Calciup D3 Forte 1000mg/880 IU Chewable Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
CALCIUM CARBONATE; Cholecalciferol concentrate (powder form)
Available from:
Rowex Ltd
ATC code:
A12AX
INN (International Name):
CALCIUM CARBONATE; Cholecalciferol concentrate (powder form)
Dosage:
1000mg/880 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:
Marketed
Authorization number:
PA0711/217/001
Authorization date:
2012-02-17

1

What Calciup D

3

Forte 1000 mg/880 IU

Chewable tablets are and what they are

used for

Calciup D

Forte 1000 mg/880 IU Chewable tablets

contain the active substances calcium and vitamin D

is a calcium-vitamin D

-supplement.

Calciup D

3

Forte 1000 mg/880 IU Chewable tablets

is 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

Forte 1000 mg/880 IU

Chewable tablets

Do not take Calciup D

3

Forte 1000 mg/880 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 a high level of calcium in the 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

Forte 1000 mg/880 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

dose or discontinue the treatment.

− simultaneous treatment with cardiac glycosides

or thiazide diuretics (water tablets) for heart

problems.

In such case the levels of calcium in your blood and

urine and your kidney function have to be monitored

regularly especially if you are elderly. Depending on

your blood levels your doctor might reduce the dose

or discontinue the treatment.

kidney problems

If you suffer from kidney problems you have to take

Calciup D

Forte 1000 mg/880 IU Chewable tablets

with special care, especially if you also receive

aluminium-containing products as the citric acid in

Calciup D

Forte 1000 mg/880 IU Chewable tablets

might increase the uptake of aluminium. Your calcium

levels of 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

Forte

1000 mg/880 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.

immobilised patients with osteoporosis

In such a case this medicine has to be used with

special care, as the level of calcium in your blood

might increase.

Children and adolescents

Calciup D

Forte 1000 mg/880 IU Chewable tablets

must not be taken by children and adolescents below

18 years of age, see “Do not take Calciup D

Forte

1000 mg/880 IU Chewable tablets”.

Other medicines and Calciup D

3

Forte 1000 mg/880

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 the simultaneous administration of

Calciup D

Forte 1000 mg/880 IU Chewable

tablets. These medicines should be taken at least

2 hours before or 4-6 hours after Calciup D

Forte

1000 mg/880 IU Chewable tablets.

− Furthermore, other medicines such as sodium

fluoride (used to strengthen the tooth enamel or

to treat osteoporosis) quinoline antibiotics and

bisphosphonate (used to treat osteoporosis)

medicines are affected by interactions. These products

should therefore be taken at least 3 hours before

Calciup D

Forte 1000 mg/880 IU Chewable tablets.

− As long an interval as possible should be left between

the administration of cholestyramine (a product to

lower raised cholesterol levels), orlistat (a medicine

used to treat obesity) or laxatives such as liquid

paraffin and Calciup D

Forte 1000 mg/880 IU

Chewable tablets since otherwise vitamin D is not

absorbed properly.

− The simultaneous administration of Calciup D

Forte

1000 mg/880 IU Chewable tablets and rifaximin

(an antibiotic used to treat traveler’s diarrhoea),

phenytoin (a product for the treatment of epilepsy) or

barbiturates (hypnotics) can result in a reduction in

the effect of vitamin D.

− The simultaneous administration of Calciup D

Forte 1000 mg/880 IU Chewable tablets and

glucocorticoids (e. g. cortisone) can result in a

reduction in the effect of vitamin D and to 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 may reduce the absorption of iron, zinc or

strontium ranelate. Take these medicines at least two

hours before or after Calciup D

Forte 1000 mg/880

IU Chewable tablets.

− Calcium may reduce the absorption of the

estramustin (a medicine used in chemotherapy) and

thyroid hormones (used to treat thyroid deficiency).

Take this medicine at least two hours after Calciup D

Forte 1000 mg/880 IU Chewable tablets.

