TOPAL TABLETS
Active substance: MAGNESIUM CARBONATE LIGHT
View full screen / Print PDF » Download PDF ⇩
Transcript
texte corp 8
210 x 157 mm
Ceuta Healthcare own label- will be marketed version
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 Topal contains Each tablet contains dried aluminium hydroxide 30mg, magnesium carbonate (light) 40mg and alginic acid 200mg. The other ingredients are sucrose, lactose monohydrate, silica gel, povidone, citric acid monohydrate, sodium hydrogen carbonate, caramel flavour, vanillin, strawberry flavour, magnesium stearate. What Topal looks like and contents of the pack Topal tablets are round, off-white or light cream coloured, flat faced bevel-edged chewable tablets, with a score line on one face. Each box of Topal contains PVC/Aluminium blisters as cards containing 14 tablets. A box of 14 tablets contains one blister card A box of 28 tablets contains two blister cards A box of 42 tablets contains three blister cards Not all pack sizes may be marketed MARKETING AUTHORISATION HOLDER PIERRE FABRE LIMITED Hyde Abbey House - 23 Hyde Street - Winchester Hampshire - SO23 7DR - United Kingdom Tel: 01962 874400 MANUFACTURER PIERRE FABRE MEDICAMENT PRODUCTION 45, place Abel-Gance - 92100 Boulogne - France Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product Name Reference Number Topal chewable tablets 00603/0021 This is a service provided by the Royal National Institute of the Blind. This leaflet was last approved in
January 2011
Imported into the U.K. by: CEUTA HEALTHCARE LTD Bournemouth - Dorset - BH2 6HS Tel : 01202 780 558
PACKAGE LEAFLET: INFORMATION FOR THE USER Topal chewable tablets (Dried Aluminium hydroxide 30 mg, Magnesium carbonate (light) 40 mg, Alginic acid 200 mg) Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Topal carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 5 days. 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 Topal is and what it is used for 2. Before you use Topal 3. How to take Topal 4. Possible side effects 5. How to store Topal 6. Further information 1. WHAT TOPAL IS AND WHAT IT IS USED FOR Topal chewable tablets belong to a group of medicines called antacids, which means they reduce the effect of stomach acid. Topal chewable tablets are used to relieve the pain and discomfort of heartburn and acid indigestion. They can also be used to treat the symptoms of conditions such as hiatus hernia, reflux sophagitis (inflamed food pipe) and gastritis (inflamed stomach).
NotTopalUKLogo.indd 1
19/10/09 13:53:25
Ceuta Healthcare own label- will be marketed version
2. BEFORE YOU USE TOPAL Do not use Topal if you are allergic (hypersensitive) to aluminium hydroxide, magnesium carbonate, alginic acid, or any of the other ingredients of Topal. Take special care with Topal Medicines are not always suitable for everyone. Speak to the pharmacist before taking this medicine if any of the following applies to you: You have kidney disease You are on a low phosphate diet. You are diabetic You have an intolerance to some sugars. You are on a controlled sodium diet. You have alkalosis (an imbalance of body fluids) You have hypermagnesaemia (too much magnesium in your blood). Taking other medicines Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as Topal can reduce the effectiveness in your body of some medicines taken at the same time. Some of these include medicines: Used to treat infections, such as antituberculosis drugs (ethambutol, isoniazide), tetracycline antibiotics, quinolone antibiotics (ciprofloxacin), and ketoconazole for an anti-fungal infection. Non-steroidal anti-inflammatory drugs (NSAIDs), which are painkillers (such as aspirin, indometacin, diflunisal), Bisphosphonates (a group of medicines used to treat bone disorders) Digoxin (a medicine use to treat heart conditions) Penicillamine (for rheumatoid arthritis), Chloroquine (to treat malaria), Antihistaminics H2, (medicines used to treat stomach acid and ulcer problems), Glucocorticoids (steroid drugs used to treat some allergic, inflammatory or auto-immune disorders) Phenothiazinic neuroleptics, such as chlorpromazine and sulpiride used to treat mental illness such as psychosis Iron salts (iron supplements) Thyroid hormones (medicines used to regulate the activity of your thyroid). It is recommended that you do not take Topal at the same time as these medicines but take it at least 2 hours later. Pregnancy and Breast-feeding If you are pregnant, think you might be pregnant, planning to get pregnant or are breast-feeding, you should not use Topal unless your doctor has told you that it is safe to do so. Important information about some of the ingredients of Topal Topal contains lactose and sucrose (types of sugar). If you are diabetic or if you
have been told by your doctor that you have an intolerance to some sugars, please contact your doctor or your pharmacist before taking this medicine. One tablet of this medicine contains 11 mg of sodium; take this into account if you are on a controlled sodium diet. 3. HOW TO TAKE TOPAL Adults including the elderly The usual dose is one to three tablets four times a day, preferably taken after meals with the last dose taken at bedtime. The tablets should be chewed. Children The usual dose is half a tablet to one and a half tablets four times a day, preferably taken after meals with the last dose taken at bedtime. The tablets should be chewed. If your symptoms do not improve after 5 days you should contact your doctor or pharmacist. If you take more Topal than you should If you accidentally take too many tablets contact your doctor at once or go to the nearest hospital casualty department. Always take the medicine package with you, whether there are any tablets left or not. If you forget to use Topal If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose. If you have any further questions on how to take this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Topal can cause side effects, although not everybody gets them. The side-effects seen with Topal are: Constipation, diarrhoea. Decreased phosphate levels and symptoms of hypophosphatemia such as muscle weakness, tingling sensations, tremors and bone weakness. 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. 5. HOW TO STORE TOPAL Keep out of the reach and sight of children. Do not use Topal after the expiry date which is stamped on the blister and the outer carton. The expiry date refers to the last day of that month. Do not store above 30 C. Keep the blisters in the outer carton in order to protect from moisture.
NotTopalUKLogo.indd 2
19/10/09 13:53:27
210 x 157 mm
Ceuta Healthcare own label- will be marketed version
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 Topal contains Each tablet contains dried aluminium hydroxide 30mg, magnesium carbonate (light) 40mg and alginic acid 200mg. The other ingredients are sucrose, lactose monohydrate, silica gel, povidone, citric acid monohydrate, sodium hydrogen carbonate, caramel flavour, vanillin, strawberry flavour, magnesium stearate. What Topal looks like and contents of the pack Topal tablets are round, off-white or light cream coloured, flat faced bevel-edged chewable tablets, with a score line on one face. Each box of Topal contains PVC/Aluminium blisters as cards containing 14 tablets. A box of 14 tablets contains one blister card A box of 28 tablets contains two blister cards A box of 42 tablets contains three blister cards Not all pack sizes may be marketed MARKETING AUTHORISATION HOLDER PIERRE FABRE LIMITED Hyde Abbey House - 23 Hyde Street - Winchester Hampshire - SO23 7DR - United Kingdom Tel: 01962 874400 MANUFACTURER PIERRE FABRE MEDICAMENT PRODUCTION 45, place Abel-Gance - 92100 Boulogne - France Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product Name Reference Number Topal chewable tablets 00603/0021 This is a service provided by the Royal National Institute of the Blind. This leaflet was last approved in
January 2011
Imported into the U.K. by: CEUTA HEALTHCARE LTD Bournemouth - Dorset - BH2 6HS Tel : 01202 780 558
PACKAGE LEAFLET: INFORMATION FOR THE USER Topal chewable tablets (Dried Aluminium hydroxide 30 mg, Magnesium carbonate (light) 40 mg, Alginic acid 200 mg) Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Topal carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 5 days. 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 Topal is and what it is used for 2. Before you use Topal 3. How to take Topal 4. Possible side effects 5. How to store Topal 6. Further information 1. WHAT TOPAL IS AND WHAT IT IS USED FOR Topal chewable tablets belong to a group of medicines called antacids, which means they reduce the effect of stomach acid. Topal chewable tablets are used to relieve the pain and discomfort of heartburn and acid indigestion. They can also be used to treat the symptoms of conditions such as hiatus hernia, reflux sophagitis (inflamed food pipe) and gastritis (inflamed stomach).
NotTopalUKLogo.indd 1
19/10/09 13:53:25
Ceuta Healthcare own label- will be marketed version
2. BEFORE YOU USE TOPAL Do not use Topal if you are allergic (hypersensitive) to aluminium hydroxide, magnesium carbonate, alginic acid, or any of the other ingredients of Topal. Take special care with Topal Medicines are not always suitable for everyone. Speak to the pharmacist before taking this medicine if any of the following applies to you: You have kidney disease You are on a low phosphate diet. You are diabetic You have an intolerance to some sugars. You are on a controlled sodium diet. You have alkalosis (an imbalance of body fluids) You have hypermagnesaemia (too much magnesium in your blood). Taking other medicines Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as Topal can reduce the effectiveness in your body of some medicines taken at the same time. Some of these include medicines: Used to treat infections, such as antituberculosis drugs (ethambutol, isoniazide), tetracycline antibiotics, quinolone antibiotics (ciprofloxacin), and ketoconazole for an anti-fungal infection. Non-steroidal anti-inflammatory drugs (NSAIDs), which are painkillers (such as aspirin, indometacin, diflunisal), Bisphosphonates (a group of medicines used to treat bone disorders) Digoxin (a medicine use to treat heart conditions) Penicillamine (for rheumatoid arthritis), Chloroquine (to treat malaria), Antihistaminics H2, (medicines used to treat stomach acid and ulcer problems), Glucocorticoids (steroid drugs used to treat some allergic, inflammatory or auto-immune disorders) Phenothiazinic neuroleptics, such as chlorpromazine and sulpiride used to treat mental illness such as psychosis Iron salts (iron supplements) Thyroid hormones (medicines used to regulate the activity of your thyroid). It is recommended that you do not take Topal at the same time as these medicines but take it at least 2 hours later. Pregnancy and Breast-feeding If you are pregnant, think you might be pregnant, planning to get pregnant or are breast-feeding, you should not use Topal unless your doctor has told you that it is safe to do so. Important information about some of the ingredients of Topal Topal contains lactose and sucrose (types of sugar). If you are diabetic or if you
have been told by your doctor that you have an intolerance to some sugars, please contact your doctor or your pharmacist before taking this medicine. One tablet of this medicine contains 11 mg of sodium; take this into account if you are on a controlled sodium diet. 3. HOW TO TAKE TOPAL Adults including the elderly The usual dose is one to three tablets four times a day, preferably taken after meals with the last dose taken at bedtime. The tablets should be chewed. Children The usual dose is half a tablet to one and a half tablets four times a day, preferably taken after meals with the last dose taken at bedtime. The tablets should be chewed. If your symptoms do not improve after 5 days you should contact your doctor or pharmacist. If you take more Topal than you should If you accidentally take too many tablets contact your doctor at once or go to the nearest hospital casualty department. Always take the medicine package with you, whether there are any tablets left or not. If you forget to use Topal If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose. If you have any further questions on how to take this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Topal can cause side effects, although not everybody gets them. The side-effects seen with Topal are: Constipation, diarrhoea. Decreased phosphate levels and symptoms of hypophosphatemia such as muscle weakness, tingling sensations, tremors and bone weakness. 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. 5. HOW TO STORE TOPAL Keep out of the reach and sight of children. Do not use Topal after the expiry date which is stamped on the blister and the outer carton. The expiry date refers to the last day of that month. Do not store above 30 C. Keep the blisters in the outer carton in order to protect from moisture.
NotTopalUKLogo.indd 2
19/10/09 13:53:27
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.
