Finasteride Teva Italia

Package leaflet: Information for the user

Finasteride Teva Italia 5 mg film-coated tablets

Generic medicine
Please read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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

1. What Finasteride Teva Italia is and what it is used for
The active substance in Finasteride Teva Italia is 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 Teva Italia is used in the treatment and management of benign enlargement of the
prostate (benign prostatic hyperplasia - BPH). It reduces the size of the enlarged prostate, 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 Teva Italia

Do not take Finasteride Teva Italia

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or may potentially be pregnant. Finasteride Teva Italia is not indicated for use in women. Pregnant women or women of childbearing age who may handle Finasteride Teva Italia tablets should exercise particular caution (see section "Pregnancy, breastfeeding and fertility").

Finasteride Teva Italia is not recommended for use in children.
IF IN DOUBT, ALWAYS ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Finasteride Teva Italia:

• If you have a significantly increased residual urinary volume and/or severely reduced urinary flow. In such cases, narrowing of the urinary tract should be carefully monitored.
• If you have impaired liver function. The plasma concentration of finasteride may increase in these patients.
• If your sexual partner is pregnant or could potentially be pregnant, you must avoid exposing her to any contact with your semen, as it may contain a small amount of the medicine.

Promptly inform your doctor of any changes in breast tissue, such as lumps, pain or nipple discharge, as these may be signs of a serious condition, such as breast cancer.

A clinical examination (including digital rectal examination) and measurement of serum prostate-specific antigen (PSA) should be performed both before starting treatment with finasteride and during treatment.

Mood changes and depression

Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Teva Italia. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.

Other medicines and Finasteride Teva Italia

No significant interactions with other medicines have been observed.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

Finasteride Teva Italia is intended for use in men only.

If you are pregnant or could be pregnant, you must not handle crushed or broken Finasteride Teva Italia tablets. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with malformed genital organs. The tablet coating prevents contact with finasteride; therefore, the tablets must not be split or crushed.

When a patient's sexual partner is pregnant or could become pregnant, the patient must avoid exposing her to his semen (e.g. by using a condom) or discontinue treatment with finasteride.

Driving and using machines

There are no data suggesting that Finasteride Teva Italia affects the ability to drive or operate machinery.

Finasteride Teva Italia contains Lactose

This medicine contains monohydrated lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Finasteride Teva Italia

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 1 tablet per day (equivalent to 5 mg of finasteride).
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The film-coated tablets may be taken with or without food. The film-coated tablets must be swallowed whole and must not be split or crushed.
Although improvements may occur almost immediately, treatment may need to be continued for at least six months to determine whether a favourable response has been achieved.
Your doctor will advise you on how long you should take Finasteride Teva Italia. Do not stop treatment prematurely, as symptoms may recur.
Impaired liver function
There are no data on the use of Finasteride Teva Italia in patients with reduced liver function (see also “Warnings and precautions”).
Impaired kidney function
Dose adjustment is not necessary. To date, no studies have been conducted on the use of Finasteride Teva Italia in patients undergoing haemodialysis.
Elderly patients
Dose adjustment is not necessary.
Tell your doctor or pharmacist if you feel that the effect of Finasteride Teva Italia is too strong or too weak.
If you take more Finasteride Teva Italia than you should
If you have taken more Finasteride Teva Italia than you should, or if a child has accidentally taken the medicine, inform your doctor immediately.
If you forget to take Finasteride Teva Italia
If you forget to take a dose of Finasteride Teva Italia, take it as soon as you remember, unless it is almost time for your next dose. In that case, continue taking the medicine as prescribed. Do not take a double dose to make up for a forgotten dose.
If you have any questions about how to use this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Allergic reactions
If you experience an allergic reaction, stop taking this medicine and contact your doctor immediately.
Symptoms may include:

• Skin rash, itching, or swelling under the skin (urticaria)

Other possible side effects include:

• You may be unable to achieve an erection (impotence)
• You may have reduced sexual desire
• You may release a lower amount of semen during sex. This amount of semen does not appear to affect normal sexual function.

The side effects listed above are common (may affect up to 1 in 10 people) and may disappear after some time if you continue taking Finasteride Teva Italia. These effects usually resolve after stopping Finasteride Teva Italia. 3 of 5

Other side effects reported in some men:
Uncommon (may affect up to 1 in 100 people):

• Skin rash
• Tenderness or enlargement of the breast
• Problems with ejaculation, which may continue after stopping treatment

Not known (frequency cannot be estimated from the available data):

• Anxiety
• Palpitations (awareness of heartbeat)
• Changes in liver function, which may be detected through blood tests
• Testicular pain
• Male infertility and/or reduced semen quality. Improvement in semen quality has been observed after stopping treatment
• Depression
• Decreased sexual desire, which may continue after stopping the medicine
• Problems with ejaculation, which may continue after stopping the medicine

Stop taking Finasteride Teva Italia and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; urticaria; or difficulty breathing.
You should immediately inform your doctor of any changes in breast tissue, such as lumps, pain, swelling, or nipple discharge, as these may be signs of a serious condition, such as breast cancer.
Finasteride may affect the results of a laboratory PSA test.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines 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 Teva Italia contains
The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
The other components are monohydrate lactose, microcrystalline cellulose, sodium carboxymethylamido
(type A), pregelatinized starch, povidone, magnesium stearate, sodium lauryl sulfate, Opadry Blue
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(hypromellose (E464), titanium dioxide (E171), polyethylene glycol 6000, polyethylene glycol 400, indigo carmine aluminum lake (E132)).
Description of the appearance of Finasteride Teva Italia and contents of the pack
Finasteride Teva Italia tablets are blue, capsule-shaped, film-coated tablets marked "FNT5" on one side.
Finasteride Teva Italia is available in packs of 14, 15, 20, 28, 30, 50, 50 x 1 (hospital pack), 56, 60, 84, 90, 98, 100, 105 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy.
Manufacturers
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park – BN22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Operations Poland Sp. z o.o. - ul. Mogilska 80, 31-546 Kraków (Poland)
This medicinal product is authorized in the European Economic Area Member States under the
following names:
France Finasteride Teva 5 mg, film-coated tablet
Belgium Finasteride Teva 5 mg filmomhulde tabletten
Denmark Finasteride Teva 5 mg
Estonia Finasteride Teva
Hungary Finasterid-TEVA 5 mg filmtabletta
Spain Finasterida Teva 5 mg comprimidos recubiertos con película EFG
Italy FINASTERIDE Teva Italia 5 mg film-coated tablets
Lithuania FinasterideTeva 5 mg plėvele dengtos tabletės
Latvia Finasteride Teva 5 mg apvalkotās tabletes
The Netherlands Finasteride 5 mg Teva
Poland Finamef
Portugal Finasterida-Teva
Sweden Finasteride Teva 5 mg filmdragerad tablett
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