Calcichew 500mg Chewable Tablets
CALCICHEW® 500MG CHEWABLE TABLETS
(calcium carbonate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Calcichew 500mg Chewable Tablets but will be referred to as Calcichew Tablets throughout this 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 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.
In this leaflet:
1. What Calcichew Tablets are and what they are used for
2. Before you take Calcichew Tablets
3. How to take Calcichew Tablets
4. Possible side-effects
5. How to store Calcichew Tablets
6. Further information
1. What Calcichew Tablets are and what they are used for
Calcichew Tablets 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 Tablets 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.
2. Before you take Calcichew Tablets
Do not take Calcichew 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 Tablets:
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 Tablets
■ 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 Tablets 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 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 Tablets 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 Tablets should be taken at least three hours afterwards.
Taking Calcichew Tablets with food and drink
Calcichew Tablets 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 breast-feeding
Ask your doctor or pharmacist for advice if you are pregnant or brea st-feed i n g b efore taki ng Ca lcichew Tablets.
Driving and using machines
Calcichew Tablets has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Calcichew Tablets
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).
3. How to take Calcichew Tablets
Always take Calcichew Tablets 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 Tablets are given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Calcichew 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 Tablets 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 Tablets 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 Tablets
If you forgot 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.
4. Possible side-effects
Like all medicines, Calcichew Tablets can cause side effects, although not everybody gets them.
Side effects with Calcichew Tablets 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 1000 people):
■ nausea
■ stomach ache
■ constipation
■ diarrhoea
■ wind (flatulence)
■ rash
■ hives
■ itching
Very rare side-effects (affecting less than 1 in 10000 people):
■ Milk alkali syndrome-(usually only seen in overdose see "if you take more than you should")
If you are taking Calcichew 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 or pharmacist. This
includes any side effects not listed in this leaflet.
You can also report side effects directly via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Calcichew Tablets
■ Do not store above 30°C. Keep the container tightly closed in order to protect from moisture.
■ Keep out of the sight and reach of children.
■ If your tablets appear discoloured or show any other signs of deterioration, take them back to your pharmacist who will advise you further.
■ If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
■ Do not throw it away with your normal household water or waste. This will help to protect the environment.
■ Do not use Calcichew Tablets after the expiry date that is printed on the container and carton label.
6. Further information
What Calcichew Tablets contain
Each tablet contains 1250mg Calcium Carbonate (equivalent to 500mg Calcium) as the active ingredient.
Calchichew Tablets also contain sorbitol (E420), polyvidone, orange oil, magnesium stearate, isomalt (E953), Antifoam 110c and aspartame (E951).
What Calcichew Tablets look like and contents of the pack
Calchichew Tablets are white, round chewable tablets with yellow specks with no markings.
Your medicine is available in packs of 60 tablets (1 bottle) and 100 tablets (5 bottles with 20 tablets in each).
Manufacturer
Your tablets are manufactured by: Nycomed Pharma AS, Drammensveien 852, 1372 Asker, Norway.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0204
Leaflet issue and revision date (Ref): 27.01.15
Calcichew® is a registered trademark of Shire Pharmaceuticals Ltd.
Additional information
Calcichew Tablets 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 Tablets 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.
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