PACKAGE LEAFLET: INFORMATION FOR THE USER
Chlorpromazine hydrochloride 25mg/ml Solution for Injection
Chlorpromazine hydrochloride
Read all of this leaflet carefully before you are given this medicine
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor, nurse or pharmacist
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist
In this leaflet:
1.
What Chlorpromazine hydrochloride is and what it is used for
2. Before you are given Chlorpromazine hydrochloride
3. How Chlorpromazine hydrochloride is given
4. Possible side effects
5. How to store Chlorpromazine hydrochloride
6.Further Information
1. What Chlorpromazine hydrochloride is and what it is used for
Chlorpromazine hydrochloride contains a medicine called chlorpromazine. This belongs to a group of medicines called ?phenothiazines?. It works by blocking the effect of a chemical in the brain.
Chlorpromazine hydrochloride can be used for:
- Schizophrenia in adults and children
- Short term treatment of anxiety
- Hiccups
- Feeling or being sick (where other anti-sickness medicines have not worked)
- Autism
2. Before you are given Chlorpromazine hydrochloride
Do not have this medicine and tell your doctor if:
- You are allergic (hypersensitive) to chlorpromazine or any of the other ingredients of Chlorpromazine hydrochloride (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You have a low number of blood cells (bone marrow depression).
- You have increased pressure in the eye (glaucoma)
- You are taking a dopaminergic antiparkinsonian drug
- You are breastfeeding
- You are taking citalopram or escitalopram
- You have a history of a low white blood cell count
- You have urine retention due to a prostate disorder
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Chlorpromazine hydrochloride
Take special care with Chlorpromazine hydrochloride
Check with your doctor or nurse before you have this medicine if:
- You have liver or kidney problems
- You have thyroid problems
- You have heart problems or a family history of heart 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 tumor 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 the formation of blood clots
- You are not eating properly
- You are allergic to other phenothiazine medicines such as prochlorperazine
- You are elderly (65 years of age or older)
- You are elderly, 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 (hyperglycemia). Your doctor may want to monitor you more closely
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before being given Chlorpromazine hydrochloride.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Chlorpromazine hydrochloride can affect the way some other medicines work. Also, some medicines can affect the way Chlorpromazine hydrochloride works.
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 heartbeats 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.
Taking Chlorpromazine hydrochloride with food and drink
Do not drink alcohol while being treated with Chlorpromazine hydrochloride. This is because alcohol can increase the effects of Chlorpromazine hydrochloride and cause serious breathing problems.
Pregnancy and breast-feeding and fertility
Talk to your doctor or nurse before having this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
The following symptoms may occur in newborn babies, of mothers that have used Chlorpromazine hydrochloride 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 Chlorpromazine hydrochloride. This is because small amounts may pass into mothers? milk. If you are breastfeeding or planning to breast-feed talk to your doctor or nurse before taking this medicine.
Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.
Chlorpromazine hydrochloride 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 this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Chlorpromazine hydrochloride
- Sodium.?This injection contains 4.78mg of sodium in each 50mg dose and is essential ?sodium-free?.
- Small amounts of sulfites.?These may cause severe allergic reactions (hypersensitivity) and difficulty in breathing (bronchospasm).
This is more likely to happen if you have a history of asthma or allergies. The chances of this happening are rare. Tell a doctor or nurse straight away if you get a rash, swallowing or breathing problems and swelling of your lips, face, throat or tongue.
3. How Chlorpromazine hydrochloride is given
Chlorpromazine hydrochloride is normally given by a doctor or nurse.
This is because it needs to be given as a deep injection into a muscle.
How much Chlorpromazine hydrochloride is given
If you are not sure why you are being given Chlorpromazine hydrochloride or have any questions about how much Chlorpromazine hydrochloride is being given to you, speak to your doctor or nurse.
The usual doses are:
Schizophrenia
Adults: 25-50mg every 6-8 hours
Elderly: 25mg every 8 hours
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)
Anxiety
Adults: 25-50mg every 6-8 hours
Elderly: 25mg every 8 hours
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)
Hiccups
Adults: 25-50mg
Feeling or being sick
Adults: 25-50mg every 3-4 hours
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)
Autism
Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours. (Maximum dose in a day is 75mg)
Children under 1 year
Chlorpromazine hydrochloride is not usually given to children under 1 year.
Exposure to sunlight
Chlorpromazine hydrochloride 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.
If you have more Chlorpromazine hydrochloride than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.
Having too much Chlorpromazine hydrochloride may make you feel drowsy or dizzy with an increased or rapid heartbeat. You may also feel very cold and restless, with writhing movements, stiffness or shaking. If you start getting any of these symptoms to tell your doctor or nurse straight away. If you are away from the hospital, return straight away and speak to your doctor or nurse or go to the casualty department.
If you miss a dose of Chlorpromazine hydrochloride
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.
If you stop having Chlorpromazine hydrochloride
Keep having Chlorpromazine hydrochloride until your doctor tells you to stop. If you stop having Chlorpromazine hydrochloride 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.
4. Possible side effects
Like all medicines, Chlorpromazine hydrochloride can cause side effects, although not everybody gets them.
Tell a doctor or nurse or go to a hospital straight away if:
Very common (affects 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 (affects 1 to 10 people in a 100 people)
- You have a fit (seizure)
- Alteration of the heart rhythm (called ?prolongation of QT interval?, seen on ECG, the electrical activity of the heart)
Frequency unknown
- 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 color. 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 an obstruction or blockage of the intestine.
- You have pain in your abdomen with vomiting or diarrhea
- 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 a nurse or doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
- Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
Frequency unknown
- You are breathing more slowly or less deeply than normal
- Changes in skin or eye color after having Chlorpromazine hydrochloride 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 (hyperglycemia)
- 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
Talk to your doctor or nurse if any of the following side effects gets serious or lasts longer than a few days:
Very common (affects more than 1 in 10 people)
- Dry mouth
- Feeling drowsy or sleepy
- Putting on weight
Common (affects 1 to 10 people in a 100 people)
- Abnormal production of breast milk in men and women
- Loss of menstrual periods
- Feeling anxious
Frequency unknown
- 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
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Chlorpromazine hydrochloride
This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.
Do not use Chlorpromazine hydrochloride after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Keep the Ampoules in the outer carton in order to protect from light.
The discolored solution should not be used.
Medicines should not be disposed of 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. Further Information
What Chlorpromazine hydrochloride contains
- Each 1ml of solution contains 25mg of the active substance, chlorpromazine hydrochloride
- The other ingredients are: Sodium sulfite (E221), Sodium citrate, Sodium metabisulphite (E223), Sodium chloride, Water for Injection
What Chlorpromazine hydrochloride looks like and contents of the pack
- Chlorpromazine hydrochloride is a clear, colorless solution
- Chlorpromazine hydrochloride is available in boxes containing 10 x 1ml or 10 x 2ml glass ampoules
Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222 825)