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Cyclizine Hydrochloride 50mg Tablets

Informations for option: Cyclizine Hydrochloride 50mg Tablets, show other option
Document: leaflet MAH GENERIC_PL 20117-0216 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tablets


Cyclizine Hydrochloride 50mg

cyclizine hydrochloride

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you use Cyclizine Tablets

3.    How to use Cyclizine Tablets

4.    Possible side effects

5.    How to store Cyclizine Tablets

6.    Further information

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

The name of your medicine is Cyclizine 50mg Tablets. Cyclizine Tablets contains the active ingredient cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting), including;

•    travel or motion sickness

•    nausea caused by cancer treatment (radiotherapy) or other medicines

•    after an operation, as general anaesthetics can sometimes cause sickness

•    vertigo (dizziness/giddiness) associated with middle ear problems, including Meniere's disease.

Your doctor may have prescribed Cyclizine Tablets for another purpose.

Ask your doctor if you have any questions about why Cyclizine Tablets have been prescribed for you.

•    you suffer from an inherited disorder which can lead to a sensitivity to sunlight (porphyria)

•    you have a drug addiction

Using other medicines

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

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

•    strong painkillers such as pethidine

•    any medicine which belong to a group of medicines called anticholinergics, used to treat urinary incontinence, irritable bowel syndrome and Parkinson's disease

Please tell your doctor if you are taking or have recently taken any other medicines including those you have obtained without a prescription.

Taking Cyclizine Tablets with food and drink

Alcohol should be avoided when you are taking CyclizineTablets.

Pregnancy and breast-feeding

You should not take Cyclizine Tablets if you are pregnant or planning to become pregnant unless your doctor feels it is necessary. You should not take Cyclizine Tablets if you are breast-feeding.

Driving and using machines

You can drive while taking Cyclizine Tablets but do not drive until you know how the tablets affect you. Cyclizine Tablets may make you feel dizzy. If they affect you in this way, do not drive or operate any machinery.

Important information about some of the ingredients of Cyclizine Tablets

Cyclizine Tablets contain lactose. If you have been told that you have intolerance to some sugars, talk to your doctor before taking these tablets.

3. HOWTO USE CYCLIZINE TABLETS

2. BEFORE YOU USE CYCLIZINE TABLETS

Do not use Cyclizine Tablets if:

•    you have ever had an allergic reaction to cyclizine 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).

Take special care with Cyclizine Tablets if:

•    You suffer from an eye disease caused by a rise of pressure within the eye (glaucoma)

•    you have chronic constipation

•    you have any liver problems

•    you have epilepsy

•    you are a man and you suffer from an enlarged prostate gland (difficulty or slowness passing urine)

•    you have been told your heart is not working properly (heart failure)

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

Dosage

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

Adults and children over 12 years

The usual dose is one tablet up to three times daily.

Children from 6 to 12 years

The usual dose is half a tablet up to three times a day.

Children under 6 years

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

The tablets should be swallowed with a little water.

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If you take more Cyclizine Tablets than you should

If you take more Cyclizine 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 take too many Cyclizine Tablets, the following symptoms may occur: Dry mouth, nose and throat, blurred vision, a fast heartrate, difficulty passing urine, drowsiness, dizziness, poor coordination, staggering, weakness, mood and thought changes, disorientation, unable to make decisions, seeing things that aren't there, restlessness, convulsions, unusual body movements, fever, and difficulty breathing.

If you forget to take Cyclizine Tablets

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

4. POSSIBLE SIDE EFFECTS

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

If you notice:

•    itching or skin rashes

•    swelling of the face, lips orthroat

•    difficulty in breathing or wheeziness

Stop taking the tablets and tell your doctor immediately. These may be signs of an allergic reaction.

Other side effects include;

•    skin rashes or itching

•    drowsiness

•    headache

•    a dry mouth, nose orthroat

•    blurred vision

•    fast heartbeat

•    difficulty in passing water

•    constipation

•    restlessness

•    nervousness

•    difficulty in sleeping

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

•    decrease in muscle tone that can cause irregular body movements

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

•    muscle twitches, spasms ortremors

•    fits and seizures

•    being confused, disorientated or unaware

•    dizziness

•    decreased consciousness/loss of conciousness

•    temporary difficulty in speaking

•    high blood pressure

•    pins and needles

•    yellowing of the skin and the whites of your eyes (jaundice)

•    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 (apnoea)

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

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 any of the side effects become severe or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist immediately.

5. HOWTO STORE CYCLIZINE TABLETS

Keep out of the reach and sight of children.

Do not use Cyclizine Tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Keep the blisters in the outer carton in order to protect from light.

Medicines should not be disposed of via waste water 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 Cyclizine Tablets contain

The active substance is cyclizine hydrochloride. Each tablet contains 50mg cyclizine hydrochloride.

The other ingredients are; lactose monohydrate, maize starch, sodium starch glycolate, povidone, colloidal anhydrous silica, magnesium stearate.

What Cyclizine Tablets look like and contents of the pack

Cyclizine Tablets are white to off white, circular shaped, flat uncoated tablets with central break line on one side and plain on other.

Tablets are supplied in blister packs of 100 tablets.

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road

Leicester

LE30PA

UK

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way

Loughborough

LE115GW

UK

This leaflet was last revised in January 2013

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