Patient leaflet - Cyclizine Hydrochloride 50 mg tablets

1. What cyclizine hydrochloride tablets are and what they are used for

The name of your medicine is cyclizine hydrochloride tablets. Cyclizine hydrochloride 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).

Cyclizine hydrochloride tablets may be used by adults and
children aged 6 years and over.
Cyclizine hydrochloride tablets may be used if you suffer from
travel or motion sickness; nausea caused by cancer treatment (radiotherapy) 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 ear problems such as Meniere’s disease.

2. What you need to know before you take cyclizine hydrochloride tablets

Do not take cyclizine hydrochloride tablets if you:

are allergic to hydrochloride or any of the other ingredients of
this medicine (listed in section 6). Allergic reactions which 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.
have been drinking alcohol. The anti-vomiting properties of
cyclizine may increase the toxicity of alcohol.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being treated with 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 from an inherited disorder which can lead to a
sensitivity to sunlight (porphyria)

Other medicines and cyclizine hydrochloride tablets

Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines including those you have obtained without a prescription especially the following:

medicines for problems such as depression, anxiety or
difficulty in sleeping
strong painkillers such as pethidine
any medicine which belongs to a group of medicines called
anticholinergics.

Cyclizine hydrochloride tablets with food, drink and alcohol Alcohol should be avoided when you are being treated with cyclizine hydrochloride tablets.

Pregnancy, breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Driving and using machines

You can drive while being treated with cyclizine hydrochloride tablets but do not drive until you know how it affects you. lt may make you feel dizzy. If it affects you in this way, do not drive or operate any machinery.

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 this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor, pharmacist or nurse 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. The tablet can be divided

into equal doses along the line scored on one side of the tablet.

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.

If you take more cyclizine hydrochloride 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 and difficulty 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 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 tablet.

4. Possible side effects

Like all medicines, this medicine 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 this medicine and tell your doctor immediately. These may be signs of an allergic reaction.

The following side effects are reported with a not known frequency (frequency cannot be estimated from the available data):

skin rashes or itching
drowsiness
lack of coordination
headache
a dry mouth, nose or throat
blurred vision
involuntary rolling of the eyes
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)

Package leaﬂet: information for the patient

Cyclizine hydrochloride 50mg tablets

Cyclizine hydrochloride

Cyclizine hydrochloride 50

mg ta

blets

uk-mockup.pdf Pg. 2

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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 red or brownish patch which appears at the same spot each time you take the medicine
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 white blood cell making infection more likely (agranulocytosis).
unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome).

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

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 Yellow Card Scheme, at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. 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 carton and label after EXP. The expiry date refers to the last day of that month.

Cyclizine hydrochloride tablets should be stored in a safe place below 25°C.

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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What cyclizine hydrochloride tablets contains:

Cyclizine hydrochloride tablets contains 50 mg of the active ingredient, cyclizine hydrochloride.
The tablet also contains the inactive ingredients lactose monohydrate, sodium starch glycolate, povidone –K30, silica colloidal anhydrous and magnesium stearate.

What cyclizine hydrochloride tablets looks like and contents of the pack:

Cyclizine hydrochloride tablets are white to off white round tablets with breakline on one side and plain on other side.
The tablet dimension is 7.10mm round tablet.
The tablets are supplied in a HDPE bottle with a child resistant closure, containing 100 tablets.

Not all packs sizes may be marketed.

Marketing Authorisation Holder

Somex Pharma

Ilford, Essex,

IG3 8BS. UK.

Manufacturer