NOZINAN 25MG TABLETS
Active substance: LEVOMEPROMAZINE MALEATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nozinan 25mg Tablets
levomepromazine maleate 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. - Please 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 you suffer from any side effects that get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Nozinan Tablets are and what they are used for 2. Before you take Nozinan Tablets 3. How to take Nozinan Tablets 4. Possible side effects 5. How to store Nozinan Tablets 6. Further information 1. What Nozinan Tablets are and what they are used for
already know you have low levels of potassium, calcium or magnesium in your blood find it difficult, or are unable, to eat are an alcoholic. Additional tests will be done by your doctor at the start of treatment if you are taking Nozinan Tablets for a long period of time, or if you are taking other medicines at the same time such as heart drugs, antidepressants or drugs for mental health disorders. These tests might include an ECG (electrocardiogram) to check your heart is working normally and/or blood tests. If you have to go to the dentist or hospital for any reason, tell them that you are taking Nozinan Tablets. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may change the way Nozinan Tablets work. These include: medicines for the treatment of irregular heartbeats antidepressants and drugs for other mental health disorders (i.e. antipsychotics) desferrioxamine (for iron poisoning) adrenaline (epinephrine) in patients overdosed with antipsychotic drugs. Taking with food and drink Avoid alcohol while you are taking these tablets. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist before taking Nozinan Tablets or any other medicine. The following symptoms may occur in newborn babies, of mothers that have used Nozinan 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. Driving and using machines Do not drive or operate machinery if taking Nozinan Tablets as they may make you feel drowsy, confused, dizzy or lightheaded. 3. HOW TO TAKE NOZINAN TABLETS Always take this medicine exactly as your doctor has told you; you should check with him/her if you are not sure. The tablets should be swallowed whole with a glass of water. Schizophrenia Adults - the initial dose is usually 1 to 2 tablets a day, divided into three doses. If you are confined to bed, the initial dose may be 4 to 8 tablets a day, divided into three doses. These doses may be
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Nozinan Tablets belong to a group of medicines called phenothiazines and are used for: schizophrenia the relief of pain and the accompanying distress in terminally ill patients. 2. BEFORE YOU TAKE NOZINAN TABLETS Do NOT take Nozinan Tablets if: You are allergic (hypersensitive) to levomepromazine maleate or any of the other ingredients in the product (see Section 6). Take special care with Nozinan Tablets Consult your doctor if you: have liver problems are elderly, frail or have heart disease as you may feel faint or light-headed when you take the tablets (if you have a large initial dose, you will have to stay in bed) suffer from slow or irregular heartbeats/ palpitations (Torsades de Pointes), or have a family history of heart problems or someone else in your family have a history of blood clots, as medicines like these have been associated with formation of blood clots suffer from dementia and are elderly have been told by your doctor that you might have a stroke are diabetic or have been told you have an increased risk of having diabetes
75 mm
increased in small steps until a suitable dose is found for you. Elderly - your doctor will decide whether these tablets are appropriate for you and will tell you how many to take. Children - will normally be given no more than 1 1/2 tablets a day. Pain management Adults and Elderly - 1/2 to 2 tablets every four to eight hours; the dose may be varied until a suitable dose is found for you. Children - these tablets are NOT recommended for children for treating pain. If you take more Nozinan Tablets than you should If you, or a child, accidentally swallow too many tablets, contact your doctor or nearest hospital casualty department immediately. Symptoms of overdose include: drowsiness or loss of consciousness, low blood pressure, irregular heartbeats, hypothermia (abnormally low body temperature) and severe extrapyramidal dyskinesias (involuntary movements). If you forget to take Nozinan Tablets If you miss a dose, just take your tablets as soon as you remember then carry on as before. Do not take a double dose to make up for the forgotten one. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nozinan Tablets can cause side effects, although not everybody gets them. STOP taking the tablets and SEEK medical help immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps. Frequent side effects include: sleepiness, weakness and dry mouth. Tell your doctor IMMEDIATELY if you experience any of the following: dizziness, feeling faint or loss of alertness fever, ulceration of the mouth or throat, or sore throat stiffness, shaking (tremor) or slow movement 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 low blood pressure, especially in elderly patients heart palpitations (usually rapid or irregular heartbeats) blood abnormalities jaundice (yellowing of the skin and eyes)
constipation, which may become severe and stop food moving through the bowel heat stroke high temperature, sweating, pale complexion, difficulty in passing urine colicky abdominal pain with bloody diarrhoea skin irritation or burning due to sensitivity to sunlight unwanted and persistent erections. Other side effects include: high blood sugar (hyperglycaemia). 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. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. HOW TO STORE NOZINAN TABLETS Keep out of the reach and sight of children. Store in the original container below 25C and protect from light. Do not use the product after the expiry date EXP (last day of the month stated) printed on the blister and carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicine no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nozinan Tablets contain The active ingredient is levomepromazine maleate, 25mg per tablet. The other ingredients are potato starch, calcium hydrogen phosphate, magnesium stearate and sodium lauryl sulfate. What Nozinan Tablets look like and contents of the pack The tablets are round, greyish-white or cream, with one side marked NOZINAN 25 and a break line on the other side. They are supplied in blister packs containing 84 tablets or plastic bottles containing 500 tablets. Not all pack sizes may be marketed. 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-aventis S.p.A. Viale Europa 11, 21040 Origgio VA, Italy Nozinan is a registered trade mark. This leaflet was last revised in 07/2012 Sanofi, 2012
