500 mg / 400 IU film-coated tablet
calcium / cholecalciferol ( Vitamin D 3 )
What Calcium / Cholecalciferol Evolan is and what it is used for
Calcium / Cholecalciferol Evolan 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.
The calcium/cholecalciferol Evolan is used for the prevention and treatment of calcium and vitamin D in the elderly, as well as additional treatment of osteoporosis ( osteoporosis ) in adults with risk of calcium – and vitamin D deficiency.
Calcium / Vitamin D contained in Calcium / Cholecalciferol Evolan 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 Calcium / Cholecalciferol Evolan
Do not take Calcium / Cholecalciferol Evolan:
- if you are allergic to calcium , cholecalciferol ( vitamin D 3 ) or any of the other ingredients of this medicine (listed in section 6).
- if you have increased levels 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, bone marrow disease ( 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 Calcium / Cholecalciferol Evola
- if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints, among other things). Then you should consult a doctor before starting treatment with Calcium / Cholecalciferol Evolan.
- if you are 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 Calcium / Cholecalciferol Evolan.
- if for any reason you become bedridden or sedentary for a long time during treatment with Calcium / Cholecalciferol Evolan.
Children and young people
Calcium / Cholecalciferol Evolan tablets are not for the treatment of children.
Other medicines and Calcium / Cholecalciferol Evolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Treatment with Calcium / Cholecalciferol Evolan may affect or be affected by concomitant treatment with certain other medicines against;
- high blood pressure (thiazide diuretics)
- heart muscle disease (heart glycosides)
- high blood fats (eg cholestyramine)
- constipation ( laxative , eg paraffin oil).
The treating physician, therefore, needs to be aware of such concomitant medication.
If you are taking certain medicines at the same time;
- infection ( tetracycline or quinolone antibiotics), you should take these two hours before or six hours after taking Calcium / Cholecalciferol Evolan.
- deficiency of thyroid hormone (levothyroxine), intake should be at least four hours apart
- osteoporosis (bisphosphonates), you should take these medicines at least three hours before Calcium / Cholecalciferol Evolan
Calcium salts can reduce the uptake of iron and zinc. Therefore, medicines containing iron or zinc should be taken at least two hours before or after Calcium / Cholecalciferol Evola.
If you are being treated with orlistat (an anti-obesity agent), your uptake of fat-soluble vitamins may be affected (eg vitamin D 3 ).
When treating with cortisone, you should consult your doctor as the dose of Calcium / Cholecalciferol Evolan may need to be increased.
Calcium / Cholecalciferol Evolan with food, drink and alcohol
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 Calcium / Cholecalciferol Evola.
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 . Calcium / Cholecalciferol Evolan can be given during pregnancy in case of calcium and vitamin D deficiency.
Calcium / Cholecalciferol Evolan 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
Calcium / Cholecalciferol Evolan 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.
Calcium / Cholecalciferol Evolan contains sucrose
One tablet of Calcium / Cholecalciferol Evolan contains 0.7 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.
How to use Calcium / Cholecalciferol Evolan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet 1-2 times daily.
The tablets can be swallowed whole, divided, or crushed.
If you use more Calcium / Cholecalciferol Evolan 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 Calcium / Cholecalciferol Evolan are loss of appetite, thirst, increased urine output, nausea, vomiting, and constipation.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Calcium / Cholecalciferol Evolan and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or lips (has been reported, may occur in an unknown number of users)
- difficulty swallowing (has been reported, may occur in an unknown number of users)
- hives and difficulty breathing (a rare side effect )
Uncommon (may affect up to 1 in 100 people): hypercalcemia (increased calcium in the blood) and/or hypercalciuria (increased calcium in the urine).
Rare (may affect up to 1 in 1,000 people): constipation, bloating, nausea, abdominal pain, diarrhea, pruritus, rash, and urticaria ( hives ).
Very rare (may affect 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 include 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.
Patients with renal impairment are at risk for high levels of phosphate in the blood, the formation of kidney stones, and calcification of the kidneys.
How to store Calcium / Cholecalciferol Evolan
Keep this medicine out of the sight and reach of children.
No special storage instructions.
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.
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, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate, sodium ascorbate, all- rac-alpha-tocopherol, modified starch , sucrose, medium chain triglycerides , titanium dioxide, macrolol, poly (vinyl alcohol).
What the medicine looks like and contents of the pack
Calcium / Cholecalciferol Evolan is a white film-coated tablet, oblong tablet, 19×8 mm.
Pack sizes: 30, 60, 90, 120, 180, 2 x 180 and 3 x 180 tablets in plastic jar with screw cap.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evola Pharma AB
Box 120
182 12 Danderyd
Manufacturer
SC Laropharm SRL, 145 A Alexandriei street, Bragadiru, Ilfov, 077025, Romania.