Calciup D

3

Forte 1000 mg/880 IU Chewable tablets

with food, drink and alcohol

Please notice that oxalic acid (e.g. contained in spinach

and rhubarb) and phytic acid (e.g. contained in

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

Forte

1000 mg/880 IU Chewable tablets in case of a calcium

and vitamin D deficiency.

The daily dose of half a 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.

Calciup D

Forte 1000 mg/880 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

Calciup D

Forte 1000 mg/880 IU Chewable tablets

have no known influence on your ability to drive and use

machines.

Calciup D

3

Forte 1000 mg/880 IU Chewable tablets

contains sodium, aspartame, sorbitol, isomalt,

sucrose and benzyl alcohol

This medicine contains less than 1 mmol sodium (23 mg)

per chewable tablet, that is to say essentially ‘sodium-

free’.

Package leaflet: Information for the patient

Calciup D

3

Forte 1000 mg/880 IU Chewable tablets

calcium/colecalciferol (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 has 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.

What is in this leaflet

1. What Calciup D

Forte 1000 mg/880 IU Chewable tablets are and what they are used for

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

Forte 1000 mg/880 IU Chewable tablets

3. How to take Calciup D

Forte 1000 mg/880 IU Chewable tablets

4. Possible side effects

5. How to store Calciup D

Forte 1000 mg/880 IU Chewable tablets

6. Contents of the pack and other information

Continued on the next page

››

This medicine contains 1.00 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 152.89 mg sorbitol (E420)

in each chewable tablet. If your doctor has told you that

you (or your child) have an intolerance to some sugars

or if you have been diagnosed with hereditary fructose

intorlerance (HFI), a rare genetic disorder in which a

person cannot break down fructose, talk to your doctor

before you (or your child) take or recieve this medicine.

This medicine also 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 medicine.

May be harmful to the teeth.

This medicine contains 0.02 mg benzyl alcohol in each

chewable tablet. Benzyl alcohol may cause allergic

reactions.

3

How to take Calciup D

3

Forte

1000 mg/880 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.

The recommended dose is:

Adults and elderly take 1 chewable tablet daily

(corresponding to 1,000 mg of calcium and 880 IU

(International Units) of vitamin D

Pregnant women take only half a chewable tablet daily

(corresponding to 500 mg of calcium and

440 IU (International Units) of vitamin D

). The daily

dose of half a tablet must not be exceeded.

Use in children and adolescents

Calciup D

Forte 1000 mg/880 IU Chewable tablets

must not be taken by children and adolescents below

18 years of age, see also “Do not take Calciup D

Forte

1000 mg/880 IU Chewable tablets”.

Method of administration

Oral use

The chewable tablet has to be chewed before it is

swallowed. You can take Calciup D

Forte

1000 mg/880 IU Chewable tablets at any time, with or

without food.

The tablet can be divided into equal doses.

Duration of treatment

Calciup D

Forte 1000 mg/880 IU Chewable tablets

should be taken as long-term treatment. Talk to your

doctor how long you should take Calciup D

Forte

1000 mg/880 IU Chewable tablets (see also section 2

Warnings and precautions).

If you take more Calciup D

3

Forte 1000 mg/880 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

Forte 1000 mg/880 IU

Chewable tablets may lead to symptoms such as

feeling sick (nausea), vomiting, thirst or excessive thirst,

increased urine output, dehydration or constipation (milk-

alkali syndrome, see also section 4 Possible side effects).

If you forget to take Calciup D

3

Forte 1000 mg/880

IU Chewable tablets

If you forget to take Calciup D

Forte 1000 mg/880

IU Chewable tablets, 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

Forte 1000 mg/880 IU

Chewable tablets

If you wish to interrupt or prematurely discontinue the

treatment, please consult your doctor.

