Recikalc-D
Package leaflet: Information for the user
Recikalc-D 500 mg/400 IU film-coated tablet
calcium
Cholecalciferol (vitamin D3)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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.
What is in this leaflet:
1. What Recikalc-D is and what it is used for
2. What you need to know before you take Recikalc-D
3. How to take Recikalc-D
4. Possible side effects
5. How to store Recikalc-D
6. Contents of the pack and otherinformation
1. What Recikalc-D is and what it is used for
Recikalc-D contains calcium and vitamin D3which both are important components for the formation of bone. Vitamin D3regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue.
Recikalc-D is used to prevent and treat calcium and vitamin D3deficiency in elderly, and as an adjunct in the management of osteoporosis in adults, when a risk of deficiency of calcium or vitamin D3is suspected.
2. What you need to know before you take Recikalc-D
Do not take Recikalc-D
- if you are allergic to the calcium or cholecalciferol or any of the other ingredients.
- at hypercalcemi (increased levels of calcium in the blood) or at hypercalciuri (increased levels in the urine).
- at hypervitaminosis D (increased levels of vitamin D in the blood).
- if you have kidney stones
Warnings and precautions
Talk to your doctor or pharmacist before taking RecikalcD
- if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints). Consult your doctor before you start treatment with Recikalc-D.
- when concomitant use of other drugs containing vitamin D or calcium.
- if you suffer from renal insufficiency. Then you should consult a doctor before starting with the treatment with Reikalc-D
- if you suddenly are confined to bed or sitting for a longer time
Children and adolescents
Recikalc-D are not intended for use in children.
Other medicines and Recikalc-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 drug is taken simultaneously with certain other drugs against:
- high blood pressure (tiaziddiuretic)
- cardiomyopathy (cardiac glycosides)
- hypercholesterolemia (cholestyramin)
- laxative (paraffinic oil)
Treating doctor need therefore to know of such concomitant medication.
If you simultaneously use certain drugs for;
- infection (tetracyclines)
you should take these two hours before or four to six hours after oral intake of Recikalc-D.
If you simultaneously take certain drugs for;
- osteoporosis (bisphosphonates)
- caries (sodium fluoride)
you should take these drugs at least three hours before Recikalc-D.
At treatment with corticosteroids you should consult your doctor as the dose of Recikalc-D might be increased.
Calcium salts may decrease the uptake of iron, zink and strontiumranelate. Thefore iron, zinc or strontiumranelate preparations should be taken at least two hours before or after Recikalc-D.
Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin
D3.
Recikalc-D with food and drink
The effect can be influenced by food containing oxalic acid (found in spinach and rhubarb) and fytinic acid (found in whole cereals). You should wait at least two hours before you take Recikalc-D if you have eaten food with high content of oxalic acid and phytic acid.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU vitamin D3.Recikalc-D can be used during pregnancy at calcium and vitamin D deficiency.
Recikalc-D can be used during breast-feeding. Calcium and vitamin D3pass over in breast milk. This should be considered when given additional vitamin D to the child.
Driving and using machines
Recikalc-D has no known effects on ability to drive or use machines.
Recikalc-D contains sucrose
One tablet consists 0.9 mg sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. how to take Recikalc-D
Always use Recikalc-D 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 1-2 times daily.
The tablets can be swallowed whole, divided or crushed.
If you take more Recikalc-D than you should
If you have taken more of this medicine than directed, or if a child accidentally has taken this medicine, please contact your doctor or emergency unit for judgement of the risk and advice.
Symptoms of an overdose of Recikalc-D are loss of appetite, thirst, abnormal increased urine secretion, nausea, vomiting and constipation.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Recikalc-D and see your doctor immediately if you experience symptoms of angioedema, such as
- swollen face, tongue or lips
- difficult to swallow
- hives and difficulties to breath
Frequency not known (cannot me estimated from the available data).
Less common (occurs in less than 1 out of 100 patients): hypercalcemia (increased levels of serum calcium) and/or hypercalciuria (increased levels of urine calcium) can occur.
Rare (occurs in less than 1 out of 1 000 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.
Side effects with frequency not known (cannot be estimated from the available data): Hypersensitivity reactions such as swelling of the throat (laryngeal oedema).
Patients with renal impairment are at potential risk of high levels of phosphate in blood, kidney stones formation and calcification of the kidneys.
Reporting 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
To be completed nationally
5. How to store Recikalc-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.
Do not store above 30 ºC. Store in the original container in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Recikalc-D contains
- The active substances are calcium carbonate 1300 mg corresponding to calcium 500 mg and cholecalciferol 10 microgram corresponding to 400 IU Vitamin D3.
- The other ingredients are maltodextrin, sucrose, sodium ascorbate, silicon dioxide, medium chain triglycerides, starch sodium octenyl succiante (E1450), all-rac-alpha-tocopherol, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hypromellose, macrogol, paraffin.
What Recikalc-D looks like and contents of the pack
Film-coated tablett.
White oval, 8,5x19 mm, engraved R104.
60, 90, 120 and 180 tablets in plastic bottles, an especially adjusted packaging with an accessibility cap for people with reduced function in the hands.
Marketing Authorisation Holder
Recip AB
Box 906
SE-170 09 Solna Sweden
Tel: +46 8 630 1900
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:
Suomi/Finland
Meda OY Vaisalantie 4
FIN-02630 Esbo
Puh/Tel: 0207 209 550
This medical product is authorised in the Member States of the EEA under the following names:
Sweden, Finland: Recikalc-D 500 mg/400 IU film-coated tablet
This patient leaflet was latest approved:
2016-03-10