Stemetil Syrup

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 possible 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 Stemetil Syrup is and what it is used for
2. What you need to know before you take Stemetil Syrup
3. How to take Stemetil Syrup
4. Possible side effects
5. How to store Stemetil Syrup
6. Contents of the pack and other information

Do not take Stemetil Syrup if:

• You are allergic (hypersensitive) to prochlorperazine, other phenothiazine medicines such as chlorpromazine or any of the other ingredients of Stemetil Syrup (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Warnings and precautions

Talk to your doctor or pharmacist before taking Stemetil Syrup if:

• You have heart problems or a family history of heart problems.
• You have ever had a stroke.
• You have unusual fast beating of your heart or low blood pressure.
• 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 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 underweight.
• 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.

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.

Other medicines and Stemetil Syrup

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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, including amitriptyline.
• 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, propranolol 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).
• 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.
• Desferrioxamine – used when you have too much iron in your blood.
• Lithium – used for some types of mental illness.

Stemetil Syrup with alcohol

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, think you may be pregnant or are planning to have a baby.
• You are breast-feeding or planning to breast-feed.

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

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.

Driving and using machines

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

Stemetil Syrup contains

• Sucrose: This medicine contains sucrose, which is a type of sugar. This may be harmful to teeth. 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 27mg of sodium per 5ml dose. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult. 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 100mg per 5ml.
• Sodium benzoate: This medicine contains 5mg sodium benzoate in each 5mg/5ml which is equivalent to 1mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Taking this medicine

• Take this medicine by mouth.
• Do not give to children under 1 year of age or who weigh less than 10kg.
• 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 5ml three times each day.
• This may be increased to a total daily dose of 30ml each day.
• After several weeks of treatment, your doctor may decide to gradually lower your daily dose to 5-10ml each day.

Stopping you feeling sick or being sick:

• The usual dose is 5ml or 10ml.
• This may be taken two or three times each day.

Treatment of feeling sick or being sick:

• To begin with you will usually take 20ml.
• This may be followed by 10ml two hours later.

Treatment of schizophrenia and over-active behaviour or thoughts (mania):

• The starting dose is usually 12.5ml twice each day for seven days.
• Your doctor may increase your dose up to a total daily dose of 75-100ml each day.
• After several weeks of treatment, your doctor may then lower your dose to a total daily dose of 25-50ml each day.

Short-term treatment of anxiety:

• The starting dose will be 15-20ml each day in divided doses.
• Your doctor may then increase your dose to a total daily dose of 40ml 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 10kg)

Stopping your child feeling sick or being sick:

• Your doctor will decide the dose according to your child’s weight.
• A dose of 0.25mg 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.

Stop taking Stemetil Syrup and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. This can occur immediately after drug administration and may be life-threatening. Symptoms 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.
• You have rigid or stiff muscles, trembling or shaking, unusual eye movements (including rolling of the eyes), difficulty moving, or loss of muscle power.

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).
• You have fits (convulsions).
• 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 (hyponatraemia).
• Feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
• Very fast, uneven or forceful heartbeats (palpitations).
• 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

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.

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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

What Stemetil Syrup contains

• Each 5ml of Stemetil Syrup contains 5mg of the active substance, prochlorperazine mesilate.
• The other ingredients are sucrose, polysorbate 80 (E433), banana flavour, caramel (E150), anhydrous citric acid (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 100ml or 125ml closed by a child-proof cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer