Information för alternativet: Calcichew-D3 Citron 1000 Mg/800 Ie Tuggtablett, visar 4 alternativ

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1. Calcichew-D3 Citron 500 Mg/1000 Ie Tuggtablett
2. Calcichew-D3 Citron 1000 Mg/800 Ie Tuggtablett
3. Calcichew-D3 Citron 500 Mg/400 Ie Tuggtablett
4. Calcichew-D3 Citron 500 Mg/800 Ie Tuggtablett
5. Calcichew-D3 Citron 500 Mg/400 Ie Tuggtablett

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.

<[To be completed nationally]>

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

6. Contents of the pack and other information

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.

Do not take Calcichew-D₃Citron:

- 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 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.

Children and adolescents

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

Other medicines and Calcichew D₃Citron

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)

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 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

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. May be harmful to the teeth.

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.

Use in children and adolescents

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

If you take more Calcichew-D₃Citron 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-D₃Citron

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 (hypercalcemia) or in the urine (hypercalcuria) may occur with large doses.

Rare side effects (may affect up to 1 in 1 000 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 getany side effects, talk to your doctor or pharmacist. This includes any possible side effectsnot 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-D₃Citron

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-D₃Citron 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, sucrose, modified maize starch, medium chain triglycerides, sodium ascorbate and colloidal anhydrous silica.

What Calcichew-D₃Citron 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 IUžvýkací tablety

Denmark: Calcichew-D3 Ultra Forte

Finland: Calcichew^® D₃ Strong sitruuna 1000 mg/20 mikrog - purutabletti

France: Calégom Vitamine D3

Germany: Calcimagon-D3 uno

Greece: Calcioral D₃^® 1000 mg + 20 µg (800 IU) μασώμενοδισκίο

Hungary: Calcichew-D3 1000 mg/800 NE rágótabletta

Ireland: Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets

Lithuania: Calcigran Forte 1000 mg / 800 TV kramtomosios tabletės

Luxembourg: Steovit Forte citron 1000 mg/800 U.I. comprimés à 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-D3Citron 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 2015-10-15

Detailed information on this medicine is available on the web site of MA/Agency