DOLMATIL 200MG TABLETS
Active substance: SULPIRIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dolmatil 200mg Tablets Dolmatil 400mg Film-Coated Tablets
sulpiride
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1.What Dolmatil Tablets are and what they are used for 2. Before you take Dolmatil Tablets 3. How to take Dolmatil Tablets 4. Possible side effects 5. How to store Dolmatil Tablets 6. Further Information 1. What Dolmatil Tablets are and what they are used for Dolmatil Tablets contains a medicine called sulpiride. This belongs to a group of medicines called benzamides. It works by blocking the effect of a chemical in the brain. Dolmatil Tablets are used to treat Schizophrenia. 2. Before you take Dolmatil Tablets Do not take this medicine and tell your doctor if: X You are allergic (hypersensitive) to sulpiride or any of the other ingredients of Dolmatil Tablets (listed in Section 6 Further Information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You have a tumour on the adrenal gland called phaeochromocytoma X You have a rare illness called porphyria which affects your metabolism
X You have breast cancer or cancer in the pituitary gland X You are taking levodopa used for Parkinsons disease (see Taking other medicines below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dolmatil Tablets. Take special care with Dolmatil Tablets Check with your doctor or pharmacist before you take this medicine if: s You have bouts of aggressive behaviour or are very agitated s You have kidney problems s You have heart problems or a family history of heart problems. Your doctor may test your heart function before you take this medicine s You have ever had a stroke s If 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 s You have low levels of potassium in your body (hypokalaemia) s The person is 65 years of age or older s You have dementia s You have Parkinsons disease s You have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these s You have epilepsy or have had fits (seizures) s You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual s You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia' If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dolmatil Tablets. 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 Dolmatil Tablets can affect the way some other medicines work. Also some medicines can affect the way Dolmatil works.
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SENS DE DEROULEMENT RECTO (Intrieur bobine) Zone de collage ct code barres
In particular, do not take this medicine and tell your doctor if you are taking: Levodopa used for Parkinsons disease Tell your doctor if you are taking any of the following medicines; Medicines to control your heartbeat such as amiodarone, sotalol, disopyramide or quinidine Medicines for high blood pressure or heart disorders, such as clonidine, diltiazem, verapamil or digitalis Other medicines for schizophrenia such as pimozide, haloperidol, thioridazine Lithium used for some types of mental illness Some medicines to help you sleep or lower your anxiety Other medicines used to calm emotional and mental problems Water tablets (diuretics) that can lower the levels of potassium in your blood Some medicines used for constipation (laxatives) that can lower the levels of potassium in your blood Some medicines used for infections (antibiotics) such as pentamidine, erythromycin or amphotericin B Tetracosactide used to test the function of your adrenal gland Steroids used to lower inflammation such as prednisolone, betamethasone, dexamethasone Some medicines for depression such as imipramine Medicines for indigestion and heartburn Sucralfate used for stomach ulcers Medicines for pain relief. These may also be included in medicines for colds and flu Some medicines used for allergies (antihistamines that make you sleepy) such as chlorphenamine, promethazine, ketotifen Ropinorole used for Parkinsons disease Methadone used for pain relief and as a drug substitute Halofantrine used for malaria Taking Dolmatil Tablets with food and drink Do not drink alcohol or take medicines that contain alcohol while being treated with Dolmatil Tablets. This is because alcohol can increase the effects of Dolmatil Tablets. Pregnancy and breast-feeding Talk to your doctor or pharmacist before having
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this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Do not breast-feed if you are taking Dolmatil Tablets. This is because small amounts may pass into mothers milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking any medicine. The following symptoms may occur in newborn babies, of mothers that have used Dolmatil Tablets 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. 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 Dolmatil Tablets Lactose. Dolmatil Tablets contain lactose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Dolmatil tablets 3. How to take Dolmatil Tablets Always take Dolmatil Tablets 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 Swallow the tablets whole with a drink of water 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 The usual starting dose is 400mg (two 200mg or one 400mg tablet) to 800mg (four 200mg or two 400mg tablets) daily depending on your illness.
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Your doctor may then change your dose depending on your illness Patients with Kidney Disease The starting dose may be lower and the rate of increasing the dose slower. Children under 14 years of age Dolmatil Tablets are not recommended for children under 14 years of age. If you take more Dolmatil Tablets than you should If you take more Dolmatil Tablets 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. The following effects may happen: feeling restless, confused or agitated, having a reduced level of consciousness, trembling, muscle stiffness or spasm, difficulty in movement, movements that you cannot control (for example of the eyes, neck, arms and legs), producing more saliva than usual. In some cases dizziness, lightheadedness, fainting (due to low blood pressure) and coma have happened. If you forget to take Dolmatil Tablets 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. If you stop taking Dolmatil Tablets Keep taking Dolmatil Tablets until your doctor tells you to stop. Do not stop taking Dolmatil Tablets just because you feel better. If you stop taking Dolmatil Tablets suddenly, your illness may come back and you may have other unwanted effects such as feeling or being sick, sweating and difficulty sleeping. In some cases you may also feel restless or have movements that you cannot control (for example of the eyes, neck, arms and legs). Your doctor will gradually lower your dose until you stop your medicine, to prevent these effects happening. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Dolmatil Tablets can cause side effects, although not everybody gets them.
