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Comments: The registered sites of batch release are -

-Qualiti (Burnley) Limited, Talbot Street, Briercliffe, Burnley, Lancashire, BB10 2JY, UK;

- Combino Pharm S.L., Fructuos Gelabert 6-8, 08790 Saint Joan Despi, Barcelona, Spain.

The printed leaflet will state the primary site of batch release. This leaflet states Combino Pharm as an example. Production codes will be inserted before printing.

PATIENT INFORMATION LEAFLET

Doxazosin 2mg and 4mg Tablets

Doxazosin

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 your 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.

In this leaflet:

1.    What Doxazosin is and what it is used for

2.    What you need to know before you take Doxazosin Tablets

3.    How to take Doxazosin Tablets

4.    Possible side effects

5.    How to store Doxazosin Tablets

6.    Contents of the pack and other information

1. WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR

Doxazosin Tablets contain the active substance doxazosin (as doxazosin mesylate) which is one of a group of medicines called alpha-blockers.

Doxazosin Tablets are used to treat:

•    high blood pressure, or

•    the symptoms caused by enlargement of the prostate gland in men (e.g. poor and/or frequent passing of urine).

In patients taking Doxazosin Tablets to treat high blood pressure (hypertension), doxazosin works by relaxing the blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with enlargement of the prostate gland, Doxazosin Tablets are taken to treat poor and/or frequent passing of urine. This is common in patients with enlargement of the prostate gland. Doxazosin works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAZOSIN TABLETS

Do not take Doxazosin 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 low blood pressure which makes you feel faint or dizzy when you stand up after sitting or lying down (postural or orthostatic hypotension)

•    if you are being treated for an enlarged prostate gland and have any kind of congestion or blockage in your urinary tract, an infection of the urinary tract or bladder stones

•    if you are being treated for an enlarged prostate gland and have low blood pressure

•    if you have a serious kidney disorder (anuria or progressive renal insufficiency)

•    if you suffer from a loss of bladder control (bladder overflow)

•    if you are breast-feeding.

Warning and precautions:

Talk to your doctor or pharmacist before taking Doxazosin Tablets:

• if you have problems with your heart • if you are going to have an or a history of heart disease    operation to remove a cataract

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. If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint.

Certain patients have also experienced these symptoms when taking medicines 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 medicines for erectile dysfunction.

Other medicines and Doxazosin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

These may include:

•    medicines called PDE-5 inhibitors (e.g. sildenafil, tadalafil or vardenafil) which are used to treat impotence as these medicines and doxazosin can reduce blood pressure

•    other medicines for the treatment of high blood pressure.

Pregnancy and breast-feeding

Pregnancy Do not take Doxazosin Tablets if you are pregnant unless your doctor tells you to. If you become pregnant whilst taking this medicine you should contact your doctor as soon as possible.

Breast-feeding You must not breast-feed whilst you are taking Doxazosin Tablets.

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.

Driving and using machines

Doxazosin Tablets can make you feel dizzy or faint especially when you first start taking them. Make sure that you are not affected in this way before you drive or operate machinery.

Doxazosin Tablets contain

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOWTO TAKE DOXAZOSIN TABLETS

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

Do not take more than the doctor told you to. Read and follow the instructions on the pharmacist's label.

Your tablets should be swallowed whole with a glass of water.

The tablets can be taken at any time of the day and before, during or after meals. Choose a time that is convenient for you and take your tablet at this time each day.

The usual starting dose of Doxazosin Tablets is one 1mg tablet taken as a single dose each day.

Your doctor may change the amount of medicine you take at intervals to ensure that your symptoms are controlled.

The usual dose is 2mg or 4mg daily; this may be increased to a maximum of 8mg daily for an enlarged prostate gland or 16mg daily for high blood pressure.

Use in children and adolescents

Doxazosin Tablets are not recommended for patients under the age of 18 years.

If you take more Doxazosin Tablets than you should, you may suffer from very low blood pressure.

You should contact your doctor immediately or go to the nearest casualty department.

Remember to take the pack and any remaining tablets with you.

If you forget to take your Doxazosin Tablets

Take your next dose at the normal time. Do not take the missed dose or a double dose to make up for the one you missed. If you stop taking Doxazosin Tablets

It is important that you continue to take Doxazosin Tablets for as long as your doctor recommends.

Do not change the dose or stop taking your tablets unless your doctor tells you to.

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.

