STEMETIL 5MG/5ML SYRUP
Active substance: PROCHLORPERAZINE MESILATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER prochlorperazine mesilate
Stemetil 5 mg / 5 ml Syrup
Take special care with Stemetil Syrup
Check with your doctor or pharmacist before taking your medicine if: You are allergic to phenothiazine medicines such as chlorpromazine Is this leaflet hard to see or read? You have heart problems or a family history of Phone 01483 505515 for help heart problems You have ever had a stroke Read all of this leaflet carefully before you start You have liver or kidney problems You have thyroid problems taking this medicine You have an enlarged prostate gland. This means Keep this leaflet. You may need to read it again you may have problems when passing water If you have any further questions, ask your doctor (urine) or pharmacist This medicine has been prescribed for you. Do not You have Parkinson s disease pass it on to others. It may harm them, even if You have dementia their symptoms are the same as yours You have epilepsy or have ever had fits (seizures) If any of the side effects gets serious, or if you You have depression notice any side effects not listed in this leaflet, please tell your doctor or pharmacist You have a tumour on your adrenal gland called phaeochromocytoma In this leaflet: You have a type of muscle weakness called 1. What Stemetil Syrup is and what it is used for myasthenia gravis 2. Before you take Stemetil Syrup You have or have ever had glaucoma (signs 3. How to take Stemetil Syrup include painful eyes with blurred vision) 4. Possible side effects You have or have ever had a low number of white 5. How to store Stemetil Syrup blood cells (agranulocytosis). This would lead you 6. Further information to get infections more easily than usual You have low blood levels of potassium, calcium 1. What Stemetil Syrup is and what it is and magnesium. Your doctor may perform blood used for tests to check on these You or someone else in your family has a history Stemetil Syrup contains a medicine called of blood clots, as medicines like these have been prochlorperazine mesilate. This belongs to a group associated with formation of blood clots of medicines called phenothiazine antipsychotics . It works by blocking the effects of a chemical in the You are not eating properly or are very underweight brain. You have a history of alcohol problems You are elderly (65 years of age or older) Stemetil Syrup can be used to: The person is a child. This is because children Treat balance problems or dizziness (vertigo). may develop unusual face and body movements This includes problems of the inner ear such as (dystonic reactions) Meniere s Syndrome or labyrinthitis You are diabetic or have high levels of sugar in Stop you feeling sick (nausea) or being sick your blood (hyperglycaemia). Your doctor may (vomiting). This can be from any cause including want to monitor you more closely migraines Treat schizophrenia If you are not sure if any of the above apply to you, Treat over-active behaviour or thoughts (mania) talk to your doctor or pharmacist before taking Treat anxiety in the short-term, when used in Stemetil Syrup. addition to other medicines 2. 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). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue 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.
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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
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 Medicines used to control your heartbeat such (hypersensitivity) reactions and difficulty in as amiodarone, disopyramide, propanolol or breathing (bronchospasm). This is more likely quinidine to happen if you have a history of asthma or Medicines for high blood pressure such as allergies. The chances of this happening are doxazosin, terazosin, guanethidine or clonidine rare. Stop taking the medicine if you get a rash, Medicines used for diabetes swallowing or breathing problems or swelling of Medicines used for cancer (cytotoxics) your lips, face, throat or tongue Medicines used for infections (antibiotics) Ethanol: This medicine contains small amounts Medicines for indigestion and heartburn (antacids) of ethanol (alcohol), less than 100 mg per 5 ml 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 3. 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 Taking Stemetil Syrup with food and drink get skin redness, swelling and itching (contact skin Do not drink alcohol while you are taking Stemetil sensitisation) Syrup. This is because alcohol can add to the effects If you feel the effect of your medicine is too weak of Stemetil Syrup and can cause serious breathing or too strong, do not change the dose yourself, but difficulties. ask your doctor 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 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 The following symptoms may occur in newborn 30 ml each day babies, of mothers that have used Stemetil Syrup After several weeks treatment, your doctor may in the last trimester (last three months of their decide to gradually lower your daily dose to 5 pregnancy): shaking, muscle stiffness and/or to 10 ml each day weakness, sleepiness, agitation, breathing problems, Stopping you feeling sick or being sick: and difficulty in feeding. If your baby develops any The usual dose is 5 or 10 ml of these symptoms you may need to contact your This may be taken two or three times each day doctor. Treatment of feeling sick or being sick: To begin with you will usually take 20 ml Ask your doctor or pharmacist for advice before This may be followed by 10 ml two hours later taking any medicine if you are pregnant or breastTreatment of schizophrenia and over-active feeding. 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 Driving and using machines total daily dose of 75 to 100 ml each day After several weeks of treatment, your doctor You may feel sleepy after taking this medicine. may then lower your dose to a total daily dose If this happens, do not drive or use any tools or of 25 to 50 ml each day 2 machines.
