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CALCICHEW D3 TABLETS

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Your medicine is known by the above name but will be referred to as Calcichew-D3 throughout this leaflet.

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BRIDGED TO
CRESTOR 6464/2069 2070

1. What Calcichew-D3 are and what they are used for
Calcichew-D3 are orange flavoured chewable tablets. They contain the active ingredients:
• Calcium (1250mg calcium carbonate: equivalent to 500mg calcium)
• Vitamin D3 (200IU colecalciferol: equivalent to 5 micrograms Vitamin D3)
Both calcium and vitamin D are found in the diet and vitamin D is also produced in the skin after exposure to
the sun.

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DATE:

If you have any of the following conditions your serum calcium or phosphate levels, or urinary calcium
excretion must be monitored.
Calcichew should be taken under close medical supervision.
• sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
• kidney problems
• you are on long-term treatment with Calcichew
• you are already taking additional doses of calcium or vitamin D
If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of
Calcichew-D3 should be reduced or the treatment discontinued.

03/07/13

Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Calcichew D3 Tablets

6464/1114D
CODE:

UK PIL DATED OCTOBER 2011

DT

Take special care with Calcichew-D3:
If any of the following applies to you, please tell your doctor:
• phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine) as these tablets
contain aspartame, a source of phenylalanine
• brittle bones (osteoporosis) as a result of being immobile
• taking medicines for your heart, or diuretics
• a high tendency to kidney stone (calculus) formation
• cancer or any other conditions that may have affected your bones.

PRODUCT:

ARTWORKER:

2. Before you take Calcichew-D3
Do not take Calcichew-D3 if you:
• are allergic (hypersensitive) to any of the ingredients (see end of Section 2 and Section 6)
• are allergic (hypersensitive) to soya or peanuts.
• have a condition causing high levels of calcium in your blood or urine (hypercalcaemia or
hypercalciuria) e.g.
- renal (kidney) failure
- cancer which has affected your bones
• have high levels of vitamin D in your blood
• have kidney stones.

DATE OF PROOF:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:
CUSTOMER: Waymade

Calcichew-D3 may be prescribed by doctors or recommended by pharmacists to treat and prevent vitamin
D/calcium deficiency, or when the diet or lifestyle does not provide enough, or when body requirements are
increased. This medicine may also be prescribed or recommended for certain bone conditions, for example
osteoporosis, or in pregnancy.

WARNING!

Notes:

In this leaflet:
1. What Calcichew-D3 are and what they are used for
2. Before you take Calcichew-D3
3. How to take Calcichew-D3
4. Possible side-effects
5. How to store Calcichew-D3
6. Further information

PROOF HISTORY:
v.4 - waymade - 03/07/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Calcichew-D3 tablets carefully
to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after two weeks.
• If any of the side effects become serious, or if you notice any side effect(s) not listed in this leaflet, please
talk to your doctor or pharmacist

In particular, the following medicines may interact with Calcichew-D3 tablets:
• diuretics (water tablets); your serum calcium levels should be monitored regularly.
• heart medicines (cardiac glycosides); you should be monitored by electrocardiogram and your
serum calcium levels measured.
• corticosteroids (e.g. prednisolone, dexamethasone); your dose of Calcichew-D3 may need to be
increased
• laxatives (such as paraffin oil) or a cholesterol-lowering drug called colestyramine
• tetracycline antibiotics; these should be taken at least two hours before, or four to six hours
afterwards.
• hormones (levothyroxine); these should be taken at least four hours before, or afterwards.
• anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin); please
speak with your doctor.
• fluoride, or bisphosphonates; Calcichew-D3 should be taken at least three hours afterwards.
Taking Calcichew-D3 with food and drink
Calcichew-D3 should not be taken within 2 hours of eating foods rich in oxalic acid (found in spinach and
rhubarb) or phytic acid (found in whole cereals).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding before taking Calcichew-D3.
Driving and using machines
Calcichew-D3 has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Calcichew-D3
The following are ingredients in this product:
• Sorbitol, isomalt and sucrose: if you have been told by your doctor that you have an intolerance
to some sugars, talk to your doctor before taking this medicine. May be harmful to the teeth.
• Aspartame contains a source of phenylalanine and may be harmful for people with phenylketonuria
(a deficiency in the enzyme which breaks down phenylalanine).
• Hydrogenated soya bean oil: if you are allergic to peanut or soya, do not use this medicinal
product.
3. How to take Calcichew-D3
Always take Calcichew-D3 exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults and elderly:
Chew or suck two or three tablets a day, preferably one tablet in the morning, midday and evening.
Children:
Chew or suck two tablets a day, preferably one tablet in the morning and evening.

