CHLORACTIL, CHLORPROMAZINE TABLETS BP 25 MG - patient leaflet, side effects, dosage

CHLORACTIL

CHLORPROMAZINE 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 or pharmacist.

• - 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.

WHAT IS IN THIS LEAFLET

1. What Chloractil is and what it is used for

2. What you need to know before you take Chloractil

3. How to take Chloractil

4. Possible side effects

5. How to store Chloractil

6. Contents of the pack and other information

1. what chloractil is and what it is used for

The name of your medicine is Chloractil. It contains the active ingredient chlorpromazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking the effect of a chemical in the brain.

Chloractil can be used to treat:

• Schizophrenia in adults and children
• short term treatment of anxiety
• feeling or being sick, (where other anti-sickness medicines have not worked) when you have a terminal illness
• hiccups
• autism
• or to calm your emotions particularly if you feel anxious, agitated, over-excited, violent or dangerously impulsive.

If you are not sure why you have been prescribed this medicine then please ask your doctor. You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before. take chloractil

Do not take Chloractil and tell your doctor if you:

• are allergic to chlorpromazine, other phenothiazines (such as prochlorperazine or trifluoperazine) or any other ingredient in Chloractil tablets (listed in section 6). The signs of an allergic reaction can include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• have a low number of blood cells (bone marrow depression).
• have increased pressure in the eye (glaucoma).
• are taking a dopaminergic antiparkinsonism drug.
• are breast-feeding.
• are taking citalopram or escitalopram.
• have a history of a low white blood cell count.
• have urine retention due to a prostate disorder.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Chloractil.

Warnings and precautions

Talk to your doctor or pharmacist before taking Chloractil Tablets 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 liver or kidney disease
• have epilepsy or have had fits (seizures)
• have Parkinson’s disease
• have hypothyroidism (reduced activity of the thyroid gland)
• have heart disease such as heart failure
• have ever had a stroke
• have myasthenia gravis (a condition where muscles become easily tired and weak leading to difficulty breathing)
• have phaeochromocytoma (high blood pressure due to a tumour near the kidney)
• have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these
• have diabetes and are taking drugs to reduce blood sugar (as Chloractil Tablets may reduce their effect)
• have enlargement of the prostate
• have depression
• have ever had alcohol problems
• have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than normal
• are elderly (65 years of age or older)
• are not eating properly
• are allergic to other phenothiazine medicines such as prochlorperazine
• have low blood pressure or feel dizzy when you stand up
• if you or members of your family have heart problems (including heart failure, heart attack or uneven heart beats) your doctor may do some tests on your heart and blood before giving you this medicine
• if you have low blood levels of potassium, calcium and magnesium. Your doctor may also want to give you regular blood tests in the first few months of your treatment
• do not go into direct sunlight if you are taking high doses of this medicine. This is because you may become more sensitive to strong sunlight while taking this medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Chloractil.

Other medicines and Chloractil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription. This is because Chloractil can affect the way some other medicines work. Also some medicines can affect the way Chloractil works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• Medicines for indigestion and heartburn (antacids)
• Medicines for diabetes
• Medicines for high blood pressure or prostate problems such as doxazosin and terazosin
• Medicines for Parkinson’s disease such as levodopa
• Medicines for fits (epilepsy) such as carbamazepine or phenobarbital
• Medicines to control your heartbeat such as amiodarone, disopyramide or quinidine
• Medicines to help you sleep (sedatives)
• Medicines for depression
• Other medicines used to calm emotional and mental problems such as olanzapine or prochlorperazine
• Some medicines used for high blood pressure such as guanethidine, clonidine or propranolol
• Some medicines used for infections (antibiotics) such as moxifloxacin
• Some medicines used for cancer (cytotoxics)
• Medicines which can alter electrolytes (salt levels) in your blood
• Amphetamines – used for Attention Deficit Hyperactivity Disorder (ADHD)
• Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence
• Adrenaline – used for life threatening allergic reactions
• Deferoxamine – used when you have too much iron in your blood
• Lithium – used for some types of mental illness
• Medicines that may interact in the metabolism of chlorpromazine, examples include ciprofloxacin, oral contraceptives.

Chloractil with food, drink and alcohol

You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and drinking alcohol will make you even more drowsy. Drinking alcohol may also cause serious breathing problems.

Pregnancy, breast-feeding and fertility

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 taking this medicine. You should not use this medicine if you are pregnant or breast-feeding unless your doctor feels it is absolutely necessary.

The following symptoms may occur in newborn babies, of mothers that have used Chloractil 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.

Do not breast-feed if you are being given Chloractil. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed talk to your doctor or nurse before taking this medicine.

Chloractil may make it more difficult for a woman to get pregnant due to it reducing her fertility.

Driving and using machines

Do not drive or use tools or machines if this medicine makes you drowsy or if it has affected your eyesight.

Chloractil contains lactose and sodium

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per 10 mg, 25 mg, 50 mg and 100 mg tablets, that is to say essentially ‚sodium-free‘.

