Calcichew-D3 Mite Apelsin 500 mg/200 IE Tuggtablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

20-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

28-04-2018

Aktiva substanser:
kalciumkarbonat; kolekalciferol
Tillgänglig från:
Takeda Pharma AB
ATC-kod:
A12AX
INN (International namn):
calcium carbonate; cholecalciferol
Dos:
500 mg/200 IE
Läkemedelsform:
Tuggtablett
Sammansättning:
kalciumkarbonat 1250 mg Aktiv substans; xylitol Hjälpämne; kolekalciferol 5 mikrog Aktiv substans; sackaros Hjälpämne; isomalt Hjälpämne
Klass:
Apotek
Receptbelagda typ:
Receptbelagt
Terapiområde:
kombinationer med vitamin D och/eller övriga läkemedel
Produktsammanfattning:
Förpacknings: Burk, 168 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 168 tabletter; Blister, 180 tabletter; Burk, 20 tabletter; Burk, 30 tabletter; Burk, 50 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter; Burk, 180 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
21889
Tillstånd datum:
2005-07-01

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

02-04-2020

Produktens egenskaper Produktens egenskaper - engelska

01-11-2019

Läs hela dokumentet

PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcichew-D3 Mite Apelsin 500 mg/200 IU chewable tablets

calcium / cholecalciferol (vitamin D

Read all of this leaflet carefully before you start taking this medicine 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.

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.

What is in this leaflet

What Calcichew-D3 Mite Apelsin is and what it is used for

What you need to know before you take Calcichew-D3 Mite Apelsin

How to take Calcichew-D3 Mite Apelsin

Possible side effects

How to store Calcichew-D3 Mite Apelsin

Contents of the pack and other information

1.

What Calcichew-D3 Mite Apelsin is and what it is used for

Calcichew-D3 Mite Apelsin are chewable tablets containing calcium and vitamin D

, which both are

important substances in bone formation. Calcichew-D3 Mite Apelsin is used in the prevention and treatment

of calcium and vitamin D deficiency, and as a supplement to specific treatment of osteoporosis.

2.

What you need to know before you take Calcichew-D3 Mite Apelsin

Do not take Calcichew-D3 Mite Apelsin

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-D

Mite Apelsin

if you are on long-term treatment, especially if you also take diuretics (used in the 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 that may increase vitamin D levels 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.

Other medicines and Calcichew-D

3

Mite Apelsin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.

For this reason, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after intake of

Calcichew-D3 Mite Apelsin.

Medicines containing bisphosphonates should be taken at least one hour before intake of Calcichew-D3 Mite

Apelsin.

Calcium can reduce the effect of levothyroxine. For this reason, levothyroxine should be taken at least four

hours before or four hours after Calcichew-D3 Mite Apelsin.

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 Mite Apelsin.

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 Mite

Apelsin.

Other medicines that may influence or be influenced by Calcichew-D3 Mite Apelsin are: thiazide diuretics

and cardiac glycosides.

Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D

If you are taking any of the above-mentioned medicines, your doctor will give you further instructions.

Calcichew-D3 Mite Apelsin with food and drink

Calcichew-D3 Mite Apelsin 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

doctor or pharmacist for advice before taking this medicine.

If you are pregnant, you may use Calcichew-D3 Mite Apelsin 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-D

Mite Apelsin can be used during breast-feeding. Calcium and vitamin D

pass into breast milk.

This should be considered when giving additional vitamin D to your child.

Driving and using machines

Calcichew-D

Mite Apelsin has no known influence on the ability to drive and use machines.

Calcichew-D3 Mite Apelsin contains isomalt and sucrose

Calcichew-D3 Mite Apelsin contains isomalt (E953), and sucrose. If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Calcichew-D3 Mite Apelsin

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Dosage:

The recommended dose for adults is one tablet 1-3 times per day.

Use in children

The recommended dose for children is one tablet 1-2 times per day.

The tablets can be chewed or sucked.

If you take more Calcichew-D3 Mite Apelsin than you should

If you may have taken more Calcichew-D3 Mite Apelsin than you should, talk to your doctor or pharmacist

immediately.

If you forget to take Calcichew-D3 Mite Apelsin

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

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 (hypercalacaemia) or in the urine (hypercalciuria) may occur with

large doses

Rare side effects (may affect up to 1 in 1000 people)

Constipation, dyspepsia, flatulence, nausea, gastric pain, diarrhoea

Very rare side effects (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 phoshate in the blood,

kidney stone formation and increased amounts of calcium in the kidneys.

Reporting of side effects

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 the national reporting system listed in Appendix

V*. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Calcichew-D3 Mite Apelsin

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. The expiry date refers to the last

day of that month.

