FINASTERIDE 5 mg Film-Coated Tablets

Зміст інструкції

1. Finasteride Aurobindo 5 mg film-coated tablets
   1. What is Finasteride Aurobindo and what is it 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

Finasteride Aurobindo 5 mg film-coated tablets

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 you take 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 is Finasteride Aurobindo and what is it used for

Finasteride Aurobindo contains the active ingredient finasteride which belongs to a group of
medicines called 5-alpha reductase inhibitors, which work by reducing the size of the
prostate gland in men.
Finasteride Aurobindo is indicated for the treatment and control of benign prostatic hyperplasia
(BPH), also known as prostatic hypertrophy, characterized by a benign enlargement of the
prostate. Finasteride Aurobindo improves urinary flow and symptoms associated with BPH 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 any of the other ingredients of this medicine (listed in section 6);
• if you are a woman or a child;
• if you are a woman who is pregnant or suspects she may be pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Aurobindo.
Although BPH is not a malignant tumor, nor can it become one, the two conditions can
coexist. Only a doctor is able to assess your symptoms, possible causes and the correct treatment
for you.
Tell your doctor:

• if you have or have had any illness or medical problems or allergies;
• if you have difficulty completely emptying your bladder or a significantly reduced urine flow.

Tell your doctor if you have been taking finasteride for 6 months or more and if you need to have blood tests to determine your PSA levels (an indicator of the possible presence of prostate cancer), as finasteride may alter the results of this test.
Changes in mood and depression
Changes in mood, 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 information.

Children and adolescents
Finasteride Aurobindo is not indicated for use in pediatric patients as safety and efficacy in
children have not been established.

Other medicines and Finasteride Aurobindo
Tell 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 found 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, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If your sexual partner is pregnant or suspects she may be pregnant, you should avoid exposing her to your
semen because it may contain a small amount of the medicine.
If a woman is pregnant or suspects she may be pregnant, she should not take Finasteride Aurobindo
(see section “Do not take Finasteride Aurobindo”). Also, she should not touch Finasteride Aurobindo
tablets if they are crushed or broken, as the active ingredient present in the
tablets could be absorbed and interfere with the normal development of a male
child.
Intact Finasteride Aurobindo tablets have a coating that prevents contact with the
active ingredient during normal manual contact, provided the tablets have not been crushed or
broken.
Breastfeeding
It is not known whether finasteride is excreted in human milk; in any case, if you are a woman, you should
not take Finasteride Aurobindo.

Driving and using machines
No effects on the ability to drive or operate machinery have been reported.

Finasteride Aurobindo containslactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have any doubts, 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 noticed after a short period, it may be necessary to continue the
treatment for at least six months. Your doctor will tell you how long to take Finasteride
Aurobindo.

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

Use in elderly patients
If you are elderly it is not necessary to modify the dose of Finasteride Aurobindo, although in patients over the age of
70 years, finasteride is eliminated in smaller quantities.

If you take more Finasteride Aurobindo than you should
In case of accidental ingestion of an excessive dose of Finasteride Aurobindo, inform
your doctor immediately or go to the nearest hospital.
No undesirable effects have been observed in patients who have taken high doses of Finasteride
Aurobindo for periods of up to three months.

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

If you stop taking Finasteride Aurobindo
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 everybody gets them.
Impotence and decreased libido are the most frequent adverse reactions. These
adverse reactions occur in the early phase of therapy and in most patients resolve during therapy.

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

• Decreased semen volume.
• Impotence.
• Decreased libido.

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 available data):

• Irregular heartbeat.
• Hypersensitivity reactions such as itching, hives and swelling (angioedema) of various parts of the body including lips, tongue, throat and face.
• Changes in liver enzymes.
• Testicular pain.
• Erectile dysfunction that may persist after discontinuation of the medicine.
• Male infertility and/or poor semen quality, which normalizes or improves after discontinuation of finasteride.
• Breast cancer in men.
• Depression.
• Persistent decrease in sexual drive after discontinuation of treatment.
• Persistent ejaculation problems after discontinuation of treatment.
• Anxiety.

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, breast tissue enlargement 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;
• difficulty breathing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through 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 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 after “EXP.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you observe visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Finasteride Aurobindo contains

• The active ingredient is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), pregelatinized starch (corn), 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 contents of the pack
Film-coated tablets.
Round, biconvex, blue film-coated tablet with bevelled edges imprinted 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 Authorisation Holder:
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102, 21047 Saronno (VA)

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy Finasteride Aurobindo