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Black

WARNING!

27mm

CALCICHEW®-D3 TABLETS
(calcium carbonate/colecalciferol)
equivalent to 500mg Calcium / 200IU colecalciferol
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you take more than you should
If you accidentally take more Calcichew-D3 than you should, you may have an increase in your blood
calcium levels.
Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness,
tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney
problems and, in severe cases, irregular heartbeat.
Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and
tingling sensation.
Do not take any more Calcichew-D3 and contact your doctor or emergency department as soon as
possible. Take the packet and any remaining tablets with you.
If you forget to take Calcichew-D3
If you forget to take a dose, leave out that dose completely. Take your next dose when it is due. Do not take
a double dose to make up for a forgotten dose.

Uncommon side effects (affecting less than 1 in 100 people):
• too much calcium in your blood (hypercalcaemia) – the symptoms include nausea, vomiting, lack
of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than
usual, muscle weakness, drowsiness and confusion.
• too much calcium in your urine (hypercalciuria)
Rare side effects (affecting less than 1 in 1000 people):
• nausea
• stomach ache
• constipation
• diarrhoea
• wind (flatulence)
• rash
• hives
• itching
Very rare side-effects (affecting less than 1 in 10000 people):
• Milk alkali syndrome – (usually only seen in overdose see ‘if you take more than you should”)




5. How to store Calcichew-D3
Do not use after the expiry date printed on the carton, carton label or bottle label. The expiry date
refers to the last day of that month.
Calcichew-D3 tablets should not be stored above 25°C.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

Calcichew-D3 tablets also contain the following inactive ingredients:
Sorbitol, povidone, isomalt, orange oil, magnesium stearate, aspartame, mono, di-fatty acid glycerides,
hydrogenated soya bean oil, tocoferol, sucrose, gelatin and maize starch.
DATE:

Q.A.
APPROVED:

6. Further Information
Calcichew-D3 tablets contain two active ingredients. Each tablet contains 1250mg of active calcium
carbonate (equivalent to 500mg calcium), and 200IU of colecalciferol (equivalent to 5 micrograms Vitamin
D3). Calcichew-D3 are large white, round unmarked tablets.

Calcichew-D3 tablets are available as plastic bottles of 100 tablets.

03/07/13

UK PIL DATED OCTOBER 2011

6464/1114D
CODE:

DT

DATE OF PROOF:

Leaflet revision and issue date (Ref.) 03.07.2013
Calcichew is a registered trademark of Shire Pharmaceuticals Ltd.

Calcichew D3 Tablets

ARTWORKER:

PL No: 6464/1114

This product is manufactured by Nycomed Pharma AS, Lillogaten 3, N-0401 Oslo, Norway and/or Nycomed
SEFA AS, 55b Jaama Street, 63308 Polvan, Estonia and is procured from within the EU and repackaged by
the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

P

Additional Information
Calcichew-D3 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 has been designed to give people, whose intake of calcium iand Vitamin D is low, a boost to
the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporoses 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 important of healthy bones.
If you concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath
BA2 0PJ Tel: 01761 471 771 Fax: 01761 471104
Or email
info@nos.org.uk
For patients in the Republic of Ireland please contact the Irish Osteoporosis Society, 33 Pearse Street,
Dublin 2, Tel/Fax:: 01 677 4267
Or email
info@irishosteoporosis.ie

Colour
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Black

WARNING!




DATE:

CUSTOMER
APPROVED:



WARNING!

If any these side-effects become serious, or if you notice any side-effect(s) not listed in this leaflet,
please talk to your doctor or pharmacist.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

Side effects with Calcichew-D3 may include:

PROOF HISTORY:
v.4 - waymade - 03/07/13

Leaflet Flat Size = 148 x 400

4. Possible side-effects
Like all medicines Calcichew-D3 can cause side-effects although not everybody gets them.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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