3. how to take chloractil

Always take Chloractil tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take this medicine by mouth.

The recommended dose is:

Adults

• The recommended dose for adults is 40 mg to 300 mg daily in divided doses
• The dose prescribed and how often you should take the doses will depend upon the condition being treated and on your response. You will start treatment on a low dose which will be increased as necessary by your doctor
• Elderly, weak or feeble patients will need to take one third or half the recommended adult dose. Your doctor will gradually increase this dose.

Children

• Children under 1 year should not take this medicine
• Children aged 1 to 5 years: the maximum dose should be no more than 40 mg a day. You must split this dose over the day
• Children aged 6 to 12 years: the maximum dose should be no more than 75 mg a day. You must split this dose over the day.

Your doctor will work out the dose for your child according to their age and weight.

If you take more Chloractil than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. Signs of an overdose may include drowsiness, low body temperature, low blood pressure, twisting of your limbs, stiffness, shaking, unusual heart beats and coma.

If you forget to take Chloractil

Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Skip the missed dose then go on as before.

If you stop taking Chloractil

Keep taking Chloractil until your doctor tells you to stop. The doctor will lower your dose gradually. If you stop taking the medicine suddenly you may get withdrawal symptoms. Signs include:

• feeling or being sick and difficulty sleeping (insomnia) your original symptoms becoming worse movements that you cannot control.

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

4. possible side effects

Like all medicines, Chloractil can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist or go to a hospital straight away if you have any of the following serious side effects: Very common (may affect more than 1 in 10 people)

• You have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs
• Trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless

Common (may affect up to 1 in 10 people)

• You have a fit (seizure)
• Alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

Not known (frequency cannot be estimated from the available data)

• You have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swollen eyelids, lips, tongue or throat
• You have a very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain. These could be signs of very serious life threatening heart problems
• You have joint aches and pains, swollen joints, feel tired or weak, with chest pain and shortness of breath. These could be signs of an illness called ‘systemic lupus erythematosus’ (SLE)
• You have yellowing of the skin or eyes (jaundice) and your urine becomes darker in colour. These could be signs of liver damage
• You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’
• You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called ‘neuroleptic malignant syndrome’
• You get a bloated feeling and cramping pain in the abdomen (stomach), be sick (vomit), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by and obstruction or blockage of the intestine.
• You have pain in your abdomen with vomiting or diarrhoea
• You have a long lasting, painful erection of the penis
• You bruise more easily than usual. This could be because of a blood disorder called ‘thrombocytopenia’
• You have 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

Tell your doctor or pharmacist as soon as possible if you have any of the following side effects:

Very common (may affect more than 1 in 10 people)

• feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)

Not known (frequency cannot be estimated from the available data)

• you are breathing more slowly or less deeply than normal
• changes in skin or eye colour after having Chlorpromazine for a long time
• problems with eyesight
• rigid or stiff muscles, trembling or shaking, difficulty moving
• passing large amounts of urine, excessive thirst and having a dry mouth or skin. You may be more likely get infections such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)
• unusual eye movements (including rolling of the eyes)
• your neck becomes twisted to one side
• your jaw is tight and stiff
• you have difficulty in passing water (urine)
• feeling tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days

Very common (may affect more than 1 in 10 people)

• Dry mouth
• Feeling drowsy or sleepy
• Putting on weight

Common (may affect up to 1 in 10 people)

• Abnormal production of breast milk in men and women
• Loss of menstrual periods
• Feeling anxious

Not known (frequency cannot be estimated from the available data)

• Breast enlargement in men
• Difficulty in getting or keeping an erection (impotence)
• Reduced sexual desire in women
• Difficulty sleeping (insomnia)
• Feeling agitated
• Being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Tiredness, low mood

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.

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in 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 chloractil

Keep out of the sight and reach of children.

Store below 25°C in a dry place and protect from light. Store in the original package or container and keep the container tightly closed.

Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What Chloractil tablets contain

The active ingredient (the ingredient that makes the tablets work) is chlorpromazine hydrochloride.

The other ingredients of Chloractil 10 mg Tablets are lactose monohydrate, maize starch, povidone k 30, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate and opadry white 21S58740 (hypromellose (E464), ethylcellulose, diethyl phthalate, titanium dioxide (E171)).

The other ingredients of Chloractil 25 mg, 50 mg and 100 mg Tablets are lactose, maize starch, povidone, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, purified water, hydroxypropylmethyl cellulose, ethylcellulose, diethylphthalate and titanium dioxide (E171).

What Chloractil tablets look like and contents of the pack

The 10 mg tablets are plain on both sides.

The 25 mg tablets are engraved ‘CHLORACTIL 25’ on one side and plain on the other side.

The 50 mg tablets are engraved ‘CHLORACTIL 50’ on one side and plain on the other side.

The 100 mg tablets are engraved ‘CHLORACTIL 100’ on one side and plain on the other side.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000 and 5000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

• 11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus