Doxazosin 2mg tablets

• 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.

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

• if you are allergic to doxazosin, other types of quinazolines (such as prazosin and 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 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.

Talk to your doctor or pharmacist before taking Doxazosin if:

• you are pregnant or trying to become pregnant
• you have liver disease
• you are also taking other medicines
• 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 Doxazosin. This is because Doxazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance. Before starting treatment with Doxazosin 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 Doxazosin 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.

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

• 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.
• Doxazosin 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.

Breast-feeding

Small amounts of doxazosin can get into your breast milk. You should not use doxazosin during breast-feeding unless your doctor advises you to do so.

Pregnancy

The safety of using doxazosin during pregnancy has not been established. If you are pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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’

The safety and efficacy of Doxazosin in children 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.

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 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 1/2/4/8 mg doxazosin (as doxazosin mesilate).
• The other ingredients are: Cellulose microcrystalline, lactose, sodium starch glycollate, magnesium stearate

Doxazosin 1mg tablets:

White to off-white coloured, circular biconvex shaped uncoated tablet debossed with ‘D O’ on one side and ‘1’ on other side

Doxazosin 2mg tablets:

White to off-white coloured, caplet shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘2’ on other side.

The tablet can be divided into equal halves.

Doxazosin 4mg tablets:

White to off-white coloured, diamond shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘4’ on other side.

The tablet can be divided into equal halves.

Doxazosin 8mg tablets:

White to off-white coloured, caplet shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘8’ on other side.

The tablet can be divided into equal halves.

PVC-PVDC Aluminium blisters:

Pack size: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets

HDPE bottle:

Pack size: 100 tablets

Not all pack sizes may be marketed.

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