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

Forte 1000 mg/880 IU

Chewable tablets and contact a doctor immediately

if you experience any of the following serious side

effects:

Not known (frequency cannot be estimated from the

available data)

− severe allergic reactions: swelling of the face, lips,

tongue or throat with sudden difficulty breathing and

severe rash.

− frequent urge to urinate, continuing headache,

continuing loss of appetite, nausea or vomiting,

unusual tiredness or weakness, hypercalcaemia,

alkalosis and renal impairment (milk-alkali syndrome).

Other side effects reported are:

Uncommon (may affect up to 1 in 100 people)

− high levels of calcium in your blood (hypercalcaemia)

or urine (hypercalciuria).

Rare (may affect up to 1 in 1,000 people)

− feeling sick (nausea), diarrhoea, abdominal pain,

constipation, wind, bloating (abdominal distension)

− skin rash, itching, hives.

Not known (frequency cannot be estimated from the

available data)

− vomiting.

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; website: www.

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

Forte

1000 mg/880 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 tablet container or on the

laminated aluminium paper foil after “EXP”. The expiry

date refers to the last day of that month.

For tablet container:

After first opening: Keep the tablet container tightly

closed in order to protect from moisture.

For strips: 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

Forte 1000 mg/880 IU Chewable

tablets contain

− The active substances are calcium and colecalciferol.

Each chewable tablet contains 1,000 mg calcium (as

calcium carbonate) and 22 micrograms colecalciferol

(vitamin D

(equivalent to 880 IU as concentrate

powder form).

− 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 silicon

dioxide colloidal. Flavour orange “CPB” also contains

benzyl alcohol as part of the natural/nature identical

mandarin oil.

What Calciup D

3

Forte 1000 mg/880 IU Chewable

tablets look like and contents of the pack

Round, white tablets with faultless surface and a break

mark.

The chewable tablets are available in polypropylene

tablet containers with polyethylene stoppers containing a

desiccant or in strips of laminated aluminium paper foil.

Pack sizes:

Bottle: 10, 20, 28, 30, 40, 50, 56, 60, 90, 100

(bundling package 5x20) chewable tablets

Strips: 10, 20, 28, 30, 40, 48, 56, 60, 60 (bundling

package 2x30), 90, 90 (bundling package 3x30),

96, 100 (bundling package 5x20) 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, Georg-Kalb-Straße 5-8,

82049 Großhesselohe / Munich, 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:

Germany:

Calcium-Sandoz D Osteo intens

1000 mg/880 I.E. Kautabletten

Czech Republic: Calcium/Vitamin D3 Sandoz

Ireland:

Calciup D

Forte 1000 mg/880IU

Chewable tablets

Poland:

Calcium Sandoz + Vitamin D3,

1000 mg + 880 IU, tabletki do

rozgrysaniai

ucia

Romania:

Calciu Sandoz Osteo 1000 mg/880

UI comprimate masticabile

(chewable tablets)

Slovenia:

Kalcij/Vitamin D

Lek 1000 mg/880

i.e.

ljive tablete

United Kingdom:

Accrete D3 One a Day 1000 mg/880

IU Chewable Tablets

This leaflet was last revised in 03/2020.

I.M. L/363a 06-20

Calcium D3 Forte 1000mg/88 IU

Chewable Tablets PIL Var 21

165 x 500 mm

Black

29/06/2020

22519

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calciup D3 Forte 1000mg/880 IU Chewable Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains

1,000 mg calcium (as calcium carbonate) and

22 micrograms colecalciferol (vitamin D

equivalent to 880 IU as concentrate powder form).

Excipient(s) with known effect

Each chewable tablet contains 1.00 mg of aspartame (E 951), up to 152.89 mg of sorbitol (E 420), 370.00 mg of isomalt (E 953),

1.694 mg of sucrose and 0.02 mg benzyl alcohol.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet.

Round, white tablet with faultless surface and a breakmark.

The tablet can be divided into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Calciup 1000 mg / 880 IU chewable tablets is 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

Posology

Adults and elderly

1 chewable tablet daily (corresponding to 1,000 mg of calcium and 880 IU of vitamin D

Hepatic impairment

No dose adjustment is required

Renal impairment

Calciup D

Forte 1000 mg/ 880 IU Chewable Tablets must not be used 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 half a tablet (see section 4.6).

Paediatric population

Calciup D

Forte 1000 mg/ 880 IU Chewable Tablets must not be used in children and adolescents below 18 years of age (see

section 4.3).

Method of administration

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 2 of 7

Oral use.

Calciup D

Forte 1000 mg/ 880 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 (glomerular filtration rate <30 ml/min/1.73 m

- 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.

Calcium/colecalciferol should be used with caution in patients with increased risk of hypercalcaemia or signs of 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 1000 mg / 880 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 1000 mg / 880 IU chewable tablets should be used cautiously in immobilised patients with osteoporosis due to

increased risk of hypercalcaemia.

The content of vitamin D (880 IU) in Calciup 1000 mg / 880 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 potential additional ingestion of calcium and alkaline products (due to the intake of nutrients, fortified foods or other

medicinal products) should be considered. 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

medicinal products (like carbonate).

Co-administration with tetracyclines or quinolones is usually not recommended, or must be done with precaution (see section

4.5).

There have been literature reports alluding to possible increased absorption of aluminium with citrate salts. Calciup 1000 mg /

880 IU chewable tablets contains citric acid.

Paediatric population

Calcium/cholecalciferol is contraindicated in children and adolescents below 18 years (see section 4.3).

Calciup 1000 mg / 880 IU chewable tablets contains sodium, aspartame, sorbitol, isomalt, sucrose and benzyl alcohol

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

14 August 2020

CRN009CPX

Page 3 of 7

This medicinal product contains 1.00 mg aspartame (E 951) in each chewable tablet. Aspartame is a source of phenylalanine

which may be harmful for people with phenylketonuria.

This medicinal product contains up to 152.89 mg sorbitol (E 420) in each chewable tablet. Patients with hereditary fructose

intolerance (HFI) should not take/be given this medicinal product.

It also contains isomalt (E 953) 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 medicine contains 0.02 mg benzyl alcohol in each chewable tablet. Benzyl alcohol may cause allergic reactions.

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 1000 mg / 880 IU chewable tablets.

Concomitant treatment with rifaximin, phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic

activation.

Simultaneous treatment with orlistat, 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 (e.g. found in spinach and rhubarb) and phytic acid (e.g. found in 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 high in 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, sodium fluoride or fluoroquinolones are used concomitantly, this preparation should be administered at

least three hours before the intake of Calciup 1000 mg / 880 IU chewable tablets since gastrointestinal absorption may be

reduced.

Calcium salts may decrease the absorption of iron, zinc or strontium ranelate. Consequently, the iron, zinc or strontium ranelate

preparations should be taken at a distance of two hours from the calcium preparation.

Calcium salts may reduce the absorption of the estramustin or thyroid hormones. It is advised to take this medicinal product

two hours after such medicinal products are administered.

4.6 Fertility, pregnancy and lactation

Pregnancy

Calciup D

Forte 1000 mg/880 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 D

. Therefore, the

daily dose must not exceed half a 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

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 4 of 7

Calciup D

Forte 1000 mg/880 IU Chewable Tablets can be used during breast-feeding. Calcium and vitamin D

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

Calcium/colecalciferol have no known influence on the ability to drive and use machines..

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

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 Drug Reactions

Immune system disorders

Not known

Hypersensitivity reactions such as angioedema or laryngeal oedema

Metabolism and nutrition disorders

Uncommon

Not known

hypercalcaemia, hypercalciuria

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

Not known

nausea, diarrhoea, abdominal pain, constipation, flatulence, abdominal distension

vomiting

Skin and subcutaneous tissue disorders

Rare

Skin rash, pruritus, urticaria

Special patient group

Renal impairment

Patients with renal impairment are at increased risk for 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 HPRA Pharmacovigilance; website: www.hpra.ie.

