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NATECAL D3 600 MG + 400 I.U. CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL / CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL / CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NATECAL D3 600mg + 400 I.U. chewable tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate
Cholecalciferol (Vitamin D3)

1500mg (equivalent to 600mg calcium)
400 I.U. (equivalent to 0.01mg)

Excipients: sorbitol, aspartame, lactose monohydrate, hydrogenated soya bean
oil, sucrose
For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Chewable tablet
The chewable tablet has a round, bevelled edge shape and is white to almost
white with the inscription "D" on one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Correction of combined vitamin D and calcium deficiencies in the elderly;
vitamin D and calcium supplementation as an adjunct to specific treatment for
osteoporosis in patients where combined vitamin D and calcium deficiencies
have been diagnosed or at a high risk of such deficiencies.

4.2

Posology and method of administration
Adults and Elderly
One tablet twice a day (e.g. one tablet in the morning and one tablet in the
evening). Dose reduction should be considered as necessary following the
monitoring of calcium levels as indicated in section 4.4 and 4.5.
The tablets may be chewed or sucked, they should not be swallowed whole.
The tablets should be taken preferably after meals.
Dosage in pregnant woman
One tablet a day (see section 4.6).
Dosage in hepatic impairment
No dose adjustment is required.

4.3

Contraindications
• Hypersensitivity to calcium, cholecalciferol or to any of the excipients (in
particular soya bean oil)
• Kidney stones (nephrolitiasis, nephrocalcinosis)
• Severe renal impairment and renal failure
• Hypercalciuria and hypercalcaemia and diseases and/or conditions resulting
in hypercalcaemia and/or hypercalciuria(e.g. myeloma, bone metastases,
primary hyperparathyroidism)
• Hypervitaminosis D

4.4

Special warnings and precautions for use
- Natecal D3 tablets are not intended for children and adolescents
- During long-term treatment it is advisable to monitor the serum and urinary
calcium levels and to monitor the kidney function through measurement of
serum creatinine. Monitoring is especially important in elderly patients on
concomitant treatment with cardiac glycosides or diuretics. In case of
hypercalcaemia or signs of impaired renal function the dose must be reduced or
the treatment interrupted. It is advisable to reduce or interrupt treatment
temporarily if urinary calcium exceeds 7.5 mmol/24 h (300 mg/24 h).
- Consider the dose of vitamin D (400 I.U.) when prescribing other drugs
containing vitamin D or food supplemented with vitamin D.
- Additional administration of vitamin D or calcium should be given under
medical supervision. In such cases the plasma and urinary levels of calcium must
be regularly monitored.
- The product should be prescribed with caution to patients suffering from
sarcoidosis, because the risk of increased metabolism of vitamin D to its active
metabolite. These patients should have their urinary and plasma calcium levels
monitored.
- Patients with renal insufficiency have disturbed metabolism of vitamin D and if
treated with cholecalciferol, the effect on calcium and phosphate homeostasis
should be monitored. The risk of soft tissue calcification should be taken into
account.
- The product should be used with caution in immobilised patients with
osteoporosis due to the increased risk of hypercalcaemia.
- The calcium and alkali intake from other sources (food, dietary supplements and
other drugs) should be taken into consideration when prescribing calcium
supplements. If very high doses of calcium are taken concomitantly with
absorbable alkali agents (like carbonate) this could lead to milk-alkali syndrome
(Burnett-Syndrome), i.e. hypercalcaemia, metabolic alkalosis, renal failure and
soft tissue calcification. In these cases, frequent monitoring of the calcium level
in the serum and urine is necessary
- The product contains aspartame, a source of phenylalanine. May be harmful for
people with phenylketonuria.
- The product contains soya bean oil, hydrogenated and is contraindicated for
patients hypersensitive to peanut or soya (see section 4.3)
- The product contains lactose, therefore patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
- The product contains sorbitol, therefore patients with rare hereditary problems of
fructose intolerance should not take this medicine.

- The product contains sucrose, therefore patients with rare hereditary problems of
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
insufficiency should not take this medicine. May be harmful to the teeth.

