Mandibular Osteonecrosis Associated with Antacid Therapy ...
BISODOL® ANTACID CHEWABLE TABLETS If you … · min pt size: 8pt 1. black 2. pms 286 ... SA...
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dimensions: 117 x 320 pharmacode: date sent: 30.07.15 Technical Approval min pt size: 8pt 1. black 2. pms 286 3. pms 288 4. pms 2995 5. 6. 1. Profile 2. Bisodol Original Peppermint 522mg, 68mg 64mg 100 Tablets PIL - Ireland item no: AAAI1732 print proof no: 06 origination date: 30.07.15 originated by: DR revision date: 25-08-2015 supplier: Brunel Healthcare technically app. date: Non Printing Colours colours/plates 3. revised by: SA approved for print/date BISODOL® ANTACID CHEWABLE TABLETS Calcium Carbonate 522 mg, Magnesium Carbonate, Light 68 mg, Sodium Hydrogen Carbonate 64 mg. Read all of this leaflet carefully before you start using this medicine, because it contains important information for you. This medicine is available without prescription. However, you still need to take Bisodol Antacid Tablets carefully to get the best results. • Always use this medicine exactly as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must contact a doctor if your signs of illness worsen or do not improve. What is in this leaflet: 1. What Bisodol Antacid Chewable Tablets are and what they are used for 2. What you need to know before you take Bisodol Antacid Chewable Tablets 3. How to take Bisodol Antacid Chewable Tablets 4. Possible side effects 5. How to store Bisodol Antacid Chewable Tablets 6. Contents of the pack and other information 1. What Bisodol Antacid Chewable Tablets are and what they are used for Bisodol Antacid Tablets are chewable tablets. They work by neutralising excess stomach acid. Bisodol Antacid Tablets treat the pain and discomfort of acid indigestion, heartburn and trapped wind. 2. What you need to know before you take Bisodol Antacid Chewable Tablets Do not take Bisodol Antacid Tablets: • If you are allergic to any of the ingredients of this medicine (listed in section 6). • If you have been told the level of phosphate in your blood is low (hypophosphataemia). • If you have kidney problems. • If you have been told the level of calcium in your blood is high (hypercalcaemia) or the level of calcium in your urine is high (hypercalciuria). Warnings and Precautions Talk to your Doctor or Pharmacist before taking Bisodol: Bisodol contains sodium and sucrose • This medicinal product also contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. • May be harmful to the teeth. • This medicinal product contains 18 mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet. Other medicines and Bisodol Antacid Chewable Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. As with other antacids, Bisodol Antacid Tablets may form complexes with certain medicines e.g. tetracyclines, digoxin and vitamins resulting in their decreased absorption. Therefore, this medicine should not be administered within two hours of taking such medicines. Bisodol Antacid Tablets may also impede the absorption of phosphates. If you are taking iron tablets speak to your doctor or pharmacist before taking Bisodol Antacid Tablets. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You should see your doctor if: • You are aged over 55 years and experiencing heartburn for the first time. • You have pain radiating to your chest and arms. • You feel unwell. • You have unintentional weight loss or loss of appetite. • You have difficulty or pain swallowing. • You are passing blood or have dark bowel motions. 3. How to take Bisodol Antacid Chewable Tablets Always take this medicine as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: • Adults, the elderly and children over 12 years Suck or chew one or two tablets, as required • Children under 12 years Not recommended. Do not take more than 12 tablets in 24 hours. Prolonged use should be avoided. If the symptoms persist medical advice should be sought. If you take more Bisodol Antacid Tablets than you should It is unlikely that they will cause you any harm. However, you may experience constipation, diarrhoea or feel bloated. Consult your doctor if these symptoms do not go away. If you stop taking Bisodol Antacid Tablets If you stop taking this medicine after you have been taking them for a long time, you may suffer a temporary worsening of symptoms. This is called rebound hyperacidity. Consult your doctor if this symptom does not go away. If you have any further questions on the use of this medicine, ask your pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience side effects such as constipation or diarrhoea. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected]. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Bisodol Antacid Chewable Tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date printed on the pack after the abbreviation ‘EXP’. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Bisodol Antacid Tablets contain: The active ingredients are calcium carbonate 522 mg, magnesium carbonate, light 68 mg and sodium hydrogen carbonate 64 mg. The other ingredients are saccharin sodium, maize starch, sucrose, calcium stearate and peppermint oil flavouring. What Bisodol Antacid Tablets look like and contents of the pack Bisodol Antacid Tablets are chewable tablets. They are round, white tablets with Bisodol imprinted on both sides. Bisodol Antacid Tablets are available in packs of 20, 30 and 100 tablets. Not all pack sizes may be marketed. Patients in the Republic of Ireland with visual impairment requiring this information in other formats should telephone Forest Laboratories UK Ltd on +44 (0)1322 421800 Marketing Authorisation Holder Forest Laboratories UK Ltd; Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. Manufacturer Brunel Healthcare Manufacturing Ltd, Swadlincote, Derbyshire DE11 0BB, UK PA 100/47/1 This leaflet was last revised in June 2015 AAAI1732 AAAI1732 Package leaflet: Information for the user Antacid Chewable Tablets
Transcript of BISODOL® ANTACID CHEWABLE TABLETS If you … · min pt size: 8pt 1. black 2. pms 286 ... SA...
dimensions: 117 x 320
pharmacode:
date sent: 30.07.15
Technical Approval
min pt size: 8pt
1. black
2. pms 286
3. pms 288
4. pms 2995
5.
