impaired judgement, hallucinations, muscle muscle hallucinations, judgement, impaired • suffer from high blood pressure blood high from suffer •

coordination, weakness, excitability, disorientation, excitability, weakness, coordination,

of the medulla of the adrenal glands) adrenal the of medulla the of

drowsiness, dizziness, lack of balance and and balance of lack dizziness, drowsiness, • suffer from phaeochromocytoma (tumour phaeochromocytoma from suffer •

irregular heartbeat, difficulty passing urine, urine, passing difficulty heartbeat, irregular liver problems liver • have any any have •

nose and throat, blurred vision, fast or or fast vision, blurred throat, and nose • have an obstructive bowel condition bowel obstructive an have •

Symptoms of overdose include dry mouth, mouth, dry include overdose of Symptoms difficulty passing urine) passing difficulty

Tablets than you should should you than Tablets • suffer from urinary retention (experience retention urinary from suffer •

If you take more Cyclizine Hydrochloride Hydrochloride Cyclizine more take you If rise of pressure within the eye (glaucoma) eye the within pressure of rise

• suffer from an eye disease caused by a by caused disease eye an from suffer • water.

Tablets if you: if Tablets medicine The tablets should be swallowed with a little little a with swallowed be should tablets The

before taking Cyclizine Hydrochloride Hydrochloride Cyclizine taking before the same spot each time you take the the take you time each spot same the

age of 6. of age

Talk to your doctor, pharmacist or nurse nurse or pharmacist doctor, your to Talk

• a red or brownish patch which appears at at appears which patch brownish or red a •

This leaflet was last revised in June 2018. June in revised last was leaflet This

Do not give this medicine to children under the the under children to medicine this give not Do

Warnings and precautions and Warnings your eyes (jaundice) eyes your

Children under 6 years 6 under Children

Fontenay sous Bois, France Bois, sous Fontenay • yellowing of the skin and the whites of of whites the and skin the of yellowing •

increase the toxicity of alcohol. of toxicity the increase

52 Rue Marcel et Jacques Gaucher, 94120, 94120, Gaucher, Jacques et Marcel Rue 52 side of the tablet. the of side • pins and needles and pins •

anti-vomiting properties of cyclizine may cyclizine of properties anti-vomiting

CENEXI SAS, CENEXI into equal doses along the line scored on one one on scored line the along doses equal into • low blood pressure blood low •

• if you have been drinking alcohol. The alcohol. drinking been have you if •

Alternative Site for batch release: batch for Site Alternative three times a day. The tablet can be divided divided be can tablet The day. a times three • high blood pressure blood high •

in swallowing or breathing) or swallowing in

The recommended dose is half a tablet up to to up tablet a half is dose recommended The

• temporary difficulty in speaking in difficulty temporary •

lips, tongue and / or throat with difficulty with throat or / and tongue lips,

London EC4N 7BL, UK 7BL, EC4N London

Children from 6 to 12 years 12 to 6 from Children

• decreased consciousness decreased •

symptoms include swelling of the face, the of swelling include symptoms

Capital House, 85 King William Street, Street, William King 85 House, Capital

• feeling weak feeling •

three times daily. times three

itching and / or rash. More severe severe More rash. or / and itching

Amdipharm UK Limited, UK Amdipharm

• dizziness •

The recommended dose is one tablet up to to up tablet one is dose recommended The

reactions include mild symptoms such as such symptoms mild include reactions

Manufacturer

• being confused, disorientated or unaware or disorientated confused, being •

Children over 12 years 12 over Children

ingredients of this medicine (allergic (allergic medicine this of ingredients

Marketing Authorisation Holder and and Holder Authorisation Marketing

• seizures •

hydrochloride or any of the other other the of any or hydrochloride

Use in children and adolescents. and children in Use

• muscle twitches, spasms or tremors or spasms twitches, muscle •

100 tablets. 100 • if you are allergic to cyclizine cyclizine to allergic are you if •

three times daily. times three your hands, arms or legs or arms hands, your

the same side. They are available in bottles of of bottles in available are They side. same the Do not take Cyclizine Hydrochloride Tablets: Hydrochloride Cyclizine take not Do

The recommended dose is one tablet up to to up tablet one is dose recommended The

• unusual body movements, particularly of of particularly movements, body unusual •

a single score line and the marking “T4A” on on “T4A” marking the and line score single a TAKE CYCLIZINE HYDROCHLORIDE TABLETS HYDROCHLORIDE CYCLIZINE TAKE

Adults

• decrease in muscle tone muscle in decrease •

Cyclizine Hydrochloride Tablets are white with with white are Tablets Hydrochloride Cyclizine 2. WHAT YOU NEED TO KNOW BEFORE YOU YOU BEFORE KNOW TO NEED YOU WHAT 2.

there (hallucinations) (hallucinations) there you are not sure. not are you like and contents of the pack the of contents and like

ear problems such as Meniere’s disease. Meniere’s as such problems ear • seeing or hearing things that are not really really not are that things hearing or seeing • Check with your doctor, pharmacist or nurse if if nurse or pharmacist doctor, your with Check What Cyclizine Hydrochloride Tablets look look Tablets Hydrochloride Cyclizine What

used to treat sickness caused by some inner inner some by caused sickness treat to used • ringing in the ears the in ringing • doctor or pharmacist has told you. you. told has pharmacist or doctor

acacia and magnesium stearate. magnesium and acacia Cyclizine Hydrochloride Tablets can also be be also can Tablets Hydrochloride Cyclizine • difficulty in sleeping in difficulty • Always take this medicine exactly as your your as exactly medicine this take Always

ingredients include: lactose, potato starch, starch, potato lactose, include: ingredients can sometimes cause sickness. sickness. cause sometimes can • euphoria • TABLETS

ingredient, cyclizine hydrochloride. The other other The hydrochloride. cyclizine ingredient, have had an operation, as general anaesthetics anaesthetics general as operation, an had have • nervousness • 3. HOW TO TAKE CYCLIZINE HYDROCHLORIDE CYCLIZINE TAKE TO HOW

Each tablet contains 50 mg of the active active the of mg 50 contains tablet Each (radiography) or other medicines; or if you you if or medicines; other or (radiography) • restlessness •

doctor before taking these tablets. these taking before doctor contains nausea caused by cancer treatment treatment cancer by caused nausea • loss of appetite of loss •

intolerance to some sugars some to intolerance , talk to your your to talk , What Cyclizine Hydrochloride Tablets Tablets Hydrochloride Cyclizine What you suffer from travel or motion sickness; sickness; motion or travel from suffer you • stomach pain stomach •

If you have been told that you have have you that told been have you If INFORMATION Cyclizine Hydrochloride Tablets may be used if if used be may Tablets Hydrochloride Cyclizine • diarrhoea •

lactose. lactose. 6. CONTENTS OF THE PACK AND OTHER OTHER AND PACK THE OF CONTENTS 6. by adults and children aged 6 years and over. over. and years 6 aged children and adults by • being sick being •

Cyclizine Hydrochloride Tablets contain contain Tablets Hydrochloride Cyclizine Cyclizine Hydrochloride Tablets may be used used be may Tablets Hydrochloride Cyclizine • feeling sick feeling •

protect the environment. environment. the protect

• heartburn (reflux) heartburn •

drive or operate any machinery. any operate or drive (nausea) or being sick (vomiting). (vomiting). sick being or (nausea)

no no longer use. These measures will help help will measures These use. longer

• constipation •

do not do way, this in you affect they If dizzy. which can be used to help stop you feeling sick sick feeling you stop help to used be can which

pharmacist how to throw away medicines you you medicines away throw to how pharmacist

• difficulty in passing water passing in difficulty •

Hydrochloride Tablets may make you feel feel you make may Tablets Hydrochloride to a group of medicines called antihistamines antihistamines called medicines of group a to

wastewater or household waste. Ask your your Ask waste. household or wastewater

• irregular heartbeat irregular •

you know how the tablets affect you. Cyclizine Cyclizine you. affect tablets the how know you substance cyclizine hydrochloride, which belongs belongs which hydrochloride, cyclizine substance

Do not throw away any medicines via via medicines any away throw not Do

• fast heartbeat fast • Hydrochloride Tablets but do not drive until until drive not do but Tablets Hydrochloride

Cyclizine Hydrochloride Tablets contain the active active the contain Tablets Hydrochloride Cyclizine

Store this medicine in a safe place below 25°C. below place safe a in medicine this Store

• involuntary rolling of the eyes the of rolling involuntary • You can drive while taking Cyclizine Cyclizine taking while drive can You

USED FOR USED

that month. that

• blurred vision blurred • Driving and using machines using and Driving

TABLETS ARE AND WHAT THEY ARE THEY WHAT AND ARE TABLETS

EXP. The expiry date refers to the last day of of day last the to refers date expiry The EXP.

• a dry mouth, nose or throat or nose mouth, dry a •

1. WHAT CYCLIZINE HYDROCHLORIDE HYDROCHLORIDE CYCLIZINE WHAT 1.

taking this medicine. medicine. this taking

which is stated on the carton and label after after label and carton the on stated is which • headache •

ask your doctor or pharmacist for advice before before advice for pharmacist or doctor your ask

Do not use this medicine after the expiry date date expiry the after medicine this use not Do Contents of the pack and other information other and pack the of Contents 6. • lack of coordination of lack •

may be pregnant or are planning to have a baby, baby, a have to planning are or pregnant be may

of children. of 5. How to store Cyclizine Hydrochloride Tablets Hydrochloride Cyclizine store to How • drowsiness •

If you are pregnant or breast-feeding, think you you think breast-feeding, or pregnant are you If

Keep this medicine out of the sight and reach reach and sight the of out medicine this Keep 4. Possible side effects side Possible 4. • skin rashes or itching or rashes skin •

Pregnancy and breast-feeding and Pregnancy

3. How to take Cyclizine Hydrochloride Tablets Hydrochloride Cyclizine take to How estimated from the available data): available the from estimated

TABLETS

taking Cyclizine Hydrochloride Tablets. Hydrochloride Cyclizine taking

Cyclizine Hydrochloride Tablets Hydrochloride Cyclizine not known frequency (frequency cannot be be cannot (frequency frequency known not

5. 5. HOW TO STORE CYCLIZINE HYDROCHLORIDE CYCLIZINE STORE TO HOW

Alcohol should be avoided when you are you when avoided be should 2. What you need to know before you take you before know to need you What 2. The following side effects are reported with a a with reported are effects side following The

and drink and medicine. and what they are used for used are they what and

allergic reaction. allergic

Cyclizine Hydrochloride Tablets with food with Tablets Hydrochloride Cyclizine more information on the safety of this this of safety the on information more 1. What Cyclizine Hydrochloride Tablets are Tablets Hydrochloride Cyclizine What 1.

immediately. These may be signs of an of signs be may These immediately.

By reporting side effects, you can help provide provide help can you effects, side reporting By What is in this leaflet this in is What

medicines called anticholinergics. called medicines stop taking this medicine and tell your doctor doctor your tell and medicine this taking stop

App Store. App

• any medicine which belong to a group of group a to belong which medicine any •

• difficulty in breathing or wheeziness or breathing in difficulty • for ease hereafter. ease for

MHRA Yellow Card in the Google Play or Apple Apple or Play Google the in Card Yellow MHRA

painkillers such as pethidine as such strong •

• swelling of the face, lips or throat or lips face, the of swelling • referred to as Cyclizine Hydrochloride Tablets Tablets Hydrochloride Cyclizine as to referred

www.mhra.gov.uk/yellowcard or search for for search or www.mhra.gov.uk/yellowcard

sleeping

• itching or skin rashes skin or itching • Hydrochloride 50 mg Tablets. It will be be will It Tablets. mg 50 Hydrochloride

Yellow Card Scheme, website: website: Scheme, Card Yellow

depression , anxiety or difficulty in difficulty or anxiety ,

If you notice: you If The name of your medicine is Cyclizine Cyclizine is medicine your of name The

You can also report side effects directly via the the via directly effects side report also can You • medicines for problems such as such problems for medicines •

leaflet. See section 4. section See leaflet.

possible side effects not listed in this leaflet. leaflet. this in listed not effects side possible other medicines especially the following: the especially medicines other them.

