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PATIENT INFORMATION LEAFLET    797-9230

Doxazosin 1 mg, 2 mg & 4 mg Tablets

Doxazosin


SOVEREIGN

■MB medical


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

• Keep this leaflet. You may

Beea to read it again, you have any further questions, ask your doctor or d larmagst.

• This medicine has been prescribed for you. Do not pass i on to others. It may harm fhem, even if their symptoms are the same as yours.

• any of the side effects becomes severe, or if you notice qny side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Doxazosin 1 mg, 2 mg and 4 mg Tablets are and what they are used for

2. Before you take Doxazosin 1 mg, 2 mg and 4 mg Tablets 3. How to take Doxazosin 1 mg, 2 mg and 4 mg Tablets 4. Possible side effects

5. How to store Doxazosin 1 mg, 2 mg and 4 mg Tablets 6. Further information

1. WHAT DOXAZOSIN 1 MG, 2 MG AND 4 MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Doxazosin 1 mg, 2 mg or 4 mg Tablets. The active ingredient is doxazosin. Doxazosin belongs to a group of medicines called alpha-blockers. They are used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.

In the treatment of high blood pressure (hypertension), Doxazosin Tablets work by relaxing 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 infrequent and/or poor passing of urine. This is common in patients with enlargement of the



more easily.


2. BEFORE YOU TAKE DOXAZOSIN 1 MG, 2 MG AND 4 MG TABLETS

Do not take Doxazosin Tablets if:

•    you have ever had an allergic reaction to doxazosin or any of the other ingredients of this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips tongue and/or throat with difficulty in swallowing or breathing);

•    you are breast-feeding;


Some patients treatment of higl maye caus.ejc

Certai wl dpi


ho take alpha-blocker therapy for the blood pressure or prqstate eplqri zzinessorlight-h

low blood pressure upon sitting or standing up


pressure or prqstate enlargement erience dizziness or light-headedness, which may be


Tents have experiencecfthese symptoms ig drugs for erectile dysfunction (impotence) with kers. In order to reduce the likenhood that these symptoms occur, you should be on a regplar daily dose pf your alpha-blocker dysfunction.


quickly. Lert when taking alpha-blockc


Take

ter to reduc

should bee    , , ........

Detore you start drugs tor erectile


:jal care with Doxazosin Tablets

you have any liver problems.


with Uoxaz

' liver probler

cloudiness ot tne?ens) please Inform your eye specialist >efore the operation tnqf 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 prepareain advance.

Taking other medicines

Tell your doctor if you are taking any other medicines, especially the following:

• medicines used to treat erectile dysfunction, such as sildenafil (Viagra)

other medicines with a blood pressure lowqri



gnaeye surgeyy because of catarapt


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

Pregnancy and breast-feeding

Inform your dodor if you are pregnant or planning to become


Uo not take Doxazosin Tablets if you are pregnant unless you have discussed the risks and benefits involved with your doctor.    ,    ,    ,

Dp not take Doxazosin Tablets if you are breast-feeding. Ask your dodor or phaimaa'st for advice before taking any medicine.

Driving and using machines

Take care when you drive or operate machinery, as Doxazosin Tablets may a fed your ability to drive or operate machinery safely, particu arly when you first start taking them.

Important information about some of the ingredients


of Doxazosin Tablets

Tell your dodor before taking this medicine, if you have been told that you have an intolerance to some sugars. This is because Doxazosin 1 mg, 2 mg & 4 mg Tablets contain ladose, a type of sugar.


3. HOW TO TAKE DOXAZOSIN 1 MG, 2 MG AND , 4 MG TABLETS ,    ,    ,    ,    ,

Always take your medicine exactly as your dodor has told you. You should check with your dodor or pharmacist if you are not sure. He or she will tell you how many to take and now often to take them.


Your tablet(s) may be taken in either the morning or in the evening. It is best fq take your tablet(s) at the same time each day with a drink of water. You can fake your tablets with or without food.


normal dose is 1 mg daily. After this, the usual dose is 2 mg or 4 mg daily. In some circumstances this may be increased to 8 mg daily. The maximum dose is 16 mg per day.


or 4 mg qailv, In some circu

8 mg daily. The maximum____________

Enlarged prostate: The usual dose is one tablet each day.


dose at the


4. POSSIBLE SIDE EFFECTS ,,

Like all medicines, Doxazosin Tablets can cause side effects, qlthpugh not everybody gets them. If you experience apy of the following symptoms whilst taking your medicine, please


icuity


•    reduction in bloocTplatelets, which increases risk of deeding qr bruising.

