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Each tablet contains 1000 mg calcium (as calcium carbonate) and 800 IU vitamin D3 (equivalent to 20 microgram colecalciferol). Also includes isomalt (E953) and sucrose.

Read the package leaflet before use.

5    Oral use. Adults and elderly: One chewable tablet

once daily. The tablet may be chewed or sucked. Keep out of the sight and reach of children. H Do not store above 30°C. Store in the original package in order to protect from light. Keep the container tightly closed in order to protect from moisture.

Calcichew*D₃ 1000 mg/800 IU

Once Daily Chewable Tablets

1000 mg calcium (as calcium carbonate) 800 IU vitamin D3 (20pg colecalciferol)

BRAILLE EXPLANATIONS AND TRANSLATIONS

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Calcichew*D₃

1000 mg/800 IU

Once Daily Chewable Tablets

1000 mg calcium (as calcium carbonate) 800 IU vitamin D3 (20pg colecalciferol)

30 chewable tablets

may occur with large doses.

Rare side effects (may affect up to 1 in

1.000    people):

•    constipation;    •    nausea;

•    dyspepsia;    •    gastric pain;

•    flatulence;    •    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 phosphate 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 United Kingdom as Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calcichew-D₃ Once Daily

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.

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. Content of the pack and other information

What Calcichew-D₃ Once Daily contains

The active substances in one tablet are:

•    calcium carbonate 2500mg (equivalent to 1000 mg calcium)

•    colecalciferol (vitamin D3) 800 IU (20 microgram)

•    T he 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 anhydrous colloidal silica (see also end of Section 2 “Important information about some of the ingredients of CaCichew-D₃ Once Daily’’).

What Calcichew-D₃ Once Daily looks like and contents of the pack

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

Pack sizes:

Tablet container with HDPE screw cap:

15, 30, 40, 60 and 90 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda UK Limited

Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF, UK

Manufacturer

Takeda AS

Drammensveien 852

P.O.Box 205

NO-1372 Asker, Norway

This leaflet was last revised in 10/2015.

Additional Information

Calcichew-D3 Once Daily are a combination of

calcium and vitamin D designed to keep bones

healthy. Calcium is an essential component of

bones while vitamin D plays an important role

in the absorption of calcium from food.

Requirements for calcium increase with age

and, although many people obtain enough

calcium from their diet, some people may

require a supplement in order that their body

has all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D intake can lead to the development of osteoporosis, a condition where bones become weak to a level that

minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew-D3 Once Daily have been designed to give people whose intakes of calcium and vitamin D are low a boost to the recommended amounts. Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.

For patients in the UK, the National Osteoporosis Society (NOS) is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis.

The NOS offers support to people with osteoporosis and raises awareness of the importance of healthy bones.

If you are concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ.

Tel: 01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk

•Registered Trademark    6108530_-04

14981 V3(13070410092302)

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Package leaflet: Information for the user

Calcichew-D₃ 1000 mg/800 IU Once Daily chewable tablets

calcium / colecalciferol (vitamin D₃ )

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-D₃ Once Daily is and what it is used for

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

3.    How to take Calcichew-D₃ Once Daily

4.    Possible side effects

5.    How to store Calcichew-D₃ Once Daily

6.    Contents of the pack and other information

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

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

Do not take Calcichew-D₃ Once Daily:

•    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 Once Daily

•    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 signs of impaired renal function or high tendency of renal stone formation.

•    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 Once Daily are not intended for use in

children and adolescents.

Other medicines and Calcichew-D₃ Once Daily Tell your doctor or pharmacist if you are taking, or 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 Once Daily. 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 Once Daily.

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 Once Daily. 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 Once Daily.

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

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

•    thiazide 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 Once Daily with food and drink

Calcichew-D₃ Once Daily 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 before taking this medicine.

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

Calcichew-D₃ Once Daily contains isomalt and sucrose

Calcichew-D₃ Once Daily 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 Once Daily

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 Once Daily chewable tablets are not intended for use in children and adolescents.

If you take more Calcichew-D₃ Once Daily than you should

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

If you forget to take Calcichew-D₃ Once Daily

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 (hypercalcuria)