any possible side effects not listed in this in listed not effects side possible any

pharmacist or nurse. This includes any any includes This nurse. or pharmacist taking, have recently taken or might take any any take might or taken recently have taking, side effects, although not everybody gets gets everybody not although effects, side

doctor, pharmacist or nurse. This includes This nurse. or pharmacist doctor,

If you get any side effects, talk to your doctor, doctor, your to talk effects, side any get you If Tell your doctor or pharmacist if you are are you if pharmacist or doctor your Tell

Like all medicines, this medicine can cause cause can medicine this medicines, all Like

• If you get any side effects, talk to your to talk effects, side any get you If •

Reporting of side effects side of Reporting Tablets Tablets

4. POSSIBLE SIDE EFFECTS SIDE POSSIBLE 4. are the same as yours. as same the are

Other medicines and Cyclizine Hydrochloride Hydrochloride Cyclizine and medicines Other

harm them, even if their signs of illness of signs their if even them, harm immediately.

make up for a forgotten tablet. forgotten a for up make

(porphyria). only. Do not pass it on to others. It may It others. to on it pass not Do only. tell your doctor or pharmacist pharmacist or doctor your tell leaflet please please leaflet

at the usual time, DO NOT take a double dose to to dose double a take NOT DO time, usual the at

can lead to a sensitivity to sunlight to sensitivity a to lead can • This medicine has been prescribed for you for prescribed been has medicine This • you notice any side effects not listed in this this in listed not effects side any notice you

If you forget to take a dose, just take the next dose dose next the take just dose, a take to forget you If

• suffer from an inherited disorder which disorder inherited an from suffer • doctor, pharmacist or nurse. or pharmacist doctor,

If any of the side effects becomes severe or or severe becomes effects side the of any If

Tablets

properly (heart failure) (heart properly • If you have any further questions, ask your your ask questions, further any have you If •

If you forget to take Cyclizine Hydrochloride Hydrochloride Cyclizine take to forget you If result of these symptoms. symptoms. these of result

• have been told your heart is not working not is heart your told been have • again.

conduct tests on your blood periodically as a a as periodically blood your on tests conduct

with you to show the doctor what you have taken. have you what doctor the show to you with

passing urine) passing • Keep this leaflet. You may need to read it read to need may You leaflet. this Keep •

your doctor. Your doctor may decide to to decide may doctor Your doctor. your

Remember to take this leaflet and/or the package package the and/or leaflet this take to Remember

prostate gland (difficulty or slowness or (difficulty gland prostate contains important information for you. for information important contains

colds and sore throats) than usual please tell tell please usual than throats) sore and colds

immediately. hospital emergency department department emergency hospital

• are a man and you suffer from an enlarged an from suffer you and man a are • start taking this medicine because it it because medicine this taking start

bruising or bleeding or more infections (e.g. (e.g. infections more or bleeding or bruising

than you should, contact your doctor or nearest nearest or doctor your contact should, you than

epilepsy • have have • Read all of this leaflet carefully before you you before carefully leaflet this of all Read

If you feel very tired, experience unexpected unexpected experience tired, very feel you If If you take more Cyclizine Hydrochloride Tablets Tablets Hydrochloride Cyclizine more take you If

high temperature and difficulty breathing. breathing. difficulty and temperature high likely (agranulocytosis). (agranulocytosis). likely Cyclizine Hydrochloride Cyclizine

spasm, involuntary movements, convulsions, convulsions, movements, involuntary spasm, white blood cell making infection more more infection making cell blood white

Cyclizine Hydrochloride 50 mg Tablets mg 50 Hydrochloride Cyclizine

• reduction in the production of a type of of type a of production the in reduction •

• reduced rate of breathing (apnoea) breathing of rate reduced •

problems with the liver the with problems

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

LF-105085-01

(photosensitivity)

Package leaflet: Information for the patient patient the for Information leaflet: Package • an increased sensitivity to sunlight sunlight to sensitivity increased an •

