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PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxazosin 2mg and 4mg Tablets

(doxazosin mesilate)

Read all of this leaflet carefully before you start taking this medicine:

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet:

1.    What Doxazosin Tablets are and what they are used for

2.    Before you take Doxazosin Tablets

3.    How to take Doxazosin Tablets

4.    Possible side effects

5.    Storing Doxazosin Tablets

6.    Further information

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

Doxazosin belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure (hypertension). It helps by widening your blood vessels making it easier for your heart to pump blood through them. Doxazosin is also used to treat enlarged prostate glands called Benign Prostatic Hyperplasia (BPH). Symptoms include frequent and/or difficulty passing urine. Doxazosin works by relaxing muscle around the bladder exit and the prostate gland so urine is passed more easily.

2.    BEFORE YOU TAKE DOXAZOSIN TABLETS Do not take Doxazosin Tablets if you:

•    are allergic (hypersensitive) to Doxazosin or any of the other ingredients of this medicine

•    are allergic to other medicines called alpha-blockers used to treat high blood pressure such as prazosin or terazosin

•    suffer from urinary tract problems such as congestion of urinary tract, urinary tract infections or bladder stones

•    have a history of fainting or dizziness when you stand up (orthostatic hypotension)

•    suffer from low blood pressure (hypotension) and are taking the tablets to treat BPH

•    are breastfeeding and are taking the tablets to treat high blood pressure

If you are taking these tablets to treat problems urinating (e. g. too much or too little) it must be used in combination with other medicines and never as the only treatment.

Take special care and tell your doctor if you:

•    suffer from heart conditions such as fluid in the lungs (pulmonary oedema) or heart failure

•    need to take further medication for high blood pressure especially PDE-5 inhibitors (see ‘Taking other medicines’ section for more information)

•    have or have ever had any liver problems as your doctor may wish to monitor you more closely

•    are undergoing cataract eye surgery (you must also tell your optician and the person conducting the surgery)

•    have been told by your doctor that you are intolerant to some sugars as this medicine contains lactose

Take care when taking this medicine as it can often cause dizziness, weakness and fainting especially at the start of treatment. Your doctor will monitor your blood pressure to try to help minimise these affects. Avoid situations where injury could occur if you were to experience dizziness, weakness or fainting.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including medicines obtained without a prescription.

Tell your doctor if you are taking:

•    Other alpha blockers or other drugs used to treat high blood pressure e.g. minoxidil, clonidine hydrochloride

•    Cimetidine used to treat an acid stomach or ulcer

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•    PDE-5 inhibitors used to treat erectile dysfunction (impotence) e.g. sildenafil, tadalafil, vardenafil. Taking Doxazosin at the same time as PDE-5 inhibitors can cause some patients to experience dizziness or light-headedness, caused by low blood pressure upon sitting or standing up quickly. 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.

Taking Doxazosin with food and drink

Doxazosin can be taken with or without food

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you may become pregnant so they can decide if the potential benefits of the medicine outweigh the risks.

Do not take Doxazosin if you are breastfeeding or are planning to breastfeed as it may be passed on to your baby through the breast milk.

Childrens

Doxazosin tablet is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or weak. This is more likely to happen at the start of your treatment.

3.    HOW TO TAKE DOXAZOSIN TABLETS

Always take your medicine exactly as told by your doctor. Ask your doctor or pharmacist if you are not sure.

Dosage for high blood pressure

The usual starting dose for high blood pressure is 1mg once daily.

After one or two weeks, your doctor may increase the dose up to 2mg and then again to 4mg if required. The dose can be increased up to a maximum of 16mg per day.

Dosage for Benign Prostatic Hyperplasia (BPH)

The usual starting dose for BPH is 1mg once daily which may be increased to 2mg after one to two weeks depending on your response. The usual recommended dose is 2-4mg daily. If required, it may be increased to 4 mg and further to a maximum of 8mg per day.

Swallow the tablets with a glass of water. The tablets can be taken in the morning or evening.

If you take more Doxazosin tablets than you should

If you take too many tablets or a child swallows some, see your doctor immediately or contact the accident and emergency department of the nearest hospital.

If you forget to take Doxazosin Tablets

If you have forgotten to take your Doxazosin Tablets, wait until it is time to take the next dose, and then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Doxazosin Tablets

Do not stop taking the tablets without first consulting your doctor. It is important that you take Doxazosin Tablets as long as your doctor prescribes it. This will keep your blood pressure controlled if you are getting treatment for hypertension and your symptoms in check if you are taking Doxazosin tablets for BPH.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Doxazosin tablets can cause side effects.

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

•    Heart attack - pain or tightness in the chest, neck shoulders or arms

•    Weakness of arms, legs or problems speaking which may be symptoms of a stroke

•    Severe allergic reaction, which can include:

o Swelling of the face which may cause difficulty in breathing o A rash which is accompanied by fever and may cause the skin to peel off leading to bleeding

o Blisters that appear on the mouth, throat, eyes, anus or the genital area

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

•    Severe chest pain, angina

•    Shortness of breath, difficulty breathing

•    Increased, decreased or irregular heartbeat

•    Feeling your heartbeat (palpitations)

•    Fainting

•    Problems with your liver (hepatitis) which may, cause fever, loss of appetite, feeling and being sick, abdominal pain, tiredness, yellowing of the skin or the eyes (jaundice)

•    Low numbers of white blood cells or blood platelets, which may result in bruising or easy bleeding

Very common side effects (experienced by more than 1 in 10 patients)

•    Dizziness

•    Headache

Common side effects (experienced by between

•    Respiratory tract infection

•    Urinary tract infection such as cystitis

•    Loss of appetite

•    Anxiety or nervousness

•    Difficulty sleeping

•    Low blood pressure

•    Dizziness or light headedness when standing up

•    Vertigo (a feeling of dizziness or spinning)

•    Pins and needles

•    Sleepiness, exhaustion or weakness

•    Bronchitis - swelling of the airways causing coughing

Uncommon side effects (experienced by between 1 in 100 and 1 in 1000 patients)

•    Gout (very painful joints)

•    Increased appetite or weight gain

•    Agitation

•    Depression

•    Numbness (loss of sensation)

•    Pain

•    Shaking

•    Ringing in ears

•    Swelling of the face

•    Hot flushes

•    Nose bleeds

•    Constipation or wind

•    Liver enzyme increases which may have an effect on some medical tests

Very rare side effects (experienced by less than 1 in

• Blurred vision    •

• Worsening of existing breathing problems •

•    Prolonged or painful erection    •

•    Cholestatis - problems with bile production - itching jaundice

Unknown frequency

•    Changes in taste sensation

•    Complications following cataract surgery

•    Retrograde ejaculation - A condition where semen travels in the wrong direction; up to the bladder instead of outside the body.

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: http://www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOXAZOSIN TABLETS

Keep out of sight and reach of children

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

Do not remove the medicine from the blister until you are ready to take the medicine. Do not use Doxazosin Tablets after the expiry date mentioned on the blister and carton.