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CALCICHEW D3 FORTE CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / COLECALCIFEROL

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BATCH No.

500 mg/400 IU
CHEWABLE TABLETS

calcichew D#c
Forte Chewable
Tablets

calcium/colecalciferol

100 Chewable Tablets

Peel here but do not remove

CALCICHEW*-D3 FORTE
500 mg/400 IU
CHEWABLE TABLETS

calcichew d#c
forte chewable
tablets
calcium/colecalciferol

100 Chewable Tablets

PATIENT INFORMATION LEAFLET

CALCICHEW*-D3 FORTE 500 mg/400 IU CHEWABLE TABLETS
calcium / colecalciferol

Read all of this leaflet carefully 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.
- You must talk to a doctor if you do not feel better or if you feel worse after
two weeks.
- 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.
In this leaflet:
1. What Calcichew-D3 Forte is and what it is used for
2. What you need to know 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. Contents of the pack and other information

6083709-05

035382 011363

EXP

CALCICHEW*-D3 FORTE

PL 16189/0026
PA 1547/7/2

5

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.
Takeda UK Ltd. Wooburn Green,
BUCKS, HP10 0DF, UK
*Registered Trademark

• Headache
• Loss of appetite, nausea or vomiting
• Unusual tiredness or weakness, along with elevated levels of
calcium in the blood and kidney impairment.
Side effects include:
Uncommon side-effects (may affect less than 1 in 100 people):
• excessive amounts of calcium in your blood (hypercalcaemia)
or in your urine (hypercalcuria) may occur with large doses
Rare side-effects (may affect less than 1 in 1,000 people):
• nausea
• wind (flatulence)
• stomach ache
• rash
• constipation
• hives
• heartburn (dyspepsia)
• itching
• diarrhoea
Very rare side-effects (may affect less than 1 in 10,000 people):
• 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.

1. WHAT CALCICHEW-D3 FORTE IS AND WHAT IT IS USED FOR
Calcichew-D3 Forte Chewable Tablets are lemon flavoured chewable tablets
containing calcium and vitamin D3 which are both important substances in bone
formation. Both are found in the diet and vitamin D is also produced in the skin
after exposure to the sun.
Calcichew-D3 Forte is used to treat and prevent vitamin D/calcium deficiency,
which may occur when your 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 during
pregnancy.
2. BEFORE YOU TAKE CALCICHEW-D3 FORTE
Do not take Calcichew-D3 Forte Chewable Tablets if you:
• are allergic to calcium, vitamin D, or any of the other ingredients of this
medicine (listed in section 6)
• have severe kidney problems
• have a condition that causes excessive anounts of calcium in your blood or
urine (hypercalcaemia or hypercalciuria) e.g.
o renal (kidney failure)
o cancer that has affected your bones

Side effects with frequency not known (cannot be estimated from the
available data):
• Hypersensitivity reactions such as swelling of the face, tongue, lips
(angioedema) or swelling of the throat (laryngeal oedema).
• 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.
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:
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
United Kingdom
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.

• have excessive amounts of vitamin D in your blood
• have kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew-D3 Forte:
• if you have phenylketonuria (a deficiency in the enzyme which breaks down
phenylalanine) as these tablets contain aspartame, a source of phenylalanine
• if you have osteoporosis (brittle bones) and are also unable to move around
• if you are on long term treatment, especially if you are taking medicines for a
heart disorder (cardiac glycosides), or diuretics (used in the treatment of
high blood pressure or oedema)
• if you have signs of impaired kidney function or a high tendency to kidney
stone (calculus) formation
• if you have cancer or any other condtions that may have affected your
bones
• if you have sarcoidosis (an immune system disorder which may cause
increased levels of vitamin D in the body).
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)





Keep out of the sight and reach of children.

sucrose, tocopherol, modified maize starch, medium-chain triglycerides,
sodium ascorbate and anhydrous colloidal silica, (see also end of Section 2
“Calcichew-D3 Forte contains isomalt, sorbitol, sucrose and aspartame”).

