Patient leaflet - Kalcipos-D 500 mg / 800 IU chewable tablets
1. What Kalcipos-D is and what it is used for
Kalcipos-D is used to prevent and treat calcium and vitamin D3 deficiency in the elderly, and as an additional treatment in the management of osteoporosis, when a risk of deficiency of calcium and vitamin D3 is suspected.
Kalcipos-D contains calcium and vitamin D3 which both are important components for the formation of bone. Vitamin D3 regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue.
Ask your doctor, pharmacist or other health personnel if you have further questions and always follow their instructions.
2. What you need to know before you take Kalcipos-D
Do not take Kalcipos-D
- if you are allergic to calcium, cholecalciferol (Vitamin D) or any of the other ingredients of this medicine (listed in section 6).
if you have hypercalcaemia (increased levels of calcium in the blood) or
hypercalciuria (increased levels in the urine).
- if you have kidney stones
- if you have calcium depositions in the kidneys
- if you have hypervitaminosis D (increased levels of vitamin D in the blood). - if you are suffering from kidney failure
Warnings and precautions
Talk to your doctor or pharmacist before taking Kalcipos-D if you
- suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints).
- are taking other medicines containing vitamin D or calcium.
- have poor kidney function or high tendency of kidney stone formation. - are immobilized with osteoporosis.
Children and adolescents
Do not give this medicine to children and adolescents as there is no relevant indication of use in this age group.
Other medicines and Kalcipos-D
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of the treatment can be affected if this medicine is taken simultaneously with certain other medicines against:
- high blood pressure (thiazide diuretic)
- heart problems (cardiac glycosides such as digoxin)
- high cholesterol (cholestyramine)
- constipation (laxatives such as liquid paraffin)
- epilepsy (phenytoin or barbiturates)
- inflammatory conditions/suppression of immunity (corticosteroids)
Please make sure your doctor knows if you are taking any of the medicines listed above. Your dosage may need to be adjusted.
How to take simultaneously used medicines
If you simultaneously use certain medicines for;
- osteoporosis (bisphosphonates) you should take this at least one hour before you take Kalcipos-D.
- infection (quinolones) you should take these two hours before or six hours after taking Kalcipos-D.
- infection (tetracyclines) you should take these two hours before or four to six hours after taking Kalcipos-D.
- dental caries (sodium fluoride) you should take these medicines at least three hours before taking Kalcipos-D.
- cancer treatment (estramustine), Kalcipos-D and estramustine should be taken at least two hours apart.
- hypothyroidism (levothyroxine) you should separate the intake with Kalcipos-D by at least four hours.
If you simultaneously use a certain medicine that contains iron, zinc or strontium ranelate (for treatment of severe osteoporosis) you should separate the intake with Kalcipos-D by at least two hours.
Treatment with orlistat (medicine against obesity) may possibly impair the absorption of fat-soluble vitamins (e.g. vitamin D3).
Kalcipos-D with food and drink
The calcium absorption may be inhibited by food containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals). You should wait at least two hours before you take Kalcipos-D if you have eaten food with high content of oxalic acid or phytic acid.
Pregnancy and breast-feeding
During pregnancy the daily intake of supplemental calcium and vitamin D should not exceed 1500 mg calcium and 600 IU vitamin D in healthy women.
Kalcipos-D should therefore not be used for the prevention of a calcium and vitamin D deficiency during pregnancy, but can be used in pregnant women who are at high risk of developing or already suffer from a calcium and vitamin D deficiency.
Kalcipos-D can be used during breast-feeding. Calcium and vitamin D3 pass over into breast milk. This should be considered when giving additional vitamin D to the child.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Kalcipos-D has no known effects on ability to drive or use machines.
Kalcipos-D contains glucose and sucrose
One Kalcipos-D chewable tablet contains 200 mg glucose and 1.8 mg sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Kalcipos-D contains glucose and sucrose that can be harmful to your teeth and it is therefore important to maintain good oral hygiene.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Kalcipos-D
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 tablet daily.
The chewable tablet should be chewed or slowly melted in the mouth, never swallowed whole.
The amount of calcium in Kalcipos-D is lower than the usually recommended daily intake. Kalcipos-D is therefore meant for patients with need for additional vitamin D, but with a dietary intake of 500-1000 mg of calcium per day. The dietary intake of calcium should be estimated by the prescriber.
If you take more Kalcipos-D than you should
If you may have taken more Kalcipos-D than you should, talk to your doctor or pharmacist immediately.
Symptoms of overdose may include loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, excessive thirst, increased urge to urinate, bone pain, calcium deposits in the kidneys, kidney stones, and in severe cases irregular heart rhythm.
If you forget to take Kalcipos-D
Do not take a double dose to make up for a forgotten tablet.
4. Possible side effects
Like all medicines, Kalcipos-D can cause side effects, although not everybody gets them.
You should stop taking Kalcipos-D and see your doctor immediately if you experience symptoms of serious allergic reactions, such as
- swollen face, lips, tongue or throat
- difficult to swallow
- hives and difficulty breathing
Uncommon (may affect up to 1 in 100 people): hypercalcaemia (increased levels of serum calcium) and/or hypercalciuria (increased levels of urine calcium).
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria.
Very rare (may affect up to 1 in 10 000 people): Milk-alkali syndrome, usually only seen when excessive amounts of calcium have been ingested (symptoms are frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment).
Not known (frequency cannot be estimated from the available data): Serious allergic reactions.
Special populations
Patients with reduced kidney function are at potential risk of developing abnormally high phosphate levels in the blood (this will generally have no symptoms), kidney stones and calcium depositions in the kidneys (symptoms may include blood in the urine, back pain or abdominal pain).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Kalcipos-D
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in order to protect from light. Keep the container tightly closed in order to protect from moisture. The shelf life after first opening the container is 6 months.
Do not throw away any medicines 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 Kalcipos-D contains
- The active substances are calcium carbonate corresponding to calcium 500 mg and cholecalciferol 20 microgram corresponding to 800 IU Vitamin D3. - The other ingredients are liquid spray dried glucose, magnesium stearate, sodium citrate, xylitol, all-rac-alfa-tocopherol, acacia, sodium laurilsulfate, sucrose, Medium chain triglycerides, starch sodium octenyl succinate (E 1450), silicon dioxide, sodium ascorbate. See also section 2 ‘Kalcipos-D contains glucose and sucrose’ and ‘Sodium content’.
What Kalcipos-D looks like and contents of the pack
Kalcipos-D is a chewable tablet, white to off white, round and engraved R 152 on one side.
Pack size of 20, 30, 40, 50, 60, 90, 100 and 180 chewable tablets in plastic bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cooper Consumer Health B.V.,
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
Rottapharm Ltd
Damastown Industrial Park,
Mulhuddart
Dublin 15,
Ireland