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1. Calcichew-D3 Citron 500 Mg/1000 Ie Tuggtablett
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4. Calcichew-D3 Citron 500 Mg/800 Ie Tuggtablett
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Package leaflet: Information for the user

Calcichew-D₃Citron 500 mg/1000 IU chewable tablets

calcium/cholecalciferol (vitamin D₃)

For medicinal products available on prescription only:

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.

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.

What is in this leaflet

1. What Calcichew-D₃Citron is and what it is used for

2. What you need to know before you take Calcichew-D₃Citron

3. How to take Calcichew-D₃Citron

4. Possible side effects

6. Contents of the pack and other information

Calcichew-D₃Citron are chewable tablets containing calcium and vitamin D₃, which both are important substances in bone formation. Calcichew-D₃Citron is used in the prevention and treatment of calcium and vitamin D deficiency, 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-D₃Citron

- 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 impaired renal function.

- 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 and adolescents

Calcichew-D₃Citron chewable tablets are not intended for use in children and adolescents.

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 two hours before or four ot six hours after intake of Calcichew-D₃Citron. 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-D₃Citron.

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-D₃Citron.

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-D₃Citron.

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-D₃Citron.

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

Other medicines that may influence or be influenced by Calcichew-D₃Citron 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-D₃Citron with food and drink

Calcichew-D₃Citron 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-D₃Citron in case of a calcium and vitamin D deficiency. During pregnancy you should not take more than2500 mg calcium and 4000 IU vitamin D per day, as overdoses may harm the unborn child.

Calcichew-D₃Citron can be used during breast-feeding. Calcium and vitamin D₃pass 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-D₃Citron contains aspartame, sorbitol, isomalt and sucrose

Calcichew-D₃ Citron contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. Calcichew-D₃ Citron contains sorbitol (E420), 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.

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 Citron is not intended for use in children and adolescents.

If you take more Calcichew-D₃Citron than you should

If you may have taken more Calcichew-D₃Citron 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 (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.

Reporting of side effects

If you get any side effects, talk to your doctororpharmacist. 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-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.

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.

Shelf life after first opening of the tablet container is 60 days.

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 1250 mg (equivalent to 500 mg calcium)

• Cholecalciferol (vitamin D₃) 1000 IU (25 microgram)

The other ingredient are: sorbitol (E420), povidone, isomalt (E953), flavouring (lemon), magnesium stearate, aspartame (E951), mono- and diglycerides of fatty acids, all-rac-alpha-tocopherol, sucrose,

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

What Calcichew-D₃Citron looks like and contents of the pack

Calcichew-D₃ Citron are white, round chewable tablets of 16 mm. May have small specks.

Pack sizes:

Tablet container with HDPE screw cap: 30, 60, 90 100 and 120 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Takeda AS

P.O. Box 205

NO-1372 Asker

Norway

Manufacturers:

<[To be completed nationally]>

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:

Belgium: Steovit D3 citroen 500 mg/1000 I.E. kauwtabletten

Czech Republic: Calcichew D3 Lemon 500 mg/1000 IU žvýkaci tablety

France: CALEGOM VITAMINED3 500mg/1000UI comprimé à croquer

Greece: Calcioral D3® Extra 500 mg + 25 μg (1000 IU) μασώμενο δισκίο

Hungary: Calcichew-D3 500 mg/1000 NE rágótabletta

Ireland: Calcichew D3 Extra Chewable Tablets

Luxembourg: Steovit D3 citron 500 mg/1000 UI comprimé à croquer

Netherlands: Calci-Chew D3 500 mg/1000 I.E. citroen kauwtabletten

Slovakia: Calcichew D3 Citrón 500mg/1000 IU žuvacie tablety

Spain: Mastical D sabor limón 500mg/1000 UI comprimidos masticables

Sweden: Calcichew-D3 Citron 500 mg/1000 IE tuggtabletter

This leaflet was last revised in 2016-06-10.