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Calcichew-D3 Apelsin

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Document: Calcichew-D3 Apelsin and Calcichew-D3 Citron chewable tablet ENG PL change

Package leaflet: Information for the user


Calcichew-D3 Citron 500 mg/800 IU chewable tablets

Calcichew-D3 Apelsin 500 mg/800 IU chewable tablets

calcium/cholecalciferol (vitamin D3)


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet

1. What Calcichew-D3 is and what it is used for

2. What you need to know before you take Calcichew-D3

3. How to take Calcichew-D3

4. Possible side effects

How to store Calcichew-D3

6. Contents of the pack and other information


What Calcichew-D3 is and what it is used for


Calcichew-D3 are chewable tablets containing calcium and vitamin D3, which both are important substances in bone formation. Calcichew-D3 is used in the prevention and treatment of calcium and vitamin D deficiency in the elderly, and as a supplement to specific treatment of osteoporosis.


What you need to know before you take Calcichew-D3


Do not take Calcichew-D3:

- if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).

if you have severe kidney problems

- if you have excessive amounts of calcium in the blood or in the urine.

-

- if you have kidney stones.

- if you have excessive amounts of vitamin D in the blood.


Warnings and precautions

Talk to your doctor or pharmacist before taking Calcichew-D3

- if you are on long-term treatment, especially if you also take diuretics (used in the treatment of high blood pressure or oedema) or cardiac glycosides (used to treat heart disorders).

- if you have signs of impaired renal function or high tendency of renal stone formation.

- if you take other products containing vitamin D. Additional doses of calcium and vitamin D should be taken under close medical supervision.


Children and adolescents

Calcichew-D3 chewable tablets are not intended for use in children or adolescents.


Other medicines and Calcichew-D3

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time. For this reason, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after intake of Calcichew-D3.


Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least one hour before intake of Calcichew-D3.


Calcium can reduce the effect of levothyroxine. For this reason, levothyroxine should be taken at least four hours before or four hours after Calcichew-D3.


The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcichew-D3.


Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew-D3.


Other medicines that may influence or be influenced by Calcichew-D3 are: thiazide diuretics (used in the treatment of high blood pressure or oedema) and cardiac glycosides (used to treat heart disorders).


Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D3.


If you are taking any of the above-mentioned medicines, your doctor will give you further instructions.


Calcichew-D3 with food and drink

Calcichew-D3 can be taken with or without food and drink.


Pregnancy, breast-feeding and fertility

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 any medicine.


If you are pregnant, you may use Calcichew-D3 in case of a calcium and vitamin D deficiency. During pregnancy you should not take more than 2500 mg calcium and 4000 IU vitamin D per day, as overdoses may harm the unborn child.


Calcichew-D3 can be used during breast-feeding. Calcium and vitamin D pass into breast milk. This should be considered when giving additional vitamin D to your child.


Driving and using machines

Calcichew-D3 has no known influence on the ability to drive and use machines.


Calcichew-D3 contains isomalt and sucrose

Calcichew-D3 contains isomalt (E953), and 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.


How to take Calcichew-D3


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Dosage:

The recommended dose is one tablet once daily. The tablets can be chewed or sucked.


Use in children and adolescents

Calcichew-D3 chewable tablets are not intended for use in children and adolescents.


If you take more Calcichew-D3 than you should

If you may have taken more Calcichew-D3 than you should, talk to your doctor or pharmacist immediately.


If you forget to take Calcichew-D3

Do not take a double dose to make up for a forgotten tablet.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from the available data). If you experience the following symptoms, you should immediately contact a doctor. Swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema).


Uncommon side effects (may affect up to 1 in 100 people)

Excessive amounts of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria) may occur with large doses


Rare side effects (may affect up to 1in 1 000 people)

Constipation, dyspepsia, flatulence, nausea, gastric pain, and diarrhoea


Very rare side effects (may affect up to 1 in 10 000 people)

Itching, rash and hives. 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.


If you have impaired renal function, you may be at risk of increased amounts of phoshate in the blood, kidney stone formation and increased amounts of calcium in the kidneys.


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 Calcichew-D3


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.


Plastic bottle: Do not store above 30C. Store in the original container in order to protect from light. Keep the container tightly closed in order to protect from moisture.

Blister pack: Do not store above 30C. Store in the original package in order to protect from moisture. Keep blister in the outer carton in order to protect from light.


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 Calcichew-D3 contains

The active substances in one tablet are:


The other ingredients are:

xylitol (E967), povidone, isomalt (E953), flavouring <lemon or orange>, magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, tocopherol, sucrose, modified maize starch, medium chain triglycerides, sodium ascorbate and colloidal anhydrous silica.


What Calcichew-D3 looks like and contents of the pack

Calcichew-D3 are white, round chewable tablets.


Pack sizes:

Plastic bottle: 20, 30, 50, 60, 90, 100, 120, 168 and 180 tablets

Blister pack: 7, 14, 28, 50 x 1 (unit dose), 56, 84, 112, 140 and 168 tablets


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation holder:

Takeda Nycomed AS, Postboks 205, NO-1372 Asker, Norway


Manufacturers:


Tablets packed in plastic bottles:

Takeda Nycomed AS

Drammensveien 852, P.O. Box 205

NO-1372 Asker, Norway


or


Takeda Pharma AS

55B Jaama Street,

63308 Polva, Estonia


Tablets packed in blister:

Takeda Christiaens

Gentsesteenweg 615

1080 Brussel, Belgium


or


Tjoapack B.V.

Columbusstraat 4

7825 VR Emmen, The Netherlands


This medicinal product is authorised in the Member States of the EEA under the following names:


Calcichew-D3 Lemon 500 mg/800 IU chewable tablet:

Austria: Cal-D-or Lemon 500mg/800 I.E. – Kautabletten

Denmark: Calcichew-D3 X-Forte Lemon

Estonia: Calcigran Forte D Lemon

Finland: Calcichew D3 Extra sitruuna

Germany: Calcimagon® Extra D3

Greece: Calcioral D3® Forte 500 mg + 20 μg (800 ΙU) μασώμενο δισκίο

Lithuania: Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės

Netherlands: Calci-Chew D3 500 mg / 800 I.E.

Norway: Calcigran Forte 500 mg/800 IE tyggetabletter med sitronsmak

Spain: MASTICAL D 500 mg/ 800 UI comprimidos masticables

Sweden: Calcichew-D3 Citron


Calcichew-D3 Orange 500 mg/800 IU chewable tablet:

Austria: Cal-D-or Orange 500 mg/800 I.E. – Kautabletten

Belgium: Steovit D3 sinaasappel 500 mg/800 I.E. kauwtabletten

Denmark: Calcichew-D3 X-Forte Orange

Finland: Calcichew D3 Extra appelsiini

Latvia: Calcigran Forte Extra D 500 mg/800 SV košļājamās tabletes

Lithuania: Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės

Luxembourg: Steovit D3 orange 500 mg/800 U.I. comprimés à croquer

Netherlands: Tacal ® D3 500 mg/800 I.E. sinaasappel

Norway: Calcigran Forte 500 mg/800 IE tyggetabletter med appelsinsmak

Sweden: Calcichew-D3 Apelsin


This leaflet was last revised in

24 March 2016

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