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 5 of 7

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.

The milk-alkali syndrome of hypercalcaemia, alkalosis and renal impairment still occur in patients who ingest large amounts of

calcium and absorbable alkali; it is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has

also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric

discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium

daily). Metastatic calcification can develop.

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 2000 mg per day, taken for several months, in persons with normal parathyroid function.

Management

Treatment is essentially symptomatic and supportive.

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

diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued (see section 4.5).

Rehydration, and, according to severity, isolated or combined treatment with loop diuretics (e.g. furosemide), bisphosphonates,

calcitonin and corticosteroids should be considered. In patients with renal failure, hydration is ineffective and they should

undergo dialysis. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be

followed.

case

persistent

hypercalcaemia,

contributing

factors

should

excluded,

e.g.

primary

hyperparathyroidism,

malignancies, renal failure or immobilisation.

Depending on the degree of hypercalcaemia and on the patient's condition, e.g. in case of oligoanuria, haemodialysis

(calcium-free dialysate) may be necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group:

Combination of calcium with other drugs, ATC code A12AX

Mechanism of action

Calciup D

Forte 1000mg/880 IU Chewable Tablets is a fixed combination of calcium and vitamin D

. The high calcium and

vitamin D

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

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 D

corrects latent vitamin D deficiency and secondary

hyperparathyroidism.

Pharmacodynamic effects

In a double-blind placebo controlled study of 18 months, including 3270 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 1387 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=1176) and 178 in the placebo group (n=1127) (p≤0.02).

5.2 Pharmacokinetic properties

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 6 of 7

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% 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 D

3

Absorption

Vitamin D

is absorbed in the intestine.

Distribution and biotransformation

Vitamin D

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 D

Non-hydroxylated vitamin D

is stored in muscle and adipose tissues.

Elimination

The plasma half-life is in the order of several days; vitamin D

is eliminated in the faeces and urine.

5.3 Preclinical safety data

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

data is available that has not been mentioned elsewhere in the SmPC (see section 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 (contains benzyl

alcohol), natural/nature identical liquid flavour tropical fruit, natural/nature identical orange oil, natural/nature identical solid

flavour multifruit, mannitol (E 421), maltodextrin, gluconolactone, sorbitol (E 420))

Flavour Orange "CVT" (containing natural orange oil, natural mandarine oil, nature identical powder flavour orange, mannitol (E

421), gluconolactone, sorbitol (E 420), medium-chained triglyceride)

Aspartame (E 951)

Acesulfam potassium

Sodium ascorbate

All-rac-alpha-tocopherol

Modified (maize) starch

Sucrose

Triglycerides, medium chain

Silicon dioxide, colloidal

Health Products Regulatory Authority

14 August 2020

CRN009CPX

Page 7 of 7

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

For tablet container:

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

For strips: This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

The chewable tablets are available in polypropylene tablet containers with polyethylene stoppers containing a desiccant or in

strips of laminated aluminium paper foil.

Pack sizes:

Bottle: 10, 20, 28, 30, 40, 50, 56, 60, 90, 100 (bundling package 5x20) chewable tablets

Strips: 10, 20, 28, 30, 40, 48, 56, 60, 60 (bundling package 2x30), 90, 90 (bundling package 3x30), 96, 100 (bundling package 5x20)

and 120 chewable tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinalproduct or waste material should be disposed of in accordance with localrequirements.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Rowex Ltd

Newtown

Bantry

Co. Cork

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0711/217/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 17

February 2012

Date of Last Renewal: 21

November 2016

10 DATE OF REVISION OF THE TEXT

August 2020

Similar products

Search alerts related to this product

View documents history

Share this information