Calcichew-D3 Melon 500 mg/1000 IE Tuggtablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

20-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

20-04-2018

Aktiva substanser:
kalciumkarbonat; kolekalciferol
Tillgänglig från:
Takeda AS
ATC-kod:
A12AX
INN (International namn):
calcium carbonate; cholecalciferol
Dos:
500 mg/1000 IE
Läkemedelsform:
Tuggtablett
Sammansättning:
sackaros Hjälpämne; kolekalciferol 25 mikrog Aktiv substans; xylitol Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans
Klass:
Apotek
Receptbelagda typ:
Receptbelagt
Terapiområde:
kombinationer med vitamin D och/eller övriga läkemedel
Produktsammanfattning:
Förpacknings: Burk, 30 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
51116
Tillstånd datum:
2015-05-27

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

10-11-2020

Produktens egenskaper Produktens egenskaper - engelska

10-11-2020

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

27-05-2015

Läs hela dokumentet

Package leaflet: Information for the user

Calcichew-D

3

Melon 500 mg/1000 IU chewable tablets

calcium/cholecalciferol (vitamin D

For medicines available only on prescription:

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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.

For medicines available without a prescription:

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.

[To be completed nationally]

What is in this leaflet

What Calcichew-D

Melon is and what it is used for

What you need to know before you take Calcichew-D

Melon

How to take Calcichew-D

Melon

Possible side effects

How to store Calcichew-D

Melon

Contents of the pack and other information

1.

What Calcichew-D

3

Melon is and what it is used for

Calcichew-D

Melon are chewable tablets containing calcium and vitamin D

, which both are

important substances in bone formation. Calcichew-D

Melon 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-D

3

Melon

Do not take Calcichew-D

3

Melon:

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

Melon

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 impaired renal function.

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.

Children and adolescents

Calcichew-D

Melon is not intended for use in children and adolescents.

Other medicines and Calcichew-D

3

Melon

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

medicines.

If you also take tetracyclines (a type of antibiotics), you should take these at least two hours before or

four to six hours after intake of Calcichew-D

Melon. Calcium carbonate may interfere with the

absorption of tetracycline preparations if taken at the same time.

Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least one hour

before intake of Calcichew-D

Melon.

Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason,

levothyroxine should be taken at least four hours before or four hours after Calcichew-D

Melon.

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-D

Melon.

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-

Melon.

Orlistat (used to treat obesity) may disturb the absorption, and thereby reduce the effect, of fat-soluble

vitamins, e.g. vitamin D3.

Other medicines that may influence or be influenced by Calcichew-D

Melon are:

tiazide diuretics (used in treatment of high blood pressure or oedema)

cardiac glycosides (used to treat heart disorders)

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

instructions.

Calcichew-D

3

Melon with food and drink

Calcichew-D

Melon 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-D

Melon 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

Melon 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

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

Calcichew-D

3

Melon contains sucrose

Calcichew-D

Melon contains sucrose (1.9 mg), which may be harmful to the teeth. If you have been

told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this

medicinal product.

Calcichew-D

3

Melon is essentially sodium-free

This medicine contains less than 23 mg sodium per tablet, that is to say essentially ‘sodium-free’.

3.

How to take Calcichew-D

3

Melon

[For medicines available on prescription only:]

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

[For medicines available without prescription:]

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 is one tablet once daily. The tablets can be chewed or sucked.

Use in children and adolescents

Calcichew-D

Melon is not intended for use in children and adolescents.

If you take more Calcichew-D

3

Melon than you should

If you may have taken more Calcichew-D

Melon than you should, talk to your doctor or pharmacist

immediately.

If you forget to take Calcichew-D

3

Melon

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 (hypercalcaemia) 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.

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-D

3

Melon

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 afterEXP. The expiry date

refers to the last day of that month.

Do not store above 30°C. Store in the original container in order to protect from light. Keep the

container tightly closed 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-D

3

Melon contains

The active substances in one tablet are:

Calcium carbonate 1250 mg (equivalent to 500 mg calcium)

Cholecalciferol (vitamin D

) 1000 IU (25 microgram)

The other ingredient are: xylitol (E967), povidone, flavouring (strawberry-watermelon), maize

maltodextrin, glyceryl triacetate (E1518), mono and diacetyl tartaric acid esters of mono-and

deglycerides of fatty acids, magnesium stearate, sucralose (E955), all-rac-alpha-tocopherol, sucrose,

modified maize starch, medium-chain triglycerides, sodium ascorbate, colloidal anhydrous silica.

What Calcichew-D

3

Melon looks like and contents of the pack

Calcichew-D

Melon are white, round chewable tablets of 14 mm. May have small specks.

Pack sizes:

Plastic bottle with HDPE screw cap: 30, 60, 90 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

[To be completed nationally]

Manufacturers:

Takeda AS

Drammensveien 852

NO-1383 Asker

Norway

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

names:

Estonia:

Calcigran Forte Red

Finland:

Calcichew D

Opti mansikka-meloni 500 mg/25 mikrog

Lithuania:

Calcigran Forte 500 mg/1000 TV kramtomosios tabletės

Spain:

Mastical D 500 mg/1000 UI comprimidos masticables sabor fresa

Sweden:

Calcichew-D3 Melon 500 mg/1000 IE tuggtabletter

This leaflet was last revised in

<{MM/YYYY}><{month YYYY}>30 September 2020.

