Mastical 500mg Chewable Tablets
Ref: 1293/141215/1/F
Calcichew ® 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Calcichew 500mg Chewable Tablets 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 two weeks.
* If any of the side effects become serious, or if you notice any side effect(s) not listed in this leaflet, please talk to your doctor or pharmacist.
Your medicine is called Calcichew 500mg Chewable Tablets, however thourghout this leaflet it will be referred to as Calcichew 500mg.
In this leaflet:
Q What Calcichew 500mg are and what they are used for Q Before you take Calcichew 500mg Q How to take Calcichew 500mg Q Possible side-effects Q How to store Calcichew 500mg Q Further information
0 What Calcichew 500mg are and what they are used for
Calcichew 500mg are orange flavoured chewable tablets. They contain the active ingredients:
* Calcium (1250mg calcium carbonate: equivalent to 500mg calcium) Calcium is found in the diet.
Calcichew 500mg may be prescribed by doctors or recommended by pharmacists to treat and prevent calcium deficiency, or when the diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or in pregnancy. It may also be given to patients receiving kidney dialysis to remove the phosphate from food that cannot be removed by dialysis.
Q Before you take Calcichew 500mg
Do not take Calcichew 500mg Chewable Tablets if you:
* are allergic (hypersensitive) to any of the ingredients (see end of section 2 and section 6)
* have a condition causing high levels of calcium in your blood or urine (hypercalcaemia or hypercalciuria) e.g.
- severe kidney failure in people not on dialysis - you should not take this medicine unless advised by your doctor
- cancer which has affected your bones
* have kidney stones.
Take special care with Calcichew 500mg:
If any of the following applies to you, please tell your doctor:
* phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine) as these tablets contain aspartame, a source of phenylalanine
* brittle bones (osteoporosis) as a result of being immobile
* taking medicines for your heart, or diuretics
* a high tendency to kidney stone (calculus) formation
* cancer or any other conditions that may have affected your bones.
Your serum calcium or phosphate levels, or urinary calcium excretion, must be monitored if you have any of the following conditions.
* kidney problems
* you are on long-term treatment with Calcichew
* you are already taking additional doses of calcium
If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Calcichew 500mg should be reduced or the treatment discontinued.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, the following medicines may interact with Calcichew 500mg tablets:
* diuretics (water tablets); your serum calcium levels should be monitored regularly.
* heart medicines (cardiac glycosides); you should be monitored by electrocardiogram and your serum calcium levels measured.
* corticosteroids (e.g. prednisolone, dexamethasone); your dose of Calcichew 500mg may need to be increased
* tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards.
* hormones (levothyroxine); these should be taken at least four hours before, or afterwards.
* anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin); please speak with your doctor.
* fluoride, or bisphosphonates; Calcichew 500mg should be taken at least three hours afterwards.
Taking Calcichew 500mg with food and drink
Calcichew 500mg should not be taken within 2 hours of eating foods rich in oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole cereals).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding before taking Calcichew 500mg.
Driving and using machines
Calcichew 500mg has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Calcichew 500mg
The following are ingredients in this product:
* Sorbitol and isomalt: if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
* Aspartame contains a source of phenylalanine and may be harmful for people with phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine).
Q How to take Calcichew 500mg
Always take Calcichew 500mg exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
For use as additional osteoporosis therapy:
Adults and the elderly: Chew or suck one tablet 2 or 3 times a day.
For calcium deficiency:
Adults, the elderly and children: Chew or suck one tablet 2 or 3 times a day
For osteomalacia (a softening of the bones):
Adults and the elderly. Chew or suck two to six chewable tablets a day.
As a phosphate binder (for kidney failure patients on dialysis):
When Calcichew 500mg Chewable Tablets are given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Calcichew 500mg Chewable Tablets you need.
The tablets should be taken just before, during or just after each meal to make sure that the calcium binds to the phosphate in the stomach.
If you take more than you should
If you accidentally take more Calcichew 500mg than you should, you may have an increase in your blood calcium levels.
Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat.
Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation.
Do not take any more Calcichew 500mg and contact your doctor or emergency department as soon as possible.
Take the packet and any remaining tablets with you.
If you forget to take Calcichew 500mg Chewable Tablets
If you forget to take a dose, leave out that dose completely.
Take your next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
Calcichew ® 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet (continued)
O Possible side-effects
Like all medicines, Calcichew 500mg can cause side effects, although not everybody gets them.
Side effects with Calcichew 500mg may include:
Uncommon side effects (affecting less than 1 in 100 people):
* too much calcium in your blood (hypercalcaemia) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion.
