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CYCLIZINE HYDROCHLORIDE 50 mgTABLETS

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 any further questions, ask your doctor, or 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.

WHAT IS IN THIS LEAFLET:

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1.    What Cyclizine Hydrochloride Tablets are and what they are used for

2.    What you need to know before you take Cyclizine Hydrochloride Tablets

3.    How to take Cyclizine Hydrochloride Tablets

4.    Possible side effects

5.    How to store Cyclizine Hydrochloride Tablets

6.    Contents of the pack and other information

OWHAT CYCLIZINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Cyclizine Hydrochloride 50 mg Tablets.

Cyclizine Hydrochloride Tablets contain the active ingredient cyclizine hydrochloride, which belongs to a group of medicines known as antihistamines. Antihistamines help prevent feelings of sickness (nausea) or being sick (vomiting).

Cyclizine Hydrochloride Tablets may be used for the following conditions:-• travel and motion sickness • post-operative nausea and vomiting • vomiting associated with cancer treatment • treatment of sickness due to inner ear problems, such as Meniere's disease You must talk to a doctor if you do not feel better or if you feel worse.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYCLIZINE HYDROCHLORIDE TABLETS

Do not take Cyclizine Hydrochloride Tablets:

• if you are allergic to cyclizine hydrochloride or any of the other ingredients of this medicine listed in section 6 (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).

Take special care with Cyclizine Hydrochloride Tablets if you:

•    have glaucoma

•    have obstructive disease of the gastrointestinal tract

•    have liver disease

•    suffer from epilepsy

•    are male and have an enlarged prostate

•    have severe heart failure

•    have an inherited disease called porphyria

•    have been told by your doctor that you have an intolerance to some sugars.

Children

Cyclizine Hydrochloride Tablets should not be used in children under six years of age.

Other medicines and Cyclizine Hydrochloride Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. In particular, tell your doctor about the following medicines:

•    medicines for problems such as depression, anxiety or difficulty in sleeping;

•    strong painkillers such as pethidine;

•    any medicine which belong to a group of medicines called anticholinergics.

Cyclizine Hydrochloride Tablets and alcohol

You should avoid taking alcohol whilst you are on these tablets.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take these tablets if you are breast-feeding.

Driving and using machines

These tablets may make you feel dizzy or drowsy. If affected, do not drive or operate machinery.

Cyclizine Hydrochloride Tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

©HOW TO TAKE CYCLIZINE HYDROCHLORIDE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow these tablets with a little water.

The recommended dose is as follows:

Adults and children over 12 years:

The usual dose is one tablet (50 mg) up to three times daily.

Children from 6 to 12 years:

The usual dose is half a tablet (25 mg) up to three times a day.

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Children under 6 years:

Do not give this medicine to children under the age of 6.

For preventing motion sickness, take the recommended dose 1-2 hours before travelling.

If you take more Cyclizine Hydrochloride Tablets than you should

If you take more tablets than you should, contact your doctor or nearest hospital emergency department immediately. Remember to take this leaflet and/or the package with you to show the doctor what you have taken.

If you forget to take Cyclizine Hydrochloride Tablets

If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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

4 | POSSIBLE SIDE EFFECTS

Like all medicines, Cyclizine Hydrochloride Tablets can cause side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately if you experience any of the following symptoms:

•    itching or skin rashes

•    swelling of the face, lips or throat

•    difficulty in breathing or wheeziness.

These may be signs of an allergic reaction.

Other side effects include:

•    skin rashes or itching

•    drowsiness or general feelings of weakness/tiredness

•    headache

•    a dry mouth, nose or throat

•    blurred vision or involuntary rolling of the eyes

•    fast heartbeat

•    difficulty in passing water

•    constipation

•    restlessness

•    nervousness

•    difficulty in sleeping

•    seeing or hearing things that are not really there (hallucinations)

•    temporary loss of movement or feeling

•    decrease in muscle tone that can cause irregular body movements

•    unusual body movements, particularly of your hands, arms or legs

•    muscle twitches, spasms or tremors

•    fits and seizures

•    being confused, disorientated or unaware

•    dizziness

•    decreased consciousness/loss of consciousness

•    temporary difficulty in speaking

•    high blood pressure

•    low blood pressure

•    pins and needles

•    yellowing of the skin and the whites of your eyes

•    a red or brownish patch which appears at the same spot each time you take the medicine

•    inflammation of the liver (hepatitis) or problems with the liver

•    reduced rate of breathing

•    reduction in the production of a type of white blood cell making infection more likely.

If you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

©HOW TO STORE CYCLIZINE HYDROCHLORIDE 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 label and carton. The expiry date refers to the last day of that month.

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.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Cyclizine Hydrochloride Tablets contain

• The active substance is cyclizine hydrochloride.

Each tablet contains 50 mg of the active ingredient, cyclizine hydrochloride.

• The other ingredients are maize starch, lactose, povidone and magnesium stearate.

What Cyclizine Hydrochloride Tablets look like and contents of the pack

Cyclizine Hydrochloride Tablets are circular, white tablets with a breakline on one side and plain on the reverse.

These tablets are available in blisters of 1, 10, 30, 40, 50, 100 and 500 tablets.

They are also available in a bottle containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Brown & Burk UK Limited 5, Marryat Close, Hounslow West, Middlesex TW4 5DQ, UK.

This leaflet was last approved in September 2012. PL 25298/0046

01081-A B&B Internal Code TBC

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