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Stop taking Dolmatil Tablets and see a doctor or go to a hospital straight away if; You have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swelling You have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs You have fits 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 have very fast or very slow, uneven or forceful heartbeats. You may also have 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. You get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia) Tell a pharmacist or doctor as soon as possible if you have any of the following side effects: 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 Feeling restless and not being able to keep still (akathisia) Feeling aggressive, agitated or feeling impulsive Talk to your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: Abnormal production of breast milk in men and women Weight gain Breast enlargement or painful breasts in men and women Loss of menstrual periods Difficulty in getting or keeping an erection or in ejaculating (impotence) Feeling drowsy or sleepy Difficulty sleeping (insomnia) Skin rashes
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Blood tests Dolmatil Tablets can increase the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly. 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. There have been very rare reports of sudden death with Dolmatil. 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 Dolmatil Tablets Keep this medicine in a safe place where children cannot see or reach it. Do not use Dolmatil Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store below 25C 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 Dolmatil Tablets contains Each 200mg tablet contains 200mg of the active substance, sulpiride The other ingredients in the 200mg tablets are: starch, lactose, methylcellulose, magnesium stearate, talc, colloidal hydrated silica Each 400mg tablet contains 400mg of the active substance, sulpiride The other ingredients in the 400mg tablets are: lactose, sodium starch glycollate, microcrystalline cellulose, hydroxypropylmethylcellulose and magnesium stearate What Dolmatil Tablets looks like and contents of the pack Dolmatil 200mg Tablets are plain white round tablets with D200 on one side and a breakline
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on the other. Supplied in blisters packs of 100 (10X10) tablets or glass bottles of 500 tablets. Dolmatil 400mg Tablets are white film coated stick shaped tablets with SLP 400 on one side and a break line on the other. Supplied in blisters packs of 100 (5X20) tablets. Not all pack sizes may be marketed. 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 Sanofi Winthrop Industrie, 6 Boulevard de LEurope, 21800 Quetigny, 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 10/2012 Sanofi, 1983 - 2012
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Dolmatil 200mg Tablets Dolmatil 400mg Film-Coated Tablets
sulpiride
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1.What Dolmatil Tablets are and what they are used for 2. Before you take Dolmatil Tablets 3. How to take Dolmatil Tablets 4. Possible side effects 5. How to store Dolmatil Tablets 6. Further Information 1. What Dolmatil Tablets are and what they are used for Dolmatil Tablets contains a medicine called sulpiride. This belongs to a group of medicines called benzamides. It works by blocking the effect of a chemical in the brain. Dolmatil Tablets are used to treat Schizophrenia. 2. Before you take Dolmatil Tablets Do not take this medicine and tell your doctor if: X You are allergic (hypersensitive) to sulpiride or any of the other ingredients of Dolmatil Tablets (listed in Section 6 Further Information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You have a tumour on the adrenal gland called phaeochromocytoma X You have a rare illness called porphyria which affects your metabolism
X You have breast cancer or cancer in the pituitary gland X You are taking levodopa used for Parkinsons disease (see Taking other medicines below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dolmatil Tablets. Take special care with Dolmatil Tablets Check with your doctor or pharmacist before you take this medicine if: s You have bouts of aggressive behaviour or are very agitated s You have kidney problems s You have heart problems or a family history of heart problems. Your doctor may test your heart function before you take this medicine s You have ever had a stroke s If 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 s You have low levels of potassium in your body (hypokalaemia) s The person is 65 years of age or older s You have dementia s You have Parkinsons disease s You have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these s You have epilepsy or have had fits (seizures) s You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual s You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia' If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dolmatil Tablets. 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 Dolmatil Tablets can affect the way some other medicines work. Also some medicines can affect the way Dolmatil works.