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) If you take more Stemetil Syrup than you should You have yellowing of your skin or eyes (jaundice). If you take more Stemetil Syrup than you should, These could be signs of liver problems tell a doctor or go to a hospital casualty department You have a very fast, uneven or forceful heartbeats straight away. Take the medicine pack with you. (palpitations) and experience breathing problems This is so the doctor knows what you have taken. such as wheezing, shortness of breath, tightness in Taking too much Stemetil Syrup may cause the chest and chest pain symptoms such as feeling sleepy or dizzy, increased You have blood clots in the veins especially in the or rapid heartbeat, feeling very cold and confused, legs (symptoms include swelling, pain and redness writhing movements, feeling restless, stiffness or in the leg), which may travel through blood vessels shaking. You may lose consciousness. to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms If you forget to take Stemetil Syrup seek medical advice immediately If you forget a dose, take it as soon as you You have rigid or stiff muscles, trembling or remember it. However, if it is nearly time for the shaking, unusual eye movements (including next dose, skip the missed dose. Do not take a rolling of the eyes), difficulty moving, or loss of double dose to make up for a forgotten dose. muscle power 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. 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) 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
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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 to 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
4. Possible side effects Like all medicines, Stemetil Syrup can cause side effects, although not everybody gets them.
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 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. 5. 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 longer required. These measures will help to protect the environment. 6. 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 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 100 or 125 ml.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Unither Liquid Manufacturing, 1-3 Allee de la Neste, Z.I. d en Sigal, 31770 Colomiers, France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in 06/2012 Sanofi, 1973 - 2012
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Stemetil 5 mg / 5 ml Syrup
Take special care with Stemetil Syrup
Check with your doctor or pharmacist before taking your medicine if: You are allergic to phenothiazine medicines such as chlorpromazine Is this leaflet hard to see or read? You have heart problems or a family history of Phone 01483 505515 for help heart problems You have ever had a stroke Read all of this leaflet carefully before you start You have liver or kidney problems You have thyroid problems taking this medicine You have an enlarged prostate gland. This means Keep this leaflet. You may need to read it again you may have problems when passing water If you have any further questions, ask your doctor (urine) or pharmacist This medicine has been prescribed for you. Do not You have Parkinson s disease pass it on to others. It may harm them, even if You have dementia their symptoms are the same as yours You have epilepsy or have ever had fits (seizures) If any of the side effects gets serious, or if you You have depression notice any side effects not listed in this leaflet, please tell your doctor or pharmacist You have a tumour on your adrenal gland called phaeochromocytoma In this leaflet: You have a type of muscle weakness called 1. What Stemetil Syrup is and what it is used for myasthenia gravis 2. Before you take Stemetil Syrup You have or have ever had glaucoma (signs 3. How to take Stemetil Syrup include painful eyes with blurred vision) 4. Possible side effects You have or have ever had a low number of white 5. How to store Stemetil Syrup blood cells (agranulocytosis). This would lead you 6. Further information to get infections more easily than usual You have low blood levels of potassium, calcium 1. What Stemetil Syrup is and what it is and magnesium. Your doctor may perform blood used for tests to check on these You or someone else in your family has a history Stemetil Syrup contains a medicine called of blood clots, as medicines like these have been prochlorperazine mesilate. This belongs to a group associated with formation of blood clots of medicines called phenothiazine antipsychotics . It works by blocking the effects of a chemical in the You are not eating properly or are very underweight brain. You have a history of alcohol problems You are elderly (65 years of age or older) Stemetil Syrup can be used to: The person is a child. This is because children Treat balance problems or dizziness (vertigo). may develop unusual face and body movements This includes problems of the inner ear such as (dystonic reactions) Meniere s Syndrome or labyrinthitis You are diabetic or have high levels of sugar in Stop you feeling sick (nausea) or being sick your blood (hyperglycaemia). Your doctor may (vomiting). This can be from any cause including want to monitor you more closely migraines Treat schizophrenia If you are not sure if any of the above apply to you, Treat over-active behaviour or thoughts (mania) talk to your doctor or pharmacist before taking Treat anxiety in the short-term, when used in Stemetil Syrup. addition to other medicines 2. 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). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue 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.