6.
1. Profile
2.
Bisodol Original Peppermint 522mg, 68mg 64mg 100 Tablets PIL - Ireland
item no: AAAI1732
print proof no: 06
origination date: 30.07.15
originated by: DR
revision date: 25-08-2015
supplier: Brunel Healthcare technically app. date:
Non Printing Colours
colours/plates
3.
revised by: SA
approved for print/date
BISODOL® ANTACID CHEWABLE TABLETSCalcium Carbonate 522 mg, Magnesium Carbonate, Light 68 mg, Sodium Hydrogen Carbonate 64 mg.
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.This medicine is available without prescription. However, you still need to take Bisodol Antacid Tablets carefully to get the best results.
• Always use this medicine exactly as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.• Ask your pharmacist if you need more information or advice.• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must contact a doctor if your signs of illness worsen or do not improve.
What is in this leaflet:1. What Bisodol Antacid Chewable Tablets are and what they are
used for2. What you need to know before you take Bisodol Antacid
Chewable Tablets3. How to take Bisodol Antacid Chewable Tablets4. Possible side effects5. How to store Bisodol Antacid Chewable Tablets6. Contents of the pack and other information
1. What Bisodol Antacid Chewable Tablets are and what theyare used for
Bisodol Antacid Tablets are chewable tablets. They work by neutralising excess stomach acid. Bisodol Antacid Tablets treat the pain and discomfort of acid indigestion, heartburn and trapped wind.
2. What you need to know before you take Bisodol Antacid Chewable Tablets
Do not take Bisodol Antacid Tablets:• If you are allergic to any of the ingredients of this medicine
(listed in section 6).• If you have been told the level of phosphate in your blood is low
(hypophosphataemia).• If you have kidney problems.• If you have been told the level of calcium in your blood is high
(hypercalcaemia) or the level of calcium in your urine is high (hypercalciuria).
Warnings and PrecautionsTalk to your Doctor or Pharmacist before taking Bisodol:
Bisodol contains sodium and sucrose• This medicinal product also contains sucrose. If you have been
told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• May be harmful to the teeth.• This medicinal product contains 18 mg sodium per tablet. To be
taken into consideration by patients on a controlled sodium diet.
Other medicines and Bisodol Antacid Chewable TabletsTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
As with other antacids, Bisodol Antacid Tablets may form complexes with certain medicines e.g. tetracyclines, digoxin and vitamins resulting in their decreased absorption. Therefore, this medicine should not be administered within two hours of taking such medicines.Bisodol Antacid Tablets may also impede the absorption of phosphates. If you are taking iron tablets speak to your doctor or pharmacist before taking Bisodol Antacid Tablets.
Pregnancy and breast-feedingAsk your doctor or pharmacist for advice before taking any medicine.
You should see your doctor if:• You are aged over 55 years and experiencing heartburn for the
first time.• You have pain radiating to your chest and arms.• You feel unwell.• You have unintentional weight loss or loss of appetite.• You have difficulty or pain swallowing.• You are passing blood or have dark bowel motions.
3. How to take Bisodol Antacid Chewable TabletsAlways take this medicine as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.The recommended dose is:• Adults, the elderly and children over 12 years Suck or chew one or two tablets, as required• Children under 12 years Not recommended.Do not take more than 12 tablets in 24 hours. Prolonged use should be avoided. If the symptoms persist medical advice should be sought.
If you take more Bisodol Antacid Tablets than you shouldIt is unlikely that they will cause you any harm.However, you may experience constipation, diarrhoea or feel bloated. Consult your doctor if these symptoms do not go away.
If you stop taking Bisodol Antacid TabletsIf you stop taking this medicine after you have been taking them for a long time, you may suffer a temporary worsening of symptoms. This is called rebound hyperacidity. Consult your doctor if this symptom does not go away.If you have any further questions on the use of this medicine, ask your pharmacist.
4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience side effects such as constipation or diarrhoea.
Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bisodol Antacid Chewable TabletsKeep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the pack after the abbreviation ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other informationWhat Bisodol Antacid Tablets contain:The active ingredients are calcium carbonate 522 mg, magnesium carbonate, light 68 mg and sodium hydrogen carbonate 64 mg.The other ingredients are saccharin sodium, maize starch, sucrose, calcium stearate and peppermint oil flavouring.
What Bisodol Antacid Tablets look like and contents of the packBisodol Antacid Tablets are chewable tablets. They are round, white tablets with Bisodol imprinted on both sides. Bisodol Antacid Tablets are available in packs of 20, 30 and 100 tablets.
Not all pack sizes may be marketed.
Patients in the Republic of Ireland with visual impairment requiring this information in other formats should telephone Forest Laboratories UK Ltd on +44 (0)1322 421800
Marketing Authorisation HolderForest Laboratories UK Ltd;Whiddon Valley, Barnstaple,North Devon, EX32 8NS,United Kingdom.
ManufacturerBrunel HealthcareManufacturing Ltd,Swadlincote,Derbyshire DE11 0BB, UK
PA 100/47/1
This leaflet was last revised in June 2015
AAAI1732
AAAI1732
Package leaflet: Information for the user
Antacid Chewable Tablets