485977
*485977*
1
SENS DE DEROULEMENT RECTO (Intrieur bobine) Zone de collage ct code barres
In particular, do not take this medicine and tell your doctor if you are taking: Levodopa used for Parkinsons disease Tell your doctor if you are taking any of the following medicines; Medicines to control your heartbeat such as amiodarone, sotalol, disopyramide or quinidine Medicines for high blood pressure or heart disorders, such as clonidine, diltiazem, verapamil or digitalis Other medicines for schizophrenia such as pimozide, haloperidol, thioridazine Lithium used for some types of mental illness Some medicines to help you sleep or lower your anxiety Other medicines used to calm emotional and mental problems Water tablets (diuretics) that can lower the levels of potassium in your blood Some medicines used for constipation (laxatives) that can lower the levels of potassium in your blood Some medicines used for infections (antibiotics) such as pentamidine, erythromycin or amphotericin B Tetracosactide used to test the function of your adrenal gland Steroids used to lower inflammation such as prednisolone, betamethasone, dexamethasone Some medicines for depression such as imipramine Medicines for indigestion and heartburn Sucralfate used for stomach ulcers Medicines for pain relief. These may also be included in medicines for colds and flu Some medicines used for allergies (antihistamines that make you sleepy) such as chlorphenamine, promethazine, ketotifen Ropinorole used for Parkinsons disease Methadone used for pain relief and as a drug substitute Halofantrine used for malaria Taking Dolmatil Tablets with food and drink Do not drink alcohol or take medicines that contain alcohol while being treated with Dolmatil Tablets. This is because alcohol can increase the effects of Dolmatil Tablets. Pregnancy and breast-feeding Talk to your doctor or pharmacist before having
485977
this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Do not breast-feed if you are taking Dolmatil Tablets. This is because small amounts may pass into mothers milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking any medicine. The following symptoms may occur in newborn babies, of mothers that have used Dolmatil Tablets 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. 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 Dolmatil Tablets Lactose. Dolmatil Tablets contain lactose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Dolmatil tablets 3. How to take Dolmatil Tablets Always take Dolmatil Tablets 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 Swallow the tablets whole with a drink of water 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 The usual starting dose is 400mg (two 200mg or one 400mg tablet) to 800mg (four 200mg or two 400mg tablets) daily depending on your illness.
2
Your doctor may then change your dose depending on your illness Patients with Kidney Disease The starting dose may be lower and the rate of increasing the dose slower. Children under 14 years of age Dolmatil Tablets are not recommended for children under 14 years of age. If you take more Dolmatil Tablets than you should If you take more Dolmatil Tablets 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. The following effects may happen: feeling restless, confused or agitated, having a reduced level of consciousness, trembling, muscle stiffness or spasm, difficulty in movement, movements that you cannot control (for example of the eyes, neck, arms and legs), producing more saliva than usual. In some cases dizziness, lightheadedness, fainting (due to low blood pressure) and coma have happened. If you forget to take Dolmatil Tablets 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. If you stop taking Dolmatil Tablets Keep taking Dolmatil Tablets until your doctor tells you to stop. Do not stop taking Dolmatil Tablets just because you feel better. If you stop taking Dolmatil Tablets suddenly, your illness may come back and you may have other unwanted effects such as feeling or being sick, sweating and difficulty sleeping. In some cases you may also feel restless or have movements that you cannot control (for example of the eyes, neck, arms and legs). Your doctor will gradually lower your dose until you stop your medicine, to prevent these effects happening. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Dolmatil Tablets can cause side effects, although not everybody gets them.
485977
Stop taking Dolmatil Tablets and see a doctor or go to a hospital straight away if; You have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swelling You have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs You have fits 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 have very fast or very slow, uneven or forceful heartbeats. You may also have 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. You get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia) Tell a pharmacist or doctor as soon as possible if you have any of the following side effects: 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 Feeling restless and not being able to keep still (akathisia) Feeling aggressive, agitated or feeling impulsive Talk to your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: Abnormal production of breast milk in men and women Weight gain Breast enlargement or painful breasts in men and women Loss of menstrual periods Difficulty in getting or keeping an erection or in ejaculating (impotence) Feeling drowsy or sleepy Difficulty sleeping (insomnia) Skin rashes
3
Blood tests Dolmatil Tablets can increase the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly. 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. There have been very rare reports of sudden death with Dolmatil. 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 Dolmatil Tablets Keep this medicine in a safe place where children cannot see or reach it. Do not use Dolmatil Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store below 25C 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 Dolmatil Tablets contains Each 200mg tablet contains 200mg of the active substance, sulpiride The other ingredients in the 200mg tablets are: starch, lactose, methylcellulose, magnesium stearate, talc, colloidal hydrated silica Each 400mg tablet contains 400mg of the active substance, sulpiride The other ingredients in the 400mg tablets are: lactose, sodium starch glycollate, microcrystalline cellulose, hydroxypropylmethylcellulose and magnesium stearate What Dolmatil Tablets looks like and contents of the pack Dolmatil 200mg Tablets are plain white round tablets with D200 on one side and a breakline
485977
on the other. Supplied in blisters packs of 100 (10X10) tablets or glass bottles of 500 tablets. Dolmatil 400mg Tablets are white film coated stick shaped tablets with SLP 400 on one side and a break line on the other. Supplied in blisters packs of 100 (5X20) tablets. Not all pack sizes may be marketed. 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 Sanofi Winthrop Industrie, 6 Boulevard de LEurope, 21800 Quetigny, 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 10/2012 Sanofi, 1983 - 2012
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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.
