Patient leaflet - Doxazosin tablets 1 mg

1. WHAT DOXAZOSIN TABLETS ARE AND WHAT THEY ARE USED FOR

Doxazosin Tablets contain the active substance doxazosin (as mesilate). Doxazosin is one of a group of medicines called alpha-blockers. It is used to treat:

! High blood pressure

! Symptoms caused by the enlargement of the

prostate gland in men.

In patients taking this medicine to treat high blood pressure (hypertension), it works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with an enlargement of the prostate gland, this medicine is taken to treat poor and/or frequent passing of urine. This medicine works by relaxing the muscle around the bladder exit and prostate gland so the 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, related

quinazolines (such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6)

! You are breast-feeding

! You have an enlarged prostate gland (benign

prostatic hyperplasia) and have low blood pressure

! 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 lightheaded when you stand up from sitting or lying down

! 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

! 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, pharmacist or nurse before taking Doxazosin Tablets if:

! You are pregnant or trying to become

pregnant

! You have liver disease

! You have heart disease

! You are also taking other medicines

If you are undergoing eye surgery because of cataracts (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Doxazosin Tablets. 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 Tablets 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 Tablets 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.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because it is unlikely to be safe. The safety and efficacy of doxazosin mesilate has not been established.

Other medicines and Doxazosin Tablets

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 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 taking drugs for erectile dysfunction.

! Doxazosin Tablets may lower your blood

pressure even more if you are already taking other medicines to treat 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.

Pregnancy and breast-feeding

The safety of using doxazosin 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.

Do not take Doxazosin Tablets if you are breast-feeding.

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

Doxazosin 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 medicinal product.

Doxazosin 2mg and 4mg Tablets also contain sunset yellow (E110)

This may cause allergic reactions.

Doxazosin contains Sodium

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

3. HOW TO TAKE DOXAZOSIN TABLETS

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

The usual dose of Doxazosin Tablets is: Adults and the elderly

For high blood pressure:

! The initial dose is 1mg once daily ! Your doctor may increase your dose after 1 or

2 weeks to 2mg daily and then again if necessary, to 4mg daily

! In some cases, the dose may be further

increased to 8mg daily or to the maximum dose of 16mg daily if necessary.

To relieve the symptoms of an enlarged prostate gland:

! The initial dose is 1mg once daily ! Your doctor may increase your dose after 1 or

2 weeks to 2mg daily and then again if necessary, to 4mg daily

! In some cases, the dose may be further

increased to the maximum dose of 8mg daily if necessary

! The usual recommended dose is 2mg to 4mg

daily.

Use in children and adolescents

Doxazosin Tablets are not recommended for children or adolescents. The safety and efficacy of doxazosin mesilate has not been established.

Doxazosin Tablets may be taken in the morning or evening. It is best to take your tablets at about the same time each day with a drink of water. Doxazosin Tablets can be taken with or without food. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Doxazosin Tablets than you should

If you have taken more than the prescribed dose, you should consult your doctor and/or pharmacist immediately. If you feel extremely dizzy or think you might faint, you should lie down immediately with your head down.

If you forget to take Doxazosin Tablets

Do not worry. If you forget to take a tablet, leave that dose out completely. Then go back to your usual schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Doxazosin Tablets

It is important to keep taking your tablets. Do not change the dose or stop taking the tablets without first checking with your doctor. Do not wait until your tablets are finished before seeing 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.

STOP taking Doxazosin and call an ambulance immediately if you experience any of the following:

! 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.

Tell your doctor immediately if you experience any of the following symptoms after taking Doxazosin:

! 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 100 people)

! Irregular heartbeat (very rare: may affect up

to 1 in 10,000 people)

! 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 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)

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

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

! Dizziness postural (dizziness as a result of

getting up from a sitting or lying position), tingling or numbness of the hands and feet, nightmares, memory loss, taste disturbance ! Blurred vision

! Hot flushes

! Bronchial spasm (difficulty in breathing,

wheezing or coughing)

! Hives (urticaria), hair loss (alopecia), rash

caused by bleeding under the skin (purpura) ! Disorder in passing urine, needing to pass

urine at night, increased volume of urine passed

! Discomfort or enlargement of the breasts in men

! Feeling tired (fatigue), malaise (general feeling of being unwell).

! Hepatitis (liver inflammation) or bile disorder

Not known (frequency cannot be estimated from the available data)

! Eye problems may occur during eye surgery for cataracts (cloudiness of the lens of the eye). See section 2, “Warnings and precautions”

! Little or no semen ejaculated at sexual climax, cloudy urine following sexual climax (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 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.

5. HOW TO 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 or blister. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not use this medicine if you notice any defects in the tablets such as chipped or broken tablets, take them to your pharmacist for advice before taking them.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Doxazosin Tablets contain

Each tablet contains 1mg, 2mg, 4mg or 8mg of the active ingredient doxazosin (as mesilate).

The tablets also contain microcrystalline cellulose (E460), sodium lauryl sulphate, lactose monohydrate (see section 2), sodium starch glycollate, colloidal silicon dioxide and magnesium stearate.

Doxazosin 2mg and 4mg tablets also contain sunset yellow (E110) (see section 2).

What Doxazosin Tablets look like and contents of the pack

Doxazosin 1mg Tablets are white to off-white, odourless biconvex uncoated tablets with D and 1 on either side of the score line and plain on the other.

Doxazosin 2mg Tablets are light orange to pink, odourless biconvex uncoated tablets with D and 2 on either side of the score line and plain on the other.

Doxazosin 4mg Tablets are light orange to pink, odourless biconvex uncoated tablets with D and 4 on either side of the score line and plain on the other.

Doxazosin 8mg Tablets are white to off-white, odourless biconvex uncoated tablets with D and 8 on either side of the score line and plain on the other.

Doxazosin Tablets are available in packs of 28, 30 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Ennogen Healthcare International Ltd

Unit G3, Riverside Industrial Estate,