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Package leaflet: Information for the patient 102409/LF/029/02

AMDIPHARM

Cyclizine Hydrochloride 50 mg Tablets

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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.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may

^— haiTTthemTevenTlheirsympTbms arelhe same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Cyclizine Hydrochloride Tablets are

andwhatjheyareusedjor _ _

What you need to know before you take Cyclizine Hydrochloride Tablets How to take Cyclizine Hydrochloride Tablets Possible side effects

How to store Cyclizine Hydrochloride Tablets Contents of the pack and other information

297 mm

WHAT 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 called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting).

Cyclizine Hydrochloride Tablets may be used

1)Tadu1tS“andTftildrenTiged“6-years~and“0ver.

Cyclizine Hydrochloride Tablets may be used if you suffer from travel or motion sickness; nausea caused by cancer treatment (radiography) or other medicines; or if you have had an operation, as general anaesthetics can sometimes cause sickness.

Cyclizine Hydrochloride Tablets can also be used to treat sickness caused by some inner ^ar problems-such as-Meniere’s disease.—

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYCLIZINE HYDROCHLORIDE TABLETS Do not take this medicine 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, tips, tongue and-/ orthroahwith difficulty in swallowing or breathing).

•    you have been drinking alcohol. The anti-vomiting properties of cyclizine may increase the toxicity of alcohol.

Cyclizine Hydrochloride Tablets should not be used in children under the age of 6 years.

Warnings and precautions

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your doctor or pharmacist before taking Cyclizine Hydrochloride Tablets if you:

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

•    suffer from urinary retention (experience difficulty passing urine);

•    have an obstructive bowel condition;

•    have any liver problems;

•    suffer from phaeochromocytoma (tumour of the medulla of the adrenal glands);

•    suffer from high blood pressure;

•    have epilepsy;

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

•    have been told your heart is not working properly (heart failure); suffer froffTan ihReritefflisordeTwhicfTcan" lead to a sensitivity to sunlight (porphyria).

Cyclizine Hydrochloride Tablets and other medicines

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

•    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.

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 Hydrochloride Tablets with food and drink

Alcohol should be avoided when you are -4aking-Gyclizfne-Hydrochloride Tablets. —

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

Driving and using machinery

-You -ean -drive -^while—taking— Cyefizine-Hydrochloride Tablets but do not drive until you know how the tablets affect you. Cyclizine Hydrochloride 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 Hydrochloride Tablets. Cyclizine Hydrochloride Tablets contain lactose.

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

3. HOW TO TAKE CYCLIZINE HYDROCHLORIDE TABLETS

Always take Cyclizine Hydrochloride Tablets exactly as your doctor has told you. You -shoulcLcheck-with your doctor or-pharmacist if_ you are not sure.

Adults

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

Use in children and adolescents.

Children over 12 years The recommended dose is one tablet up to three times daily.

Children from 6 to 12 years The recommended 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.

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REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc.) and that Amdipharm have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

(Please strike off whichever NOT applicable)

Signature ...................................................................

Name .........................................................................

Date ...........................................................................

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The tablets should be swallowed with a little -water.—    — — — — —

If you take more tablets than you should

Symptoms of overdose include dry mouth, nose and throat, blurred vision, fast or irregular heartbeat, difficulty passing urine, drowsiness, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgement, hallucinations, muscle spasm, involuntary movements, convulsions, "high temperature antTdifficnity breathing:

If you take more Cyclizine Hydrochloride 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 your medicine

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

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

If you notice:

•    itching or skin rashes;

•    swelling of the face, lips or throat;

» 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; lack of coordination; headache;

a dry-mouth-, nose-or threat; —    —

blurred vision; fast heartbeat; irregular heartbeat; difficulty in passing water; constipation; heartburn (reflux); feeling sick; being sick;

diarrhoea;_ _ _ _ _

stomach pain; loss of appetite; restlessness; nervousness; euphoria;

difficulty in sleeping; ringing in the ears;

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

Rare side effects include:

decrease in muscle tone; unusual body movements, particularly of your hands, arms or legs; muscle twitches, spasms or tremors; seizures;

being confused, disorientated or unaware; dizziness;

feeling weak;

decreased consciousness; temporary difficulty in speaking; high blood pressure; low blood pressure; pins and needles;

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

■ a retfor brownistrpatcfrwhich appearsatthe^-same spot each time you take the medicine;

•    an increased sensitivity to sunlight (photosensitivity);

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

Very rare side effects include:

•    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.

Reporting of side effects

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

You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

5. HOW TO STORE CYCLIZINE HYDROCHLORIDE — TABLETS— — — — —

Store your tablets in a safe place below 25°C. Do not take any tablets after the “use by” date shown on the pack.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Return any unused tablets to your pharmacist.

JL CONTENTS OFJHE PACK AND OTHER INFORMATION What Cyclizine Hydrochloride Tablets contain

Each tablet contains 50 mg of the active ingredient, cyclizine hydrochloride. The other ingredients include: lactose, potato starch, acacia and magnesium stearate.

What Cyclizine Hydrochloride Tablets look like and the contents of the pack

-Gyclizme Hydrochloride Tablets are-white-with-a single score line and the marking “T4A” on the same side. They are available in bottles of 100 tablets.

Marketing Authorisation Holder and Manufacturer responsible for batch release:

Amdipharm UK Limited,

Capital House, 85 King William Street, London_EC4N7BL, UK

Alternative Site for batch release:

CENEXI SAS,

52 Rue Marcel et Jacques Gaucher, 94120 Fontenay sous Bois, France

This leaflet was last revised in June 2016.

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REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc.) and that Amdipharm have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

(Please strike off whichever NOT applicable)

Signature ...................................................................

Name .........................................................................

Date ...........................................................................

--J

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AMDIPHARM

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