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Chlorpromazine 50mg Tablets

Document: leaflet MAH GENERIC_PL 08553-0075 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorpromazine 25mg, 50mg, 100mg Tablets

Read all of this leaflet carefully before you start taking this medicine:

-    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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

In this leaflet

1.    What Chlorpromazine Tablets are and what they are used for

2.    Before you take Chlorpromazine Tablets

3.    How to take Chlorpromazine Tablets

4.    Possible side effects

5.    How to store

6.    Further information

1. What Chlorpromazine Tablets are and what they are used for

Chlorpromazine tablets belong to a group of drugs known as phenothiazines, which act on the central nervous system. They are used to treat the following conditions: schizophrenia and other psychosesparticularly paranoia (delusions and feelings of persecution), mania (overactive behaviour and hypomania (elated moods and excitability), anxiety, agitation and violent or dangerously impulsive behaviour.

Chlorpromazine is also used for prolonged periods of hiccups, nausea and vomiting (when other drugs have failed), to lower body temperature and for childhood schizophrenia and autism (learning and communication difficulties).

2. Before you take Chlorpromazine Tablets

Do not take Chlorpromazine Tablets if you:

are pregnant, likely to be pregnant or breast-feeding.


• have had any unusual or allergic reactions to

Chlorpromazine, other phenothiazines or to any of the other ingredients in the tablets (see Section 6).

Check with your doctor before taking Chlorpromazine Tablets if you:

have phaeochromocytoma (high blood pressure

due to a tumour near the kidney)

have glaucoma (raised eyeball pressure)

have diabetes and are taking drugs to reduce

blood sugar (as Chlorpromazine Tablets may reduce

their effect)

have enlargement of the prostate.


•    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 liver or kidney disease

•    have epilepsy

•    have Parkinson’s disease

•    have hypothyroidism (reduced activity of the thyroid gland)

•    have heart disease such as heart failure

•    have myasthenia gravis (a condition where muscles become easily tired and weak leading to difficulty breathing)

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained

without a prescription, (which may alter the effects of Chlorpromazine Tablets) especially:

guanethidine (for lowering blood pressure) clonidine (for migraine and to lower blood pressure) lithium, sulpiride, haloperidol or thioridazine (drugs to treat psychiatric disorders)


•    sedatives such as phenobarbitone

•    drugs to reduce blood pressure such as propranolol or atenolol

•    anticholinergic drugs such as atropine and hyoscinehydrobromide (used in motion-sickness and pre-medication).

•    central nervous system stimulants such as adrenaline or amphetamines

•    anti-Parkinson’s drugs such as levadopa, carbidopa (as these may interfere with the absorption of Chlorpromazine Tablets)

Alcohol

Alcohol must not be used with Chlorpromazine.

Pregnancy and breast-feeding

Chlorpromazine Tablets should not be used in pregnancy or while breast-feeding, unless your doctor considers it absolutely necessary.

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.

Driving and using machines

This medicine may cause some people, especially elderly patients, to become drowsy, dizzy, light-headed, clumsy, unsteady or less alert than normal. If you are affected, do not drive or operate dangerous machinery.

Sugar intolerance

If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking these tablets, as they contain a type of sugar called lactose.

3. How to take Chlorpromazine Tablets

You will be prescribed the lowest dose needed to control your symptoms. You should check with your doctor or pharmacist if you are unsure. Do not stop taking your medicine or change the dose unless your doctor tells you to.

The tablets should be swallowed with a glass of water.

Dose for nausea and vomiting Adults: 10mg-25mg every 4-6 hours.

Dose for schizophrenia, other psychoses, anxiety and agitation

Adults: Start with 25mg three times a day or 75mg at bedtime.

This may be increased by 25mg a day to an effective dose. This is usually 75mg - 300mg daily, but some patients need up to 1000mg (1g) daily. Elderly weak or infirm patients: Start with 1/3—1/2 usual adult dose with a more gradual increase in dose.

Children 6-12years 1/3-1/2 adult dose to a maximum daily dose of 75mg.

