•    dizziness on standing. This is more likely to happen at the beginning of the treatment.

•    hair loss

•    bruising because of bleeding into the skin (purpura)

•    muscle cramps

•    muscle weakness

•    hot flushes

•    fatigue.

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

•    intraoperative floppy iris syndrome (IFIS)

•    taste disturbances

•    retrograde ejaculation.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    HOW TO STORE DOXAZOSIN

Keep out of the reach and sight of children.

Do not use Doxazosin after the expiry date, which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Doxazosin contains:

Each Doxazosin 1 mg, 2 mg or 4 mg tablet contains either 1 mg, 2 mg or 4 mg of the active ingredient doxazosin as doxazosin mesilate. The other ingredients are microcrystalline cellulose, anhydrous lactose, sodium starch glycollate Type A, magnesium stearate and sodium laurylsulfate.

What Doxazosin looks like and contents of the pack:

Doxazosin 1 mg Tablets are white, round tablets with DX1' marked on one side. Doxazosin 2 mg Tablets are white, scored, capsule-shaped tablets with 'DX|2' marked on one side. Doxazosin 4 mg Tablets are white, scored, capsule-shaped tablets with 'DX|4' marked on one side.

Doxazosin is available in containers of 10, 20, 28, 30, 50, 60, 90,100, 250, 500, 1000 tablets and in blister packs of 10, 20, 28, 30, 50, 60, 90, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Mylan,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Doxazosin 'Arcana' 2 mg & 4 mg Tabletten Germany: Doxazosin dura 1 mg, 2 mg & 4 mg Tabletten Spain: Doxazosina 2 mg & 4 mg, comprimidos Sweden: Doxazosin 1 mg, 2 mg & 4 mg Tabletter United Kingdom: Doxazosin 1 mg, 2 mg and 4 mg Tablets

This leaflet was last revised in 05.2015

641313

PACKAGE LEAFLET: INFORMATION FOR THE USER

DOXAZOSIN 1 mg, 2 mg AND 4 mg 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Doxazosin is and what it is used for.

2.    Before you take Doxazosin.

3.    How to take Doxazosin.

4.    Possible side effects.

5.    How to store Doxazosin.

6.    Further information.

1.    WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR

Your medicine belongs to a group of medicines called alpha-blockers. Doxazosin can treat high blood pressure (hypertension) by relaxing the blood vessels in the body and lowering blood pressure. Doxazosin can also be given to men suffering from an enlarged prostate gland, as it can relax the muscles allowing urine to be passed more easily.

2.    BEFORE YOU TAKE DOXAZOSIN

Do not take Doxazosin if you:

• are allergic (hypersensitive) to doxazosin, or other types of quinazolines (e.g. prazosin, terazosin) or any of the other ingredients of Doxazosin Tablets (see Section 6 for a full list of ingredients)

•    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

•    have an enlarged prostate gland (benign prostate hyperplasia) and problems with your bladder, a long standing infection of the urinary tract or difficulty in passing urine

•    have low blood pressure

•    are breast-feeding (See Pregnancy and Breastfeeding)

•    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.

Take special care with Doxazosin

You should tell your doctor before taking this medicine if you:

•    have heart disease or a heart condition

•    have liver problems

•    have kidney disease or kidney problems

•    have diabetes

•    are on a low-salt diet

•    are elderly

•    need a blood test as Doxazosin can affect some test results

•    are undergoing eye surgery because of cataract (cloudiness of the lens). Please inform your eye specialist before the operation

that you are taking or have previously taken medicine containing doxazosin. This is because doxazosin may cause complications during the surgery, which can be managed if your eye specialist is informed in advance.

When you start to take Doxazosin or when your dose is increased 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 or when your dose is increased to reduce the possibility of these effects happening.

Children and adolescents

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

Other medicines and Doxazosin:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without

Date: 26 MAY 2015

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a prescription, or the following:

•    other medicine to lower blood pressure such as beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)

•    medicine to treat a heart condition such as nitrates (e.g. glyceryl trinitrate)

•    painkillers called non-steroidal anti-inflammatory medicine (NSAIDs) e.g. ibuprofen

•    medicine containing oestrogen such as HRT or oral contraceptive medicines

•    cimetidine, used to treat stomach ulcers

•    diuretics or 'water tablets'

•    medicine containing dopamine, metaraminol, methoxamine, adrenaline (epinephrine), cough and cold remedies as they may contain ephedrine, phenylephrine

•    medicine for erection problems, such as sildenafil, tadalafil, vardenafil. You should not take such medicines until your blood pressure is well controlled. You should take the lowest possible dose of medicine for erection problems.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant as Doxazosin should not be given to pregnant women unless the benefits to the mother outweigh the risks to the baby.

Do not breast-feed your baby, as small amounts of doxazosin can pass into breast milk.

Driving and using machines

Do not drive or operate machinery if you feel less alert while taking this medicine. They make you feel weak or dizzy. This is more likely at the start of the treatment or if the doctor increases your dose.

Important information about some of the ingredients of Doxazosin

Doxazosin contains lactose. If your doctor has told you that you have intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. HOW TO TAKE DOXAZOSIN

Always take Doxazosin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults including the elderly High blood pressure: The usual starting dose is 1 mg once a day. If necessary, your doctor may gradually increase the dose (e.g. 2 mg, 4 mg,

8 mg) at intervals of 1 to 2 weeks until the desired blood pressure is achieved. The maximum daily dose is 16 mg. Your doctor may give you another medicine to take along with Doxazosin.

Enlarged prostate: The usual starting dose is 1 mg once a day. If necessary, your doctor may gradually increase the dose at intervals of 1 to 2 weeks until your symptoms are controlled. The maximum daily dose is 8 mg.

Take your tablets at about the same time each day with a drink of water.

Children: Doxazosin is not recommended in children.

If you take more Doxazosin than you should:

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include headache, dizziness, confusion, fainting, breathlessness, low blood pressure, palpitations (feeling your heartbeat), racing heartbeat, irregular heartbeat, slow heartbeat, feeling sick, vomiting, low levels of sugar and potassium in your blood.

If you forget to take Doxazosin:

Take the next dose as soon as you remember. Unless it is almost time for your next dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Doxazosin:

Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Doxazosin can cause side effects, although not everybody gets them.

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

•    Heart Attack (uncommon).

•    Weakness of arms, legs or problems speaking which may be symptoms of a stroke (uncommon).

•    Swelling of the face, tongue or throat, which may be the result of an allergic reaction to this medicine (uncommon).

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

•    Chest pain (common), angina (uncommon).

•    Shortness of breath, difficulty breathing (very rare).

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