Other sources of information

Detailed information on this medicine is available on the website of {name of MS Agency (link)}.

Läs hela dokumentet

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

Calcichew-D

Melon 500 mg/1000 IU chewable tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Calcium carbonate equivalent to 500 mg calcium

Cholecalciferol concentrate (powder form) equivalent to 1000 IU (25 microgram) cholecalciferol

(vitamin D

Excipient(s) with known effect:

One tablet contains 1.9 mg sucrose

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Chewable tablet.

Round, white, uncoated and convex tablets of 14 mm. 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

Posology

Adults and elderly

One tablet once daily.

The amount of calcium in Calcichew-D

Melon is lower than the recommended daily intake.

Calcichew-D

Melon is therefore primarily to be used by patients with need of D-vitamin

supplementation, but who have some dietary intake of calcium.

Special Patient Populations

Paediatric population:

Calcichew-D

Melon is not intended for use in children or adolescents.

Impaired renal function

Calcichew-D

Melon should not be used in patients with severe renal impairment (see section 4.3).

Dosage in hepatic impairment

No dose adjustment is required

Method of administration

Oral. The tablets should be chewed or sucked.

4.3

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m

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

Renal calculi (nephrolithiasis)

Hypervitaminosis D

4.4

Special warnings and precautions for use

During long-term treatment, serum calcium levels should be monitored. Renal function should also be

monitored, through measurements 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.

Calcium carbonate with cholecalciferol tablets should be used with caution in patients with

hypercalcaemia or signs of impaired renal function and the effect on calcium and phosphate levels

should be monitored. The risk of soft tissue calcification should be taken into account.

During concomitant treatment with other sources of vitamin D and/or medications or nutrients (such

as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with

subsequent kidney function impairment. In these patients serum calcium levels and renal function

should be monitored.

Calcichew-D

Melon 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

Melon should be used cautiously in immobilised patients with osteoporosis due to

increased risk of hypercalcaemia.

Calcichew-D

Melon contains sucrose, which may be harmful to the teeth. Patients with rare

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

insufficiency should not take this medicine.

Calcichew-D

Melon contains less than 23 mg sodium per tablet, that is to say essentially ‘sodium-

free’.

4.5

Interaction with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium, therefore 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 carbonate.

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

Melon 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.

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-

Melon.

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g. vitamin D

4.6

Fertility, pregnancy and lactation

Pregnancy

Calcichew-D

Melon can be used during pregnancy, in case of a calcium and vitamin D deficiency.

During pregnancy the daily intake should not exceed 2500 mg calcium and 4000 IU vitamin D.

Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). 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.

Breastfeeding

Calcichew-D

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

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

Calcichew-D

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

4.8

Undesirable effects

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

very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000

to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Not known: Hypersensitivity reactions such as angioedema or laryngeal oedema

.

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of

appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal

impairment). Seen usually only in overdose (see section 4.9).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Very rare: Pruritus, rash and urticaria.

Other special population

Patients with renal impairment: potential risk of hyperphosphataemia, nephrolithiasis and

nephrocalcinosis. See section 4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V*.

4.9

Overdose

Symptoms

Overdose can lead to hypercalcaemia and hypervitaminosis D. 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.

Treatment of hypercalcaemia

Treatment is essentially symptomatic and supportive. The treatment with calcium and vitamin D must

be discontinued. Treatment with thiazide diuretics and cardiac glycosides must also be discontinued

(see section 4.5). 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, Calcium, combinations with vitamin D and/or

other drugs.

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 1000 mg calcium and 800 IU vitamin D for six months normalised the value of the 25-

hydroxylated metabolite of vitamin D

and reduced secondary hyperparathyroidism and alkaline

phosphatases.

An 18 month double-blind, placebo controlled study including 3270 institutionalised women aged

84+/- 6 years who received supplementation of vitamin D (800 IU/day) and calcium phosphate

(corresponding to 1200 mg/day of elemental calcium), showed a significant decrease of PTH

secretion. After 18 months, an "intent-to treat" analysis showed 80 hip fractures in the calcium-

vitamin D group and 110 hip fractures in the placebo group (p=0.004). A follow-up study after 36

months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176)

and 178 in the placebo group (n=1127) (p≤0.02).

5.2

Pharmacokinetic properties

Calcium

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

of the swallowed dose.

Distribution and biotransformation: 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.

Cholecalciferol

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

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

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

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

dihydroxycholecalciferol. 1,25-dihydroxycholecalciferol 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

Xylitol (E967)

Povidone

Flavouring (strawberry-watermelon)

Maize maltodextrin

Glyceryl triacetate (E1518)

Mono and diacetyl tartaric acid esters of mono-and deglycerides of fatty acids

Magnesium stearate

Sucralose (E955)

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

HDPE bottle: 30 months

6.4

Special precautions for storage

HDPE bottle: Do not store above 30°C. Store in the original container in order to protect from light.

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

6.5

Nature and contents of container

The chewable tablets are packed in:

HDPE bottles with HDPE screw caps

Pack sizes: 30, 60, 90, 100 and 120 tablets

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}

Date of latest renewal: {DD month YYYY}

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

30 September 2020

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