500 mg / 200 IU film-coated tablet
calcium / cholecalciferol ( vitamin D 3 )
What Kalcipos-D mite is and what it is used for
Kalcipos-D mite is used for the prevention and treatment of calcium and vitamin D 3 and as an adjunct in osteoporosis ( osteoporosis ) in patients at risk for calcium – and vitamin D 3 deficiency.
Calcipos-D mite contains calcium and vitamin D 3, both of which are important substances for new bone formation. Vitamin D 3 regulates the uptake and metabolism of calcium as well as the storage of calcium in the skeleton.
Calcium / Vitamin D 3 found in Calcipos-D mite 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 using Kalcipos-D mite
Do not use Kalcipos-D mite
- 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 mite
- if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints, among other things. You should consult a doctor before starting treatment with Calcipos-D mite .
- if you are taking other medicines that contain calcium or vitamin D.
- if you have impaired kidney function. You should then consult a physician before starting treatment with Calcipos-D mite .
- if for any reason you become bedridden or sedentary for a long time during treatment with Kalcipos-D mite .
Other medicines and Calcipos-D mite
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Treatment with Kalcipos-D mite 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 taking certain medicines at the same time;
- infection ( tetracycline ), you should take these two hours before or four to six hours after taking Kalcipos-D mite .
- infection ( quinolones ), you should take these medicines two hours before or six hours after taking Calcipos-D mite .
- hypothyroidism (levothyroxine), leave at least four hours between the intake of Calcipos-D mite and levothyroxine.
- osteoporosis (bisphosphonates), you should take these preparations at least three hours before Calcipos ‑ D mite .
- caries (sodium fluoride), you should take these preparations at least three hours before Kalcipos ‑ D mite .
Calcium salts can reduce the uptake of iron, zinc, and strontium ranelate. Therefore, medicines containing iron, zinc, or strontium ranelate should be taken at least two hours before or after Calcium D- mite.
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 mite 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 mite.
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 mite can be given during pregnancy in case of calcium and vitamin D deficiency.
The calipers-D mite 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
The calcipos-D mite 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 mite contains sucrose
One tablet of Calcipos-D contains 0.4 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 mite
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Recommended dose:
Adults: 1 tablet 1-3 times daily.
Children: 1 tablet 1-2 times daily.
The tablets can be swallowed whole, divided, or crushed.
If you take more Kalcipos-D mite than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center tel. 112 for risk assessment and advice.
Symptoms of a high dose of Kalcipos-D mite are loss of appetite, thirst, increased urination, 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 mite 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 for high levels of phosphate in the blood, the formation of kidney stones, and calcification in the kidneys.
How to store Kalcipos-D mite
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 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 your pharmacist how to dispose of medicines no longer required. 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 5 micrograms equivalent to 200 IU vitamin D 3 .
- The other ingredients are maltodextrin, sodium ascorbate, medium chain triglycerides , silica, sucrose, sodium octenyl succinate starch (E1450), all- rac- alpha-tocopherol, croscarmellose sodium, anhydrous colloidal silicone dioxide, magnesium promolium, magnesium promolase. See also section 2 ‘Calcipos-D mite contains sucrose’ and ‘Sodium content’.
What the medicine looks like and contents of the pack
Kalcipos-D mite is a film-coated tablet that is white, oval, engraved with R118.
Package sizes: 60, 120, 180 tablets in a plastic jar
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
or
Rottapharm Ltd
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland