Calcichew-D3 Chewable Tablets
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-D3 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.
PATIENT INFORMATION LEAFLET
Calcichew-D3® Chewable Tablets
(calcium carbonate/colecalciferol)
Your medicine is known as Calcichew-D3 Chewable Tablets, but will be referred to as Calcichew-D3 throughout this leaflet:
In this leaflet:
1. What Calcichew-D3 are and what they are used for
2. Before you take Calcichew-D3
3. How to take Calcichew-D3
4. Possible side-effects
5. How to store Calcichew-D3
6. Further information
1. What Calcichew-D3 are and what they are used for
Calcichew-D3 are orange flavoured chewable tablets. They contain the active ingredients:
• Calcium (1250mg calcium carbonate: equivalent to 500mg calcium)
• Vitamin D3 (200IU colecalciferol: equivalent to 5 micrograms Vitamin D3)
Both calcium and vitamin D are found in the diet and vitamin D is also produced in the skin after exposure to the sun.
Calcichew-D3 may be prescribed by doctors or recommended by pharmacists to treat and prevent vitamin D/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.
2. Before you take Calcichew-D3 Do not take Calcichew-D3 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.
- renal (kidney) failure
- cancer that has affected your bones
• have high levels of Vitamin D in your blood
• have kidney stones
Take special care with Calcichew-D3:
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.
If you have any of the following conditions your serum calcium or phosphate levels, or urinary calcium excretion must be monitored. Calcichew-D3 should be taken under close medical supervision.
• sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
• kidney problems
• you are on long-term treatment with Calcichew
• you are already taking additional doses of calcium or vitamin D
If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Calcichew-D3 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-D3 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-D3 may need to be increased
• laxatives (such as paraffin oil) or a cholesterol-lowering drug called colestyramine
• 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-D3 should be taken at least three hours afterwards.
• Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew-D3 tablets.
• Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D3.
Taking Calcichew-D3 with food and drink
Calcichew-D3 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-D3.
Driving and using machines
Calcichew-D3 has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Calcichew-D3
The following are ingredients in this product:
• Sorbitol, isomalt and sucrose: if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. May be harmful to the teeth.
• 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-D3
Always take Calcichew-D3 exactly as your doctor has told you. You s hould check with your doctor or pharmacist if you are not sure.
Adults and elderly:
Chew or suck two or three tablets a day, preferably one tablet in the morning, midday and evening.
Children:
Chew or suck two tablets a day, preferably one tablet in the morning and evening.
If you take more than you should
If you accidentally take more Calcichew-D3 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-D3 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-D3
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.
4. Possible side-effects
Like all medicines, Calcichew-D3 can cause side effects, although not everybody gets them.
Side effects with Calcichew-D3 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")
Frequency not known (cannot be estimated from the available data):
• Hypersensitivity reactions such as swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema).
• If you have impaired renal function, you may be at risk of increased amounts of phosphate in the blood, renal stone formation and increased amounts of calcium in the kidneys.
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.
5. How to store Calcichew-D3
• Keep out of the sight and reach of children.
• Keep the container tightly closed to protect from moisture.
• Do not store above 30°C.
• Do not use Calcichew-D3 after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. If the tablets have changed shape or colour do not use.
• 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.
• If your medicine gets discoloured or shows any other signs of deterioration, seek the advice of your pharmacist.
6. Further information What Calcichew-D3 contain
Each chewable tablet contains 1250mg calcium carbonate (equivalent to 500mg calcium) and 200IU colecalciferol (equivalent to 5 micrograms Vitamin D3).
The tablet also contains; sorbitol (E420), povidone, isomalt (E953), orange flavour, magnesium stearate, fatty acid mono- and diglycerides, medium chain triglycerides, sodium ascorbate, anhydrous colloidal silica, aspartame (E951), sucrose, tocopherol and modified maize starch.
What Calcichew-D3 looks like and contents of the pack
Tablets are round, white, uncoated, convex and orange flavoured; they may have small specks.
The tablets are packed in white, plastic bottles of 100 tablets.
Manufactured by:
Takeda Nycomed AS, Drammensveien 852, NO-1372 Asker, Norway.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL.
Calcichew-D3 Chewable Tablets,
PL 39352/0188
Calcichew-D3® is a registered trademark of Shire Pharmaceuticals
Ltd. F]
Leaflet date: 06.07.2015
Additional Information
Calcichew-D3 are a combination of calcium and vitamin D designed to keep bones healthy. Calcium is an essential component of bones while vitamin D plays an important role in the absorption of calcium from food.
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. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.
People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D 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-D3 has been designed to give people, whose intakes of calcium and vitamin D are 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 vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.
For patients in the UK, the National Osteoporosis Society (NOS) is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS offers support to people with osteoporosis and raises awareness of the importance of healthy bones.
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, 33 Pearse Street, Dublin 2. Tel/Fax: 01 677 4267, email: info@irishosteoporosis.ie