500 mg / 400 IU film-coated tablet
calcium / cholecalciferol ( Vitamin D 3 )
What Kalcipos-D is and what it is used for
Calcipos-D contains calcium and vitamin D 3, both of which are important substances for bone formation. Vitamin D 3 regulates the uptake and metabolism of calcium as well as the storage of calcium in the skeleton.
Kalcipos-D is used for the prevention and treatment of calcium and vitamin D in the elderly, as well as additional treatment of osteoporosis ( osteoporosis ) in patients at risk for calcium – and vitamin D deficiency.
Calcium/vitamin D contained in Calcipos-D may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Kalcipos-D
Do not use 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 an increased amount of calcium in your blood ( hypercalcaemia ) or in your urine ( hypercalciuria ) or if you have a condition that can lead to increased levels of calcium in your blood or urine (eg overactive parathyroid glands, a disease of the bone marrow ( myeloma) ), malignant bone tumors (bone metastases).
- if you have an excess of vitamin D in your blood (hypervitaminosis D).
- if you have kidney stones ( nephrolithiasis ) or calcification of the kidneys ( nephrocalcinosis ).
- if you have severe kidney function or kidney failure .
Warnings and cautions
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, among other things). You should then consult a doctor before starting treatment with Calcipos-D.
- if you are taking other medicines that contain calcium or vitamin D.
- if you have impaired kidney function. You should then consult a doctor before starting treatment with Calcipos-D.
- if for any reason you become bedridden or sedentary for a long time during treatment with Kalcipos-D.
Children and young people
Calcipos-D tablets are not intended for use in children.
Other medicines and Calcipos-D
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Treatment with Kalcipos-D may affect or be affected by concomitant treatment with certain other drugs against;
- high blood pressure (thiazide diuretics).
- heart problems (cardiac glycosides such as digoxin ).
- high blood fats (cholestyramine).
- constipation ( laxatives , such as liquid paraffin).
- epilepsy ( phenytoin or barbiturate is).
- inflammatory conditions / impaired immunity ( cortisone )
The treating physician, therefore, needs to be aware of such concomitant medication.
Dosage one of your medications may need to be adjusted.
If you are also taking certain medicines for:
- infection ( tetracycline ), you should take these two hours before or four to six hours after taking Calcipos-D.
- infection ( quinolones ), you should take these medicines two hours before or six hours after taking Calcipos-D.
- hypothyroidism (levothyroxine), you should allow at least four hours between the intake of Calcipos-D and levothyroxine.
- osteoporosis (bisphosphonates), you should take these medicines at least three hours before Calcipos-D.
- caries (sodium fluoride), you should take these preparations at least three hours before Kalcipos-D.
Calcium salts can reduce the uptake of iron, zinc, and strontium ranelate. Therefore, medicines containing iron, zinc, and strontium ranelate should be taken at least two hours before or after Calcipos-D.
If you are being treated with orlistat (an anti-obesity agent), your uptake of fat-soluble vitamins may be affected (eg vitamin D 3 ).
Calcipos-D with food and drink
The effect can also be affected by foods containing oxalic acid (found in spinach and rhubarb, for example) and phytic acid (found in whole grain flakes, for example). You should wait at least two hours after eating foods high in oxalic acid or phytic acid before taking Kalcipos-D.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, the daily intake should not exceed 1500 mg calcium and 600 IU (15 micrograms) vitamin D 3 . Calcipos-D can be given during pregnancy in case of calcium and vitamin D deficiency.
Calcipos-D can be used during breastfeeding. Calcium and vitamin D 3 pass into breast milk. This should be considered when giving vitamin D supplements to the baby.
Driving and using machines
Calcipos-D has no known effects on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Calcipos-D contains sucrose
One tablet of Calcipos-D contains 0.9 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free.
How to use Kalcipos-D
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Recommended dose: 1 tablet 1-2 times daily.
The tablets can be swallowed whole, divided, or crushed.
If you take more Kalcipos-D than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
Symptoms of an overdose of Kalcipos-D include loss of appetite, thirst, increased urine output, nausea, vomiting, and constipation.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Kalcipos-D and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or lips
- difficulty swallowing
- hives and difficulty breathing
Has been reported (occurs in an unknown number of users).
Uncommon (affects up to 1 in 100 people): Hypercalcaemia (increased calcium content in the blood) and/or hypercalciuria (increased urinary calcium content).
Rare (affects up to 1 in 1,000 people): Constipation, bloating, nausea, abdominal pain, diarrhea, pruritus, rash, and urticaria ( hives ).
Very rare (affects up to 1 in 10,000 people): Milk-alkali syndrome (also known as Burnett’s syndrome and usually occurs only in patients who have ingested large amounts of calcium ), whose symptoms are frequent urination, headache, loss of appetite, nausea, or vomiting, unusual fatigue or weakness as well as increased calcium content in the blood and kidney failure.
Has been reported (occurs in an unknown number of users): Severe allergic hypersensitivity reactions such as swelling of the throat (throat edema).
Patients with renal impairment are at risk of high levels of phosphate in the blood, the formation of kidney stones, and calcification of the kidneys.
How to store Kalcipos-D
Keep this medicine out of the sight and reach of children.
Used before the expiry date which is stated on the carton after EXP.
The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Close the jar tightly. Sensitive to light and moisture.
The medicine should not be disposed of via wastewater or household waste. Ask the pharmacy staff how to dispose of medicines that are no longer in use. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are calcium carbonate 1300 mg equivalent to calcium 500 mg and cholecalciferol 10 micrograms equivalent to 400 IU vitamin D 3 .
- The other ingredients are maltodextrin, sodium ascorbate, silica, sucrose, sodium octenyl succinate starch (E1450), medium chain triglycerides , all-rac-alpha-tocopherol, croscarmellose sodium, anhydrous colloidal silicone dioxide, magnesium promolysis, magnesium promolysis. See also section 2 ‘Calcipos-D contains sucrose’ and ‘Sodium content’.
What the medicine looks like and contents of the pack
Calcipos-D is a film-coated tablet that is white, oval, engraved with R104.
Pack sizes: 60, 90, 120, and 180 tablets in a plastic jar, packs with accessibility lids specially adapted for people with impaired function in the hands.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Recip AB
Box 906
170 09 Solna
Manufacturer:
Recipharm Stockholm AB
Lagervägen 7
136 50 Jordbro
Rottapharm Ltd
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Germany