28053233 125 mm 15 mm 35 mm

• an increased sensitivity to sunlight (photosensitivity) • inflammation of the liver (hepatitis) or problems with the liver • reduced rate of breathing (apnoea) • reduction in the production of a type of spasm, involuntary movements, convulsions, white blood cell making infection more high temperature and difficulty breathing. likely (agranulocytosis). If you take more Cyclizine Hydrochloride Tablets If you feel very tired, experience unexpected Read all of this leaflet carefully before you • have epilepsy than you should, contact your doctor or nearest bruising or bleeding or more infections (e.g. start taking this medicine because it • are a man and you suffer from an enlarged hospital emergency department immediately. colds and sore throats) than usual please tell contains important information for you. prostate gland (difficulty or slowness Remember to take this leaflet and/or the package your doctor. Your doctor may decide to • Keep this leaflet. You may need to read it passing urine) with you to show the doctor what you have taken. conduct tests on your blood periodically as a again. • have been told your heart is not working result of these symptoms. • If you have any further questions, ask your properly (heart failure) If you forget to take Cyclizine Hydrochloride doctor, pharmacist or nurse. • suffer from an inherited disorder which Tablets If any of the side effects becomes severe or • This medicine has been prescribed for you can lead to a sensitivity to sunlight If you forget to take a dose, just take the next dose you notice any side effects not listed in this only. Do not pass it on to others. It may (porphyria). at the usual time, DO NOT take a double dose to leaflet please tell your doctor or pharmacist make up for a forgotten tablet. immediately. harm them, even if their signs of illness Other medicines and Cyclizine Hydrochloride are the same as yours. Tablets 4. POSSIBLE SIDE EFFECTS Reporting of side effects • If you get any side effects, talk to your Tell your doctor or pharmacist if you are Like all medicines, this medicine can cause If you get any side effects, talk to your doctor, doctor, pharmacist or nurse. This includes taking, have recently taken or might take any side effects, although not everybody gets pharmacist or nurse. This includes any any possible side effects not listed in this other medicines especially the following: them. possible side effects not listed in this leaflet. leaflet. See section 4. • medicines for problems such as You can also report side effects directly via the The name of your medicine is Cyclizine If you notice: depression, anxiety or difficulty in Yellow Card Scheme, website: Hydrochloride 50 mg Tablets. It will be • itching or skin rashes sleeping www.mhra.gov.uk/yellowcard or search for referred to as Cyclizine Hydrochloride Tablets • swelling of the face, lips or throat • strong painkillers such as pethidine MHRA Yellow Card in the Google Play or Apple for ease hereafter. • difficulty in breathing or wheeziness • any medicine which belong to a group of App Store. stop taking this medicine and tell your doctor What is in this leaflet medicines called anticholinergics. By reporting side effects, you can help provide immediately. These may be signs of an 1. What Cyclizine Hydrochloride Tablets are more information on the safety of this Cyclizine Hydrochloride Tablets with food allergic reaction. and what they are used for and drink medicine. 2. What you need to know before you take Alcohol should be avoided when you are The following side effects are reported with a Cyclizine Hydrochloride Tablets taking Cyclizine Hydrochloride Tablets. not known frequency (frequency cannot be 5. HOW TO STORE CYCLIZINE HYDROCHLORIDE 3. How to take Cyclizine Hydrochloride Tablets estimated from the available data): TABLETS Pregnancy and breast-feeding 4. Possible side effects • skin rashes or itching Keep this medicine out of the sight and reach If you are pregnant or breast-feeding, think you 5. How to store Cyclizine Hydrochloride Tablets • drowsiness of children. may be pregnant or are planning to have a baby, 6. Contents of the pack and other information • lack of coordination Do not use this medicine after the expiry date ask your doctor or pharmacist for advice before • headache which is stated on the carton and label after taking this medicine. 