Diffundox Xl 400 Microgram Capsules
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DIFFUNDOX™ XL 400 MICROGRAM CAPSULES
(tamsulosin hydrochloride)
Patient Information Leaflet
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, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
The Marketing Authorisation holder is: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK The Manufacturer is: Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands or Synthon Hispania S.L., Castello, Poligono las Salinas, 08830 Sant Boi de Llobregat, Spain.
1. WHAT DIFFUNDOX™ XL IS AND WHAT IT IS USED FOR
Diffundox™ XL is a hard gelatin modified-release capsule with orange coloured body and olive coloured cap. The capsule is filled with white to off-white pellets.
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.
2. 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.
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! Before you start taking Diffundox™ XL, your doctor will give you a blood test and examine your prostate to Srule out other illnesses which can cause the same symptoms as BPH.
! Children
Do not give this medicine to children or adolescent under 18 years because it does not work in this population. 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.
3. 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 DiffundoxTM XL is too strong or too weak, talk to your doctor or pharmacist.
Patients with impaired hepatic or renal function
In patients with renal or mild to moderate hepatic insufficiency it is not necessary to adjust the dose.
Use in children
These capsules are not intended for use in children 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diffundox™ XL can have side effects.
Stop taking DiffundoxTM XL and seek medical help immediately
If you get a hypersensitivity reaction with purplish spots or patches on the skin, blisters on the skin, peeling of the skin, (high) fever, joint pain or eye inflammation (this could be a condition known as Stevens-Johnson syndrome*)
Common side effects (affects between 1 in 10 and 1 in 100 people) are: dizziness, abnormal ejaculation 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, 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), Stevens-Johnson syndrome*.
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.
5. 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 October 2014
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