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Doxazosin 1 mg, 2mg, 4 mg & 8 mgLeaflet cutter guidesize: 140 x 480 mm

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Ennogen

Doxazosin Leaflet

UK

English

140 x 480 mm

9 pt

1 of 1

2

04-04-19

Coreldraw 12

Packaging Development Quality Assurance (QA) Quality Control (QC) Production

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Keyline

Doxazosin 1mg, 2mg, 4mg and 8mg Tablets(Doxazosin mesilate)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 further questions, ask your

doctor, pharmacist or nurse.! 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:1. What Doxazosin Tablets are and what

they are used for2. What you need to know before you

take Doxazosin Tablets3. How to take Doxazosin Tablets4. Possible side effects5. How to store Doxazosin Tablets6. Contents of the pack and other

information

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

The name of your medicine is Doxazosin Tablets. 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 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 e.g. prazosin or terazosin, or any of the other ingredients of this medicine (listed in section 6)

! You are breast-feeding! You have a history of

blood pressure dropping on standing up

! You have any form of obstruction of the urinary tract

! You are suffering from benign hyperplasia (an enlarged prostate gland) together with bladder stones or blockages or infections of the urinary tract

! You are suffering from bladder leakage, problems producing urine or worsening kidney problems.

Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking this medicine if:! You have kidney or liver problems! You suffer from serious heart problems

such as severely reduced cardiac function or a restrictive and painful sensation in the chest (angina pectoris)

! You have a tendency to faint or dizziness (hypotension)

! You suffer from an accumulation of fluid on the lungs.

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. This is because Doxazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Dizziness, weakness and in rare cases fainting may occur, especially when you first start taking this medicine. You should therefore be careful at the beginning of treatment, and avoid situations that could lead to injury if these symptoms occur.

Doxazosin mesilate (Doxazosin Tablets) is not recommended for use in children or adolescents below 18 years as safety and efficacy have 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.

! 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

! Nitrates (medicines for heart problems) such as nitroglycerine and isosorbide mononitrate: these can exacerbate the hypotensive effect

! Medications that could also possibly affect the liver metabolism, e.g. cimetidine (a medicine for stomach problems).

Doxazosin Tablets with food and drink:Swallow each tablet whole with a glass of water.You can take these tablets with or without food.

Pregnancy and breast-feeding:If you are pregnant do not take Doxazosin Tablets without consulting your doctor first. The safety of this medicine is not sufficiently established in pregnancy. You must not take Doxazosin Tablets if you are breast-feeding.Doxazosin should only be used during pregnancy if your doctor decides that the benefits for the mother outweigh the possible risk for the foetus.

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.

3. HOW TO TAKE DOXAZOSIN TABLETS

Always take Doxazosin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Doxazosin Tablets are normally taken once a day.

The usual dose of Doxazosin Tablets is:Adults and the elderly:For high blood pressure:! The initial dose is 1mg taken at bedtime! 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 taken

at bedtime! Your doctor may increase your dosage

at 1-2 weekly intervals to 2mg and then again to 4mg up to a maximum of 8mg daily

! The usual recommended dose is 2mg to 4mg daily.

Use in children Doxazosin Tablets are not recommended for children.

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.

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the nearest hospital casualty department:! Allergic reaction such as wheezing,

shortness of breath, extreme dizziness or collapse, swelling of the face or throat, or a serious skin rash with red spots or blisters (especially affecting the whole body)

! Chest pain (angina pectoris), increased or irregular heartbeat, heart attack or stroke (symptoms may include collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech)

! Yellowing of the skin or whites of the eyes caused by liver problems (jaundice)

! Unusual bruising or bleeding caused by low blood platelets

! Presence of blood in the urine! Hepatitis (liver disease with nausea,

vomiting, loss of appetite, generally feeling unwell, fever)

! Cholestasis (blocked flow of bile - can cause itchy skin, pale stool and dark urine)

! Leukopenia (reduced number of white blood cells. Symptoms may include frequent infections such as fever, severe chills, sore throat or mouth ulcers)

! Persistent painful erection of of the penis. Seek urgent medical advice.

Common (may affect up to 1 in 10 people):

! Respiratory tract infection (nose, throat, lung)

! Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate)

! Urinary incontinence (inability to control passing urine)

! Dizziness, sleepiness (somnolence), headache

! Feeling of dizziness or “spinning” (vertigo)

! Low blood pressure and low blood pressure as a result of getting up from a sitting or lying position (postural hypotension)

! Inflammation of the air passages within the lungs, cough, shortage of breath, nasal stuffiness and/or runny nose

! Abdominal pain, indigestion, dry mouth, feeling sick (nausea)

! Itching (pruritus) ! Back pain, muscle pain (myalgia)! Inflammation of the bladder (cystitis)! Feeling of weakness (asthenia), chest

pain, influenza like symptoms! Swelling of the ankles, feet or fingers

(peripheral oedema).

Uncommon (may affect up to 1 in 100 people):! Gout, increased appetite, anorexia (loss

of appetite)! Agitation, depression, anxiety,

sleeplessness (insomnia), nervousness, tremor

! Stroke, reduced sense of touch or sensation, fainting

! Ringing or noise in the ears (tinnitus)! Nose bleed! Constipation, flatulence, vomiting (being

sick), inflammation of the gastrointestinal tract, diarrhoea

! Abnormal liver function test ! Skin rash! Joint pain! Painful or difficult urination! Difficulty to develop an erection

(impotence)! Pain, swelling of the face! Weight increase! Need to urinate more often than usual

(micturition frequency).

Rare (may affect up to 1 in 1,000 people):! Muscle cramps, muscle weakness! Polyuria (passing large volumes of

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 (paraesthesia)

! Blurred vision! Reduced heart rate! 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

! Temporary enlargement of the breasts in men (gynecomastia)

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

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 effectsIf 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/yellowcardBy 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.Not all pack sizes may be marketed.

Marketing Authorisation Holder and ManufacturerEnnogen Pharma LimitedUnit G4, Riverside Industrial EstateRiverside Way, Dartford, DA1 5BSUnited Kingdom.

This leaflet was last revised in November 2017.

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