information for the patient

Finedor 5 mg film-coated tablets

finasteride
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could 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 Finedor is and what it is used for
2. What you need to know before taking Finedor
3. How to take Finedor
4. Possible side effects
5. How to store Finedor
6. Contents of the pack and other information

1. What Finedor is and what it is used for

Finedor contains the active substance finasteride, which belongs to a group of medicines called 5α-reductase inhibitors. Finedor is used only in men.
Finedor helps reduce the size of the prostate gland in men when it is enlarged. The prostate is a gland located below the bladder (but only in men). It produces seminal fluid. An enlarged prostate can lead to a condition called "benign prostatic hyperplasia" or BPH.

What is BPH?
If you have BPH, it means your prostate is swollen. This can press on the tube through which urine passes and leaves the body.

This may lead to the following problems:

• Feeling the need to urinate more often, especially at night
• Feeling of not being able to hold urine
• Difficulty urinating
• Weak urine flow
• Intermittent urine stream
• Feeling of incomplete bladder emptying

In some men, BPH can lead to serious problems such as:

• Urinary tract infection
• Sudden inability to urinate
• Need for surgery

What else you should know about BPH:
BPH is not cancer and does not cause cancer, but both conditions can occur at the same time.

• Before you take Finedor, your doctor will carry out some simple tests to determine whether you have prostate cancer.

If you have any doubts, consult your doctor.

2. What you should know before taking Finedor

Do not take Finedor

• if you are allergic to finasteride or 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 might be pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finedor.
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 or a markedly reduced urine flow.

Inform your doctor if you have been taking finasteride for 6 months or more and need to have 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 Finedor. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
Finedor is not indicated for paediatric use, as safety and efficacy in children have not been established.
Other medicines and Finedor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No clinically significant interactions between Finedor and other medicines have been identified.
Specifically, 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).

Finedor with food and drinks
Finedor may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If your sexual partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen, as it may contain a small amount of the medicine.
If a woman is pregnant or suspects she might be pregnant, she must not take Finedor (see section “Do not take Finedor”). Furthermore, she should not handle crushed or broken Finedor tablets, as the active ingredient in the tablets could be absorbed through the skin and interfere with the normal development of a male fetus.
Intact Finedor 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 must not take Finedor.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Finedor contains sunset yellow FCF
This medicine contains sunset yellow FCF, which may cause allergic reactions.
Finedor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Finedor

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How to take this medicine
The recommended dose is one tablet once daily.

• Take this medicine by mouth.
• The break line is only intended to help you split the tablet if you have difficulty swallowing it whole.

Your doctor may prescribe Finedor together with another medicine called doxazosin to
help control your BPH.
If you take more Finedor than you should
If you accidentally take too much Finedor, contact your doctor immediately or go
to the nearest hospital.
No adverse effects have been reported in patients who have taken high doses of Finedor for periods up to
three months.
If you forget to take Finedor
Do not take a double dose to make up for the missed dose.
If you stop taking Finedor
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Impotence and decreased sexual desire are the most common adverse reactions. These adverse reactions occur during the initial phase of treatment and resolve during treatment in most patients.

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, urticaria, and swelling (angioedema) of various parts of the body including lips, tongue, throat, and face
• increased liver enzymes
• testicular pain
• blood in the semen
• erectile dysfunction, which may continue after discontinuation of finasteride
• male infertility and/or poor semen quality, which normalizes or improves after stopping finasteride
• breast cancer in men
• 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 (a marker for possible prostate cancer), be aware that finasteride may affect the results of this test.

Immediately inform your doctor of 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 breast cancer.

Stop treatment with Finedor 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

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 Finedor

This medicine does not require any special storage conditions. 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.
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 Finedor contains

• The active substance is finasteride.
• Each coated tablet contains 5 mg of finasteride.
• The excipients are: Tablet core: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, yellow iron oxide (E172), sodium docusate, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E171), talc, propylene glycol (E1520), indigotine (E132), quinoline yellow (E104), sunset yellow FCF (E110).

Description of the appearance of Finedor and pack contents
Finedor is available as blue, round, film-coated, biconvex tablets with a score line on one side.
Finedor is available in blisters containing 15, 28, 30, 98 or 100 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.R.L.
Via Conca D’Oro, 212
00141 Rome
Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA), Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Finedor