Oxandosin Xl 4 Mg Prolonged-Release Tablets
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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 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 Oxandosin XL 4 mg prolonged release tablets is and what it is used for
2. What you need to know before before you take Oxandosin XL 4 mg prolonged release tablets
3. How to take Oxandosin XL 4 mg prolonged release tablets
4. Possible side effects
5. How to store Oxandosin XL 4 mg prolonged release tablets
6. Contents of the pack and other information
1. WHAT OXANDOSIN XL 4 MG PROLONGED RELEASE TABLETS IS AND WHAT IT IS USED FOR
Your doctor may have prescribed Oxandosin XL 4 mg prolonged release tablets because your blood pressure is high, which if left uncontrolled can increase the risk of heart disease or stroke. The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-blockers. These medicines work by widening your blood vessels, making it easier for your heart to pump blood through them. This helps to lower raised blood pressure.
Or you may have been prescribed Oxandosin XL 4 mg prolonged release tablets because you have enlargement of the prostate gland (prostatic hyperplasia). This makes it difficult to pass urine. The prostate gland is just underneath the bladder in men. Oxandosin XL 4 mg prolonged release tablets works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine.
2. What you need to know before you take BEFORE YOU TAKE OXANDOSIN XL 4 MG PROLONGED RELEASE TABLETS
Do not take Oxandosin XL 4 mg prolonged release tablets
• if you are allergic to doxazosin or any of the other ingredients of this medicine (listed in section 6)
• if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs
• if you have orthostatic hypotension in your history. Orthostatic hypotension is a fall in blood pressure which can occur when getting up quickly from a seated or lying position, a situation which can be accompanied by dizziness.
• if you suffer or have suffered from any form of obstruction of the digestive tract (for patients taking the sustained release tablets only)
• if, besides benign prostate enlargement, you have an infection or an obstruction of the urinary tract or bladder stones
• if, besides benign prostate enlargement, your blood pressure is too low.
• if you suffer from continuous leakage of urine (overflow incontinence) do not produce urine (anuria), or have kidney failure (for patients with benign prostate enlargement taking doxazosin as monotherapy only)
• if you are breast-feeding (see section “Pregnancy and breast-feeding”) (for patients with hypertension indication only)
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxandosin XL 4 mg prolonged release tablets
• if you suffer from liver problems
• if you suffer from acute heart disease such as pulmonary oedema or heart failure
• if you take a medicine to treat erection disorders (see also section “Taking other medicines”)
• if you start taking Oxandosin XL 4 mg. At the start of treatment you should therefore avoid situations in which injuries can occur as a result of dizziness or weakness or rarely loss of consciousness.
If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Oxandosin XL. This is because Oxandosin XL may cause complications during the surgery which can be managed if your specialist is prepared in advance.
The active substance in Oxandosin XL is enclosed by an inert, non absorbable covering, which was developed for the controlled release of the active substance during an extended period. Once the tablet has passed through the gastro-intestinal tract the empty tablet covering is separated. There is no cause for concern, if you occasionally see something in your faeces which looks like a tablet.
Children and adolescents
Oxandosin XL 4 mg prolonged release tablets is not recommended for children and adolescents
Taking oOther medicines and Oxandosin XL 4 mg prolonged release tablets
You should always tell your doctor about any medicines you are taking. This includes any medicines you have bought for yourself, as well as those prescribed for you by a doctor. Some medicines may interact with Oxandosin XL 4 mg prolonged release tablets. These include:
• Other medicines used in the treatment of high blood pressure
• medicines used to treat erection disorders (e.g. sildenafil [Viagra], tadalafil [Cialis], vardenafil [Levitra]) see section “Take special care with Oxandosin XL 4 mg”. 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 drugs for erectile dysfunction (impotence) with alpha-blockers. 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.
Oxandosin XL 4 mg prolonged release tablets with food and drink Oxandosin XL 4 mg prolonged release tablets can be taken with or after food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Take Oxandosin XL 4 mg only during pregnancy if prescribed by a doctor after a careful risk-to-benefit assessment.
You must not take and Oxandosin XL 4 mg during breast-feeding.
Driving and using machines
Oxandosin XL 4 mg prolonged release tablets and associated names can cause drowsiness. Be especially careful when you first start taking the tablets. If this happens do not drive or operate machinery.
3.How to take Oxandosin XL 4 mg prolonged release tablets and associated names
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many tablets you should take and when. The tablets should be swallowed whole with a glass of water. Do not crush or chew the tablets.
