Package leaflet: Information for the user
Cal-D-Vita 600 mg/400 IU, effervescent tablets
Cal-D-Vita 600 mg/400 IU, chewable tablets
Calcium, vitamin D3
Read all of this leaflet carefully before you start taking 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.
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 Cal-D-Vita is and what it is used for
2.
What you need to know before you take Cal-D-Vita
3.
How to take Cal-D-Vita
4.
Possible side effects
5.
How to store Cal-D-Vita
6.
Contents of the pack and other information
1.
What Cal-D-Vita is and what it is used for
Cal-D-Vita is a calcium preparation combined with vitamin D3. Calcium and vitamin D3 are important in the
formation of bone mass. Vitamin D3 regulates the absorption and conversion of calcium and acts on the
storage of calcium in the skeleton.
Cal-D-Vita is used in the prevention and treatment of vitamin D and calcium deficiency in elderly subjects
and as supplementary treatment for brittle bones (osteoporosis) when a deficiency of calcium and vitamin D
is present or suspected.
2.
What you need to know before you take Cal-D-Vita
Do not take Cal-D-Vita
- if you are allergic to calcium, vitamin D or any of the other ingredients of this medicine (listed in section
6).
- if you are allergic to peanut or soya
- if you have increased amounts of calcium in the blood or, and/or a condition that leads to increased
amounts of calcium in the blood
- if you have increased amounts of calcium in the urine
- if you suffer from an excess of vitamin D
- if you have kidney stones
- if you have severe kidney problems
Warnings and precautions
Talk to your doctor or pharmacist before taking Cal-D-Vita.
- The recommended dosages must not be exceeded.
- During long-term treatment, the amount of calcium in the blood and urine and kidney function should be
monitored.
- If you are taking other single vitamin or multivitamin preparations, containing vitamin D and/or calcium
or any other medicines, you should consult your doctor before starting treatment with Cal-D-Vita
- If you are immobilized, since this may increase the risk of increased calcium in the blood
Other medicines and Cal-D-Vita
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of Cal-D-Vita can be altered if Cal-D-Vita and certain other medicines are taken together, so you
should consult your doctor before taking other medicines at the same time.
If you take Cal-D-Vita together with drugs containing sodium fluoride for caries or bisphosphonates for
osteoporosis, these medicines should be taken at least 1 hour before or after taking Cal-D-Vita, but
preferably at a different time of day.
Tetracyclines, quinolones (ciprofloxacin, levoflaxacin, nalidixic acid, norfloxacin, ofloxacin) used for
infections should be taken at least 2 hours before or 4-6 hours after taking Cal-D-Vita. Protease inhibitors
used for infections (e.g. amprenavir, atezanavir and tipranavir) should be taken at least 2 hours before or 1
hour after taking Cal-D-Vita.
Iron supplements should be taken at least 2 hours before or after taking Cal-D-Vita.
Ion exchange resins, laxatives and orlistat should be taken at least 2 hour before or 4-6 hours after taking
Cal-D-Vita.
Levothyroxine, which is a thyroid hormone, should be taken at least 4 hours before or after taking Cal-DVita.
Other drugs that can affect or are affected by treatment with Cal-D-Vita are certain diuretics used for
example in patients with high blood pressure, cortisone products, cardiac glycosides, barbiturates and
phenytoin, used for example in epilepsy and eltrombopag used for increase the number of platelets.
Cal-D-Vita with food and drink
The effect of Cal-D-Vita can be influenced by certain foodstuffs (e.g. foods containing oxalic acid,
phosphates, phytic acid or a high-fibre diet). It is not recommended to take Cal-D-Vita within 2 hours of
eating foods containing high oxalic and phytic acid concentrations.
Cal-D-Vita may decrease the absorption of dietary iron, zinc and magnesium. Patients at risk for deficiency
should take Cal-D-Vita at bedtime, instead of with meals.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 vitamin D, as overdoses
of calcium and vitamin D may have adverse effects on the unborn child. If you are pregnant, you may use
Cal-D-Vita in case of a calcium and vitamin D deficiency.
If you are breast-feeding you can use Cal-D-Vita, but the fact that the active ingredients of Cal-D-Vita pass
into breast milk should be considered if your child is given additional vitamin D.
