Stemetil 12.5 mg/ml Injection
1. What Stemetil Injection is and what it is used for
Stemetil Injection contains a medicine called Prochlorperazine Mesilate. This belongs to a group of medicines called ‘phenothiazine antipsychotics‘. It works by blocking the effects of a chemical in the brain.
Stemetil Injection can be used to:
• Stop you feeling sick (nausea) or being sick (vomiting)
• Treat schizophrenia
• Treat overactive behaviour or thoughts (mania)
2. Before you have Stemetil Injection
Do not have this medicine and tell your LAS doctor if:
You are allergic (hypersensitive) to prochlorperazine mesilate or any of the other ingredients of Stemetil Injection Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
The person is a child. This is because children may develop unusual face and body movements (dystonic reactions)
Take special care with Stemetil Injection Check with your doctor or pharmacist before having your medicine if:
- You are allergic to phenothiazine medicines such as chlorpromazine
- You have heart problems or a family history of heart problems
- You have ever had a stroke
- You have liver or kidney problems
- You have thyroid problems
- You have an enlarged prostate gland. This means you may have problems when passing water (urine)
- You have Parkinson’s disease
- You have dementia
- You have epilepsy or have ever had fits (seizures)
- You have depression
- You have a tumour on your adrenal gland called ‘phaeochromocytoma’
- You have a type of muscle weakness called ‘myasthenia gravis’
- You have or have ever had glaucoma (signs include painful eyes with blurred vision)
- You have or have ever had a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual
- 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 have low blood levels of potassium, calcium and magnesium. Your doctor may perform blood tests to check on these
- You are not eating properly or are very underweight
- You have a history of alcohol problems
- You are elderly (65 years of age or older)
- You are diabetic or have high levels of sugar in your blood (hyperglycaemia). 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 having Stemetil Injection.
Taking other medicines
Please tell your doctor or pharmacist 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 Stemetil Injection can affect the way some other medicines work. Also some medicines can affect the way Stemetil Injection works.
In particular, tell your doctor if you are taking any of the following:
• Medicines to helpyou sleep (sedatives, barbiturates)
• Other medicines used to calm emotional and mental conditions
• Medicines used for depression
• Medicines used for Parkinson’s disease such as levodopa
• Medicines for fits (epilepsy) such as carbamazepine
• Medicines used to control your heartbeat such as amiodarone, disopyramide, propanolol or quinidine
• Medicines for high blood pressure such as doxazosin, terazosin, guanethidine or clonidine
• Medicines used for diabetes
• Medicines used for cancer (cytotoxics)
• Medicines used for infections (antibiotics)
• Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence
• Amphetamines – used for Attention Deficit Hyperactivity Disorder (ADHD)
• Adrenaline – used for life threatening allergic reactions
• Desferroxamine – used when you have too much iron in your blood
• Lithium – used for some types of mental illness
Having Stemetil Injection with food and drink
Do not drink alcohol while you are having Stemetil Injection. This is because alcohol can add to the effects of Stemetil Injection and can cause serious breathing difficulties.
Pregnancy and breast-feeding
Do not have Stemetil Injection if:
• You are pregnant, might become pregnant or think you might be pregnant
• You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking or having any medicine if you are pregnant or breast-feeding.
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 Stemetil Injection
• Sodium: This medicine contains 2.91 mg of sodium per injection. This should be taken into consideration by people on a controlled sodium diet
• Sulphites: This medicine contains small amounts of sulphites. These may cause severe allergic (hypersensitivity) reactions 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. Stop having the medicine if you get a rash, swallowing or breathing problems or swelling of your lips, face, throat or tongue
3. How Stemetil Injection is given
Stemetil Injection 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 Stemetil Injection is given
If you are not sure why you are being given Stemetil Injection or have any questions about how much Stemetil Injection is being given to you, speak to your doctor or nurse. The usual doses are:
Schizophrenia and overactive behaviour or thoughts (mania]
|Adults:||12.5-25 mg two or three times a day You will be given injections until you are able to take Stemetil Tablets or syrup|
Stopping you feeling sick or being sick:
|Adults:||To begin with 12.5 mg by injection This may be followed by oral medication 6 hours later if necessary|
|Elderly:||Your doctor may prescribe a lowerdose |
You should be careful during very hot or very cold weather to
make sure that you do not get too
hot or too cold.
|Children:||Stemetil Injection is not given to children|
- If you have more Stemetil Injection 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 Stemetil may make you feel sleepy or dizzy, increased or rapid heartbeat, feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking. You may lose consciousness.
- If you miss a dose of Stemetil Injection
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 Stemetil Injection
Keep having Stemetil Injection until your doctor tells you to stop. If you stop having Stemetil Injection, your illness may come back and you may have other effects such as feeling or being sick or difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.
- Exposure to sunlight
Stemetil Injection can cause your skin to be more sensitive to sunlight. You should avoid exposure to direct sunlight while having this medicine.
Your doctor may do regular tests while you are having this medicine. These might include blood tests and an ECG to check your heart is working properly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Stemetil Injection can cause side effects, although not everybody gets them.
Tell a doctor or nurse straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have an unusually pale complexion, sweating, high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’
• You have frequent infections such as fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia
• You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• You have yellowing of your skin or eyes (jaundice). These could be signs of liver problems
• You have very fast, uneven or forceful heartbeats (palpitations) and experience breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain
• 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 as soon as possible if you have any of the following side effects:
• Breathing problems
• Changes in your skin or eye colour after having Stemetil Injection for a long period of time
• Problems with your eyesight after having Stemetil Injection for a long period of time
• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
• Rigid or stiff muscles, trembling or shaking, difficulty moving, or loss of muscle power
• 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)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days
• Abnormal production of breast milk in men and women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an erection (impotence)
• Difficulty sleeping (insomnia)
• Feeling restless or agitated
• Dry mouth
• Your skin being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Skin redness, swelling and itching from touching the medicine
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
As with other phenothiazine medicines, there have been very rare reports of sudden death with Stemetil Injection. These are possibly caused by heart problems.
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.
5. How to store Stemetil Injection
This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.
Do not use Stemetil Injection 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.
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 Stemetil Injection contains
• Each 1 ml of Stemetil Injection contains 12.5 mg of the active substance, prochlorperazme mesilate. • The other ingredients are sodium sulphite anhydrous (E221), sodium metabisulphite powder (E223), sodium chloride, ethanolamine and water for injection
What Stemetil Injection looks like and contents of the pack
Stemetil Injection is a colourless sterile solution. Stemetil Injection is available in packs containing 10×1 ml ampoules or 10 x 2 ml ampoules. Not all Dack sizes mav be marketed