* too much calcium in your urine (hypercalciuria)
Rare side effects (affecting less than 1 in 1,000 people):
* nausea * wind (flatulence)
* stomach ache * rash
* constipation * hives
* diarrhoea * itching
Very rare side-effects (affecting less than 1 in 10,000 people):
* Milk alkali syndrome - (usually only seen in overdose see “if you take more than you should”)
If you are taking Calcichew 500mg Chewable Tablets because you are having kidney dialysis, tell your doctor if you notice any white deposits on your skin.
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
O How to store Calcichew 500mg
* Do not store above 30oC
* Keep container tightly closed to protect from moisture
* Keep out of the sight and reach of children
* Do not use this medicine after the expiry date which is stated on the pack
* If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do
* 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
Additional Information
Calcichew 500 mg contains calcium designed to keep bones healthy. Calcium is an essential component of bones.
Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones.
People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium are at risk of weakened bones. Prolonged lack of adequate calcium intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.
Calcichew 500 mg have been designed to give people, whose intake of calcium is low, a boost to the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and, for some people, advice on how to prevent falls which may lead to fracture.
The National Osteoporosis Society (NOS) in the UK and the Irish Osteoporosis Society (IOS) in the Republic of Ireland, are national charities dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS and IOS offer support to people with osteoporosis and raise awareness of the importance of healthy bones.
For patients in the UK, if you are concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ.
Tel: 01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk. For patients in the Republic of Ireland, please contact the Irish Osteoporosis Society, 114 Pembroke Road, Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751, Fax: +353 (0)1 668 0098, email: info@irishosteoporosis.ie. •Registered Trademark
Q Further information
What this medicine contains:
Each tablet contains calcium carbonate 1250mg equivalent to 500mg of calcium. Also contains sorbitol (E420), povidone, isomalt (E953), orange flavour unspecified, magnesium stearate, aspartame (E951) and fatty acids mono- and di- glycerides.
What this medicine looks like and contents of the pack
Calcichew are round, white, uncoated, orange flavoured and convex tablets. May have small specks. They come in a pack size of 90 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Takeda Nycomed AS, Drammensveien 852, PO. Box 205, 1372 Asker, Norway and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
P
PL 15184/1293
Calcichew is a registered trademark of Shire Pharmaceuticals Limited.
Revision date: 14/12/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Mastical ® 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Mastical 500mg Chewable Tablets 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 two weeks.
* If any of the side effects become serious, or if you notice any side effect(s) not listed in this leaflet, please talk to your doctor or pharmacist.
Your medicine is called Mastical 500mg Chewable Tablets, however thourghout this leaflet it will be referred to as Mastical 500mg.
In this leaflet:
Q What Mastical 500mg are and what they are used for Q Before you take Mastical 500mg Q How to take Mastical 500mg Q Possible side-effects Q How to store Mastical 500mg Q Further information
O What Mastical 500mg are and what they are used for
Mastical 500mg are orange flavoured chewable tablets. They contain the active ingredients:
* Calcium (1250mg calcium carbonate: equivalent to 500mg calcium) Calcium is found in the diet.
Mastical 500mg may be prescribed by doctors or recommended by pharmacists to treat and prevent calcium deficiency, or when the diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or in pregnancy. It may also be given to patients receiving kidney dialysis to remove the phosphate from food that cannot be removed by dialysis.
Q Before you take Mastical 500mg
Do not take Mastical 500mg Chewable Tablets if you:
* are allergic (hypersensitive) to any of the ingredients (see end of section 2 and section 6)
* have a condition causing high levels of calcium in your blood or urine (hypercalcaemia or hypercalciuria) e.g.
- severe kidney failure in people not on dialysis - you should not take this medicine unless advised by your doctor
- cancer which has affected your bones
* have kidney stones.
Take special care with Mastical 500mg:
If any of the following applies to you, please tell your doctor:
* phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine) as these tablets contain aspartame, a source of phenylalanine
* brittle bones (osteoporosis) as a result of being immobile
* taking medicines for your heart, or diuretics
* a high tendency to kidney stone (calculus) formation
* cancer or any other conditions that may have affected your bones.
Your serum calcium or phosphate levels, or urinary calcium excretion, must be monitored if you have any of the following conditions.
* kidney problems
* you are on long-term treatment with Mastical
* you are already taking additional doses of calcium
If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Mastical 500mg should be reduced or the treatment discontinued.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, the following medicines may interact with Mastical 500mg tablets:
* diuretics (water tablets); your serum calcium levels should be monitored regularly.
* heart medicines (cardiac glycosides); you should be monitored by electrocardiogram and your serum calcium levels measured.
* corticosteroids (e.g. prednisolone, dexamethasone); your dose of Mastical 500mg may need to be increased
* tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards.
* hormones (levothyroxine); these should be taken at least four hours before, or afterwards.
* anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin); please speak with your doctor.
* fluoride, or bisphosphonates; Mastical 500mg should be taken at least three hours afterwards.
Taking Mastical 500mg with food and drink
Mastical 500mg should not be taken within 2 hours of eating foods rich in oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole cereals).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding before taking Mastical 500mg.
Driving and using machines
Mastical 500mg has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Mastical 500mg
The following are ingredients in this product:
* Sorbitol and isomalt: if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
* Aspartame contains a source of phenylalanine and may be harmful for people with phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine).
Q How to take Mastical 500mg
Always take Mastical 500mg exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
For use as additional osteoporosis therapy:
Adults and the elderly: Chew or suck one tablet 2 or 3 times a day.
For calcium deficiency:
Adults, the elderly and children: Chew or suck one tablet 2 or 3 times a day
For osteomalacia (a softening of the bones):
Adults and the elderly: Chew or suck two to six chewable tablets a day.
As a phosphate binder (for kidney failure patients on dialysis):
When Mastical 500mg Chewable Tablets are given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Mastical 500mg Chewable Tablets you need.
The tablets should be taken just before, during or just after each meal to make sure that the calcium binds to the phosphate in the stomach.
If you take more than you should
If you accidentally take more Mastical 500mg than you should, you may have an increase in your blood calcium levels.
Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat. Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation.
Do not take any more Mastical 500mg and contact your doctor or emergency department as soon as possible.
Take the packet and any remaining tablets with you.
If you forget to take Mastical 500mg Chewable Tablets
If you forget to take a dose, leave out that dose completely.
Take your next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
Mastical 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet (continued)
G Possible side-effects
Like all medicines, Mastical 500mg can cause side effects, although not everybody gets them.
Side effects with Mastical 500mg may include:
Uncommon side effects (affecting less than 1 in 100 people):
* too much calcium in your blood (hypercalcaemia) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion.
* too much calcium in your urine (hypercalciuria)
Rare side effects (affecting less than 1 in 1,000 people):
* nausea * wind (flatulence)
* stomach ache * rash
* constipation * hives
* diarrhoea * itching
Very rare side-effects (affecting less than 1 in 10,000 people):
* Milk alkali syndrome - (usually only seen in overdose see “if you take more than you should")
If you are taking Mastical 500mg Chewable Tablets because you are having kidney dialysis, tell your doctor if you notice any white deposits on your skin.
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
G How to store Mastical 500mg
* Do not store above 30oC
* Keep container tightly closed to protect from moisture
* Keep out of the sight and reach of children
* Do not use this medicine after the expiry date which is stated on the pack
* If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do
* 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
Additional Information
Calcichew 500 mg contains calcium designed to keep bones healthy. Calcium is an essential component of bones.
Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones.
People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium are at risk of weakened bones. Prolonged lack of adequate calcium intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.
Calcichew 500 mg have been designed to give people, whose intake of calcium is low, a boost to the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and, for some people, advice on how to prevent falls which may lead to fracture.
The National Osteoporosis Society (NOS) in the UK and the Irish Osteoporosis Society (IOS) in the Republic of Ireland, are national charities dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS and IOS offer support to people with osteoporosis and raise awareness of the importance of healthy bones.
For patients in the UK, if you are concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ.
Tel: 01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk. For patients in the Republic of Ireland, please contact the Irish Osteoporosis Society, 114 Pembroke Road, Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751, Fax: +353 (0)1 668 0098, email: info@irishosteoporosis.ie. •Registered Trademark
G Further information
What this medicine contains:
Each tablet contains calcium carbonate 1250mg equivalent to 500mg of calcium. Also contains sorbitol (E420), povidone, isomalt (E953), orange flavour unspecified, magnesium stearate, aspartame (E951) and fatty acids mono- and di- glycerides.
What this medicine looks like and contents of the pack
Mastical are round, white, uncoated, orange flavoured and convex tablets. May have small specks. They come in a pack size of 90 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Takeda Nycomed AS, Drammensveien 852, P.O. Box 205, 1372 Asker, Norway and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
P PL 15184/1293
Mastical is a registered trademark of Takeda GmbH.
Revision date: 14/12/15