Plastic bottle: Do not store above 30

C. Keep the container tightly closed in order to protect from moisture.

Blister pack: Do not store above 25

C. Store in the original package in order to protect from moisture.

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.

Contents of the pack and other information

What Calcichew-D3 Mite Apelsin contains

The active substances in one tablet are:

calcium carbonate 1250 mg (equivalent to 500 mg calcium)

cholecalciferol (vitamin D

) 200 IU (5 microgram )

The other ingredients are:

xylitol (E967), povidone, isomalt (E953), flavouring (orange), magnesium stearate, sucralose (E955), mono-

and diglycerides of fatty acids, tocopherol, sucrose, modified maize starch, medium chain triglycerides,

sodium ascorbate and colloidal anhydrous silica.

What Calcichew-D3 Mite Apelsin looks like and contents of the pack

Calcichew-D3 Mite Apelsin are white, round chewable tablets.

Pack sizes:

20, 30, 50, 60, 90, 100, 120, 168 and 180 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Takeda Pharma AB

Box 3131

169 03 Solna

Manufacturers:

Tablets packed in plastic bottles:

Takeda AS

Drammensveien 852

1372 Asker, Norway

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

Takeda Pharma AS

55B Jaama Street

63308 Polva, Estonia

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Steovit D3sinaasappel

Finland: Calcichew D3 appelsiini 500 mg/5 mikrog purutabletti

France: Orocal Vitamine D3 500 mg/200 U.I.

Luxembourg: Steovit D3 orange

Sweden: Calcichew-D3 Mite Apelsin

This leaflet was last approved in

2016-10-20

Läs hela dokumentet

Produktinformationen för Calcichew-D3 Mite Apelsin 500 mg/200 IE tuggtablett, MTnr

21889, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att

uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte

någon svensk produktinformation.

Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige

är referensland.

Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på

dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn.

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Calcichew-D

Mite Apelsin 500 mg/200 IU chewable tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Calcium carbonate equivalent to 500 mg calcium

Cholecalciferol concentrate (powder form) equivalent to 200 IU (5 microgram) cholecalciferol

(vitamin D3)

Excipients:

Aspartame (E951)

Isomalt (E953)

Sorbitol (E420)

Sucrose

For a full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Chewable tablet

Round, white and convex tablets. May have small specks.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Prevention and treatment of vitamin D and calcium deficiency.

Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who

are at risk of vitamin D and calcium deficiency.

4.2

Posology and method of administration

Adjunctive therapy in osteoporosis

One chewable tablet 2-3 times per day

Calcium and vitamin D deficiency

Adults: 1 chewable tablet 1-3 times per day

Children: 1 tablet 1-2 times per day

The tablet may be chewed or sucked.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in renal impairment

Calcichew-D

Mite Apelsin tablets should not be used in patients with severe renal impairment.

4.3

Contraindications

Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria

Nephrolithiasis

Hypervitaminosis D

Hypersensitivity to the active substances or to any of the excipients

4.4

Special warnings and precautions for use

During long-term treatment, serum calcium levels should be followed and renal function should be

monitored through measurement of serum creatinine. Monitoring is especially important in elderly

patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients

with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal

function the dose should be reduced or the treatment discontinued.

Vitamin D should be used with caution in patients with impairment of renal function and the effect on

calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken

into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not

metabolised normally and other forms of vitamin D should be used (see section 4.3).

Calcichew-D

Mite Apelsin tablets should be prescribed with caution to patients suffering from

sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients

should be monitored with regard to the calcium content in serum and urine.

Calcichew-D

Mite Apelsin tablets should be used cautiously in immobilised patients with

osteoporosis due to increased risk of hypercalcaemia.

The content of vitamin D (200 IU) in Calcichew-D

Mite Apelsin tablets should be considered when

prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D

should be taken under close medical supervision. In such cases it is necessary to monitor serum

calcium levels and urinary calcium excretion frequently.

Milk-alkali syndrome

(Burnett’s

syndrome),

i.e. hypercalcaemia, alkalosis and renal impairment, can develop when large

amounts of calcium are ingested with absorbable alkali.

Co-administration with tetracyclines or quinolones is usually not recommended, or must be done with

precaution (see section 4.5).

Calcichew-D

Mite Apelsin tablets contain aspartame (E951, a source of phenylalanine). May be

harmful for people with phenylketonuria.

Calcichew-D

Mite Apelsin tablets contain sorbitol (E420), isomalt (E953) and sucrose. Patients with

rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-

isomaltase insufficiency should not take this medicine.