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Cal-D-Vita contains aspartame (E 951), a phenylalanin source, which can be harmful to individuals with
phenylketonuria.
Effervescent tablets
The effervescent tablets also contain the sweeteners sucrose and sorbitol (E 420). If you have been told
by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal
product. The effervescent tablets can be used by patients with diabetes.
The effervescent tablet contains 98 mg sodium. Patients who are recommended a low-sodium diet should
avoid the effervescent tablets.
The effervescent tablet contains soya-bean oil. If you are allergic to peanut or soya, do not use this
medicinal product
Chewable tablets
The chewable tablet contains 583 mg of mannitol and 1.7 mg of sucrose and is therefore suitable for
diabetics. If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product. This medicinal product contains sucrose and may be harmful to
the teeth in case of chronic use.
Cal-D-Vita chewable tablets contain soya oil. If you are allergic to peanut or soya, do not use this
medicinal product.
Driving and using machines
Ca-D-Vita does not have any known effects on the ability to drive and use machines.
3.
How to take Cal-D-Vita
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Effervescent tablets:
Usual dosage 1-2 effervescent tablets daily.
Dissolve the effervescent tablet in a glass of water.
Chewable tablets:
Usual dosage 1-2 chewable tablets daily.
The chewable tablet should be chewed or sucked and not swallowed whole.
Cal-D-Vita is recommended for adults.
If you take more Cal-D-Vita than you should
If you take too much medicine, or if a child takes the medicine by mistake, contact a doctor, hospital or
poison information centre (tel 112) to get an evaluation of the risk and guidance.
Some symptoms of overdose are confusion, constipation, diarrhea, nausea and Milk-alkali syndrome
(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.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of
the listed side effects is not known, as it cannot be estimated from the available data.
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Stomach disorders such as constipation, flatulence, nausea, stomach pain and diarrhoea can occur as well as
skin disorders such as itch, nettle rash and eczema. Immune system disorders, such as allergic reaction, may
also occur. Increased amount of calcium in the blood (hypercalcaemia) and/or urine (hypercalciuria) has
been observed with high doses.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V*. By reporting side effects you can help provide more information on the safety of this
medicine.
5.
How to store Cal-D-Vita
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Effervescent tablet:
Chewable tablet:
Keep the container tightly closed in order to protect from moisture.
Bottle: Keep the container tightly closed in order to protect from moisture.
Blister: Store in the original package in order to protect from moisture.
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 Cal-D-Vita contains
-
-
The active substances are calcium, 600 mg, and vitamin D3, 400 IU (10 microgram).
The other ingredients in the effervescent tablet are:
sorbitol (E 420) 84 mg, aspartame (E 951) 15 mg, sucrose 20,38 mg, citric acid, sodium bicarbonate,
flavouring (orange), fumaric acid, sodium chloride, β-carotene (E 160a), beetroot red (E 162),
acesulfam potassium, macrogol, α-tocopherol, sucrose esters of fatty acids, maize starch, gelatin,
partially hydrogenated soybean oil, sodium ascorbate, medium chain triglycerides, silicon dioxide,
maltodextrine and acacia.
The other ingredients in the chewable tablet are:
mannitol 583 mg, povidone, talc, magnesium stearate, aspartame (E 951) 6 mg, sucrose 1.7 mg, citric
acid, flavouring (orange), α-tocopherol, soybean oil, gelatin and maize starch.
What Cal-D-Vita looks like and contents of the pack
Cal-D-Vita effervescent tablet:
One aluminium tube containing 10 effervescent tablets.
Two aluminium tubes, each tube containing 10 effervescent tablets.
10 aluminium tubes, each tube containing 10 effervescent tablets.
The tablets are orange-white to reddish-white with an odour of orange when in solution.
Cal-D-Vita chewable tablet
Plastic bottle containing 60 chewable tablets and blister pack containing 60 tablets.
The tablets are white.
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Marketing Authorisation Holder and Manufacturer
Bayer AB, Box 606, 169 26 Solna, Sweden
Manufacturer:
Delpharm Gaillard
33, Rue de l’industrie
74240 Gaillard, France
Only for plastic bottles:
GP Grenzach Produktions GmbH
Emil-Barell-Strasse 7
79639 Grenzach-Wyhlen, Germany
This leaflet was last revised in 2015-05-13
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