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nnogen Pharmd

I PACKAGE LEAFLET: INFORMATION FOR THE USER

I Doxazosin 1mg, 2mg, 4mg and 8mg Tablets

| (Doxazosin mesllata)

Read all of (his leaflet carefully before you atari taking this medicine because It contains Important Information for you.

•    Keep this leaflet You may need to read It I again.

•    If you have any further questions, ask your ¹ doctor or pharmacist or nurse.

^ This medicine has been prescribed for you only. Do not pass It on to others. It may harm I them, even If their signs of Illness are the same as yours.

I If you get any side effects, talk to your doctor or ■ pharmacist or nurse. This Includes any possible side effects not listed In this leaflet See section

I «■

kvhat Is In this leaflet:

.1. What Doxazosin Tablets are and what they are

•    used for

p. What you need to know before you take Doxazosin Tablets (3. How to take Doxazosin Tablets 4. Possible side effects 6. How to store Doxazosin Tablets |5, 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-btockers.

It Is used to treat:

^ High blood pressure

• Symptoms caused by the enlargement of the I prostate gland In men.

In patients taking this medicine to treat high blood

eressure (hypertension), it works by relaxing blood essels so that blood passes through them more Easily. This helps to lower blood pressure.

Dizziness, weakness and in rare cases fainting may occur, especially when you first stad 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.

Doxasozln mesllate (Doxasozin 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:

Tel your doctor or pharmacist If you are taking, have recently taken or might take any other medicines.

It Is especially Important to mention the following before taking Doxazosin Tablets:

•    Medicines for high blood pressure (called anllhypertensives)

•    Antidepressants (for depression)

•    Drugs used for the treatment of erection problems (PDE-5 Inhibitors e.g. sildenafil (vlagra), tadafil, vardenafil).

If you are going lo havo surgery. Including denial, you should tell your doctor you are taking this medicine.

If you need to have 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 Tablets may cause complications during surgery which can be managed If your specialist Is prepared In advance.

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 tako Doxazosin Tablets If you are breast-feeding.

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 urine Is passed frnore easily.

po not take this medicine If:

•    You are allergic (hypersensitive) to doxazosin,

I related qulnazolines e.g. prazosin or terazosin, or any of the other Ingredients In this medicine I (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 I 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 I problems.

Ivarnlngs and precautions:

[Talk to your doctor or pharmacist or nurse before hiking this medicine if:

You have liver disease

•    You have heart disease

l You have a previous history of stroke

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

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

Driving and using machines:

Take care if you drive or operate machinery. Your tablets may aflect 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.

[a. HOW TO TAKE DOXAZOSIN TABLETS    j

Always lake 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 end the elderly:

For high blood pressure:

•    The Initial dose is 1 mg taken at bedtime

•    Your doctor may increase your dose alter 1 or 7 weeks to 2mg dally and then again if necessary, to 4mg dally

« In some cases, the dose may be further

Increased to 8mg dally or to the maximum dose

el 16mg daily if necessary.

To relieve symptoms of an enlarged prostate gland:

•    The initial dose Is 1 mg once dally 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

—dally. _ _ _ _ _ _ _ _ _i

Children:

Doxazosin Tablets are not recommended for children.

If you take more Doxazosin Tablets than you should:

■faking loo many tablets at once may make you unwell. If several tablets are taken It may be dangerous. Tell your doctor Immediately or go to pour nearest hospital casualty department.

If you forget to take Doxazosin Tablets: bo not worry. If you forget to take a tablet, loave that dose out completely. Then go back to your usual schedule.

If you stop taking Doxazosin Tablets:

It is important to keep taking your tablets. Do nol 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 product, ask your doctor or pharmacist.

|Llke all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happens, stop taking this )nedlclne and tell your doctor Immediately or go to the nearest hospital casualty department:

|> Allergic reactions such as skin rash and/or itching, swelling of the face and throat and | difficulty breathing

• Chest pain, Increased or irregular heartbeat,

I heart attack or stroke (symptoms such as weakness of amis, legs, problems speaking) k Yellowing of the skin or whites of the eyes caused by liver or bile problems b Unusual bruising or bleeding caused by low blood platelets.

btlier side effects:

Very common (may affect more than 11n 10 people):

C Headaches Dizziness.

k Arthralgia (painful Joints) k Agitation

k Rash caused by bleeding under the skin (purpura)

k Presence of red blood cells In the urine (haematuria) k Reduced sense of touch (hypoaesthesla) k Weight gain.

Very rare (may affect less than 1 In 10,000 people): k Breast enlargement in men k Painful persistent erection ol Ihe penis k Increased need to urinate during Ihe night k Blurring of vision a Slow heart beat a Urticaria (hives) a Aggravation of asthma.

Other reported side effects whose frequency Is unknown Include: a Taste disturbances

a Intraoperative Floppy Iris Syndromo (normally seen during cataract surgery - See Section 2, II you need to have eye surgery) a Ejaculation problems.

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 Bt: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more Information on Ihe safety of this medicine

bommon (may affect 1 to 10 people In 100):

C Sleepiness

Nasal stuffiness or runny nose (rhinitis)

C Weakness, fatigue, generally feeling unwell Swollen legs or ankles f Feeling sick (nausea)

l Infections In the lungs, windpipe or urinary tract • Loss of appetite l> Feeling anxious or nervous » Sleeplessness (Insomnia)

L Drowsiness t Vertigo l Palpitations « Fast heart beat k Feeling of pins and needles • Feeling dizzy when gelling up from sitting or I while standing (dizziness postural)

» Low blood pressure t Cough • Bronchitis |> Shortness of breath • Indigestion )i Abdominal pain • Diarrhoea |p Itching • Dry mouth ^ Back pain • Muscle pain |. Cystitis

• Inability to control urination k Flu-like symptoms • Chest pain.

Uncommon (may affect 1 to 100 people In rl000):

Gout

k Increased appetite • Depression k Tremor '• Fainting k Constipation k Flatulence P Stomach upsets k Abnormal liver function tests •> Impotence k Generalised pain

C Facial swelling

Increase In the frequency of urination or In the l amount of urine produced 1 Pain on urinating

C Tinnitus (ringing in the ears)

Hot flushes

CNose bleeds Vomiting

CSkln rashes Hair loss

Musc^cramps^jnuscle weakness_

Keep out of Ihe sight and reach of children.

Do not use Doxazosin Tablets after the expiry date which Is staled on the carton or blister.

The expiry dale refers to the last day of that month Do not store above 25°C. Store in Ihe original package.

Do nol take Doxazosin Tablots If you notice any defects in the tablets such as chipped or broken tablets, taka them to your pharmacist for advice before taking them.

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

What Doxazosin Tablets contain:

Each tablet contains 1mg, 2mg, 4mg or Omg of Ihe active Ingredient doxazosin (as mesilate).

The tablets also contain mlcrocrystalline cellulose (£460), sodium lauryi sulphate, lactose monohydrate, sodium starch gtycollate, colloidal silicon dioxide and magnesium stearate. Doxazosin 2mg and 4mg tablets also contain sunset yellow (E110).

What Doxnzosln Tablets look like and contents of the pack:

Doxazosin Img Tablets are white to off-while biconvex tablets with a division mark on both sides end DZS 1 on one side.

Doxazosin 2mg Tablets are light orange to pink biconvex tablets with a division mark on both sides and DZS 2 on one side.

Doxazosin 4mg Tablets are light orange to pink biconvex tablets with a division mark on both sldos and DZS 4 on one side.

Doxazosin 8mg Tablets are white to off white biconvex tablets with a division mark on both sides and DZS 8 on one side.

Doxazosin Tablets are available In packs of 28.30 and 56.

Nol all pack sizes may be marketed.

Marketing Authorisation Holder Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way, Dartford, DA1 5BS,

United Kingdom

Manufacturer

Dragenopharm, Apotheker Puschl Gmbh & Co KG GollstraBe 1.84528 Tillmonlng. Germany

This leaflet wai last amended In June 2015.