4850061A 599514-TO-NOZT084-PIL10A
44 mm
Nozinan 25mg Tablets
levomepromazine maleate 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. - Please 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 you suffer from any side effects that get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Nozinan Tablets are and what they are used for 2. Before you take Nozinan Tablets 3. How to take Nozinan Tablets 4. Possible side effects 5. How to store Nozinan Tablets 6. Further information 1. What Nozinan Tablets are and what they are used for
already know you have low levels of potassium, calcium or magnesium in your blood find it difficult, or are unable, to eat are an alcoholic. Additional tests will be done by your doctor at the start of treatment if you are taking Nozinan Tablets for a long period of time, or if you are taking other medicines at the same time such as heart drugs, antidepressants or drugs for mental health disorders. These tests might include an ECG (electrocardiogram) to check your heart is working normally and/or blood tests. If you have to go to the dentist or hospital for any reason, tell them that you are taking Nozinan Tablets. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may change the way Nozinan Tablets work. These include: medicines for the treatment of irregular heartbeats antidepressants and drugs for other mental health disorders (i.e. antipsychotics) desferrioxamine (for iron poisoning) adrenaline (epinephrine) in patients overdosed with antipsychotic drugs. Taking with food and drink Avoid alcohol while you are taking these tablets. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist before taking Nozinan Tablets or any other medicine. The following symptoms may occur in newborn babies, of mothers that have used Nozinan 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. Driving and using machines Do not drive or operate machinery if taking Nozinan Tablets as they may make you feel drowsy, confused, dizzy or lightheaded. 3. HOW TO TAKE NOZINAN TABLETS Always take this medicine exactly as your doctor has told you; you should check with him/her if you are not sure. The tablets should be swallowed whole with a glass of water. Schizophrenia Adults - the initial dose is usually 1 to 2 tablets a day, divided into three doses. If you are confined to bed, the initial dose may be 4 to 8 tablets a day, divided into three doses. These doses may be
i
Nozinan Tablets belong to a group of medicines called phenothiazines and are used for: schizophrenia the relief of pain and the accompanying distress in terminally ill patients. 2. BEFORE YOU TAKE NOZINAN TABLETS Do NOT take Nozinan Tablets if: You are allergic (hypersensitive) to levomepromazine maleate or any of the other ingredients in the product (see Section 6). Take special care with Nozinan Tablets Consult your doctor if you: have liver problems are elderly, frail or have heart disease as you may feel faint or light-headed when you take the tablets (if you have a large initial dose, you will have to stay in bed) suffer from slow or irregular heartbeats/ palpitations (Torsades de Pointes), or have a family history of heart problems or someone else in your family have a history of blood clots, as medicines like these have been associated with formation of blood clots suffer from dementia and are elderly have been told by your doctor that you might have a stroke are diabetic or have been told you have an increased risk of having diabetes
75 mm
increased in small steps until a suitable dose is found for you. Elderly - your doctor will decide whether these tablets are appropriate for you and will tell you how many to take. Children - will normally be given no more than 1 1/2 tablets a day. Pain management Adults and Elderly - 1/2 to 2 tablets every four to eight hours; the dose may be varied until a suitable dose is found for you. Children - these tablets are NOT recommended for children for treating pain. If you take more Nozinan Tablets than you should If you, or a child, accidentally swallow too many tablets, contact your doctor or nearest hospital casualty department immediately. Symptoms of overdose include: drowsiness or loss of consciousness, low blood pressure, irregular heartbeats, hypothermia (abnormally low body temperature) and severe extrapyramidal dyskinesias (involuntary movements). If you forget to take Nozinan Tablets If you miss a dose, just take your tablets as soon as you remember then carry on as before. Do not take a double dose to make up for the forgotten one. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nozinan Tablets can cause side effects, although not everybody gets them. STOP taking the tablets and SEEK medical help immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps. Frequent side effects include: sleepiness, weakness and dry mouth. Tell your doctor IMMEDIATELY if you experience any of the following: dizziness, feeling faint or loss of alertness fever, ulceration of the mouth or throat, or sore throat stiffness, shaking (tremor) or slow movement 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 low blood pressure, especially in elderly patients heart palpitations (usually rapid or irregular heartbeats) blood abnormalities jaundice (yellowing of the skin and eyes)
constipation, which may become severe and stop food moving through the bowel heat stroke high temperature, sweating, pale complexion, difficulty in passing urine colicky abdominal pain with bloody diarrhoea skin irritation or burning due to sensitivity to sunlight unwanted and persistent erections. Other side effects include: high blood sugar (hyperglycaemia). 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. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. HOW TO STORE NOZINAN TABLETS Keep out of the reach and sight of children. Store in the original container below 25C and protect from light. Do not use the product after the expiry date EXP (last day of the month stated) printed on the blister and carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicine no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nozinan Tablets contain The active ingredient is levomepromazine maleate, 25mg per tablet. The other ingredients are potato starch, calcium hydrogen phosphate, magnesium stearate and sodium lauryl sulfate. What Nozinan Tablets look like and contents of the pack The tablets are round, greyish-white or cream, with one side marked NOZINAN 25 and a break line on the other side. They are supplied in blister packs containing 84 tablets or plastic bottles containing 500 tablets. Not all pack sizes may be marketed. 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-aventis S.p.A. Viale Europa 11, 21040 Origgio VA, Italy Nozinan is a registered trade mark. This leaflet was last revised in 07/2012 Sanofi, 2012
4850061A 599514-TO-NOZT084-PIL10A
44 mm
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.
