Patient leaflet - CARDURA XL 8 MG TABLETS
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CARDURA XL contains the active substance doxazosin mesilate and is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
CARDURA XL can be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. In patients with an enlarged prostate gland, CARDURA XL is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. CARDURA XL works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
|j^ 2. What you need to know before you take CARDURA XL
Do not take CARDURA XL:
- If you are allergic to doxazosin, other quinazolines (e.g. prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6). This may have been itching, reddening of the skin or difficulty in breathing.
- If you have any form of obstruction of the digestive tract
- If you have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
- If you have a history of a condition known as ‘orthostatic hypotension’ which is a form of low blood pressure that causes you to feel dizzy or light-headed when you stand up from sitting or lying down
- If you have an enlarged prostate gland with one of the following: any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones
- If you have overflow incontinence (you do not feel the urge to urinate), or anuria (your body is not producing any urine) with or without kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking CARDURA XL as it may not be suitable for you:
- If you are pregnant or trying to become pregnant
- If you have liver disease
- If you have heart disease
- If you are also taking other medicines
If you are undergoing eye surgery because of cataract (cloudiness of the lens of the eye), please inform your eye specialist before the operation that you are using or have previously used CARDURA XL. This is because CARDURA XL may cause complications during the surgery which can be managed if your specialist is prepared in advance.
If any of these apply to you speak to your doctor before taking this medicine.
When you start to take CARDURA XL you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself. Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening.
Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.
Before starting treatment with CARDURA XL your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia.
Children and adolescents
CARDURA XL is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established. Benign prostate hyperplasia is not relevant in children.
Other medicines and CARDURA XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
- There are some medicines that may interact with CARDURA XL. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of CARDURA XL: Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines called PDE-5 inhibitors for the treatment of erectile dysfunction (impotence) with alpha-blockers e.g. sildenafil, tadalafil, vardenafil (please see Section “Warnings and precautions”. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha blocker before you start drugs for erectile dysfunction.
- CARDURA XL may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure such as terazosin and prazosin.
- Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
- Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir.
- Nefazodone, a medicine used to treat depression.
CARDURA XL with food and drink
See section 3 How to take CARDURA XL
Pregnancy, breast-feeding and fertility
Pregnancy
The safety of using CARDURA XL during pregnancy has not been established. If you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
Small amounts of doxazosin, the active substance of
CARDURA XL, can get into your breast milk. You should not use CARDURA XL during breast-feeding unless your doctor advises you to do so.
Driving and using machines
Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If affected, do not drive or operate machinery and contact your doctor immediately.
CARDURA XL contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take cardura 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. CARDURA XL is a prolonged release tablet. The medicine is contained within a non-absorbable shell that has been specially designed to slowly release the medicine. Once swallowed, doxazosin is slowly released into the body from the tablet, until the tablet is empty.
Since the empty tablet is eliminated from the body in bowel movements, you may occasionally observe in the stools, something that looks like a tablet. This is to be expected and you should not be concerned.
How to take your medicine
|T[> 4. POSSIBLE SIDE EFFECTS
5. how to store cardura xl
Keep your tablets out of the sight and reach of children.
Do not use CARDURA XL after the expiry date which is stated on carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package to protect from moisture.
The tablets should be whole to work effectively, if you notice any defects (such as broken tablets) consult your pharmacist immediately.
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 to protect the environment.
If your tablets become discoloured or show any signs of deterioration, return them to your pharmacist.
6. contents of the pack and other information
What CARDURA XL contains and its package:
Each prolonged-release tablet contains 8 mg doxazosin as doxazosin mesilate.
The other ingredients in each tablet are: sodium chloride, red iron oxide (E172), magnesium stearate, cellulose acetate, macrogol, hypromellose, titanium dioxide (E171), black iron oxide E172 and shellac.
CARDURA XL are round, white, film-coated tablets marked with a hole in one side and marked ‘CXL8’.
They are available in packs of 30 tablets.
Manufacturer
Pfizer Manufacturing Deutschland GmbH Betriebsstatte Freiburg Mooswaldallee 1 D-79090 Freiburg, Germany.
Procured from within the EU and Repackaged by PL holder PilsCo Ltd, 10–16 Colvilles Place, East Kilbride, G75 0SN.
PL 39467/0313 CARDURA XL 8 mg Tablets poM
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Leaflet last revised 08/10/2020
CARDURA® is a registered trademark of Pfizer Products Inc.
PIL0313.5