Store in the original package. Keep container tightly closed to protect from
moisture. Do not store above 30°C
Do not use Calcichew-D3 Forte Tablets after the expiry date which is stated on
the label after EXP. The expiry date refers to the last date of that month. If the
tablets have changed shape or colour do not use.

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 and 100 tablets. Not all
pack sizes may be marketed.

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 to protect the environment.

Marketing Authorisation Holder
Takeda UK Ltd., Building 3, Glory Park, Glory Park Avenue, Wooburn Green,
BUCKS, HP10 0DF, United Kingdom

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Manufacturer
Takeda AS, Drammensveien 852, N-1385 Asker, Norway.

5. HOW TO STORE CALCICHEW-D3 FORTE

What Calcichew-D3 Forte Chewable Tablets contain
The active ingredients in each tablet are:
• 1250mg calcium carbonate (equivalent to 500mg calcium)
• 400IU colecalciferol (equivalent to 10 micrograms vitamin D3)

This leaflet was last revised in April 2016.

The other ingredients are: sorbitol (E420), povidone, isomalt (E953), fatty acid
mono- and di-glycerides, magnesium stearate, lemon flavour, aspartame (E951),

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.
Other medicines and Calcichew-D3 Forte
Please inform your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
In particular, the following medicines may interact with Calcichew-D3 Forte
chewable tablets:
• thiazide diuretics (water tablets); your serum calcium levels should be
monitored regularly.
• cardiac glycosides (heart medicines); you should be monitored by
electrocardiogram (ECG) and your serum calcium levels measured.
• tetracycline antibiotics; these should be taken at least two hours before, or
four to six hours afterwards. Calcium carbonate may interfere with the
absorption of tetracycline preparations if taken at the same time.
• levothyroxine (hormone used to treat thyroid deficiency); these should be
taken at least four hours before or after taking Calcichew-D3 Forte.

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 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 Forte 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.
The National Osteoporosis Society (NOS) in the UK and the Irish Osteoporosis
Society (IOS) in the Republic of Ireland, are national charities dedicated to
improving the diagnosis, prevention and treatment of osteoporosis. The NOS
and IOS offer support to people with osteoporosis and raise awareness of the
importance of healthy bones.
For patients in the UK, 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, 114 Pembroke Road,
Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751, Fax: +353 (0)1 668
0098, email: info@irishosteoporosis.ie.
*Registered Trademark

6083709-05

• quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin,
sparfloxacin): the effect of these medicines may be reduced if taken at the
same time as calcium. Take quinolone antibiotics two hours before or six hours
after taking Calcichew-D3 Forte.
• bisphosphonates; should be taken at least one hour before Calcichew-D3
Forte
• 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-D3 Forte
• 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.
Taking Calcichew-D3 Forte with food and drink
Calcichew-D3 Forte can be taken with or without food and drink.
Pregnancy and breastfeeding
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
Calcichew-D3 Forte.

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.

3. HOW TO TAKE CALCICHEW-D3 FORTE

Like all medicines, this medicine can cause side-effects, although not
everybody gets them.

If you are pregnant, you may use Calcichew-D3 Forte in case of a calcium and
vitamin D deficiency.

Always take Calcichew-D3 Forte Tablets exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Stop taking your medicine and see a doctor immediately if you experience:
• Frequent urge to urinate

Calcichew-D3 Forte 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.

Dosage
The recommended dose is two tablets a day, preferably one tablet in the
morning and one tablet in the evening.The tablet may be chewed or sucked.
Children
Calcichew-D3 Forte Tablets are not recommended for use in children

Driving and using machines
Calcichew-D3 Forte has no known influence on the ability to drive or use
machines.

If you take more than you should
If you have taken more Calcichew-D3 Forte than you should, talk to your doctor
or pharmacist immediately.

Calcichew-D3 Forte contains isomalt, sorbitol, sucrose and aspartame.
Calcichew-D3 Forte contains sorbitol, isomalt (E953) and sucrose (E420): 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 teeth.
Calcichew-D3 Forte contains aspartame (E951), a source of phenylalanine,
which may be harmful to people with phenylketonuria (a deficiency in the
enzyme which breaks down phenylalanine).

If you forget to take Calcichew-D3 Forte Chewable Tablets
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

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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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