1
301248 - 848
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
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 Medicines used to control your heartbeat such (hypersensitivity) reactions and difficulty in as amiodarone, disopyramide, propanolol or breathing (bronchospasm). This is more likely quinidine to happen if you have a history of asthma or Medicines for high blood pressure such as allergies. The chances of this happening are doxazosin, terazosin, guanethidine or clonidine rare. Stop taking the medicine if you get a rash, Medicines used for diabetes swallowing or breathing problems or swelling of Medicines used for cancer (cytotoxics) your lips, face, throat or tongue Medicines used for infections (antibiotics) Ethanol: This medicine contains small amounts Medicines for indigestion and heartburn (antacids) of ethanol (alcohol), less than 100 mg per 5 ml 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 3. 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 Taking Stemetil Syrup with food and drink get skin redness, swelling and itching (contact skin Do not drink alcohol while you are taking Stemetil sensitisation) Syrup. This is because alcohol can add to the effects If you feel the effect of your medicine is too weak of Stemetil Syrup and can cause serious breathing or too strong, do not change the dose yourself, but difficulties. ask your doctor 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 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 The following symptoms may occur in newborn 30 ml each day babies, of mothers that have used Stemetil Syrup After several weeks treatment, your doctor may in the last trimester (last three months of their decide to gradually lower your daily dose to 5 pregnancy): shaking, muscle stiffness and/or to 10 ml each day weakness, sleepiness, agitation, breathing problems, Stopping you feeling sick or being sick: and difficulty in feeding. If your baby develops any The usual dose is 5 or 10 ml of these symptoms you may need to contact your This may be taken two or three times each day doctor. Treatment of feeling sick or being sick: To begin with you will usually take 20 ml Ask your doctor or pharmacist for advice before This may be followed by 10 ml two hours later taking any medicine if you are pregnant or breastTreatment of schizophrenia and over-active feeding. 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 Driving and using machines total daily dose of 75 to 100 ml each day After several weeks of treatment, your doctor You may feel sleepy after taking this medicine. may then lower your dose to a total daily dose If this happens, do not drive or use any tools or of 25 to 50 ml each day 2 machines.
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) If you take more Stemetil Syrup than you should You have yellowing of your skin or eyes (jaundice). If you take more Stemetil Syrup than you should, These could be signs of liver problems tell a doctor or go to a hospital casualty department You have a very fast, uneven or forceful heartbeats straight away. Take the medicine pack with you. (palpitations) and experience breathing problems This is so the doctor knows what you have taken. such as wheezing, shortness of breath, tightness in Taking too much Stemetil Syrup may cause the chest and chest pain symptoms such as feeling sleepy or dizzy, increased You have blood clots in the veins especially in the or rapid heartbeat, feeling very cold and confused, legs (symptoms include swelling, pain and redness writhing movements, feeling restless, stiffness or in the leg), which may travel through blood vessels shaking. You may lose consciousness. to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms If you forget to take Stemetil Syrup seek medical advice immediately If you forget a dose, take it as soon as you You have rigid or stiff muscles, trembling or remember it. However, if it is nearly time for the shaking, unusual eye movements (including next dose, skip the missed dose. Do not take a rolling of the eyes), difficulty moving, or loss of double dose to make up for a forgotten dose. muscle power 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. 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) 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
3
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 to 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
4. Possible side effects Like all medicines, Stemetil Syrup can cause side effects, although not everybody gets them.
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 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. 5. 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 longer required. These measures will help to protect the environment. 6. 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 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 100 or 125 ml.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Unither Liquid Manufacturing, 1-3 Allee de la Neste, Z.I. d en Sigal, 31770 Colomiers, France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in 06/2012 Sanofi, 1973 - 2012
301248 - 848 4
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
