Kalcipos
Package leaflet: Information for the user
Kalcipos 500 mg film-coated tablet
Calcium
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.
- - You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Kalcipos is and what it is used for
2. What you need to know before you take Kalcipos
3. How to take Kalcipos
4. Possible side effects
5. How to store Kalcipos
6. Contents of the pack and other information.
1. What Kalcipos is and what it is used for
Kalcipos is important for the formation of bone. The intake of calcium has an important influence at osteoporosis.
Kalcipos is used to prevent and treat osteoporosis, at calcium deficiency and at increased need for calcium. If the diet does not cover this need an extra supply of calcium is needed. At renal insufficiency that cause an increased concentration of phosphates in the blood (hyperphosphatemia) calcium can in high doses be added as a phosphate binder.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Kalcipos
Do not take Kalcipos
- if you are allergic to the active substance or any of the other ingredients in this medicine (listed in section 6)..
- if you have increased levels of calcium in the blood (hypercalcemi) or in the urine (hyperkalciuri).
- if you have kidney stones
-
Warnings and precautions
Talk to your doctor or pharmacist before taking Kalcipos
- if you suffer from renal insufficiency.
- at high dose therapy and especially during concomitant treatment with vitamin D, there is a risk for increased amount of calcium in the blood. In these patient the calcium level should be followed in serum and the renal function should be monitored regularly.
Other medicines and Kalcipos
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 drug is taken simultaneously with certain other drugs for;
- high blood pressure (tiaziddiuretic)
- cardiomyopathy (cardiac glycosides)
Treating doctor need therefore to know of such concomitant medication.
If you simultaneously use certain drugs for;
- infection ( tetracyclines)
you should take these at least two hours before or four to six hours after the intake of Kalcipos.
If your simultaneously take certain drugs for;
- osteoporosis (bisphosphonates)
- caries (sodium fluoride)
you should take these drugs at least three hours before Kalcipos.
At treatment with corticosteroids you should consult your doctor as the dose of Kalcipos might be increased.
Kalcipos with food and drink
The effect can also be influenced by food containing oxalic acid (found in spinach and rhubarb) and fytinic acid (found in whole grains). You should wait at least two hours before you take Kalcipos if you have eaten food with high fiber content.
Pregnancy and breast-feeding
Kalcipos can be used during pregnancy. For pregnant women a normal daily intake is 1000-1300 mg calcium (through food and supplement). The daily intake of calcium should not exceed 1500 mg.
For lactating women a normal daily intake is 1000-1300 mg calcium (through food and supplement). Calcium passes over to breast milk but is not likely to have an effect on the child.
Driving and using machines
Kalcipos has no known effects on ability to drive or use machines.
3. How to take Kalcipos
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The tablet could be swallow whole, divide or crushed.
Prevention and treatment of calcium deficiency:
Adults: 1 tablet 1-3 times daily.
Children: 1 tablet 1-2 times daily.
Adjunctive therapy in osteoporosis:
1 tablet 1-3 times daily.
At hyperfosfatemi:
The dosage is individually decided for you by your doctor. The tablets should be taken with meals in order to bind phosphate in the food.
If you take more Kalcipos than you should
If you have taken more Kalcipos than you should, or if children have been taken medicine by accident, please contact your doctor, the hospital or Giftinformationscentralen (tel 112 in Sweden, 09-4711 in Finland) to get an opinion of the risk and advice on action to be taken.
Symptoms of an overdose of Kalcipos are anorexia, thirst, polyuria, nausea, vomiting and constipation.
If you stop taking Kalcipos
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Less common (occurs in less than 1 of 100 patients): Increased levels of serum calcium (hypercalcemia) or urine calcium (hypercalciuria) can occur.
Rare (occurs in less than 1 of 1000 patients): constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria.
Very rare occurs in less than 1 out of 10 000 patients)
Milk-alkali syndrome (also called Burnett´s syndrome and 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.
Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effets not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below).
Medical Products Agency
Box 26
751 03 Uppsala
www.mpa.se
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Kalcipos
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 package. The expiry date refers to the last day of that month.
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 contains
- The active substances is calcium carbonate corresponding to calcium 500 mg.
- The other ingredients are maltodextrin, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hypromellose, macrogol, paraffin.
What Kalcipos looks like and contents of the pack
Film-coated tablett.
White oval, ingraved R103.
60 and 180 tablets in plastic bottles.
Marketing Authorisation Holder
Recip AB
Box 906
SE-170 09 Solna
Sweden
Tel: +46 8 630 1900
Fax: +46 8 630 1950
e-mail: info@recip.se
Manufacturer
Recipharm Stockholm AB
Lagervägen 7
SE-136 50 Jordbro
Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sweden
Recip AB
Box 906
SE-170 09 Solna
Sweden
Tel: +46 8 630 1900
Fax: +46 8 630 1950
e-mail: info@recip.se
Suomi/Finland
Meda AB
Vaisalavägen 4
02130 Esbo
Finland
Tel: 020 720 9550
e-mail: info@meda.fi
This patient leaflet was latest changed: 2014-11-28