Prosurin Xl 400 Micrograms Capsules
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prosurin xl
400 microgram 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.
• I f you have any further questions, ask your doctor or 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.
• I f 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 Prosurin XL is and what it is used for.
2. What you need to know before you take Prosurin XL.
3. How to take Prosurin XL.
4. Possible side effects.
5. How to store Prosurin XL.
6. Contents of the pack and other information.
1. What Prosurin XL is and what it is used for
Prosurin XL is a modified release capsules. it contains an active ingredient in the capsules which is a so-called alpha 1A-blocker that reduces muscle contraction in the prostate and urethra. This facilitates the flow of urine through the urethra and aids urination.
Prosurin XL modified-release capsules are used for the treatment of urination symptoms caused by benign prostatic hyperplasia (bPh - enlarged prostate).
2. What you need to know before you take Prosurin XL Do not take Prosurin XL:
• I f you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride can express itself as sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, swollen lips, tongue or throat (angio-oedema).
• I f you have experienced dizziness or have fainted from lowered blood pressure (e.g. when suddenly sitting or standing up).
• I f you have been found to suffer from severe liver problems.
Warnings and precautions
Talk to your doctor before taking Prosurin XL:
• I f you have been found to suffer from severe kidney problems.
• I f you experience dizziness or fainting during the use of Prosurin XL. Please sit or lie down straight away until the symptoms disappear.
• I f you experience sudden swelling of hands or feet, swollen lips, tongue or throat, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angio-oedema) during the use of Prosurin XL.
• I f you are about to have an operation on your eye for cloudiness of the lens (cataract).
Please consult your doctor, even if these statements were applicable to you at any time in the past.
You should have your prostate examined by a doctor before taking Prosurin XL and at regular intervals thereafter.
Children and adolescents
Prosurin XL is not indicated for use in the paediatric population (patients below 18 years of age).
Other medicines and Prosurin XL
Tell your doctor if you are taking, have recently taken
or might take any other medicines:
• Prosurin XL may lower blood pressure when taken with other alpha lA-blockers. e.g. doxazosin, prazosin and indoramin.
• Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting) may have an influence on how fast Prosurin XL is removed from the body.
• Medicines which lower your blood pressure such as verapamil and diltiazem.
• Medicines which are used to suppress your immune system e.g. ciclosporin.
• Antibiotics to treat infection e.g. erythromycin, clarithromycin.
• Medicines to treat fungal infections e.g. ketoconazole, itraconazole, fluconazole, voriconazole.
• Medicines used to treat HIV e.g. ritonavir, saquinavir.
Please note that these statements may also apply to products used some time ago or at some time in the future.
Prosurin XL with food and drink
Prosurin XL should be taken after the first meal of the day. Taking Prosurin XL on an empty stomach may increase the number of side effects or increase the severity of a side effect.
Pregnancy, breast-feeding and fertility
Prosurin XL is not indicated for use in women.
Prosurin XL may cause ejaculation disorders including inability to ejaculate.
Driving and using machines
Up until now, there is no evidence that Prosurin XL affects the ability to drive or use machines.
Patients should nevertheless be aware that dizziness may occur.
3. How to take Prosurin XL
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 after the first meal of the day.
The capsule should be taken while standing or sitting upright (not lying down) and should be swallowed whole with a glass of water.
The capsule must not be chewed.
Your physician has prescribed a suitable dose for you and your illness, and has specified the duration of the treatment.
The dose should not be independently changed.