1. WHAT CYCLIZINE HYDROCHLORIDE • a dry mouth, nose or throat EXP. The expiry date refers to the last day of TABLETS ARE AND WHAT THEY ARE Driving and using machines • blurred vision that month. USED FOR You can drive while taking Cyclizine • involuntary rolling of the eyes Store this medicine in a safe place below 25°C. Cyclizine Hydrochloride Tablets contain the active Hydrochloride Tablets but do not drive until • fast heartbeat Do not throw away any medicines via substance cyclizine hydrochloride, which belongs you know how the tablets affect you. Cyclizine • irregular heartbeat to a group of medicines called antihistamines wastewater or household waste. Ask your Hydrochloride Tablets may make you feel • difficulty in passing water pharmacist how to throw away medicines you which can be used to help stop you feeling sick dizzy. If they affect you in this way, do not • constipation (nausea) or being sick (vomiting). no longer use. These measures will help drive or operate any machinery. • heartburn (reflux) protect the environment. Cyclizine Hydrochloride Tablets may be used Cyclizine Hydrochloride Tablets contain • feeling sick by adults and children aged 6 years and over. lactose. • being sick 6. CONTENTS OF THE PACK AND OTHER Cyclizine Hydrochloride Tablets may be used if If you have been told that you have • diarrhoea INFORMATION you suffer from travel or motion sickness; intolerance to some sugars, talk to your • stomach pain What Cyclizine Hydrochloride Tablets nausea caused by cancer treatment doctor before taking these tablets. • loss of appetite contains (radiography) or other medicines; or if you • restlessness Each tablet contains 50 mg of the active have had an operation, as general anaesthetics 3. HOW TO TAKE CYCLIZINE HYDROCHLORIDE • nervousness ingredient, cyclizine hydrochloride. The other can sometimes cause sickness. TABLETS • euphoria ingredients include: lactose, potato starch, Cyclizine Hydrochloride Tablets can also be Always take this medicine exactly as your • difficulty in sleeping acacia and magnesium stearate. used to treat sickness caused by some inner doctor or pharmacist has told you. • ringing in the ears ear problems such as Meniere’s disease. Check with your doctor, pharmacist or nurse if • seeing or hearing things that are not really What Cyclizine Hydrochloride Tablets look you are not sure. there (hallucinations) like and contents of the pack 2. WHAT YOU NEED TO KNOW BEFORE YOU Cyclizine Hydrochloride Tablets are white with Adults • decrease in muscle tone TAKE CYCLIZINE HYDROCHLORIDE TABLETS a single score line and the marking “T4A” on The recommended dose is one tablet up to • unusual body movements, particularly of Do not take Cyclizine Hydrochloride Tablets: the same side. They are available in bottles of three times daily. your hands, arms or legs • if you are allergic to cyclizine • muscle twitches, spasms or tremors 100 tablets. hydrochloride or any of the other Use in children and adolescents. • seizures Marketing Authorisation Holder and ingredients of this medicine (allergic Children over 12 years • being confused, disorientated or unaware Manufacturer reactions include mild symptoms such as The recommended dose is one tablet up to • dizziness Amdipharm UK Limited, itching and / or rash. More severe three times daily. • feeling weak Capital House, 85 King William Street, symptoms include swelling of the face, • decreased consciousness Children from 6 to 12 years London EC4N 7BL, UK lips, tongue and / or throat with difficulty • temporary difficulty in speaking in swallowing or breathing) The recommended dose is half a tablet up to three times a day. The tablet can be divided • high blood pressure Alternative Site for batch release: • if you have been drinking alcohol. The • low blood pressure anti-vomiting properties of cyclizine may into equal doses along the line scored on one CENEXI SAS, side of the tablet. • pins and needles 52 Rue Marcel et Jacques Gaucher, 94120, increase the toxicity of alcohol. • yellowing of the skin and the whites of Children under 6 years Fontenay sous Bois, France your eyes (jaundice) Warnings and precautions Do not give this medicine to children under the • a red or brownish patch which appears at This leaflet was last revised in June 2018. Talk to your doctor, pharmacist or nurse age of 6. before taking Cyclizine Hydrochloride the same spot each time you take the Tablets if you: The tablets should be swallowed with a little medicine • suffer from an eye disease caused by a water. rise of pressure within the eye (glaucoma) If you take more Cyclizine Hydrochloride • suffer from urinary retention (experience Tablets than you should difficulty passing urine) Symptoms of overdose include dry mouth, • have an obstructive bowel condition nose and throat, blurred vision, fast or • have any liver problems irregular heartbeat, difficulty passing urine, • suffer from phaeochromocytoma (tumour drowsiness, dizziness, lack of balance and of the medulla of the adrenal glands) coordination, weakness, excitability, disorientation, • suffer from high blood pressure impaired judgement, hallucinations, muscle