What it is and what it is used for

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 adults with an identified risk of calcium and vitamin D deficiency, and as a supplement to specific treatment of osteoporosis. 2.

What you need to know before you take it

e 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 is not intended for use in children and adolescents. Other medicines and Calcichew-D3 Once Daily 1

Tell your 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, iron, zinc or strontium ranelate 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 pharmacist 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 pharmacist for advice 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 sucrose (1.5 mg), which may be harmful to the teeth. The tablet also contains isomalt (E953). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Calcichew-D3 Once Daily is essentially sodium-free This medicine contains less than 23 mg sodium per tablet, that is to say essentially 'sodium-free'. 3.

How to take it

Calcichew-D3 Once Daily

Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

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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 is 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 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 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. Other possible side effects with this medicine: Rare side effects (may affect up to 1 in 1,000 people):
• constipation;
• dyspepsia;
• flatulence;
• nausea;
• gastric pain;
• diarrhoea; Very rare (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, renal stone formation and increased amounts of calcium in the kidneys. Reporting of side effects If you get any side effects talk to your pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: 3

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

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 after EXP. The expiry date refers to the last day of that month. Plastic Bottle: 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.

Content of the pack and other information

What Calcichew-D3 Once Daily contains The active substances in one tablet are: –

calcium carbonate 2500 mg (equivalent to 1000 mg calcium) colecalciferol (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 anhydrous colloidal silica (see also end of Section 2 'Calcichew-D3 Once Daily contains isomalt and sucrose'). 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: Plastic bottle 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 Not all pack sizes may be marketed. Marketing Authorisation Holder Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, UK Manufacturers Tablets packed in plastic bottles: Asker Contract Manufacturing AS Drammensveien 852 NO-1383 Asker Norway 4

or Takeda Pharma AS 55B Jaama Street, 63308 Polva Estonia Tablets packed in blister: Tjoapack Netherlands B.V. Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands or Delpharm Novara S.r.L. Via Crosa 86 28065 Cerano (No), Italy 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 žvýkací tablety Germany: Calcimagon-D3 uno Greece: Calcioral D3® 1000 mg + 20 μg (800 IU) μασώμενο δισκίο 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 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 03/2023. 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. 5

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 Royal Osteoporosis Society is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The Royal Osteoporosis Society offers support to people with osteoporosis and raises awareness of the importance of healthy bones. If you are concerned about osteoporosis, please contact the Royal Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel: 01761 471 771, or email:[email protected]. *Registered Trademark

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