Calcichew-D3 Forte Chewable Tablets, Calcium Carbonate / Colecalciferol, Equivalent to 500 mg Calcium / 400 IU Colecalciferol

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Colecalciferol; Calcium carbonate
Available from:
PCO Manufacturing Ltd.
ATC code:
A12AX
INN (International Name):
Colecalciferol; Calcium carbonate
Dosage:
500mg/400IU mg/IU
Pharmaceutical form:
Chewable tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Calcium, combinations with vitamin D and/or other drugs
Authorization status:
Authorised
Authorization number:
PPA0465/156/002
Authorization date:
2007-09-28

PATIENT INFORMATION LEAFLET

CALCICHEW*-D3 FORTE CHEWABLE TABLETS

calcium carbonate / colecalciferol

equivalent to 500mg Calcium / 400IU colecalciferol

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 effects not listed in this leaflet, please talk to your doctor or

pharmacist.

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 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 Chewable Tablets 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.

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.

o renal (kidney failure)

o 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

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 condtions 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.

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.

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.

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.

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 teeth.

Aspartame contains a source of phenylalanine and may be harmful to people with phenylketonuria (a deficiency in the

enzyme which breaks down phenylalanine).

3. HOW TO TAKE CALCICHEW- D3 FORTE

Always take Calcichew- D3 Forte Tablets 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 the two tablets a day, preferably one tablet in the morning and one in the evening.

Children:

Calcichew- D3 Forte Tablets are not recommended for use in children

If you take more than you should

If you accidentally take more Calcichew- D3 Forte Chewable Tablets 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 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 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”)

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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report

side effects directly to HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website:www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of

this medicine.

5. HOW TO STORE CALCICHEW-D3 FORTE

Keep this medicine out of the sight and reach of children.

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.

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 active ingredients in each tablet are:

1250mg calcium carbonate (equivalent to 500mg calcium)

400IU colecalciferol (equivalent to 10 micrograms vitamin D3)

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

Chewable Tablets”).

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.

Manufacturer

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

Product is procured from within the EU, repackaged and distributed by the Parallel Product Authorisation Holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath, Ashbourne, Co. Meath

PPA No.: 465/156/2

This leaflet was prepared by PCO Manufacturing in October 2016.

Calcichew is a registered trademark of Takeda AS.

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.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calcichew-D3 Forte Chewable Tablets, Calcium Carbonate / Colecalciferol, Equivalent to 500 mg Calcium / 400 IU

Colecalciferol

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Per tablet:

Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10

micrograms vitamin D3)

Excipients: Sucrose, sorbitol (E 420), isomalt (E953), aspartame (E951).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet.

Round, white, uncoated and convex tablet. May have small specks.

4 CLINICAL PARTICULARS

As per PA1547/007/002

5 PHARMACOLOGICAL PROPERTIES

As per PA1547/007/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitol (E420)

Povidone

Isomalt (E953)

Flavouring (lemon)

Fatty acid mono- and di-glycerides

Aspartame (E951)

Magnesium stearate

Sucrose

Tocopherol

Modified Maize starch

Medium chain triglycerides

Sodium ascorbate

Anhydrous colloidal silica

6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the

market in the country of origin.

6.4 Special precautions for storage

Do not store above 30°C. Keep the container tightly closed to protect from moisture.

6.5 Nature and contents of container

White, high density polyethylene bottles.

Bottles containing 60 or 100 tablets with tamper evident seal.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10 Ashbourne Business Park

Rath

Ashbourne

Co. Meath

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/156/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28th September 2007

10 DATE OF REVISION OF THE TEXT

October 2016

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