4.5

Interaction with other medicinal products and other forms of interaction
-

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4.6

Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin
D3 since the metabolism increases.
Rifampicin, may reduce the activity of vitamin D3, since it increases the rate of
its metabolism
If a biphosphonate, sodium fluoride or fluoroquinolones are used concomitantly,
this preparation should be administered at least three hours before the intake of
Natecal D3 since gastrointestinal absorption may be reduced.
In case of treatment with thiazide diuretics, that reduce the renal elimination of
calcium, it is recommended that the calcium levels in plasma are monitored
regularly.
Concomitant administration of glucocorticoids may decrease the effect of
vitamin D3.
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 digoxin and other cardiac
glycosides during treatment with calcium and vitamin D. Patients should be
monitored with regard to electrocardiogram (ECG) and serum calcium levels.
Orlistat, combined treatment with ion exchange resins such as cholestyramine or
laxatives such as paraffin oil may reduce the gastrointestinal absorption of
vitamin D.
Calcium salts may decrease the absorption of iron, zinc or strontium ranelate.
Consequently, the iron, zinc or strontium ranelate preparation 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 recommended that taking Natecal D3 be spaced at least 2 hours
from these medicines.
Oxalic acid (found in spinach and rhubarb) and phytic acid (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.

Pregnancy and lactation
Pregnancy
During pregnancy the daily intake should not exceed 1500mg calcium and
600I.U. vitamin D. Studies in animals have shown reproductive toxicity of
high doses of vitamin D. In pregnant women, overdoses of calcium and
cholecalciferol 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. Natecal D3 can
be used during pregnancy, in case of a calcium and vitamin D deficiency.
Lactation

Natecal D3 can be used during breast-feeding. Calcium and vitamin D3 pass
into breast milk. This should be considered when given additional vitamin D
to the child.
4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed. An effect is, however, unlikely.

4.8

Undesirable effects
Undesirable effects are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10),
uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000),
not known (cannot be estimated from the available data).
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, stomach pain and diarrhoea
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria
Immune system disorders:
Not known (cannot be estimated from the available data): Serious allergic
(hypersensitivity) reactions such as angioedema or laryngeal oedema.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9

Overdose
Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of
hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation,
abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia,
polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases,
cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death.
Persistently high calcium levels may lead to irreversible renal damage and soft
tissue calcification.
Treatment
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.
Emptying of the stomach in patients with impaired consciousness.
Rehydration and, according to severity, isolated or combined treatment with

loop diuretics, biphosphonates, 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: calcium, combination with other drugs
ATC code: A12AX
Vitamin D corrects an insufficient intake of vitamin D. It increases intestinal
absorption of calcium. The optimal amount of vitamin D in the elderly is 5001000 I.U./day.
Calcium intake corrects a lack of calcium in the diet. The commonly accepted
requirement of calcium in the elderly is 1500mg/day.
Vitamin D and calcium correct secondary senile hyperparathyroidism.

5.2

Pharmacokinetic properties
Calcium carbonate
In the stomach, calcium carbonate releases calcium ions depending upon pH.
Calcium administered as calcium carbonate is absorbed to the extent of 2030% and the absorption takes place mainly in the duodenum through vitamin
D-dependent, saturable, active transport. Calcium is eliminated in urine, faeces
and sweat. The urinary calcium excretion depends upon glomerular filtration
and tubular reabsorption of calcium.
Vitamin D
Vitamin D is absorbed in the small intestine and bound to specific alpha
globulins and transported to the liver where it is metabolised to 25-hydroxycholecalciferol. A second hydroxylation to 1,25-dehydroxy-cholecalciferol
occurs in the kidney. This metabolite is responsible for the increase in calcium
absorption. Non metabolised vitamin D is stored in tissues such as fat and
muscle. Vitamin D is eliminated via faeces and urine.

5.3

Preclinical safety data
At doses far higher than the human therapeutic range teratogenicity has been
observed in animal studies. There is further no information of relevance to the
safety assessment in addition to what is stated in other parts of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sorbitol (E 420)
Maltodextrin
Croscarmellose sodium (E 468)
Aspartame (E 951)
Saccharin sodium (E 954)
Lactose monohydrate

Aniseed flavour (flavouring substances identical to natural substances, natural
flavouring preparations, maltodextrin)
Peppermint flavour (natural flavouring preparations, maltodextrin, pulegone)
Molasses flavour (flavouring substances identical to natural substances,
natural flavouring preparations, maltodextrin, triethyl citrate)
Magnesium stearate
DL-α-tocopherol (E 307)
Hydrogenated soya-bean oil
Gelatin
Sucrose
Maize starch
6.2

Incompatibilities
Not applicable

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store in the original package in order to protect from moisture.

6.5

Nature and contents of container
High density polyethylene tablet container closed with a PE cap.
The tablet container contains 12 or 60 chewable tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
Chiesi Limited
333 Styal Road
Manchester
M22 5LG
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 08829/0161

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/07/2007 / 22/09/2011

10

DATE OF REVISION OF THE TEXT
23/09/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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