Cal-D-Vita

Information för alternativet: Cal-D-Vita 600 Mg/400 Ie Brustablett, visa andra alternativ

Document: Cal-D-Vita effervescent tablet, chewable tablet ENG PL change

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

How to store Cal-D-Vita

6. Contents of the pack and other information

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.

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-D-Vita.

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.

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.

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.

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: Keep the container tightly closed in order to protect from moisture.

Chewable tablet: 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.

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