SPASMONAL CAPSULES
Active substance: ALVERINE CITRATE
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5. How to store SPASMONAL
Keep all medicines out of the reach and sight of children. Do not store above 25C and store in a dry place. Do not use SPASMONAL after the expiry date which is printed or embossed on the carton and blister as month/year. The expiry date refers to the last day of the month.
Spasmonal alverine citrate
60 mg
6. Further information
What SPASMONAL contains The active substance is alverine citrate. Each capsule contains 60 milligrams of alverine citrate. The other ingredients are maize starch, magnesium stearate, gelatin and colours (E132, E171 and E172). What SPASMONAL looks like and contents of the pack Each carton contains 3, 10, 12, 20, 90 or 100 blue/grey capsules marked SP 60 in blisters. The Marketing Authorisation Holder in the UK is Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, CM22 6PU, United Kingdom. Manufacturer: Norgine Ltd, Hengoed, Mid Glamorgan CF82 8HJ, UK.
Read all of this leaflet carefully before you start taking this medicine. * Keep this leaflet. You may need to read it again. * f you have any further questions, ask your doctor I or pharmacist. * his medicine has been prescribed for you. Do not T pass it on to others. It may harm them, even if their symptoms are the same as yours. * f any of the side effects become serious, or if you I notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet: 1. What SPASMONAL is and what it is used for 2. Before you take SPASMONAL 3. How to take SPASMONAL 4. Possible side effects 5. How to store SPASMONAL 6. Further information
1. What SPASMONAL is and what it is used for
SPASMONAL is an anti-spasmodic medicine. It relaxes the muscles in the intestine (gut) and uterus (womb). This helps stop the pain you feel when the muscles become tense. It is used to help people who have Irritable Bowel Syndrome ( IBS), some of the symptoms of IBS are: * Abdominal pains like cramp which come and go * Diarrhoea * Constipation * Feeling full and bloated * Wanting to go to the toilet urgently Sometimes these symptoms are worse if you are worried or under stress. SPASMONAL can also be used for a condition of the large intestine called painful diverticular disease of the colon and to relieve period pains.
Health tips for you
Try to make your everyday life a bit healthier: * Allow plenty of time to do things, and avoid stress * Do not rush meals * Try to eat a balanced diet with high fibre foods * Do not eat foods which seem to make your IBS worse The leaflet was last approved in November 2011
56UK2060120-00 78616102
0212_GI_Spasmonal_60mg_56UK2060120-00.indd 1
23.02.12 17:29
2. Before you take SPASMONAL
If this is the first time you have had these symptoms, consult your doctor before using any treatment. Do not take SPASMONAL if: * ou are allergic (hypersensitive) to alverine citrate or Y any of the other ingredients of SPASMONAL. * our doctor has told you that you have obstruction of Y the gut or that your small bowel is not working properly. Do not take SPASMONAL if any of the following apply to you, it may not be the right treatment for you. See your doctor as soon as possible if: * ou are aged 40 years or over Y * ou have passed blood from the bowel Y * ou are feeling sick or vomiting Y * ou have lost your appetite or lost weight Y Y * ou are looking pale and feeling tired * ou are suffering from severe constipation Y Y * ou have a fever * ou have recently travelled abroad Y * ou are, or may be, pregnant Y * ou are breast feeding Y * ou have abnormal vaginal bleeding or discharge Y * ou have difficulty or pain passing urine Y Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking SPASMONAL with food and drink It does not matter if you take SPASMONAL with or without food. Pregnancy and breast-feeding Do not take SPASMONAL during pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines If you feel dizzy while taking SPASMONAL you should a void driving or operating machinery.
3. How to take SPASMONAL
Always take SPASMONAL exactly as your doctor has told you. * he usual dose is 1 or 2 capsules taken up to 3 times a T day. You should check with your doctor or pharmacist if you are not sure. SPASMONAL is not suitable for children under 12 years old. If you take more SPASMONAL than you should, contact a doctor. If you forget to take SPASMONAL, take it when you remember. If you forget for more than 4 hours, just take the next dose when you remember it is due. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, SPASMONAL can cause side effects, although not everybody gets them. Stop taking SPASMONAL and see your doctor as soon as possible if you notice: * ellowing of the whites of the eyes and the skin, as Y inflammation of the liver has been known to occur. * ifficulties in breathing, shortness of breath, wheezing, D swelling of your face or other parts of your body, as s erious allergic reactions have been known to occur. Other side effects may include: * a feeling of sickness or dizziness, * headache, * allergic reactions, which may include itching or skin rash. If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
56UK2060120-00 78616102
23.02.12 17:29
Keep all medicines out of the reach and sight of children. Do not store above 25C and store in a dry place. Do not use SPASMONAL after the expiry date which is printed or embossed on the carton and blister as month/year. The expiry date refers to the last day of the month.