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Description |
Tamsulosin Hydrochloride 4QQmcg Q.4mg |
No. of colours |
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Leaflet |
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Black |
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Affiliate Item Code |
382138 |
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n/a | ||
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Superceded Affiliate Item Code |
332996 |
Vendor Job No. |
225328 | ||
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TrackWise PR No. |
382138 |
Proof No. |
2 |
Equate CMYK | |
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MA No. |
04569/0735 |
Client Market |
UK |
with | |
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Packing Site/Printer |
Komarom |
Keyline/DrawingNo] |
n/a |
Main Font |
Myriad Pro Body Text Size 9 pt |
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Supplier Code |
tbc |
Barcode Info |
n/a |
Dimensions |
170 x 240mm |
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if you have the impression that the effect of tamsulosin is too strong or too weak, talk to your doctor or pharmacist.
if you take more Prosurin XL than you should
if you may have taken more Prosurin XL than you should, talk to your doctor or pharmacist immediately.
if you forget to take Prosurin XL
if you have forgotten to take Prosurin XL after the first meal of the day, it can be taken later the same day after food. if you have missed a day, just continue to take your daily capsule as prescribed.
Do not take a double dose to make up for forgotten individual doses.
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.
Serious side effects:
if you have any of the following symptoms, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:
Rare (may affect up to 1 in 1,000 people):
• sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, swollen lips, tongue or throat (angio-oedema).
Very rare (may affect up to 1 in 10,000 people):
• a widespread rash with severe blisters, peeling skin and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from the available data):
• a severe inflammation of the skin with pale-red, pale centred blotches known as erythema multiforme.
The following other side effects may also occur: Common (may affect up to 1 in 10 people):
dizziness, ejaculation disorders including inability to ejaculate and ejaculation into the bladder (retrograde ejaculation).
Uncommon (may affect up to 1 in 10 people):
headache, a sensation of abnormal heart beat (palpitations), dizziness especially when sitting or standing up, common cold, constipation, diarrhoea, nausea, vomiting, rash, itching, hives, feeling of weakness.
Rare (may affect up to 1 in 1,000 people):
fainting.
Very rare (may affect up to 1 in 10,000 people):
painful, prolonged, unwanted erection (priapism).
Not known (frequency cannot be estimated from the available data):
an irregular heartbeat (atrial fibrillation), abnormal heart rhythm (arrhythmia), accelerated heart beat (tachycardia), shortness of breath (dyspnoea), blurred vision, impaired vision, nose bleed, scaly skin rash (dermatitis exfoliative), dry mouth.
in some occasions possible complications in connection to cataract operations have been observed.
Reporting of side effects
if you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Prosurin XL
Keep this medicine out of the sight and reach of children.
Store in the original package.
Keep the container tightly closed.
Do not use after the expiry date which is stated on the label 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 medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Prosurin XL contains:
One modified-release capsule contains 0.4 mg of tamsulosin hydrochloride as the active substance.
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 (E172) and black iron oxide (E172).
What Prosurin XL looks like and contents of the pack
The Prosurin XL modified-release capsules are orange/ olive-green in colour.
They are available in blister packaging or in containers of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Mylan, Potters Bar, Herts., EN6 1TL,
United Kingdom.
Manufacturer
Synthon Hispania S.L., Castello, 1, Poligono las Salinas, 08830 Sant Boi de Llobregat - Spain
Gerard Laboratories, 35/36 Baldoyle industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
This leaflet was last revised in
February 2015 382138
I
|
Description |
Tamsulosin Hydrochloride 4QQmcg Q.4mg |
No. of colours |
Page Count | ||
|
Component Type |
Leaflet |
Pharma Code |
tbc |
Colours |
Black |
|
Affiliate Item Code |
382138 |
SAP No. |
n/a | ||
|
Non-Print Colours | |||||
|
Superceded Affiliate Item Code |
332996 |
Vendor Job No. |
225328 | ||
|
TrackWise PR No. |
382138 |
Proof No. |
2 |
Equate CMYK | |
|
MA No. |
04569/0735 |
Client Market |
UK |
with | |
|
Packing Site/Printer |
Komarom |
Keyline/DrawingNo] |
n/a |
Main Font |
Myriad Pro Body Text Size 9 pt |
|
Supplier Code |
tbc |
Barcode Info |
n/a |
Dimensions |
170 x 240mm |
|
Sign-offs | |||||