•    qw white blood cells which c of infection.

ringing or similar noise in the ears, ilurrea vision.


What Doxazosin 1 mg, 2 mg and 4 mg 1

• The active substance is doxazosin mesilate.


Jjablets contain

ilfine cellulose,

, gnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate.


The usual dose is:

Adults and the Elderly:

High blood pressure-. The usual dose is one tablet each day. If you are faking Doxazosin Tablets for the first time the if you are taking Doxazosin Tablets for the fi rst time the normal dose is 1 mg daily. After this, the usual dose is 2 mg or 4 mg daily. In some circumstances this may be increased to 8 mg daily. The maximum dose is 8 mg per day.

Children:

DOXAZOSIN TABLETS ARE NOT RECOMMENDED FOR USE IN CHILDREN.

Do not exceed the prescribed dose.

If you take more tablets than you should

If you accidentally take too much or your medicine, tell your doctor at once or contact your nearest hospitaf casualty department immediately. Take your medicine and this leaflet wifh you.

If you forget to take your medicine

If you forget to take a aose. just take the next usual time, DO NOT take a double dose.

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

contact your doctor immediately:

•    allergic reactiop which may include severe sympjoi swelling of the face, lips tongue and or throat wil in swallowing or breathing;

• chest pain .increased or irregular heartbeat, heart attack or stroke. These may be due to the underlying disease rather than the medication;

•    feeling very tired and experiencing unexpected bruising or bleeding or more infections (eg colds and sore throats/ than usual.

The most common side effects include:

•    feeling faint and/or dizzy after getting up from a sitting or lying position, dizziness.

vertigo (a sensation that you or your surroundings are n a state of constant movement).

;ee ing sick, eelipg of weakness.

swelling of feet or lower legs (oedema), tiredness/sleepiness. genera feeling of being unwell, leadache. ainting.

nasal stuffiness and/or runny nose (rhinitis).

^SOVEREIGN

Ml MEDICAL

l can lead to an increased risk

•    digestive system complaints including stomach/abdominal payis,constipation, diarrhoea, indigestion, heartburn

•    painfurjoints, painful muscles, muscle cramps, muscle weakness back pqin or general paim

•    iver problems such as. an increase in liver enzymes, hepafitis (liver infection] or yellowing of the skin or whites of The eyes caused by liver or blooa problems.

•    weightgain.

•    qnqrexia.

•    shaking, tingling or qltered sensitivity of the feet or hands.

•    agitation, anxiety, depression or nervousness.

•    urinary disorder (including pain on pqssing urine, increased vo ume of urine passed, needing fo pass urine at night and increased number of times of passing urine),

B'ncontinence or blood in urine.

art or enlargement of the breasts in men.

• painful persistent erection of the penis or failure/inability o achieve penile erection.

•    lairjoss.

: low wowfpressure. especially an getting up from a sitting or lying position.

If any side effect becomes severe, or if yqp notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE DOXAZOSIN 1 MG, 2 MG AND 4 MG TABLETS ,,

Do not store Doxazosin Tablets at temperatures above 25°C. Store in the original package.

Do nqt use Doxazosin Tablets after the expiry date which is stated on the carton.

Keep all medicines out of the reach and sight of children. Return any unused medicine to your pharmacist.

6.. FURTHER INFORMATION

/lie other ingredients are lactose, jodium stard ihydi

What Doxazosin 1 mg, 2 mg and the contents of tne pack

Doxazosin 1 mg Tablets are white, round tablets, embossed D1. Doxazosin 2 mg Tablets are white, oblong tablets, scored and embossed D2 on the same side.

Doxazosin 4 mg Tablets are white, oblong tablets, scored and embossed D4 on the same side.

All three strengths are available in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer responsible for batch release

Waymade Pic trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SSI 4 3FR.

Date of preparation of the leaflet October 2009.