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Calcichew-D3 Citron

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Calcichew-D3 Citron 500 mg/400 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.

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 Calcichew-D3 Citron is and what it is used for

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

3. How to take Calcichew-D3 Citron

4. Possible side effects

How to store Calcichew-D3 Citron

6. Contents of the pack and other information


What Calcichew-D3 Citron is and what it is used for


Calcichew-D3 Citron are chewable tablets containing calcium and vitamin D3, which both are important substances in bone formation. Calcichew-D3 Citron 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 Citron


Do not take Calcichew-D3 Citron

- 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 Citron

- 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 have sarcoidosis (an immune system disorder that may increase vitamin D levels in the body).

- if you have osteoporosis and at the same time are unable to move around.

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


Children

Calcichew-D3 Citron chewable tablets are not intended for use in children


Other medicines and Calcichew-D3 Citron

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 Citron.


Medicines containing bisphosphonates should be taken at least one hour before intake of Calcichew-D3 Citron.


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 Citron.


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 Citron.


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 Citron.


Other medicines that may influence or be influenced by Calcichew-D3 Citron are:

thiazide diuretics and cardiac glycosides.


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 Citron with food and drink

Calcichew-D3 Citron 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 this medicine.


If you are pregnant, you may use Calcichew-D3 Citron 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 Citron 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 Citron has no known influence on the ability to drive and use machines.


Calcichew-D3 Citron contains isomalt and sucrose

Calcichew-D3 Citron 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 Citron


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 twice daily. The tablets can be chewed or sucked.


Use in children

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


If you take more Calcichew-D3 Citron than you should

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


If you forget to take Calcichew-D3 Citron

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 1 in 1000 people)

Constipation, dyspepsia, flatulence, nausea, gastric pain, 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 Citron


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: Do not store above 25C. 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 Citron contains

The active substances in one tablet are:


The other ingredients are:

xylitol (E967), povidone, isomalt (E953), flavouring (lemon), 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 Citron looks like and contents of the pack

Calcichew-D3 Citron are white, round chewable tablets. May have small specks.


Pack sizes:

Tablet container with HDPE screw cap: 20, 30, 50, 60, 90, 100, 120, 168 and 180 tablets

Blister: 20, 30, 50, 50 x 1 (unit dose), 60, 90, 100, 120, 168 and 180 tablets


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation holder:

Takeda Nycomed AS, Postboks 205, N-1372 Asker, Norge


Manufacturers:


Tablets packed in plastic bottles:

Takeda Nycomed AS

Drammensveien 852, P.O. Box 205

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


or


Takeda Pharma AS

55B Jaama Street

63308 Polva, Estonia


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


Austria: Cal-D-Or

Belgium: Steovit D3 citroen 500 mg/400 I.E.

Czech Republic: CALCICHEW D3 400 IU žvýkací tablety

Denmark: Calcichew-D3 Forte

Finland: Calcichew D3 Forte sitruuna 500 mg/400 IU – purutabletti

France: Calégom Vitamine D3

Germany: Calcimagon D3

Greece: Calcioral D3

Hungary: Calcichew-D3 500 mg/400 NE rágótabletta

Luxembourg: Steovit D3 citron 500 mg/400 I.E

Netherlands: Calci-Chew D3 500 mg/400 I.E., kauwtabletten

Norway: Calcigran Forte

Poland: Orocal D3 Lemon’

Romania: CALCIU D3 PLUS 500 mg/400UI Comprimate masticabile

Spain: Mastical D sabor limón 500mg/400 UI comprimidos masticables

Slovakia: Calcichew-D3

Sweden: Calcichew-D3 Citron


This leaflet was last approved in 2015-12-14

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