Stemetil Syrup (Prochlorperazine Mesilate)

Stemetil 5 mg / 5 ml Syrup (Prochlorperazine Mesilate)

What Stemetil Syrup is and what it is used for

Stemetil Syrup 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 Syrup can be used to:

• Treat balance problems or dizziness (vertigo). This includes problems of the inner ear such as’Meniere’s Syndrome’ or ‘labyrinthitis’
• Stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines
• Treat schizophrenia
• Treat over-active behaviour or thoughts (mania)
• Treat anxiety in the short-term, when used in addition to other medicines

Before you take Stemetil Syrup

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to prochlorperazine mesilate or any of the other ingredients of Stemetil Syrup (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Take special care with Stemetil Syrup

Check with your doctor or pharmacist before taking your medicine if:

• You are allergic to phenothiazine medicines such aschlorpromazine A You have heart problems or a family history of heart problems A You have ever had a stroke A You have liver or kidney problems A 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 have low blood levels of potassium, calcium and magnesium.
• Your doctor may perform 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 or are very under-weight
• You have a history of alcohol problems
• You are elderly (65 years of age or older)

The person is a child. This is because children may develop unusual face and body movements (dystonic reactions)

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 taking Stemetil Syrup.

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 Syrup can affect the way some other medicines work. Also some medicines can affect the way Stemetil Syrup works.

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

• Medicines to help you 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 orquinidine
• 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)
• Medicines for indigestion and heartburn (antacids)
• 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

Taking Stemetil Syrup with food and drink

Do not drink alcohol while you are taking Stemetil Syrup. This is because alcohol can add to the effects of Stemetil Syrup and can cause serious breathing difficulties.

Pregnancy and breast-feeding

Do not take Stemetil Syrup 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 any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy after taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Stemetil Syrup

Sucrose: This medicine contains sucrose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking the syrup

Sodium: This medicine contains 27 mg of sodium per 5 ml dose. 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 taking the medicine if you get a rash, swallowing or breathing problems or swelling of your lips, face, throat or tongue

Ethanol: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml

How to take Stemetil Syrup

Always take Stemetil Syrup exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• Do not give to children under 1 year of age or who weigh less than 10 kg
• Do not let the syrup touch your skin, as you may get skin redness, swelling and itching (contact skin sensitisation)
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take Adults:

Treatment of balance problems or dizziness (vertigo):

• The usual dose is 5 ml three times each day
• This may be increased to a total daily dose of 30 ml each day
• After several weeks treatment, your doctor may decide to gradually lower your daily dose to 5 to 10 ml each day

How much to take (continued) Adults:

Stopping you feeling sick or being sick:

• The usual dose is 5 or 10 ml
• This may be taken two or three times each day Treatment of feeling sick or being sick:
• To begin with you will usually take 20 ml
• This may be followed by 10 ml two hours later Treatment of schizophrenia and over-active behaviour or thoughts (mania):
• The starting dose is usually 12.5 ml twice each day for seven days
• Your doctor may increase your dose up to a total daily dose of 75 to 100 ml each day
• After several weeks of treatment, your doctor may then lower your dose to a total daily dose of 25 to 50 ml each day

Short-term treatment of anxiety:

• The starting dose will be 15 to 20 ml each day in divided doses
• Your doctor may then increase your dose to a total daily dose of 40 ml each day

Elderly:

• Your doctor may prescribe a lower dose
• 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 (over 1 year of age and weighing more than 10 kg):

Stopping your child feeling sick or being sick:

• Your doctor will decide the dose according your child’s weight
• A dose of 0.25 mg for each kilogram of your child’s weight is usually given
• This dose may be given two or three times a day

If you take more Stemetil Syrup than you should

If you take more Stemetil Syrup than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much Stemetil Syrup may cause symptoms such as feeling 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 forget to take Stemetil Syrup

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Stemetil Syrup

Keep taking Stemetil Syrup until your doctor tells you to stop. Do not stop taking Stemetil Syrup just because you feel better. If you stop, 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 Syrup can cause your skin to be more sensitive to sunlight. You should avoid exposure to direct sunlight while taking this medicine.

Tests

Your doctor may do regular tests while you are taking 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.

Possible side effects

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

Stop taking Stemetil Syrup and see a doctor or go to a hospital 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 a 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 taking Stemetil Syrup for a long period of time
• Problems with your eyesight after taking Stemetil Syrup for a long period of time
• Feeling dizzy, light-headed or faint when you stand or sit up quickly (due to low blood pressure)
• Very fast, uneven or forceful heartbeats (palpitations)
• 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 usua
• 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 post.

As with other phenothiazine medicines, there have been very rare reports of sudden death with Stemetil Syrup. 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.

How to store Stemetil Syrup

Keep this medicine in a safe place where children cannot see or reach it

Do not use Stemetil Syrup after the expiry date which is stated on the bottle label and carton, after EXP. The expiry date refers to the last day of that month.

Store protected from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no onger required. These measures will help to protect the environment.

Further information

What Stemetil Syrup contains

Each 5 ml of Stemetil Syrup contains 5 mg of the active substance, prochlorperazine mesilate

The other ingredients are sucrose, polysorbate 80 (E433), banana flavour, caramel (E150), anhydrous citricacid (E330), sodium citrate (E331), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite powder (E223), ascorbic acid L(+) (E300) and purified water

What Stemetil Syrup looks like and contents of the pack

Stemetil is a dark straw coloured syrup.

Stemetil Syrup is available in amber glass bottles containing 100 or125 ml.