DIFFUNDOX XL 400 MICROGRAM 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, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours.
- Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.
In this leaflet:
1. What Diffundox XL is and what it is used for
2. Before you take Diffundox XL
3. How to take Diffundox XL
4. Possible side effects
5. Storing Diffundox XL
The name of this medicine is Diffundox XL 400 microgram Capsules (referred to as Diffundox XL
throughout this leaflet).
One modified-release capsule contains 400 micrograms 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 ingredients in the capsule body 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).
The Marketing Authorisation holder is:
The Manufacturer is:
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What Diffundox Xl Is And What It Is Used For
Diffundox XL modified-release capsules are orange/olive-green in colour. There is a black stripe at both ends of the capsule body, and the mark ‘TSL 0.4’ is printed on the capsule in black.
They are available in blister packaging of 30 modified-release capsules.
Diffundox XL modified-release capsules are used for the treatment of urination symptoms caused by benign prostatic hyperplasia (BPH - enlarged prostate).
Diffundox XL belongs to a group of medicines known as alpha blockers. It is used to treat benign prostatic hyperplasia (BPH). This condition is caused by the prostate gland growing too big and obstructing the flow of urine from the bladder. The usual symptoms are weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water. BPH is not cancerous, and occurs mainly in older men and is fairly common.
Your capsules work by relaxing the muscle of the prostate gland and bladder exit, widening the urethra (the tube through which urine passes from the bladder to the outside of the body) and so relieving the symptoms of BPH.
Before You Take Diffundox Xl
Do not take Diffundox XL:
- If you are hypersensitive (allergic) to tamsulosin hydrochloride or one of the product’s other components.
- If you have experienced dizziness or have fainted from lowered blood pressure (e.g. when suddenly sitting or standing up)
- If you have experienced sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angio-oedema)
- If you have been found to suffer from severe liver problems.
Take special care with Diffundox XL:
- If you have been found to suffer from severe kidney problems
- If you experience dizziness or fainting during the use of Diffundox XL. Please sit or lie down straight away until the symptoms disappear
- If you experience sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angio-oedema) during the use of Diffundox XL
- If you have been scheduled for cataract surgery.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Before you start taking Diffundox XL, your doctor will give you a blood test and examine your prostate to rule out other illnesses which can cause the same symptoms as BPH.
Taking Diffundox XL with food and drink
Diffundox XL should be taken after the first meal of the day. Taking Diffundox XL on an empty stomach may increase the number of side effects or increase the severity of a side effect.
Pregnancy and breast-feeding
Diffundox XL is intended for males only.
Driving and using machines
Up until now, there is no evidence that Diffundox XL affects the ability to drive or use machines. Patients should nevertheless be aware that dizziness may occur.
Taking Diffundox XL with other medicines
Diffundox XL may lower blood pressure when taken with other alpha-blockers and antihypertensive agents such as doxazosin, indoramin, prazosin or alfusozin (medicines used to treat high blood pressure). Please note that these statements may also apply to products used some time ago or at some time in the future. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those not prescribed.
How To Take Diffundox Xl
Always take Diffundox XL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual 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.
If you have the impression that the effect of Diffundox XL is too strong or too weak, talk to your doctor or pharmacist.
If you take more Diffundox XL than you should
If you may have taken more Diffundox XL than you should, talk to your doctor or pharmacist immediately.
If you forget to take Diffundox XL
If you have forgotten to take Diffundox 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.
Possible Side Effects
Like all medicines, Diffundox XL can have side effects.
Common side effects (affects between 1 in 10 and 1 in 100 people) are: dizziness
Uncommon side effects (affects between 1 in 100 and 1 in 1000 people) are: headache, rapid or irregular heart beat, dizziness especially when sitting or standing up, irritation and inflammation of the nose (rhinitis) – symptoms include runny nose, sneezing or blocked or stuffy nose, constipation, diarrhoea, nausea, vomiting, rash, itching, nettlerash or hives, abnormal ejaculation, feeling of weakness.
Rare side effects (affects between 1 in 1000 and 1 in 10,000 people) are: fainting, swelling of hands or feet, difficulties in breathing and/or itch and rash (angio-oedema)
Very rare side effects (affects fewer than 1 in 10,000 people) are: painful, prolonged, unwanted erection (priapism).
On some occasions possible complications in connection to cataract operations have been observed.
If you notice any side effects not mentioned in this leaflet, please inform you doctor or pharmacist.
Storing Diffundox Xl
Keep all medicines out of the reach and sight of children.
Store in the original package. Keep the container tightly closed.
The expiry date (Exp) is printed on the label of the container, the blisters and on the outer package. Do not take the capsules after this date.
You should take any capsules that are out of date or which you no longer need back to your pharmacist.
This leaflet was prepared in March 2007
‘Winthrop’ is a registered trademark. ©2007 Winthrop Pharmaceuticals.
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