CALCICHEW D3 FORTE CHEWABLE TABLETS

Active substance: COLECALCIFEROL

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BATCH No.

calcium carbonate/colecalciferol
equivalent to 500mg Calcium / 400IU colecalciferol

100 Chewable Tablets

2468 V6
6083709-1

EXP

Chewable Tablets

PL 08557/0029
PA 535/1/3

5 022690 000226

Each tablet contains 1250mg calcium carbonate
(equivalent to 500mg calcium) and 400IU
colecalciferol (equivalent to 10 micrograms
Vitamin D3). Also includes sorbitol (E420), isomalt
(E953), sucrose, and aspartame (E951).
Please read the patient information
leaflet for further information.
For oral administration. Adults and
elderly: 2 chewable tablets a day,
preferably one tablet morning and
evening. The tablets should be
P
chewed or sucked.
Keep out of the sight and reach of
children. Do not store above 30ºC.
Keep the container tightly closed to
protect from moisture.
Shire Pharmaceuticals Ltd.
Basingstoke, RG24 8EP, UK.
*Registered Trademark

Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation.

Peel here but do not remove

Chewable Tablets
Calcichew D#3
calcium carbonate/colecalciferol
FORTE Chewable
Tablets
equivalent to 500mg Calcium / 400IU colecalciferol

100 Chewable Tablets

PATIENT INFORMATION LEAFLET

CALCICHEW*-D3 FORTE CHEWABLE TABLETS
calcium carbonate / colecalciferol
equivalent to 500mg Calcium / 400IU colecalciferol

BRAILLE EXPLANATIONS AND TRANSLATIONS

Calcichew D#3 calcichew D#3
Forte Chewable Forte Chewable
Tablets
Tablets

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 Forte Chewable 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 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.

Do not take any more Calcichew-D3 Forte 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 Forte
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.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Calcichew-D3 Forte can cause side-effects,
although not everybody gets them.
Side-effects with Calcichew-D3 Forte may include:
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

In this leaflet:
1. What Calcichew-D3 Forte Tablets are and what they are used for
2. Before you take Calcichew-D3 Forte
3. How to take Calcichew-D3 Forte
4. Possible side-effects
5. How to store Calcichew-D3 Forte
6. Further information
1. WHAT CALCICHEW-D3 FORTE TABLETS ARE AND WHAT
THEY ARE USED FOR
Calcichew-D3 Forte are lemon flavoured chewable tablets. They contain
the active ingredients:
• Calcium (1250mg calcium carbonate: equivalent to 500mg calcium)
• vitamin D3 (400IU colecalciferol: equivalent to 10 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.
Calcichew-D3 Forte may be prescribed by doctors or recommended by
pharmacists to treat and prevent vitamin D/calcium deficiency, or when

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
• wind (flatulence)
• stomach ache
• rash
• constipation
• hives
• diarrhoea
• 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”)
If any of 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.
5. HOW TO STORE CALCICHEW-D3 FORTE
Keep out of the sight and reach of children.
Store in the original package. Keep the container tightly closed to protect
from moisture. Do not store above 30ºC.

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.
2. BEFORE YOU TAKE CALCICHEW-D3 FORTE
Do not take Calcichew-D3 Forte if you:
• are allergic (hypersensitive) to any of the ingredients (see end of
Section 2 and Section 6)
• have a condition causing high levels of calcium in your blood or urine
(hypercalcaemia or hypercalciuria) e.g.
- renal (kidney) failure
- cancer that has affected your bones
• have high levels of vitamin D in your blood
• have kidney stones.
Take special care with Calcichew-D3 Forte:
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

Do not use Calcichew-D3 Forte after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that month.
If the tablets have changed shape or colour do not use.
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.
6. FURTHER INFORMATION
What Calcichew-D3 Forte Chewable Tablets contain

The other ingredients are: sorbitol (E420), povidone, isomalt (E953), fatty
acid mono- and di-glycerides, magnesium stearate, lemon flavour,
aspartame (E951), sucrose, tocopherol, 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 Calcichew-D3 Forte”).

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.

Marketing Authorisation Holder
Shire Pharmaceuticals Ltd, Hampshire International Business Park,
Chineham, Basingstoke, Hampshire RG24 8EP, UK.

Additional information
Calcichew-D3 Forte 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

In particular, the following medicines may interact with Calcichew-D3
Forte 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 Forte 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 Forte should be taken at
least three hours afterwards.

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.

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.

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.

Manufacturer
Takeda Nycomed AS, Drammensveien 852, N-1385 Asker, Norway.
This leaflet was last revised in March 2013

The active ingredients in each tablet are:
• 1250mg calcium carbonate (equivalent to 500mg calcium)
• 400IU colecalciferol (equivalent to 10 micrograms vitamin D3)

• 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.
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 Forte should be reduced or
the treatment discontinued.

What Calcichew-D3 Forte look like and contents of the pack
The tablets are round, white, uncoated, convex and lemon flavoured; they
may have small specks.
The tablets are packed in white, plastic bottles of 60 or 100 tablets. Not
all pack sizes may be marketed.

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. For patients in the Republic of
Ireland, please contact the Irish Osteoporosis Society,
33 Pearse Street, Dublin 2. Tel/Fax: 01 677 4267,
email: info@irishosteoporosis.ie

Calcichew-D3 Forte has been designed to give people whose intakes of
calcium and vitamin D are low a boost to the recommended amounts.

*Registered Trademark

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

Taking Calcichew-D3 Forte with food and drink
Calcichew-D3 Forte 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 Forte.
Driving and using machines
Calcichew-D3 Forte has no known effect on your ability to drive or use
machines.
Important information about some of the ingredients of
Calcichew-D3 Forte
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 to
people with phenylketonuria (a deficiency in the enzyme which breaks
down phenylalanine).

2468 V6
6083709-1

3. HOW TO TAKE CALCICHEW-D3 FORTE
Always take Calcichew-D3 Forte exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Adults and the elderly:
Chew or suck the two tablets a day, preferably one tablet in the morning
and one in the evening.
Children:
Calcichew-D3 Forte are not recommended for use in children.
If you take more than you should
If you accidentally take more Calcichew-D3 Forte 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.

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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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