4.5

Interactions with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia,

serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline

preparations. For this reason, tetracycline preparations should be administered at least two hours

before or four to six hours after oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and

vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium

levels.

If a bisphosphonate is used concomitantly, this preparation should be administered at least one hour

before the intake of Calcichew-D

Mite Apelsin since gastrointestinal absorption may be reduced.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased

levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least

four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium.

Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.

4.6

Pregnancy and lactation

Pregnancy

During pregnancy the daily intake should not exceed 1,500 mg calcium and 600 IU vitamin D. Studies

in animals have shown reproductive toxicity of high doses of vitamin D. In pregnant women,

overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related

to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic

doses is teratogenic in humans. Calcichew-D

Mite Apelsin can be used during pregnancy, in case of a

calcium and vitamin D deficiency.

Breast-feeding

Calcichew-D

Mite Apelsin can be used during breast-feeding. Calcium and vitamin D3 pass into

breast milk. This should be considered when giving additional vitamin D to the child.

4.7

Effects on ability to drive and use machines

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

4.8

Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as:

uncommon (>1/1,000, <1/100)

,

rare (>1/10,000, <1/1,000), or very rare (<1/10,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose (see section 4.9) Milk-alkali syndrome

Gastrointestinal disorders

Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.

Very rare: Dyspepsia

Skin and subcutaneous tissue disorders

Very rare: Pruritus, rash and urticaria.

4.9

Overdose

Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may

include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue,

mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe

cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high

calcium levels may lead to irreversible renal damage and soft tissue calcification.

Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and

absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing

loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis

and renal impairment.

Treatment: The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide

diuretics and cardiac glycosides must also be discontinued. Emptying of the stomach in patients with

impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with

loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and

diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Mineral supplements

ATC code: A12AX

Vitamin D increases the intestinal absorption of calcium.

Administration of calcium and vitamin D

counteracts the increase of parathyroid hormone (PTH)

which is caused by calcium deficiency and which causes increased bone resorption.

A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily

intake of two tablets of calcium 500 mg/vitamin D 400 IU for six months normalised the value of the

25-hydroxylated metabolite of vitamin D3 and reduced secondary hyperparathyroidism and alkaline

phosphatases.

5.2

Pharmacokinetic properties

Calcium

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30%

of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of

bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the

total blood-calcium content is in the physiologically active ionised form with approximately 10%

being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins,

principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on

glomerular filtration and calcium tubular reabsorption.

Vitamin D

Absorption: Vitamin D is easily absorbed in the small intestine.

Distribution and metabolism: Cholecalciferol and its metabolites circulate in the blood bound to a

specific globulin. Cholecalciferol is converted in the liver by hydroxylation to the active form 25-

hydroxycholecalciferol. It is then further converted in the kidneys to 1,25 hydroxycholecalciferol. 1,25

hydroxycholecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D

which is not metabolised is stored in adipose and muscle tissues.

Elimination: Vitamin D is excreted in faeces and urine.

5.3

Preclinical safety data

At doses far higher than the human therapeutic range teratogenicity has been observed in animal

studies. There is further no information of relevance to the safety assessment in addition to what is

stated in other parts of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sorbitol (E420)

Povidone

Isomalt (E953)

Flavouring (orange)

Magnesium stearate

Aspartame (E951)

Mono- and diglycerides of fatty acids

All-rac-alpha-tocopherol

Sucrose

Modified maize starch

Triglycerides, medium-chain

Sodium ascorbate

Silica, colloidal anhydrous

6.2

Incompatibilities

Not applicable

6.3

Shelf life

High Density Polyethylene tablet container:

Pack sizes: 20, 30, 50, 60, 90, 100, 120 and 168 tablets: 3 years

Pack size 180 tablets: 2 years

Blister pack: 2 years

6.4

Special precautions for storage

High Density Polyethylene tablet container: Do not store above 30°C. Keep the container tightly

closed in order to protect from moisture.

Blister pack: Do not store above 25

C. Store in the original package in order to protect from moisture.

6.5

Nature and content of container

The chewable tablets are packed in:

HDPE

tablet containers with HDPE/LDPE screw cap, or LDPE cap

Blister pack (PVC/PE/PVdC/Al)

Pack sizes: 20, 30, 50, 60, 90, 100, 120, 168 and 180 tablets

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements

7.

MARKETING AUTHORISATION HOLDER

Nycomed AB

Box 27264

102 53 Stockholm

Sweden

8.

MARKETING AUTHORISATION NUMBERS

21889

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2005-07-01/ 2008-06-01

10.

DATE OF THE REVISION OF THE TEXT

2011-11-28

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