Tell your doctor immediately if:

•    You get any swelling of the face, tongue or throat, intense itching, skin rashes, difficulty in swallowing and/or breathing. This may be the sign of a serious allergic reaction.

•    You feel pain in your chest, shoulder and/or arms and tightening of your chest (signs of angina) or any other effects on your heart (including a rapid or irregular heartbeat)

•    You develop severe fatigue, loss of appetite or if your skin or eyes look yellow (signs of jaundice).

You may feel faint or dizzy when standing up from a sitting or lying position especially at the beginning of your treatment or if you restart your treatment after a break. If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint.

If these symptoms persist or become a problem please contact your doctor.

The following side effects have also been reported: Common (may affect up to 1 in 10 people)

• Dizziness	• Shortness of breath	• Swelling and irritation	• Bronchitis
• Headache	• Faster heart beat	inside the nose (rhinitis)	• General feeling of
• Low blood pressure with	(tachycardia)	• Chest pain	weakness or being unwell
or without dizziness when	• Infections of the lung or	• Dry mouth	• Abdominal pain
you get up from a sitting	urinary tract	• Sleepiness or tiredness	• Itching
or lying position	• Back and muscle pain	• Cough	• Indigestion.
• Feeling of dizziness or	• Swelling (mainly of the	• Flu-like symptoms
“spinning" (vertigo)	hands and feet)	• Urinary incontinence or
• Palpitations or heart	• Feeling sick	pain on urination
flutters
Uncommon (may affect up to	1 in 100 people):
• Constipation	• Impotence	• Fainting	• Allergic (hypersensitivity)
• Flatulence ('wind')	• Joint pain	• Nervousness	reactions
• Inflammation of the	• Gout (causing pain in	• Decreased sensitivity to	• Ringing in the ears
stomach	joints)	touch, pain, heat or cold	(tinnitus)
• Being sick (vomiting)	• Pain	• Increased appetite	• Stroke
• Blood in the urine	• Shaking	• Increase in weight	• Heart attack
• Diarrhoea	• Swelling of the face	• Eating disorders (anorexia)	• Chest pain (angina
• Increased desire or need	• Depression	• Nose bleeds	pectoris).
to urinate	• Feeling agitated	• Changes in the results of
• Difficulty with or pain on	• Anxiety	tests for liver function
urinating	• Difficulty in sleeping	• Skin rash
Rare (may affect up to 1 in 1,000 people)
• Muscle cramps or weakness • Increase number of times of passing urine.
Very rare (may affect up to 1 in 10,000 people):
• Tiredness, generally	• Yellowing of the skin or	• Increased need to urinate	• Hair loss (alopecia)
feeling unwell	white of the eyes	especially at night	• Difficulty breathing
• Low blood pressure with	(Jaundice)	• Painful persistent erection	(wheezing)
or without dizziness when	• Reduction of blood	of the penis	• Eruption of the skin
you get up from a sitting	platelets, which increases	• Slow heartbeat	(purpura)
or lying position	risk of bleeding or bruising	• Increase in breast size in	• Tingling or numbness in
• Reduction in white cells in	• Liver inflammation	men	the hands and feet
the blood (which makes	(hepatitis) or bile disorder	• Irregular heart beat	• Skin eruptions (urticaria).
infections more likely)	(cholestasis)	(cardic arrhythmias)
• Blurred vision	• Hot flushes

The following side effects have been observed in patients taking doxazosin but the frequency is not known:

• Eye problems (especially in patients with a cataract)    • Difficulty with ejaculation.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

5. HOWTO STORE DOXAZOSIN TABLETS

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 after EXP:

The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines which are no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION_

What Doxazosin Tablets contain:

•    This medicine contains 2mg or 4mg of doxazosin (as doxazosin mesylate).

•    The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, magnesium stearate and sodium lauril sulfate.

What Doxazosin Tablets look like and contents of the pack:

Your medicine is in the form of a round white tablet.

The 2mg tablet is marked “DXN 2" on one side with a scoreline on the other side.

The 4mg tablet is marked “DXN 4" on one side with a scoreline on the other side.

Doxazosin Tablets are available in blister packs of 28 tablets.

Marketing Authorisation Holder:

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.

Manufacturer:

Combino Pharm S.L., Fructuos Gelabert 6-8, 08790 Saint Joan Despi, Barcelona, Spain.

This leaflet was last approved in 05/2012.