Calcichew-D3 1000mg/800iu Once Daily Chewable Tablets
Package leaflet: Information for the user
Calcichew-D3 Citron 1000 mg/800 IU chewable tablets calcium/cholecalciferol (vitamin D3)
For medicinal products available only on prescription:
Read all of this leaflet carefully before you start taking this medicine because it contains important information for 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.
For medicinal products available without prescription:
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 have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
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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
5. How to store Calcichew-D3 Citron
6. Contents of the pack and other information
1. 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.
2. What you need to know before you take Calcichew-D3 Citron Do not take Calcichew-D3 Citron:
- if you have excessive amounts of calcium in the blood or in the urine.
- if you have severe kidney problems
- if you have kidney stones.
- if you have excessive amounts of vitamin D in the blood.
- if you are allergic to soya or peanut. Calcichew-D3 Citron contains soya oil.
- if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
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 treatment of high blood pressure or oedema) or cardiac glycosides (used to treat heart disorders).
- if you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D 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.
If any of the conditions mentioned above are relevant for you, please talk to your doctor before you start taking Calcichew-D3 Citron.
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.
If you also take tetracyclines (a type of antibiotics), you should take these at least 2 hours before or 4-6 hours after intake of Calcichew-D3 Citron. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.
Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least one hour before intake of Calcichew-D3 Citron.
Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). 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:
- tiazide diuretics (used in treatment of high blood pressure or oedema)
- cardiac glycosides (used to treat heart disorders)
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.
During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU vitamin D. Calcichew-D3 Citron is therefore not suitable in pregnancy because of the content of vitamin D. Calcichew-D3 Citron can be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.
Driving and using machines
No studies on the effects on the ability and use of machines have been performed. An effect is however unlikely.
Calcichew-D3 Citron contains soya oil, isomalt and sucrose
Calcichew-D3 Citron contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. 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. May be harmful to the teeth.
3. 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 once daily. The tablet may be chewed or sucked.
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.
Uncommon side effects (may affect up to 1 in 100 people): Excessive amounts of calcium in the blood (hypercalcemia) or in the urine (hypercalcuria) may occur with large doses.
Rare side effects (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, gastric pain, diarrhoea.
Very rare side effects (may affect up to 1 in 10,000 people): itching and rash and dyspepsia. 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.
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.
Tablet container: Do not store above 30°C. 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 25°C. 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:
- calcium carbonate 2500 mg (equivalent to 1000 mg calcium)
- cholecalciferol (vitamin D3 ) 800 IU (20 microgram )
- The other ingredients are xylitol (E967), povidone, isomalt (E953), flavouring (lemon), magnesium stearate, sucralose (E955), mono-and diglycerides of fatty acids, all-rac-alpha-tocopherol, soya-bean oil, sucrose, gelatin and maize starch.
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: 15, 30, 40, 60 and 90 tablets Blister: 7, 14, 28, 50 x 1 (unit dose), 56, 84, 112, 140 and 168 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Takeda Nycomed AS Postbox 205
NO-1372 Asker, Norway
Manufacturers:
Tablets packed in containers:
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:
Austria: Cal-D-or 1000 mg/800 I.E. - Kautabletten Belgium: Steovit Forte citroen 1000 mg/800 I.E. kauwtabletten Czech Republic: Calcichew D3 Lemon 800 IU zvykaci tablety Denmark: Calcichew-D3 Ultra Forte
Finland: Calcichew® D3 Strong sitruuna 1000 mg/20 mikrog - purutabletti France: Calegom Vitamine D3 Germany: Calcimagon-D3 uno
Greece: Calcioral D3® 1000 mg + 20 pg (800 IU) paoropevo SroKo Hungary: Calcichew-D3 1000 mg/800 NE ragotabletta
Ireland: Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets Lithuania: Calcigran Forte 1000 mg / 800 TV kramtomosios tabletes Luxembourg: Steovit Forte citron 1000 mg/800 U.I. comprimes a croquer Netherlands: Calci-Chew D3 1000 mg/800 I.E., kauwtabletten Norway: Calcigran Forte 1000 mg/800 IE tyggetabletter Poland: Orocal D3 Forte
Romania: CALCIU D3 FORTE 1000 mg/800 UI comprimate masticabile
Slovakia: Calcichew-D3 Citron 1000 mg/800 IU
Spain: Mastical D Unidia 1000 mg/800 IU comprimidos masticables
Sweden: Calcichew-D3 Citron 1000 mg/800 IE tuggtablett
UK: Calcichew-D3 1000mg/800IU Once Daily Chewable tablets
This leaflet was last revised in 25 October 2013
Detailed information on this medicine is available on the web site of MA/Agency
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