Finasteride Aurobindo

Package leaflet: Information for the user

Finasteride Aurobindo 5 mg film-coated tablets

Generic medicine
Please read this entire leaflet carefully before you start using 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, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Finasteride Aurobindo is and what it is used for

Finasteride Aurobindo contains the active substance finasteride, which belongs to a group of
medicines called 5-alpha reductase inhibitors. These work by reducing the size of the prostate
gland in men.
Finasteride Aurobindo is indicated for the treatment and management of benign prostatic hyperplasia
(BPH), also known as prostate enlargement, which is characterized by a non-cancerous enlargement of the prostate. Finasteride Aurobindo improves urinary flow and BPH-related symptoms, and reduces the risk of acute urinary retention and the need for surgical intervention.

2. What you need to know before taking Finasteride Aurobindo

Do not take Finasteride Aurobindo:

• 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 Finasteride Aurobindo.
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 significant reduction in urine flow.

Inform your doctor if you have been taking finasteride for 6 months or longer and if you 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 Finasteride Aurobindo. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
Finasteride Aurobindo is not indicated for paediatric use, as its safety and efficacy in children have not been established.
Other medicines and Finasteride Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No clinically significant interactions between Finasteride Aurobindo and other medicines have been identified. 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 and breastfeeding
If you are pregnant, suspect you may be pregnant, plan 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.
If a woman is pregnant or suspects she may be pregnant, she must not take Finasteride Aurobindo (see section “Do not take Finasteride Aurobindo”). She should also avoid touching crushed or broken Finasteride Aurobindo tablets, as the active substance in the tablets could be absorbed through the skin and may interfere with the normal development of a male fetus.
Intact Finasteride Aurobindo tablets have a coating that prevents contact with the active substance during normal handling, provided the tablets have not been crushed or broken.
Breastfeeding
It is not known whether finasteride is excreted in human milk; however, women must not take Finasteride Aurobindo.
Driving and using machines
No effects on the ability to drive or use machines are known.
Finasteride Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Finasteride Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Finasteride Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 5 mg tablet daily, which can be taken independently 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 Aurobindo.

Use in patients with renal impairment
If you have reduced kidney function (renal insufficiency), it is not necessary to adjust the dose of Finasteride Aurobindo.

Use in elderly patients
If you are elderly, it is not necessary to adjust the dose of Finasteride Aurobindo, although in patients over 70 years of age finasteride is eliminated to a lesser extent.

If you take more Finasteride Aurobindo than you should
In case of accidental overdose, 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 Aurobindo for periods up to three months.

If you forget to take Finasteride Aurobindo
Do not take a double dose to make up for the forgotten dose.

If you stop taking Finasteride Aurobindo
If you have any doubts about using 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.
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.
• Erectile dysfunction.
• Decreased sexual desire.

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

• 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 body parts including lips, tongue, throat, and face.
• Changes in liver enzymes.
• Testicular pain.
• Erectile dysfunction which may persist after discontinuation of the medicine.
• 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.

Diagnostic tests:
If you need to have blood tests to determine PSA levels (a marker for the possible presence of prostate cancer), keep in mind that finasteride may alter the results of this test.
Report immediately 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 breast cancer.
Stop treatment with Finasteride Aurobindo 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 (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 the following website: 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack/box after “EXP.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 Aurobindo contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (Type A), pregelatinized starch (maize), sodium docusate, magnesium stearate, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, aluminium indigo carmine (E132), yellow iron oxide (E172).

Description of the appearance of Finasteride Aurobindo and package contents
Film-coated tablets.
Round, biconvex, blue film-coated tablet with bevelled edges, marked with "E" on one side and "61" on the other.
Finasteride Aurobindo 5 mg is available in PVC/PE/PVdC-aluminium blisters containing 15 film-coated tablets.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102, 21047 Saronno (VA)
Italy

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy Finasteride Aurobindo