Chlorpromazine 50mg Tablets
Package leaflet: Information for the patient
Chlorpromazine 25mg Tablets Chlorpromazine 50mg Tablets Chlorpromazine 100 mg Tablets
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 symptoms 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.
What is in this leaflet
1. What Chlorpromazine Tablets are and what they are used for
2. What you need to know before you take Chlorpromazine Tablets
3. How to take Chlorpromazine Tablets
4. Possible side effects
5. How to store Chlorpromazine Tablets
6. Contents of the pack and other information
1. What Chlorpromazine Tablets are and what they are used for
Chlorpromazine Tablets contains ingredient medicine called chlorpromazine. This belongs to a group of medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the brain.
This medicine can be used for:
• Schizophrenia in adults and children
• Short treatment of anxiety
• Hiccups
• Feeling or being sick (where other anti-sickness medicines have not worked)
• Autism
2. What you need to know before you take Chlorpromazine Tablets Do not take Chlorpromazine Tablets:
• If you are allergic to chlorpromazine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face throat or tongue
• If you have a low number of blood cells (bone marrow depression)
• If you have increased pressure in the eye (glaucoma)
• If you are taking a dopaminergic antiparkinsonism drug
• If you are breast feeding
• If you are taking citalopram or escitalopram
• If you have a history of a low white blood cell count
• If you have urine retention due to a prostate disorder
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
• You have heart, liver or kidney problems
• You have thyroid problems
• You have ever had a stroke
• You have Parkinson’s disease
• You have epilepsy or have had fits (seizures)
• You have depression
• You have ever had alcohol problems
• You have an enlarged prostate gland
• You have had glaucoma (painful eyes with blurred vision)
• You have a tumour on the adrenal gland called ‘phaeochromocytoma’
• You have a form of muscle weakness called ‘myasthenia gravis’
• You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual
• You have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these
• 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
• You are not eating properly
• You are allergic to other phenothiazine medicines such as prochlorperazine
• You are older people (65 years of age or older), particularly during very hot or very cold weather. In these conditions, you could be at risk of hyperthermia or hypothermia
• You have low blood pressure or feel dizzy when you stand up
• You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely
Exposure to sunlight
Chlorpromazine can make your skin more sensitive to sunlight. Keep out of direct sunlight while having this medicine.
Tests
Before and during treatment your doctor may want to carry out some tests. These might include blood tests and an ECG to check your heart is working properly and eye tests.
Your doctor may want to carry out tests every year during your child's treatment to evaluate your child's learning capacity.
Other medicines and Chlorpromazine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, check with your doctor 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 to treat stomach problems such as cimetidine or cisapride
- Strong pain killers (e.g. codeine)
Chlorpromazine Tablets with alcohol
Do not drink alcohol while being treated with this medicine. This is because alcohol can increase the effects of chlorpromazine and can 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.
Pregnancy
The following symptoms may occur in newborn babies, of mothers that have used chlorpromazine 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.
Breast-feeding
Do not breast-feed if you are being given Chlorpromazine. This is because small amounts may pass into mothers’ milk.
Fertility
Chlorpromazine may make it more difficult for a woman to get pregnant due to it reducing her fertility.
Driving and using machines
You may feel sleepy after having this medicine. If it happens, do not drive or use any tools or machines.
Chlorpromazine Tablets contains Lactose
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 Chlorpromazine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Schizophrenia
Adults
25mg three times a day or 75 mg at bedtime. This may be increased by daily amounts of 25 mg to an effective maintenance dose in the range of 75 mg to 300 mg daily. Some patients may need up to 1,000mg a day.
Older people 25 mg every 8 hours
Paediatric population
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40 mg) Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75 mg)
Anxiety
Adults
25mg three times a day or 75 mg at bedtime. This may be increased by daily amounts of 25 mg to an effective maintenance dose in the range of 75 mg to 300 mg daily. Some patients may need up to 1,000 mg a day.
Older people 25 mg every 8 hours
Paediatric population
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40 mg) Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75 mg)
Hiccup
Adults
25-50mg every 6-8 hours
Feeling or being sick
Adults
10-25 mg every 4-6 hrs Paediatric population
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40 mg) Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75 mg)
Autism
Paediatric population
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40 mg) Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75 mg)
Children under age 1 year
Chlorpromazine is not usually given to children under 1 year Swallow the tablets with a glass of water.
If you take more Chlorpromazine than you should
If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take this leaflet with you and any remaining tablets and so that the medical staff know exactly what you have taken.
Having too much chlorpromazine may make you feel drowsy or dizzy with increased or rapid heartbeat. You may also feel very cold and restless, with writhing movements, stiffness or shaking.
If you forget to take Chlorpromazine Tablets
If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.
If you stop taking Chlorpromazine Tablets
It may take several weeks for you to feel the full benefit of this medicine. Keep having Chlorpromazine Tablets until your doctor tells you to stop. If you stop having this medicine your illness may come back and you may have other effects such as feeling or being sick and difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell a doctor or go to a hospital straight away if:
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
• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
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 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
• You are breathing more slowly or less deeply than normal
• Changes in skin or eye color 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 to 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
Other side effects:
Very common (may affect more than 1 in 10 people)
• Dry mouth
• Feeling drowsy or sleepy
• Putting on weight
• Constipation
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
• High cholesterol levels
• Feeling thirsty, fainting, dizziness, tiredness, stomach disorders like diarrhea or constipation indicating a temperature regulation disorder.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Chlorpromazine 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 box. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
Do not store above 25°C.
Store in the original package.
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.
6. Contents of the pack and other information
What Chlorpromazine Tablets contains
The active substance in Chlorpromazine Tablets is chlorpromazine hydrochloride.
Chlorpromazine Tablets are available in three strengths, containing either 25 mg, 50mg or 100mg chlorpromazine hydrochloride.
Chlorpromazine Tablets also contains lactose, maize starch, povidone, sodium starch glycollate and magnesium stearate.
What Chlorpromazine Tablets look like and contents of the pack
Chlorpromazine Tablets are round, white, film coated tablets.
They are packed in securitainers of 28, 50, 100, 250, 500, 1000 or 5000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Mercury Pharmaceuticals Ltd
No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
This leaflet was last revised in June 2015.