Calciup D3 500 mg/440 IU Chewable Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALCIUM CARBONATE; Cholecalciferol concentrate
Available from:
Rowex Ltd
ATC code:
A12AX
INN (International Name):
CALCIUM CARBONATE; Cholecalciferol concentrate
Dosage:
500mg/440 international unit(s)
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:
Not marketed
Authorization number:
PA0711/217/002
Authorization date:
2014-08-01

Package leaflet: Information for the patient

Calciup D

3

500 mg/440 IU chewable tablets

calcium / colecalciferol

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.

You must talk to a doctor if you do not feel better or if you feel worse after one month.

What is in this leaflet

What Calciup D

500 mg/440 IU chewable tablets are and what they are used for

What you need to know before you take Calciup D

500 mg/440 IU chewable tablets

How to take Calciup D

500 mg/440 IU chewable tablets

Possible side effects

How to store Calciup D

500 mg/440 IU chewable tablets

Contents of the pack and other information

1. What Calciup D

3

500 mg/440 IU chewable tablets are and what they are used for

Calciup D

500 mg/440 IU chewable tablets contain the active substances calcium and vitamin D

are a calcium-vitamin D

-supplement.

Calciup D

500 mg/440 IU chewable tablets are used

to prevent and treat a lack of calcium and vitamin D in elderly,

for vitamin D- and calcium supplementation as supportive treatment of osteoporosis (brittle

bones).

2. What you need to know before you take Calciup D

3

500 mg/440 IU chewable tablets

Do not take Calciup D

3

500 mg/440 IU chewable tablets:

if you are allergic to calcium, vitamin D

or any of the other ingredients of this medicine (listed in

section 6)

if you have high levels of calcium in your blood (hypercalcaemia)

if you have increased excretion of calcium with your urine (hypercalciuria)

if you suffer from overactive parathyroid glands (hyperparathyroidism)

if you suffer from bone marrow cancer (myeloma)

if you suffer from cancer that has affected your bones (bone metastases)

if you have a restraint of the limbs (prolonged immobilisation) accompanied with hypercalcaemia

and / or hypercalciuria

if you have kidney stones (nephrolithiasis)

if you have calcium deposits in your kidneys (nephrocalcinosis)

if you suffer from an excessive supply of vitamin D (hypervitaminosis D)

if you have severe kidney problems

if you are below 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calciup D

500 mg/440 IU chewable tablets if any of

the following applies to you:

long-term treatment

During long-term treatment the levels of calcium in your blood and urine and your kidney

function have to be monitored regularly. This is especially important if you have a tendency to

develop kidney stones. Depending on your blood levels your doctor might reduce the dosage or

discontinue the treatment. If you are taking chewable tablets without medical advice, please

always consult its use over the period of one month with your doctor.

simultaneous treatment with cardiac glycosides or thiazide diuretics (water tablets) for heart

problems

In such a case the levels of calcium in your blood and urine and your kidney function have to be

monitored regularly especially if you are older. Depending on your blood levels your doctor might

reduce the dosage or discontinue the treatment.

kidney problems

If you suffer from kidney problems you have to take Calciup D

500 mg/440 IU chewable tablets

with special care, especially if you also receive aluminium-containing products as the citric acid

in Calciup D

500 mg/440 IU chewable tablets might increase the uptake of aluminium. Your

calcium levels in the blood and urine have to be checked. If you suffer from severe kidney

problems, use other forms of vitamin D than cholecalciferol.

additional intake of calcium and vitamin D supplementation

Medical supervision is needed and your doctor will require frequent monitoring of the calcium

levels in your blood and urine.

sarcoidosis (an immune system disorder which may affect your liver, lung, skin or lymph nodes)

Take special care when taking Calciup D

500 mg/440 IU chewable tablets if you suffer from

sarcoidosis. There is a risk that the effect of this medicine gets too strong which can result in an

overdose of calcium in the body. The levels of calcium in the blood and urine have to be

monitored.

immobilization and osteoporosis.

In such a case this medicine has to be used with special care, as the level of calcium in your blood

might increase. If you are taking Calciup D

500 mg/440 IU chewable tablets in osteoporosis, it is

recommended to check your calcium levels in the blood before you start using this product.

