Finasteride stada 5 mg coated tablets

Package leaflet: Information for the patient

Finasterid Stada 5 mg film-coated tablets
(Finasteridum)
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Finasterid Stada is and what it is used for

The active substance in Finasterid Stada is finasteride. Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. These medicines work by reducing the size of the prostate gland in men.
Finasterid Stada is used for the treatment and control of benign enlargement of the prostate gland (benign prostatic hyperplasia – BPH).

2. Important information before using Finasterid Stada

When not to use Finasterid Stada

• If the patient is allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is a woman (see also "Pregnancy and breastfeeding" in this section).
• If the patient is a child.

Warnings and precautions
Before starting treatment with Finasterid Stada, discuss this with your doctor, pharmacist, or
nurse.

• If the patient has reduced liver function.
• If the patient has difficulty completely emptying the bladder or significantly reduced urine flow. In such cases, the patient should be thoroughly examined by a doctor to exclude other causes of urinary tract obstruction.
• If the patient's sexual partner is or may be pregnant, exposure to the patient's semen should be avoided (e.g. by using a condom), as it may contain small amounts of the medicine (see also section 2 "Pregnancy and breastfeeding").

The patient should immediately report to the doctor any changes in breast tissue, such as lumps, pain,
breast enlargement, or nipple discharge, which may indicate a serious medical condition,
such as breast cancer.
Before starting treatment with finasteride and periodically during treatment, the doctor will likely
perform certain simple tests to rule out the possibility of prostate cancer. These may include
a digital rectal examination and a blood test to measure prostate-specific antigen (PSA) levels.
If the patient is due to have a blood test to measure PSA levels, the doctor or nurse should be informed,
as finasteride may affect the results of this test.

Mood changes and depression
Mood changes such as depressive mood and depression, and rarely suicidal thoughts, have been reported
in patients taking Finasterid Stada. If any of these symptoms occur, the patient should immediately
seek medical advice from a doctor.

Finasterid Stada and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Finasterid Stada can normally be used together with other medicines; however, the doctor should be
informed before starting any new medicine.

Finasterid Stada and food
Finasterid Stada can be taken with or without food.

Pregnancy and breastfeeding
Finasterid Stada is intended for use in men only and must not be used in women
(see section 2 "When not to use Finasterid Stada").
Women who are pregnant or may become pregnant must not handle crushed or broken tablets of
Finasterid Stada. If finasteride is absorbed through the skin or taken orally by a pregnant woman
carrying a male fetus, the baby may be born with abnormalities of the genital organs.
The tablets containing finasteride are film-coated, which during normal handling protects against
contact with the active substance, provided the tablet is not crushed or broken.
If a pregnant woman has come into contact with crushed or broken tablets of Finasterid Stada,
medical advice should be sought immediately.
If the patient's sexual partner is pregnant or potentially could become pregnant, exposure to the
patient's semen, which may contain small amounts of the medicine, should be avoided (e.g. by using
a condom).
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
There are no data suggesting that Finasterid Stada impairs the ability to drive motor vehicles or
operate mechanical equipment.

Finasterid Stada contains lactose and sodium.
Lactose: if the patient has previously been diagnosed with intolerance to certain sugars, the patient
should consult a doctor before taking this medicine.
Sodium: this medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to take Finasterid Stada tablets

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day.
The tablet should be swallowed whole and must not be split or crushed. This medicine may be taken during or independent of meals.

Taking more Finasterid Stada than prescribed
If a patient takes more than the prescribed dose of Finasterid Stada 5 mg tablets or if a child accidentally swallows this medicine, contact a doctor or go to a hospital immediately.

If you miss a dose of Finasterid Stada
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Finasterid Stada
Although improvement may be observed within a short time, treatment may need to be continued for at least 6 months.
Do not change the dose or stop treatment without consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You must stop taking Finasterid Stada and contact your doctor immediately if you experience any of
the following symptoms of angioedema (frequency unknown (frequency cannot be estimated from the
available data)):

• Swelling of the face, tongue or lips or throat,
• Difficulty in swallowing,
• Hives (urticaria),
• Difficulty in breathing.

Common (may affect up to 1 in 10 patients):

• Difficulty in achieving an erection (impotence) and reduced sexual desire (decreased libido). These side effects usually occur at the beginning of treatment, are mostly temporary and resolve while continuing treatment.
• Decreased volume of ejaculate.

Uncommon (may affect up to 1 in 100 patients):

• Breast tenderness and/or enlargement.
• Difficulty in achieving ejaculation.
• Rash.

Very rare (may affect up to 1 in 10,000 patients):
Nipple discharge, breast lumps.
Not known (frequency cannot be estimated from the available data):

• Increased liver enzyme activity.
• • Palpitations (awareness of heartbeat).
• Persistent inability to achieve an erection after stopping the medicine.
• Infertility and/or poor quality semen.
• Depression.
• Persistent decrease in sexual desire after stopping the medicine.
• Testicular pain.
• Itching (pruritus), hives.
• Anxiety.

You should immediately consult your doctor if you notice any changes in breast tissue, such as lumps, pain, breast tissue enlargement or nipple enlargement, as these may be symptoms of a serious condition such as breast cancer.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Finasterid Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special precautions for storage of the medicinal product are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Finasterid Stada contains

• The active substance is finasteride. Each tablet contains 5 mg of finasteride.
• The other ingredients are: tablet core – monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch type A, sodium lauryl sulphate, magnesium stearate. Tablet coating – microcrystalline cellulose, hypromellose, polyglycol stearate (8) (type I).

What Finasterid Stada looks like and contents of the pack
Finasterid Stada is a white, round, biconvex coated tablet with the letter "F" and the number "5" embossed on one side of the tablet. The diameter is 7 mm.
PVC/PVDC/Aluminium blister packs in cardboard boxes containing 30, 90, 105, 100 and 120 coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany

Manufacturers:
STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany
Eurogenerics NV, Heizel Esplanade b 22, 1020 Brussels, Belgium
Kern Pharma S.L., Venus 72, 08228 Terrassa-Barcelona, Spain
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
PharmaCoDane ApS, Marielundsvej 46A, DK-2730 Herlev, Denmark
STADA Arzneimittel GesmbH, Muthgasse 36/2, 1190 Vienna, Austria
Siegfried Malta Ltd., HHF070 Hal Far Industrial Estate, Hal Far BBG3000, Malta

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Austria: Finasterid 'Stada' 5 mg – Filmtabletten
Belgium: Finasteride EG 5 mg filmomhulde tabletten
Denmark: Finasterid „Stada“
Germany: Finasterid AL 5 mg Filmtabletten
Iceland: Finasterid Stada 5 mg filmuhúðuð tafla
Italy: Finasteride EG 5 mg compresse rivestite con film
Luxembourg: FINASTERIDE - EG
Poland: Finasterid Stada 5 mg tabletki powlekane
Sweden: Finasterid Stada 5 mg filmdragerad tablett