Doxadura 4mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• DOXADURA is a treatment for high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
• 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.
• You should take DOXADURA regularly to get the maximum benefit, even if you are feeling well.
• Most people do not have serious problems when taking DOXADURA but side effects can occur. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines.
• If you are, or are trying to become pregnant, do not take DOXADURA and tell your doctor or pharmacist.

1. What DOXADURA is and what it is used for
2. What you need to know before you take DOXADURA
3. How to take DOXADURA
4. Possible side effects
5. How to store DOXADURA
6. Contents of the pack and other information

The name of your medicine is DOXADURA 1 mg Tablets, DOXADURA 2 mg Tablets, DOXADURA4 mg Tablets (referred to as DOXADURA throughout this leaflet).

• If you are allergic to doxazosin, other types of quinazolines (such as prazosin or terazosin) or 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 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 an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
• 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

Talk to your doctor or pharmacist before taking DOXADURA:

• If you are pregnant or trying to become pregnant
• If you have liver disease
• If you are also taking other medicines
• If you have heart disease

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 DOXADURA. This is because DOXADURA may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Before starting treatment with DOXADURA your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland).

Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.

When you start to take DOXADURA 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.

DOXADURA 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.

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 DOXADURA. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of DOXADURA.

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.

DOXADURA may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.

• 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

Please refer to section 3.

Pregnancy

The safety of using DOXADURA during pregnancy has not been established. If you are pregnant, think you may be 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 DOXADURA, can get into your breast milk. You should not use DOXADURA during breast-feeding unless your doctor advises you to do so.

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 you are affected, do not drive or operate machinery and contact your doctor immediately.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

DOXADURA is usually taken once daily. DOXADURA may be taken in the morning or the evening.

You can take your tablets before or after food.

You should take your tablets at the same time each day with a small amount of water.

The initial dose of DOXADURA is 1mg once daily. There after the dose may be gradually increased (within 1-2 weeks interval) to the recommended dose (2mg or 4mg daily).

In some circumstances the dose may be increased to a maximum of 8mg daily if you are being treated for prostate enlargement, or to a maximum of 16mg if you are being treated for high blood pressure.

You have been given a calendar pack that will help you remember to take your tablets. If you are taking more than one tablet a day, you must ignore the marking for the day, printed on the back of the blister.

Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking DOXADURA. Even if this is so and you feel well, you should not stop taking your blood pressure medication unless instructed to by your doctor.

Don't change the dose or stop taking the tablets without first checking with your doctor.

Don't wait until your tablets are finished before seeing your doctor.

If you have impression that the effect of DOXADURA is too strong or too weak, talk to your doctor or pharmacist.

The safety and efficacy of DOXADURA in children and adolescents have not been established.

Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous.

Tell your doctor immediately or go to your nearest hospital casualty department.

Do not worry. If you forget to take a tablet, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten tablet.

• Heart attack
• Weakness of arms, legs or problems speaking which may be symptoms of a stroke
• Swelling of the face, tongue or throat which may be the result of an allergic reaction to this medicine

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased or decreased heartbeat (common: may affect up to 1 in 10 people)
• Feeling your heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain, angina (uncommon: may affect up to 1 in 100people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000people)
• Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1 in 10,000 people)
• Low numbers of white blood cells or blood platelets, which may result in increasing frequency of infection, bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection of the penis. Seek urgent medical advice (very rare: may affect up to 1 in 10,000 people)

The following events have been reported in patients being treated with doxazosin. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common: may affect up to 1 in 10 people

• Dizziness, feeling of spinning or rotation of surroundings(vertigo), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Chest cold, coughing, respiratory tract (nose, throat, lungs) infection
• Nasal stuffiness, sneezing and/or runny nose caused by inflammation of the lining of the nose (rhinitis)
• Stomach/abdominal pains, feeling/being sick
• Urinary tract infection, urinary incontinence (inability to control passing urine), inflammation of bladder (cystitis)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, painful muscles
• Flu-like symptoms

Uncommon: may affect up to 1 in 100 people

• Constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhoea and vomiting
• Pain or discomfort on passing urine, increased frequency in passing urine, blood in urine
• Inflammation of the joints (gout), painful joints, general pain
• Swelling of the face
• Sleeplessness, agitation, anxiety, depression or nervousness
• Reduced or altered sense of touch or sensation of the hands and feet
• Increased appetite or loss of appetite, weight gain
• Nose bleeds
• Skin rash
• Ringing or noise in the ears, tremor
• Failure/ inability to achieve penile erection
• Liver enzyme increases, which may have an effect on some medical tests
• Stroke

Rare: may affect up to 1 in 1,000 people

• Increased number of times of passing urine
• Muscle cramps, muscle weakness

Very rare: may affect up to 1 in 10,000 people

• Faintness or dizziness caused by low blood pressure when getting up from a sitting or lying position
• Hepatitis (liver inflammation) or bile disorder
• Hives, hair loss, red or purple patches on the skin, bleeding under the skin
• Tingling or numbness of the hands and feet
• Tiredness, generally feeling unwell
• Aggravated wheezing
• Blurred vision
• Hot flushes
• Disorder in passing urine, needing to pass urine at night, increased volume of urine passed
• Discomfort or enlargement of the breasts in men

Not known: frequency cannot be estimated from the available data

• Little or no semen ejaculated at sexual climax, cloudy urine following sexual climax
• Eye problems may occur during eye surgery for cataract (cloudiness of the lens of the eye). See section “Warnings and precautions”.

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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is doxazosin. Each tablet contains 1mg,2mg, or 4mg of doxazosin (as mesilate).

The other ingredients are: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) and colloidal anhydrous silica.

Doxadura comes in three different strengths:

Doxadura 1 mg tablet is a round white to off-white tablet scored on one side.

Doxadura 2 mg tablet is a white to off-white capsule-shaped tablet scored on one side.

Doxadura 4 mg tablet is a white to off-white capsule-shaped tablet, scored on both sides, with embossment “D4” on one side.

Doxadura 1 mg, 2 mg and 4 mg tablets are available in calendar packs of 28 tablets in foil blister strips.