Spasmonal alverine citrate
60 mg
6. Further information
What SPASMONAL contains The active substance is alverine citrate. Each capsule contains 60 milligrams of alverine citrate. The other ingredients are maize starch, magnesium stearate, gelatin and colours (E132, E171 and E172). What SPASMONAL looks like and contents of the pack Each carton contains 3, 10, 12, 20, 90 or 100 blue/grey capsules marked SP 60 in blisters. The Marketing Authorisation Holder in the UK is Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, CM22 6PU, United Kingdom. Manufacturer: Norgine Ltd, Hengoed, Mid Glamorgan CF82 8HJ, UK.
Read all of this leaflet carefully before you start taking this medicine. * Keep this leaflet. You may need to read it again. * f you have any further questions, ask your doctor I or pharmacist. * his medicine has been prescribed for you. Do not T pass it on to others. It may harm them, even if their symptoms are the same as yours. * f any of the side effects become serious, or if you I notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet: 1. What SPASMONAL is and what it is used for 2. Before you take SPASMONAL 3. How to take SPASMONAL 4. Possible side effects 5. How to store SPASMONAL 6. Further information
1. What SPASMONAL is and what it is used for
SPASMONAL is an anti-spasmodic medicine. It relaxes the muscles in the intestine (gut) and uterus (womb). This helps stop the pain you feel when the muscles become tense. It is used to help people who have Irritable Bowel Syndrome ( IBS), some of the symptoms of IBS are: * Abdominal pains like cramp which come and go * Diarrhoea * Constipation * Feeling full and bloated * Wanting to go to the toilet urgently Sometimes these symptoms are worse if you are worried or under stress. SPASMONAL can also be used for a condition of the large intestine called painful diverticular disease of the colon and to relieve period pains.
Health tips for you
Try to make your everyday life a bit healthier: * Allow plenty of time to do things, and avoid stress * Do not rush meals * Try to eat a balanced diet with high fibre foods * Do not eat foods which seem to make your IBS worse The leaflet was last approved in November 2011
56UK2060120-00 78616102
0212_GI_Spasmonal_60mg_56UK2060120-00.indd 1
23.02.12 17:29
2. Before you take SPASMONAL
If this is the first time you have had these symptoms, consult your doctor before using any treatment. Do not take SPASMONAL if: * ou are allergic (hypersensitive) to alverine citrate or Y any of the other ingredients of SPASMONAL. * our doctor has told you that you have obstruction of Y the gut or that your small bowel is not working properly. Do not take SPASMONAL if any of the following apply to you, it may not be the right treatment for you. See your doctor as soon as possible if: * ou are aged 40 years or over Y * ou have passed blood from the bowel Y * ou are feeling sick or vomiting Y * ou have lost your appetite or lost weight Y Y * ou are looking pale and feeling tired * ou are suffering from severe constipation Y Y * ou have a fever * ou have recently travelled abroad Y * ou are, or may be, pregnant Y * ou are breast feeding Y * ou have abnormal vaginal bleeding or discharge Y * ou have difficulty or pain passing urine Y Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking SPASMONAL with food and drink It does not matter if you take SPASMONAL with or without food. Pregnancy and breast-feeding Do not take SPASMONAL during pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines If you feel dizzy while taking SPASMONAL you should a void driving or operating machinery.
3. How to take SPASMONAL
Always take SPASMONAL exactly as your doctor has told you. * he usual dose is 1 or 2 capsules taken up to 3 times a T day. You should check with your doctor or pharmacist if you are not sure. SPASMONAL is not suitable for children under 12 years old. If you take more SPASMONAL than you should, contact a doctor. If you forget to take SPASMONAL, take it when you remember. If you forget for more than 4 hours, just take the next dose when you remember it is due. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, SPASMONAL can cause side effects, although not everybody gets them. Stop taking SPASMONAL and see your doctor as soon as possible if you notice: * ellowing of the whites of the eyes and the skin, as Y inflammation of the liver has been known to occur. * ifficulties in breathing, shortness of breath, wheezing, D swelling of your face or other parts of your body, as s erious allergic reactions have been known to occur. Other side effects may include: * a feeling of sickness or dizziness, * headache, * allergic reactions, which may include itching or skin rash. If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
56UK2060120-00 78616102
23.02.12 17:29
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.
