Stronazon 400 Micrograms Mr Capsules
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Stronazon 400micrograms MR capsules tamsulosin hydrochloride
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 further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Stronazon is and what it is used for
2. What you need to know before you take Stronazon
3. How to take Stronazon
4. Possible side effects
5. How to store Stronazon
6. Contents of the pack and other information
1. What Stronazon is and what it is used for
Stronazon modified-release capsules relax the muscles in the prostate gland, making the urethra wider and easing the passing of urine.
Stronazon modified-release capsules capsules are used in the treatment of the lower urinary tract symptoms associated with 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.
2. What you need to know before you take Stronazon Do not take Stronazon:
• If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Symptoms include sudden swelling of hands or feet, swollen lips, tongue or throat causing difficulty in breathing and/or itch and rash (angioedema).
• If you have a history of being dizzy or fainting when standing suddenly caused by low blood pressure (orthostatic hypotension).
• If you have severe liver problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Stronazon if you:
• suffer from severe kidney problems
• experience dizziness or fainting whilst taking your medicine. Please sit or lie down straight away until the symptoms disappear.
• have experienced rapid swelling of any or all of the following; hands, feet, lips, tongue or throat causing breathing difficulties (angioedema) and/or skin rash and itching due to an allergic reaction.
• are planning to have cataract surgery (cataract removal eye surgery): Tell you ophthalomologist if you have used or are currently using this drug (or any other tamsulosin containing drug). This will influence your doctor's decisions concerning your medication as well as the surgery technique to be used. Ask your doctor if you should stop taking the medication for the duration of the surgery.
You should have your prostate examined by a doctor before taking Stronazon and at regular intervals thereafter.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years because it does not work in this population.
Other medicines and Stronazon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When used with other alpha 1-receptor -blockers e.g. doxazosin, prazosin and indoramin. If you take these with Stronazon your blood pressure may fall.
Diclofenac (an anti-inflammatory painkiller), warfarin (used to thin blood), clarithromycin and erythromycin (antibiotics), ketoconazole, itraconazole, voriconazole and fluconazole (antifungals), antivirals used to treat HIV (e.g. ritonavir, saquinavir), diltiazem and verapamil (calcium channel blockers), ciclosporin (an immunosuppressant) may affect the way that Stronazon is handled by your body.
Stronazon with food and drink
Tamsulosin should be taken after the first meal of the day. Taking tamsulosin on an empty stomach may aggravate its adverse effects.
Pregnancy, breast-feeding and fertility Stronazon is not indicated for use in women.
Stronazon can cause ejaculation disorders including an inability to ejaculate. 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.
3. How to take Stronazon
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one capsule a day, to be taken after the first meal of the day. The capsule should be taken when sitting or standing (not lying down) with a full glass of water (about 1.5 decilitres). The capsule should be swallowed whole—not broken or chewed.
If you take more than you should
The symptoms of overdose are low blood pressure, vomiting and diarrhoea. 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.
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.
Stop taking Stronazon and contact your doctor at once if you experience any of the following:
• sudden swelling of any or all of the following, hands, feet, lips, tongue or throat causing difficulties in breathing and/or itch and rash, caused by an allergic reaction (angio-oedema).
• severe skin flushing (Steven-Johnson syndrome)
• a severe skin rash or skin lesions with pink/red ring and pale, itchy, scaly or fluid-filled centre known as erythema multiforme.
• Common (occurs in less than 1 in 10 users): dizziness, ejaculation disorders including inability to ejaculate and retrograde ejaculation (ejaculation into the bladder).
• Uncommon (occurs in less than 1 in 100 users): headache, palpitations (fast or uneven heart beats), dizziness especially when sitting or standing up, runny nose, constipation, diarrhoea, feeling sick, being sick, rash, itching, feeling of weakness.
• Rare (occurs in less than 1 in 1,000 users): fainting, swelling of hands or feet, difficulties in breathing and/or itch and rash (angioedema).
• Very rare (occurs in less than 1 in 10,000 users): painful, prolonged, unwanted erection (priapism), severe skin flushing (Stevens-Johnson syndrome).
• Frequency not known: There have been reports of irregular heart beat/pulse rate, racing heart, dry mouth and difficulty breathing, nosebleeds, skin rash or skin lesions with pink/red ring and pale, itchy, scaley or fluid-filled centre (erythema multiforme), mild to severe peeling rash (exfoliative dermatitis), and blurry or impaired vision associated with Tamsulosin use.
Tamsulosin therapy has been associated with Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Stronazon
Keep this medicine out of the sight and reach of children.
Store in the original package.
Keep the container tightly closed.
Do not use Stronazon after the expiry date which is stated on the label, blister and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicinesyou no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Stronazon contains
• One capsule contains 0.4 mg of the active substance 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) and black iron oxide (E 172).
What Stronazon looks like and contents of the pack
The Stronazon modified-release capsules have an orange body with an olive coloured cap. The capsule is filled with white to off-white pellets.
Pack sizes are 30
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Synthon Hispania S. L., Castello, 1, Poligono Las Salinas, Sant Boi de Llobregat, Spain.
Date of Revision: February 2014
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Actavis, Barnstaple, EX32 8NS, UK