Tamsulosin Teva

Package Leaflet: Information for the User

Tamsulosin Teva 0.4 mg modified-release hard capsules

tamsulosin hydrochloride
Generic medicine
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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

1. What Tamsulosin Teva is and what it is used for
The active substance in Tamsulosin Teva is tamsulosin. This is a selective α-adrenoceptor antagonist. It reduces the tone of the smooth muscle in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. It also reduces the urge to urinate.
Tamsulosin Teva is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), urine leakage, urgency, and the need to urinate frequently during both day and night.

2. What you need to know before taking Tamsulosin Teva

Do not take Tamsulosin Teva if:

• you are allergic to tamsulosin hydrochloride or to any of the excipients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of soft tissues of the body (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema).
• you suffer from fainting due to low blood pressure when changing posture (e.g. when sitting up after lying down or standing up).
• you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosin Teva:

• periodic medical check-ups are necessary to monitor the condition for which you are being treated.
• rarely, fainting may occur during treatment with Tamsulosin Teva, as with other medicines of this type. At the first signs of dizziness or weakness, sit or lie down until symptoms disappear.
• if you have severe kidney problems, inform your doctor.
• if you are undergoing or have planned eye surgery due to clouding of the lens (cataract) or increased pressure inside the eye (glaucoma), inform your ophthalmologist that you have previously used, are currently using, or plan to use Tamsulosin Teva. The specialist can then take appropriate precautions regarding the medications and surgical techniques to be used. Ask your doctor whether it might be possible to postpone or temporarily interrupt treatment when undergoing eye surgery due to a cloudy lens (cataract) or increased intraocular pressure (glaucoma).

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.
Other medicines and Tamsulosin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking any of the following medicines:

• any other alpha-adrenoreceptor antagonists (medicines used to treat prostate disease), e.g. alfuzosin, doxazosin or terazosin
• diclofenac (a non-steroidal anti-inflammatory painkiller)
• warfarin (used to prevent blood clotting)
• ketoconazole (used to treat fungal infections)

Pregnancy, breastfeeding and fertility
Tamsulosin Teva modified-release capsules are not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen does not leave the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This phenomenon is harmless.
Driving and using machines
There is no evidence that Tamsulosin Teva affects the ability to drive or operate machinery or equipment. However, you should bear in mind that dizziness may occur; in such a case, you should not engage in activities requiring alertness.

3. How to take Tamsulosin Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Adult males, including elderly people

• The recommended dose is one capsule per day, taken after breakfast or after the first meal of the day.
• The capsule must be swallowed whole and must not be crushed or chewed.
• Tamsulosin modified-release capsules are usually prescribed for a long period of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin modified-release capsules.

If you take more Tamsulosin Teva than you should
Taking too much Tamsulosin Teva may cause an unwanted drop in blood pressure
and an increased heart rate, with feelings of fainting. Contact your doctor immediately
if you have taken too much Tamsulosin Teva.
If you forget to take Tamsulosin Teva
If you forget to take your daily dose, you may take Tamsulosin Teva later on the
same day. If you miss a day, continue taking your daily capsule as prescribed. Do not
take a double dose to make up for a forgotten capsule.
If you stop taking Tamsulosin Teva
When treatment with Tamsulosin Teva is stopped prematurely, your initial
symptoms may return. Therefore, continue using Tamsulosin Teva for as long as your doctor prescribes it, even if
your symptoms have already improved. If you are considering stopping treatment, always consult your
doctor.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following conditions, stop treatment immediately and contact your doctor
or go to the nearest emergency department:

• allergic reaction (swelling of the lips, face or neck with severe breathing difficulties, skin rash or hives).
• a serious illness with blistering of the skin, mouth, eyes and genitals called Stevens-Johnson syndrome (may affect up to 1 in 10,000 people).

These are very serious but rare side effects that require immediate medical attention or emergency hospitalisation.
The following side effects have been reported. If you experience any of these and they concern you, consult your doctor.
Common (may affect up to 1 in 10 people):

• dizziness
• abnormal ejaculation (ejaculation disorders). This means that semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This phenomenon is harmless.

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

• headache
• fast heartbeat
• dizziness (due to lowering of blood pressure), especially when sitting or standing
• runny nose and nasal itching
• diarrhoea, constipation, nausea, vomiting
• itching, skin rash including urticaria
• feeling of weakness

Rare (may affect up to 1 in 1,000 people):

• fainting
• severe allergic reaction causing swelling of the face or throat

Very rare (may affect up to 1 in 10,000 people):

• prolonged and painful erection which may last from several hours to a few days

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

• irregular abnormal heartbeat (atrial fibrillation, arrhythmia, tachycardia)
• breathing difficulty (dyspnoea)
• blurred vision
• visual impairment
• nosebleeds (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• dry mouth
• If you have undergone eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma) and are currently taking or have previously taken tamsulosin, the pupil may not dilate properly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

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 Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website: http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsulosin Teva

Keep this medicine out of the sight and reach of children. Store in the original packaging and keep the container tightly closed. Do not transfer to another container.
Do not use this medicine after the expiry date stated on the outer packaging. The expiry date refers to the last day of the 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 Tamsulosin Teva contains:

• The active substance is tamsulosin hydrochloride 400 micrograms.
• The excipients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), shellac and propylene glycol.

Description of the appearance of Tamsulosin Teva and contents of the pack:

• Tamsulosin Teva are modified-release hard capsules, orange/olive green in colour, with a black line at each end and marked with 'TSL 0.4'. The capsules contain white to off-white granules.
• The product is available in packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milano
Responsible manufacturer for batch release
Synthon B.V. – Microweg, 22 – 6545 CM Nijmegen (The Netherlands)
Synthon Hispania S.L. – Castelló, 1 – Poligono Las Salinas – Sant Boi de Llobregat (Spain)
Teva Santé – Rue Bellocier – BP 713 – 89107 Sens Cedex (France)
Pharmachemie B.V. - Swensweg 5 – 2031 GA Haarlem (The Netherlands)
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