500 mg / 400 IU film-coated tablet
calcium/cholecalciferol ( Vitamin D 3 )
What Recikalc-D is and what it is used for
Recikalc-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.
Recikalc-D is used to prevent and treat a deficiency of calcium and vitamin D 3 in the elderly, as well as as an adjunctive treatment for osteoporosis in patients at risk of calcium and vitamin D deficiency.
Calcium / Vitamin D contained in Recikalc-D may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Recikalc-D
Do not use Recikalc-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 (hypercalcemia) or 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 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 using Recikalc-D:
- if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints). Then you should consult a doctor before starting treatment with Recikalc-D.
- if you are already taking other medicines that contain calcium or vitamin D.
- if you have impaired kidney function. Then you should consult a doctor before starting treatment with Recikalc-D.
- if for some reason you become bedridden or sedentary for a long time.
Children and young people
Recikalc-D tablets 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 treatment effect of Recikalc-D can be affected if it is taken at the same time as certain other medicines:
- 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. The dosage of 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 Recikalc-D.
- infection ( quinolones ), you should take these medicines two hours before or six hours after taking Recikalc-D.
- hypothyroidism (levothyroxine), leave at least four hours between the intake of Recikalc-D and levothyroxine.
- osteoporosis (bisphosphonates), you should take these medicines at least three hours before Recikalc-D.
- caries (sodium fluoride), you should take these preparations at least three hours before Recikalc-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 Recikalc-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 ).
Recikalc-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 Recikalc-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 of calcium and 600 IU of vitamin D 3 . Recikalc-D can be given during pregnancy in case of calcium and vitamin D deficiency.
Recikalc-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
Recikalc-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.
Recikalc-D contains sucrose
One tablet Recikalc-D contains 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 medicine.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to use Recikalc-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 Recikalc-D than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose of Recikalc -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 Recikalc-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 (to occur 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 levels 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 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 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.
Medicines 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 10 micrograms equivalent to 400 IU vitamin D 3.
- The other ingredients are maltodextrin, sucrose, sodium ascorbate, silica, medium-chain triglycerides, sodium starch octenyl succinate (E1450), and all -rac -alpha-tocopherol, croscarmellose sodium, anhydrous colloidal silica, dioxpromol, magnesium. See also section 2 ‘Recikalc-D contains sucrose’ and ‘Sodium content’.
What the medicine looks like and the contents of the pack
Film-coated tablet.
White, oval, engraved with R104.
60, 90, 120, and 180 tablets in a plastic jar, packages 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