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Chlorpromazine Tablets Bp 25mg

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Patient Information Leaflet CHLROPROMAZINE tablets BP

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What are Chlorpromazine tablets?

Chlorpromazine tablets contain the active ingredient chlorpromazine hydrochloride, which belongs to a group of medicines known as antipsychotics.

The tablets are white, shiny, biconvex and sugar-coated. They contain 25mg chlorpromazine hydrochloride and the inactive ingredients lactose, sucrose, maize starch, potato starch, magnesium stearate stearic acid, talc, gelatin and titanium dioxide.

The tablets come in packs of 100, 250, 500 and 1000.

The product Licence/Authorisation holder is Strides Pharma Limited, Themistokli, Dervi 3, Julia House, CY-1066 Nicosia, Cyprus.

The manufacturer is Sussex Pharmaceuticals Ltd, Charlwoods Road, East Grinstead, West Sussex, RH19 2HL.

What is Chlorpromazine used for?

Chlorpromazine is used the following conditions:

•    Psychotic conditions (especially paranoid) including schizophrenia, mania and hypomania.

•    Used to control severely disturbed, agitated or violent behaviour.

•    As an adjunct for the short-term treatment of severe anxiety.

•    Used to control nausea and vomiting and is useful in terminal care.

•    In the alleviation of intractable hiccup.

•    Induction of hypothermia to prevent shivering and cause vasodilation.

When must Chlorpromazine not be used?

•    If you are allergic to the group of medicines known as antipsychotics.

•    If you are allergic to any of the ingredients in the tablet.

•    If you are affected with coma.

•    If you are in the influence of alcohol or other central nervous system depressants.

•    If you suffer from bone-marrow depression.

When should you be extra careful while talking Chlorpromazine?

Make sure your doctor knows if you:

•    Or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

•    Have a liver or kidney condition.

•    Have had a cardiac failure.

•    Suffer from epilepsy, Parkinson’s disease or have a thyroid condition.

•    Are pregnant or breast-feeding.

•    Are taking any other medicines, including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. For example chlorpromazine may oppose the action of some drugs including amphetamine, levodopa, adrenaline, clonidine and guanethidine. Also the effect of blood pressure reducing agents may be exaggerated.

IMPORTANT

Chlorpromazine may affect your ability to drive or operate machinery. If affected you should not drive or operate machinery. This may be made worse if you take alcoholic drinks. Because of this it is best that you do not drink alcohol for as long as you are using this medicine.

May Chlorpromazine be taken during pregnancy or while breast feeding?

You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Chlorpromazine tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

How should Chlorpromazine be taken?

• Always take the tablets as your doctor tells you to. He/she will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.

The dosage should be low to begin with and increase gradually under close supervision until the optimum level of control is achieved.

Dosage in Schizophrenia, other Psychoses, Anxiety and Agitation:

Adults: Initially 1 tablet three times daily or 3 tablets at bedtime, increasing by daily amount of 1 tablet to the effective maintenance dose. The usual maintenance dose is in the range of 3 to 12 tablets daily, although some patients may require up to 40 tablets daily.

Children & the elderly: As directed by the doctor.

Dosage in Hiccup:

Adults: 1 to 2 tablets three to four times daily.

Children & the elderly: As directed by the doctor.

Dosage in nausea and vomiting of terminal illness:

Adults: 1/2 to 1 tablet every 4 to 6 hours.

Children & the elderly: As directed by the doctor.

•    If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when it is due.

•    Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.

•    If you take too many tablets or someone else accidently takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

What are the possible unwanted effects of Chlorpromazine?

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately

In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

As with other medicines, some unwanted effects can occur rarely.

These may include:

Nasal stuffiness, dry mouth, insomnia, agitation, cardiovascular hypotension, blood disorder, respiratory depression, skin rashes and vision changes.

If you are concerned about these or any other unwanted effects, talk to your doctor.

How should Chlorpromazine be stored?

•    The tablets should be stored in a dry place below 25°C.

•    Keep this medicine out of the reach and sight of children.

•    This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

•    REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Further information

You can get further information from your doctor or pharmacist.

Date of Preparation

October 2012