Children 15years: 0.5mg per kg body weight every 4-6 hours to a maximum daily dose of 40mg.

Children under 1 year. Not to be used unless the need is life saving.


Elderly weak or infirm patients: Start with 1/3-1/2 adult dose.

Your doctor will then increase the dose as needed. Children 6-12years: 0.5mg per kg bodyweight every 4-6 hours. Maximum daily dose 75mg.

Children 1-5years. 0.5mg per kg bodyweight every 4-6 hours. Maximum daily dose 40mg.

Children under 1 year. Not to be used unless the need is life saving.

Dose for hiccups

Adults, elderly, weak or infirm patients: 25-50mg 3-4 times a day.

Children: Not recommended in children.

If you don’t feel better

If you don’t feel the tablets are working as well after you have taken them for a short time (3-4 days), do not increase the dose; instead check with your doctor.

If you take more than you should or if you forget to take the tablets

If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets with you and the container or packaging, so they can be identified.

If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking the tablets

Withdrawal symptoms can occur after you stop treatment (see Section 4), so gradual withdrawal is advisable. Do not stop taking the tablets without talking to your doctor or pharmacist.

4. Possible side effects

Like all medicines Chlorpromazine can cause side effects. Do not be alarmed by this list of side effects. Most people take Chlorpromazine without any problems.

If any of the following happen, stop taking the tablets and contact your doctor at once:

•    jaundice (yellowing of the skin and white of the eyes )

•    skin reactions such as rashes, inflammation and flaking of skin (exfoliative dermatitis), raised red patches of skin which may blister (erythema multiforme).

Tell your doctor or pharmacist at once if you think you have any of these or problems with Chlorpromazine:

Unknown Frequency:

-    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.

-    high cholesterol levels

-    fits, feeling agitated, unable to sleep

-    nausea, dizziness, headache, oedema (water retention)

-    swelling of breasts particularly in men and breast milk production

-    a prolonged, painful erection. If this happens to you, go to your nearest hospital

-    light periods or absence of periods.


Less common side effects

-    increased pigmentation of melanin in the skin, which may develop a bluish-grey colour.

-    pigment deposits may also occur in the eye and other tissues and may affect vision.

Common side effects

-    drowsiness, sedation, reduced alertness, dry mouth, nasal stuffiness, weight gain

-    postural hypotension (fall of blood pressure when moving from lying down or sitting to a standing position), blurring of vision, rapid heart beat

-    constipation, difficulty passing urine or not being able to pass urine at all

-    increased tendency to sunburn, therefore avoid prolonged exposure to sunlight and UV light.

Rare side effects

-    impaired control of body temperature causing heat stroke in hot weather and lowering of body temperature (hypothermia) in very cold weather, lowering of blood pressure (particularly in the elderly)

-muscle rigidity, tremor (shaking), jerky body movements and inability to control movements of the hand and body, disturbances in heart rhythm, heart attack -hyperglycaemia (high levels of glucose in the blood). The symptoms of this are feeling thirsty, urinating more often and tiredness.

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.

Withdrawal effects: If this medicine is stopped suddenly nausea, vomiting and difficulty sleeping (insomnia), tremor (shaking), jerky body movements and the inability to control movements of the hands and body can occur.

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. How to store

Do not store above 25°C. Store in a dry place, protect from light. Keep the container tightly closed. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. Return any unused tablets to your pharmacist for safe disposal.

6.Further information

The active ingredient (which makes the tablets work) is chlorpromazine hydrochloride. The tablets also contain lactose, maize starch, povidone, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, hypromellose, purified water, ethylcellulose, diethylphthalate and titanium dioxide (E171). The tablets are round, white, and film coated.

The 25mg tablets are marked with CPZ25. The 50mg tablets are marked with CPZ50. The 100mg tablets are marked with CPZ100.

Chlorpromazine 25mg Tablets PL08553/0074 Chlorpromazine 50mg Tablets PL08553/0075 Chlorpromazine 100mg tablets PL08553/0076


Marketing authorisation holder and manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK. Leaflet revised September 2015 © Dr. Reddy’s Laboratories (UK) Ltd CZ01234P