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Document: leaflet MAH GENERIC_PL 36390-0172 change

• leaflet MAH GENERIC_PL 20072-0241
• leaflet MAH GENERIC_PL 25298-0046
• leaflet MAH GENERIC_PL 36390-0172
• leaflet TEVA UK_PL 25298-0046

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Package leaflet: Information for the patient Cyclizine hydrochloride 50 mg tablets

Cyclizine hydrochloride

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, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 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 ear problems such as Meniere's disease.

Do not take Cyclizine hydrochloride tablets

•    If you are allergic to cyclizine or any 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.

Warnings and precautions:

Take special care with this medicine and tell your doctor or pharmacist if you:

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

•    have an obstructive bowel condition;

•    have any liver problems;

•    have fits (epilepsy);

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

Children and adolescents (below 6 years)

Do not give this medicine to children age below 6 years.

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 taken without

prescription.

Tell your doctor or pharmacist if you are taking especially 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 with food and alcohol

Alcohol should be avoided when you are taking Cyclizine 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 can drive while taking Cyclizine 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.

Cyclizine hydrochloride tablets contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. How to take Cyclizine hydrochloride tablets

Always take this medicine exactly as your doctor has told you.

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 dally.

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.

If you take more Cyclizine hydrochloride tablets than you should

If you accidentally take too many Cyclizine hydrochloride tablets than you have been told to take, tell your doctor at once or 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.

Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.

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

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;

•    headache;

•    a dry mouth, nose or throat;

•    blurred vision;

•    fast heartbeat;

•    difficulty in passing urine;

Pantone Black C