TAMSULOSIN 0.4 mg Modified-release hard capsules

Зміст інструкції

1. Tamsulosin Teva 0.4 mg extended-release hard capsules
   1. What you need to know before taking Tamsulosin Teva
   2. How to take Tamsulosin Teva
   3. Possible side effects
   4. How to store Tamsulosin Teva
   5. Contents of the pack and other information

Tamsulosin Teva 0.4 mg extended-release hard capsules

tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before you start taking 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What is Tamsulosin Teva and what it is used for

2. What you need to know before you take 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 is Tamsulosin Teva and what it is used for

The active ingredient of Tamsulosin Teva is tamsulosin. This is a selective α -
adrenoceptor antagonist. It reduces the tension of the smooth muscles of the prostate and urethra, allowing
urine to pass more easily through the urethra and facilitating urination. It also decreases the
sensation of needing 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 (poor flow), leakage of urine, urgency and the need to urinate frequently at
night and during the day.

2. What you need to know before taking Tamsulosin Teva

Do not take Tamsulosin Teva if:

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

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

• periodic medical examinations are necessary to monitor the development of the condition for which you are being treated.
• Rarely, fainting may occur during the use of Tamsulosin Teva, as with other drugs of this type. At the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.
• if you suffer from severe kidney problems, tell your doctor.
• if you have undergone or are planning to undergo eye surgery due to a clouding of the lens (cataract) or an increase in pressure inside the eye (glaucoma), inform your ophthalmologist that you have previously used, are using or plan to use Tamsulosin Teva. The specialist can then take appropriate precautions regarding the drugs and surgical techniques to be used. Ask your doctor if it is possible to postpone or temporarily interrupt treatment when undergoing eye surgery due to an opaque lens (cataract) or an increase in pressure inside the eye (glaucoma).

Children and adolescents
Do not give this medicine to children or adolescents under the age of 18, because it does not
work in this population.

Other medicines and Tamsulosin Teva
Tell 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-adrenoceptor antagonists (medicines used to treat prostate disease), e.g. alfuzosin, doxazosin or terazosin
• diclofenac (a non-steroidal anti-inflammatory pain reliever)
• warfarin (used to block blood clotting).
• Ketoconazole (used to treat fungal infections)

Pregnancy, breastfeeding and fertility
Tamsulosin Teva modified-release capsules are not indicated in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that the
semen does not leave the body through the urethra, but goes into the bladder (retrograde ejaculation) or that the volume of
ejaculate is reduced or absent (lack of ejaculation). This phenomenon is harmless.

Driving and operating machinery
There is no evidence that Tamsulosin Teva affects the ability to drive vehicles or operate machinery
or equipment. However, it should be kept in mind that dizziness may occur, in which case you should not
engage in activities that require attention.

3. How to take Tamsulosin Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Adult males, including elderly people

• The recommended dose is one capsule a day, to be taken after breakfast or after the first meal of the day.
• The capsule must be swallowed whole and must not be crushed or chewed.
• Usually, Tamsulosin modified-release capsules are 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 can lead to an undesirable reduction in blood pressure
and an increase in 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 have forgotten to take the recommended daily dose, you can take Tamsulosin Teva later on the
same day. If you have missed a day, continue to take 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 reappear. Therefore, use Tamsulosin Teva until your doctor prescribes it, even if your
problems have already disappeared. If you are considering stopping therapy, always consult your
doctor.
If you have any further questions on the use of 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 any of the following occur, stop treatment and immediately inform your
doctoror go to the nearest emergency room:

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

These are very serious but rare side effects that require urgent medical attention or hospitalisation.
The following side effects have been reported. If any of these occur and they worry you,
speak to 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 goes into the bladder (retrograde ejaculation) or that the volume of ejaculate is reduced or absent (lack of ejaculation). This phenomenon is harmless.

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

• headache
• fast heartbeat
• dizziness (due to low blood pressure), especially when standing up or sitting down
• runny nose and itchy nose
• diarrhoea, constipation, nausea, vomiting
• itching, skin rash, including hives
• feeling weak

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 that can last for several hours to a few days

Not known(frequency cannot be estimated from available data)

• irregular abnormal heartbeat (atrial fibrillation, arrhythmia, tachycardia)
• difficulty breathing (dyspnoea)
• blurred vision
• impaired vision
• nosebleed (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• dry mouth
• If you have undergone eye surgery for cataracts or increased eye pressure (glaucoma) and are currently taking or have previously taken tamsulosin, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the Italian Medicines Agency,
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
package and keep the container tightly closed. Do not transfer to another container.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date
refers to the last day of the month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tamsulosin Teva contains:

• The active substance is tamsulosin hydrochloride 400 micrograms.
• The excipients are microcrystalline cellulose, ethyl acrylate-methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigotine (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 orange/olive green modified-release hard capsules. They are imprinted with ‘TSL 0.4’, with a black line on both ends. The capsules contain white-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

Manufacturer responsible for batch release
Synthon B.V. – Microweg, 22 – 6545 CM Nijmegen (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 (Netherlands)