Stronazon 400micrograms MR capsules
(tamsulosin hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
In this leaflet:
1 What Stronazon is and what it is used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
What Stronazon is and what it is used for
Stronazon modified-release capsules are used to treat symptoms caused by an enlarged prostate gland (benign prostatic hyperplasia BPH). The prostate gland surrounds the urethra (the tube with which urine passes from the bladder). When the prostate gland is enlarged it presses on the urethra causing it to narrow, so that it is difficult to pass urine.
Stronazon modified-release capsules relax the muscles in the prostate gland, making the urethra wider and easing the passing of urine.
Before starting treatment with Stronazon, your doctor may want to carry out tests to check that you do not have any other conditions which are causing your symptoms.
Before you take
Do not take Stronazon and tell your doctor if you:
- are allergic (hypersensitive) to tamsulosin hydrochloride or one of the other ingredients (see section 6). Symptoms include sudden swelling of hands or feet, difficulty in breathing and/or itch and rash (angioedema).
- have a history of being dizzy or fainting when standing suddenly caused by low blood pressure (orthostatic hypotension).
- have severe liver problems.
Check with your doctor or pharmacist before taking Stronazon if you:
- suffer from severe kidney problems
- have cataracts.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
- alpha 1A-blockers e.g. doxazosin, prazosin and indoramin. If you take these with Stronazon your blood pressure may fall.
- diclofenac (an anti-inflammatory painkiller) and warfarin (used to thin blood) may affect the way that Stronazon is handled by your body.
Pregnancy and breast-feeding
Stronazon is intended for males only.
Driving and using machines
Stronazon should not affect your ability to drive or use machinery. However, in some people Stronazon may cause dizziness, if you are affected do not drive or use machinery.
How to take
Always take Stronazon exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Take after the first meal of the day whilst standing or sitting upright (not lying down). Swallow whole with a glass of water. Do not open the capsule this will affect how the medicine works.
Doses:
One capsule a day.
Your doctor has prescribed a suitable dose for you and your illness, and has specified the duration of the treatment.
You should not change the dose without speaking to your doctor first.
If you take more than you should
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take the capsules
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose after the first meal of the day, it can be taken later the same day after food. If you have missed a day skip the forgotten dose and then take the next dose at the right time.
Possible side effects
Like all medicines, Stronazon can cause side effects, although not everybody gets them.
Stop taking Stronazon and contact your doctor at once if you experience sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angiooedema).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users):dizziness.
Uncommon (occurs in less than 1 in 100 users): headache, rapid or irregular heart beat, dizziness especially when sitting or standing up, nasal inflammation causing a runny nose, constipation, diarrhoea, feeling sick, being sick, rash, itching, abnormal ejaculation, feeling of weakness.
Rare (occurs in less than 1 in 1,000 users): swelling of hands or feet, difficulties in breathing and/or itch and rash (angio-oedema). Symptoms of low blood pressure (dizziness, fainting or weakness) occur rarely, sit or lie down straight away until the symptoms disappear. If you do not feel better please contact your doctor.
Very rare (occurs in less than 1 in 10,000 users): painful, prolonged, unwanted erection (priapism).
Changes in the eye have been noticed during cataract surgery.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store in the original package.
Do not use Stronazon after the expiry date stated on the label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Stronazon contains
- The active substance (the ingredient that makes the capsule work) is tamsulosin hydrochloride.
- The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, triethyl citrate and talc.The capsule body ingredients are gelatine, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), and printing ink (black iron oxide E 172, shellac, propylene glycol).
What Stronazon looks like and contents of the pack
The Stronazon modified-release capsules are orange/ olive-green in colour with a black stripe at both ends of the capsule body.
Pack sizes are 30
Marketing Authorisation Holder
Manufacturer
Date of revision: September 2008
SYNPL017
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