Adults and the elderly:
The dose of Oxandosin XL 4 mg prolonged release tablets and associated names is the same whether you are taking it for high blood pressure or to treat the symptoms of prostatic hyperplasia. The recommended dose is one tablet each day. Your doctor may increase your dose to the maximum recommended dose of two tablets each day.
If you take more Oxandosin XL 4 mg prolonged release tablets and associated names than you should
If you take too many tablets, the most likely symptoms would be a feeling of light-headedness or dizziness due to a fall in blood pressure. You should lie down on your back with your feet higher than your head. Contact your nearest casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any left-over tablets with you, so the doctor knows what you have taken.
If you forget to take Oxandosin XL 4 mg prolonged release tablets and associated names
Try to take your tablets daily as prescribed. However, if you miss a dose, just take it as soon as you remember. Do not take two doses at the same time.
If you stop taking Oxandosin XL 4 mg prolonged release tablets and associated names
Do not stop taking your medicine without consulting your doctor.
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.
Common side effects that may occur (may affect up to 1 in 10 people) are:
- respiratory tract infection, urinary tract infection
- dizziness, headache, sleepiness
- a feeling of dizziness or “spinning”
- feeling your heartbeat, faster heart beat
- low blood pressure, a fall in blood pressure on standing up which causes dizziness, lightheadedness or fainting
- bronchitis, cough, shortness of breath, running nose or stuffiness
- abdominal pain, acid indigestion, dry mouth, feeling sick
- itching
- back pain, muscle pain
- inflammation of the urinary bladder, inability to control urination
- feeling of weakness, chest pain, influenza-like symptoms, peripheral oedema (swelling of the ankles, feet or fingers)
Uncommon side effects that may occur (may affect up to 1 in 100 people) are:
- allergic drug reaction
- loss of appetite, inflammation of the joints (gout), increased appetite
- anxiety, depression, difficulty in sleeping
- stroke, reduce sense of touch or sensation, fainting, shaking
- ringing in the ears
- chest pain, heart attack
- nosebleed
- constipation, diarrhoea, flatulence, vomiting, gastroenteritis
- abnormal liver function tests
- skin rash
- joint pain
- difficulty or pain on passing urine, red blood cells in the urine, frequent urgency to urinate
- impotence (inability to achieve an erection, painful persistent erections)
- pain, swelling of the face (facial oedema)
- weight increase
Very rare side effects that may occur (may affect up to 1 in 10,000 people) are:
- low white blood cells: low blood platelets, which may result in bruising or easy bleeding
- restlessness, nervousness
- dizziness especially on getting up from a sitting or lying position, tingling in the hands and feet
- blurred vision
- low heart beat, irregular heartbeat
- flush
- difficulty in breathing
- cholestasis, inflammation of the liver (hepatitis), jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems)
- hair loss, bruising of the skin, urticaria
- muscle cramps, muscle weakness
- urinating disorders, increase nightly production of urine, increased volume of urine passed, increased need to pass urine
- breast enlargement in males, persistent erection of the penis without sexual desire
- tiredness (fatigue), being sick (malaise)
Not known (frequency cannot be estimated from the available data):
- IFIS (Intraoperative Floppy Iris Syndrome, certain eye disorder which can be experienced during surgery for cataracts) (see section 2. “Take special care with Oxandosin XL 4 mg prolonged release tablets and associated names”)
- taste disturbances
- retrograde ejaculation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Oxandosin XL 4 mg prolonged release tablets and associated names
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater. 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 Oxandosin XL 4 mg prolonged release tablets contains:
• The active substance is doxazosin (as the mesilate).
• One prolonged-release tablet contains 4.85 mg doxazosin mesilate corresponding to 4 mg doxazosin
• The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone, a-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid — ethyl acrylate co-polymer (1:1), macrogol, and titanium dioxide (E171).
What Oxandosin XL 4 mg prolonged release tablets looks like and contents of the pack: Oxandosin XL 4 mg prolonged release tablets are white, round, biconvex tablets with bossing “DL” on one side. They are available in PVC/PVDC/aluminium blisters packs of 20, 28, 30, 50, 98, 100 and 500 prolonged release tablets (normal blister: 20, 30, 50, 100, 500; calendar blister: 28, 98; unit dose blister: 30x1, 50x1 and 100x1).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder:
ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany.
For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392 313592.
This leaflet was last revised in March 2014.