Children and adolescents

Calciup D

500 mg/440 IU chewable tablets must not be taken by children and adolescents below 18

years of age, see above under the headline “Do not take Calciup D

500 mg/440 IU chewable tablets”.

Other medicines and Calciup D

3

500 mg/440 IU chewable tablets

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

medicines.

In the case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from

foxglove), cardiac arrhythmias can occur. Rigorous medical monitoring including an ECG and

measurement of the blood calcium level is therefore necessary.

In the case of simultaneous administration of diuretics of the thiazide medicine class (also called

water tablets), the blood calcium level should be regularly monitored since thiazides decrease the

excretion of calcium in the urine.

The absorption and thus also the effectiveness of certain antibiotics (called tetracyclines) are

decreased by simultaneous administration of Calciup D

500 mg/440 IU chewable tablets. These

medicines should be taken at least 2 hours before or 4-6 hours after Calciup D

500 mg/440 IU

chewable tablets.

Furthermore, other medicines such as sodium fluoride (used to strengthen the tooth enamel or to treat

osteoporosis) and bisphosphonate (used to treat osteoporosis) medicines are affected by interactions.

These products should therefore be taken at least 3 hours before Calciup D

500 mg/440 IU chewable

tablets.

As long an interval as possible should be left between the administration of cholestyramine (a product

to lower raised cholesterol levels) or laxatives such as liquid paraffin and Calciup D

500 mg/440 IU

chewable tablets since otherwise vitamin D is not absorbed properly.

The simultaneous administration of Calciup D

500 mg/440 IU chewable tablets and phenytoin (a

product for the treatment of epilepsy) or barbiturates (hypnotics) can result in a reduction of the effect

of vitamin D.

The simultaneous administration of Calciup D

500 mg/440 IU chewable tablets and glucocorticoids

(e.g. cortisone) can result in a reduction of the effect of vitamin D and in a decreased calcium level in

the blood.

The additional supplementation of calcium and vitamin D should be given only under medical

supervision and will require frequent monitoring of the calcium levels in the blood and urine.

Calcium salts may decrease the absorption of iron, zinc or strontium. For this reason, iron, zinc or

strontium preparations should be administered at least two hours after oral intake of calcium.

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

levothyroxine should be taken at least 4 hours before or 4 hours after Calciup D

500 mg/440 IU

chewable tablets.

The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take

quinolone antibiotics 2 hours before or 6 hours after taking Calciup D

500 mg/440 IU chewable

tablets.

Calciup D

3

500 mg/440 IU chewable tablets with food, drink and alcohol

Please notice that oxalic acid (contained in e.g. spinach and rhubarb) and phytic acid (contained in

e.g. wholegrain cereals) can reduce the amount of calcium you absorb in your bowel. In the 2 hours

before or after eating food containing high amounts of oxalic or phytic acid you should not take

medicines that contain calcium.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant you may use Calciup D

500 mg/440 IU chewable tablets in case of a calcium and

vitamin D deficiency.

The daily dose of one chewable tablet must not be exceeded. During pregnancy the total daily amount

of calcium should not be higher than 1,500 mg and the total daily amount of vitamin D

should not be

higher than 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy must be avoided since this may lead

to high levels of calcium in the blood and may have a negative effect on the unborn child.

Breast-feeding

Calciup D

500 mg/440 IU chewable tablets can be used during breast-feeding. As calcium and

vitamin D pass into breast-milk check with your doctor first if your child receives any other products

containing vitamin D.

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.

Driving and using machines

No data are available regarding the effects of Calciup D

500 mg/440 IU chewable tablets on your

ability to drive and use machines. However, an influence is unlikely.

Calciup D

3

500 mg/440 IU chewable tablets contain aspartame, sorbitol, isomalt, sucrose and

sodium

This medicine contains 0.5 mg aspartame in each chewable tablet. Aspartame is a source of

phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which

phenylalanine builds up because the body cannot remove it properly.

This medicine contains up to 59.66 mg sorbitol in each chewable tablet.

It also contains isomalt and sucrose. If you have been told by your doctor that you have an intolerance

to some sugars, contact your doctor before taking this medicine.

May be harmful to the teeth.

This medicine contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say

essentially ‘sodium-free’.

3. How to take Calciup D

3

500 mg/440 IU chewable tablets

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. Do not take Calciup D

500 mg/440 IU

chewable tablets over the period of one month without medical advice. If you want to use this product

over this period, please consult your doctor (see also Section 2 - Warnings and precautions).

The recommended dose is:

Adults and elderly take one chewable tablet twice daily (corresponding to a total daily dose of

1,000 mg of calcium and 880 IU (International Units) of vitamin D

Pregnant women take one chewable tablet only once daily (corresponding to 500 mg of

calcium and 440 IU (International Units) of vitamin D

). The daily dose of one chewable

tablet must not be exceeded.

Use in children and adolescents

Calciup D

500 mg/440 IU chewable tablets must not be taken by children and adolescents below 18

years of age, see above under the headline “Do not take Calciup D

500 mg/440 IU chewable tablets”.

Method of administration

Oral use

The chewable tablet has to be chewed before it is swallowed.

You can take Calciup D

500 mg/440 IU chewable tablets at any time, with or without food.

Duration of treatment

Calciup D

500 mg/440 IU chewable tablets should be taken as long-term treatment. Talk to your

doctor or pharmacist about how long you should take this medicine (see also section 2 under the

headline “Warnings and precautions”).

If you take more Calciup D

3

500 mg/440 IU chewable tablets than you should

Contact your doctor or pharmacist immediately if you suspect an overdose and have the package and

any remaining chewable tablets available.

Overdose of Calciup D

500 mg/440 IU chewable tablets may lead to symptoms such as feeling sick

(nausea), vomiting, thirst or excessive thirst, increased urine output, depletion of body fluids or

constipation, frequent urination, enduring headache, enduring loss of appetite, unusual fatigue or

weakness together with elevated calcium levels in your blood and kidney problems.

If you forget to take Calciup D

3

500 mg/440 IU chewable tablets

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In

that case just take the next dose at the usual time. Do not take a double dose to make up for a

forgotten dose.

If you stop taking Calciup D

3

500 mg/440 IU chewable tablets

Please consult your doctor if you wish to interrupt or prematurely discontinue treatment.

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.

STOP taking Calciup D

3

500 mg/440 IU chewable tablets and contact your doctor immediately

if you experience any of the following serious side effects:

Very rare side effects: may affect up to 1 in 10,000 people:

allergic reactions: swelling of the face, lips, tongue or throat with sudden difficulty breathing and

severe rash.

Other side effects reported are:

Uncommon side effects: may affect up to 1 in 100 people:

high levels of calcium in your blood (hypercalcaemia)

high levels of calcium in your urine (hypercalciuria).

Rare side effects: may affect up to 1 in 1,000 people:

feeling sick (nausea)

vomiting

diarrhoea

abdominal pain

constipation

wind

bloating (abdominal distension)

rash

itching

hives

allergy.

Very rare side effects: may affect up to 1 in 10,000 people

milk-alkali syndrome (Burnett-Syndrome) which usually occurs after excessive calcium intake.

Symptoms are: frequent urination, enduring headache, enduring loss of appetite, nausea or

vomiting, unusual fatigue or weakness together with elevated calcium levels in your blood and

kidney problems.

If you have renal impairment, you are at increased risk for high level of phosphate in the blood,

increased calcium levels in the kidneys and kidney stones.

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 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 Calciup D

3

500 mg/440 IU chewable tablets

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 carton and on the laminated

aluminium paper foil after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Calciup D

3

500 mg/440 IU chewable tablets contain

The active substances are calcium and colecalciferol (vitamin D

). Each chewable tablet contains

500 mg of calcium (as carbonate) and 440 IU of colecalciferol (vitamin D

) (equivalent to 11

micrograms of colecalciferol (vitamin D

The other ingredients are isomalt (E953), xylitol, sorbitol (E420), citric acid, anhydrous, sodium

dihydrogen citrate, magnesium stearate, carmellose sodium, flavour orange “CPB” and flavour

orange “CVT” (which both contain sorbitol (E420)), aspartame (E951), acesulfam potassium,

sodium ascorbate, all-rac-alpha-tocopherol, modified (maize) starch, sucrose, triglycerides

medium chain and silica, colloidal anhydrous.

What Calciup D

3

500 mg/440 IU chewable tablets look like and contents of the pack

Round, white tablets with faultless surface.

The chewable tablets are packed in strips of laminated aluminium paper foil and inserted in a carton.

Pack sizes:

10, 20, 30, 48, 50, 90, 100 and 120 chewable tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder

Rowex Ltd., Bantry, Co. Cork, Ireland.

Manufacturers

Hermes Arzneimittel GmbH, Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany.

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

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

names:

Calcium-D-Sandoz 500 mg/440 NE rágótabletta

Calciup D

500 mg/440 IU chewable tablets

Calcium/Vitamine D

Sandoz 500 mg/440 IE,

kauwtabletten

This leaflet was last revised in 05/2019.

Health Products Regulatory Authority

27 February 2020

CRN009N2V

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calciup D3 500 mg/440 IU Chewable Tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains 500 mg of calcium (as carbonate) and 440 IU of colecalciferol (vitamin D

) (equivalent to 11

micrograms of colecalciferol (vitamin D

Excipient(s) with known effect

Each chewable tablet contains 0.5 mg of aspartame (E 951), up to 59.66 mg of sorbitol (E 420), 185.00 mg of isomalt (E 953)

and 0.847 mg of sucrose.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablets.

Round, white tablets, diameter 18 mm with a faultless surface.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Calciup D

500 mg/ 440 IU Chewable Tablets are indicated:

- for the prevention and treatment of vitamin D and calcium deficiency in elderly,

- as 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

The product should not be used over a period of one month without medical advice.

Posology

Adults and elderly

One chewable tablet twice daily, corresponding to a total daily dose of 1,000 mg of calcium and 880 IU of vitamin D

Hepatic impairment

No dose adjustment is required.

Renal impairment

Calciup D

500 mg/ 440 IU Chewable Tablets are contraindicated in patients with severe renal impairment (see section 4.3).

Pregnant patients

During pregnancy the daily intake should not exceed 1,500 mg of calcium and 600 I.U. of vitamin D

. Therefore, the daily dose

must not exceed one chewable tablet (see section 4.6).

Paediatric population

Calciup D

500 mg/ 440 IU Chewable Tablets are contraindicated in children and adolescents below 18 years of age (see section

4.3).

Method of administration

Oral use

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27 February 2020

CRN009N2V

Page 2 of 7

Calciup D

500 mg/ 440 IU Chewable Tablets can be taken at any time, with or without food. The chewable tablets should be

chewed and swallowed.

4.3 Contraindications

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

- Hypercalciuria and hypercalcaemia and diseases and/or conditions, which lead to hypercalcaemia and/or hypercalciuria (e.g.

myeloma, bone metastases, primary hyperparathyroidism, prolonged immobilisation accompanied by hypercalciuria and/or

hypercalcaemia)

- Nephrolithiasis

- Nephrocalcinosis

- Hypervitaminosis D

- Severe renal impairment

- Use in children or adolescents below 18 years of age due to the high content of vitamin D in this medicinal product

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

measurements of serum creatinine. Monitoring is especially important in geriatric patients on concomitant treatment with

cardiac glycosides or thiazide 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, if urinary calcium excretion exceeds 300 mg/24 hours (7.5 mmoles/24

hours) 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).

Calciup D

500 mg/ 440 IU Chewable 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.

Calciup D

500 mg/ 440 IU Chewable Tablets should be used cautiously in immobilised patients with osteoporosis due to

increased risk of hypercalcaemia.

The content of vitamin D (440 IU) in Calciup D

500 mg/ 440 IU Chewable Tablets should be considered when prescribing other

medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken only under close medical

supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

A milk-alkali syndrome (Burnett-Syndrome), i.e. hypercalcaemia, metabolic alkalosis, renal failure and soft tissue calcification

can occur if high doses of calcium are taken concomitantly with absorbable alkali agents (like carbonate).

There have been literature reports alluding to possible increased absorption of aluminium with citrate salts. Calciup D

500 mg/

440 IU Chewable Tablets (which contains citric acid) should be used with caution in patients with severely impaired renal

function, especially in those also receiving aluminium-containing preparations.

Calciup D

500 mg/440 IU chewable tablets contain aspartame, sorbitol, isomalt, sucrose and sodium

This medicinal product contains 0.5 mg aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be

harmful for patients with phenylketonuria (PKU).

This medicinal product contains up to 59.66 mg sorbitol in each chewable tablet.

It also contains isomalt and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose

malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.

May be harmful to the teeth.

This medicinal product contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially 'sodium-free'.

Health Products Regulatory Authority

27 February 2020

CRN009N2V

Page 3 of 7

4.5 Interaction with other medicinal products and other forms of interactions

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.

Systemic corticosteroids reduce calcium absorption. Moreover the effect of vitamin D may be decreased. During concomitant

use, it may be necessary to increase the dose of Calciup D3 500 mg/440 IU chewable tablets.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the

gastrointestinal absorption of vitamin D. Therefore a time interval as long as possible between the intakes is recommended.

Oxalic acid (contained in e.g. spinach and rhubarb) and phytic acid (contained in e.g. whole cereals) may inhibit calcium

absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within

two hours of eating foods with a high content of oxalic acid and phytic acid.

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 or sodium fluoride is used concomitantly, this preparation should be administered at least three hours

before the intake of Calciup D3 500 mg/440 IU chewable tablets 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 or strontium. For this reason, iron, zinc or strontium preparations

should be administered at least two hours after oral intake of calcium.

4.6 Fertility, pregnancy and lactation

Pregnancy

Calciup D3 500 mg/440 IU chewable tablets can be used during pregnancy in case of a calcium and Vitamin D deficiency.

During pregnancy the daily intake should not exceed 1,500 mg of calcium and 600 I.U. of vitamin D3. Therefore, the daily dose

must not exceed one chewable tablet.

High doses of vitamin D have been shown to have teratogenic effects in animal experiments. In pregnant women, overdoses of

calcium and vitamin D should be avoided, since prolonged hypercalcaemia has been sometimes associated with retardation of

physical and mental development, supravalvular aortic stenosis and retinopathy in the child.

Breast-feeding

Calciup D3 500 mg/440 IU chewable tablets can be used during breast-feeding. Calcium and vitamin D3 pass into the

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

Fertility

No data available.

4.7 Effects on ability to drive and use machines

No data are available regarding the effects of Calciup D3 500 mg/440 IU chewable tablets on the ability to drive and use

machines. However, an influence is unlikely.

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27 February 2020

CRN009N2V

Page 4 of 7

4.8 Undesirable effects

Summary of the safety profile:

The medicinal product may cause hypersensitivity reactions including rash, pruritis, urticaria and other systemic allergic

reactions including anaphylactic reaction, face oedema, angioneurotic oedema. Uncommon cases of hypercalcaemia,

hypercalciuria have been observed and rare cases of gastrointestinal disorders such as nausea, diarrhoea, abdominal pain,

constipation, flatulence, abdominal distension and vomiting have been reported.

All adverse reactions are listed by system organ class and frequency which is defined as follows:

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)

Tabulated list of adverse reactions:

System Organ Class

Frequency

Adverse Reactions

Immune system disorders

Rare

Very rare

hypersensitivity

systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic

oedema)

Metabolism and nutrition disorders

Uncommon

Very rare

hypercalcaemia, hypercalciuria

milk-alkali syndrome (Burnett-Syndrome, usually in case of overdose, see section

4.9)

Gastrointestinal disorders

Rare

nausea, vomiting, diarrhoea, abdominal pain, constipation, flatulence, abdominal

distension

Skin and subcutaneous tissue disorders

Rare

rash, pruritus, urticaria

Special patient group

Renal impairment

Patients with renal impairment are at increased risk for hyperphosphataemia, nephrolithiasis and nephrocalcinosis.

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

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Symptoms

Overdose can lead to hypervitaminosis, hypercalciuria and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia,

dehydration, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia,

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, soft tissue calcification, vascular and

organ calcification. A milk-alkali syndrome (Burnett-Syndrome) can occur in patients who take high doses of calcium together

with absorbable alkali agents (like carbonate). Symptoms are: frequent urination, enduring headache, enduring loss of appetite,

nausea or vomiting, unusual fatigue or weakness, hypercalcaemia, alkalosis and renal disorder.

Health Products Regulatory Authority

27 February 2020

CRN009N2V

Page 5 of 7

The threshold for vitamin D intoxication is between 40,000 and 100,000 IU per day and for calcium intoxication is from

supplementation in excess of 2,000 mg per day, taken for several months, in persons with normal parathyroid function.

Management

In the case of intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.

Where overdose requires treatment it should be via hydration, including i.v. solution when needed. A loop diuretic (e.g.

furosemide) may then be used to further increase calcium excretion and to prevent volume overload, but thiazide diuretics

should be avoided. In patients with renal failure, hydration is ineffective and they should undergo dialysis. In the case of

persistent hypercalcaemia, contributing factors should be excluded, e.g. vitamin A or D hypervitaminosis, primary

hyperparathyroidism, malignancies, renal failure or immobilisation.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Combination of calcium with other drugs

ATC code: A12AX

Mechanism of action

Calciup D3 500 mg/440 IU, chewable tablets is a fixed combination of calcium and vitamin D3. The high calcium and vitamin

D3 concentration in each dose unit enables sufficient absorption of calcium with a limited number of doses. Vitamin D3 is

involved in calcium-phosphorus metabolism. It allows the active absorption of calcium and phosphorus from the intestine and

their uptake by bone. Supplementation with calcium and vitamin D3 corrects latent vitamin D deficiency and secondary

hyperparathyroidism.

Pharmacodynamic effects

In a double-blind placebo controlled study of 18 months, including 3,270 women aged 84 ± 6 and living in nursing homes,

supplemented with cholecalciferol (800 IU/day) + calcium (1.2 g/day), a significant decrease in PTH secretion has been

observed. After 18 months, the results of the 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). So in the conditions of this study, the treatment of 1,387 women

prevented 30 hip fractures. After 36 months of follow-up, 137 women presented at least one hip fracture in the calcium-vitamin

D group (n=1,176) and 178 in the placebo group (n=1,127) (p≤0.02).

5.2 Pharmacokinetic properties

Calcium

Absorption

30-40% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine.

Distribution and biotransformation

99% of the calcium in the body is concentrated in the mineral component 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 5% being complexed to citrate, phosphate or other anions. The remaining 45% are being bound to

proteins, principally albumin.

Elimination

Calcium is excreted in the urine, faeces and in sweat. Urinary excretion depends on glomerular, filtration and tubular resorption.

Vitamin D3

Absorption

Vitamin D3 is absorbed in the intestine.

Distribution and biotransformation

Vitamin D3 is transported by protein binding in the blood to the liver (where it undergoes the first hydroxylation to

25-hydroxycholecalciferol) and to the kidneys (second hydroxylation to 1,25- dihydroxycholecalciferol, the active metabolite of

vitamin D3). Non-hydroxylated vitamin D3 is stored in muscle and adipose tissues.

Health Products Regulatory Authority

27 February 2020

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Elimination

The plasma half-life is in the order of several days; vitamin D3 is eliminated in the faeces and urine.

5.3 Preclinical safety data

Teratogenicity has been observed in animal studies at doses far higher than the human therapeutic range. No other relevant

data is available that has not been mentioned elsewhere in this Summary of Product Characteristics (see sections 4.6 and 4.9).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Isomalt (E953)

Xylitol

Sorbitol (E420)

Citric acid, anhydrous

Sodium dihydrogen citrate

Magnesium stearate

Carmellose sodium

Flavour Orange “CPB” (containing natural orange oil concentrate, natural/nature identical mandarine

oil, natural/nature identical liquid flavour tropical fruit, natural/nature identical orange oil,

natural/nature identical solid flavour multifruit, mannitol (E421), maltodextrin, gluconolactone,

sorbitol (E420))

Flavour Orange “CVT” (containing natural orange oil, natural mandarine oil, nature identical powder

flavor orange, mannitol (E421), gluconolactone, sorbitol (E420), medium-chained triglyceride)

Aspartame (E951)

Acesulfam potassium

Sodium ascorbate

All-rac-alpha-tocopherol

Modified (maize) starch

Sucrose

Triglycerides, medium chain

Silica, colloidal anhydrous

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

The chewable tablets are packed in strips of laminated aluminium paper foil and inserted in a carton.

Pack sizes:

10, 20, 30, 48, 50, 90, 100 and 120 chewable tablets

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Rowex Ltd

Newtown

Bantry

Co. Cork

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0711/217/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

August 2014

Date of last renewal: 17

June 2019

10 DATE OF REVISION OF THE TEXT

February 2020

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