Tel: 961 4 930252 - Email: info@pheniciagroup.com

Versalya Pharma S.L (Italfarmaco Group) - Italy

BLISSEL
FARMODOXI
FERPLEX
IFENEC
INOFERT
NATECAL D3
TRIMEDAT
YODOCEFOL

Forms and presentation

Orodispersible tablet: Box of 60.

Composition

Each tablet contains: calcium carbonate: 1500 mg (equivalent to 600 mg calcium), Colecalciferol (Vitamin D3): 400 IU (equivalent to 0.01 mg).

Excipients: maltodextrin, aspartame, hydroxypropyl cellulose low-substituted, lactose monohydrate, citric acid anhydrous, orange flavour, stearic acid, DL-α-tocopherol, hydrogenated soya bean oil, gelatine, sucrose, maize starch.

Properties

Natecal D3 orodispersible tablets contain 2 active substances, calcium carbonate and cholecalciferol (vitamin D3). Both calcium and vitamin D3 are found in the diet and vitamin D is also produced in the skin after exposure to the sun. Natecal D3 orodispersible tablets may be prescribed to treat and prevent vitamin D/calcium deficiency.

Indications

Natecal D3 is used:

- In the correction of calcium and vitamin D deficiencies in the elderly.

- In combination with osteoporosis treatments where calcium and vitamin D levels are too low or where there is a high risk of them being too low.

Contraindications

Hypersensitivity to calcium, vitamin D3 or to any of the other ingredients of Natecal D3 (in particular soya bean oil). Hypercalcaemia, hypercalciuria. Renal failure. Kidney stones. Hypervitaminosis D.

Precautions

Natecal D3 must be used with caution in patients suffering from kidney stones or other kidney, in immobilized patients, in patients suffering from osteoporosis and in patients suffering from sarcoidosis.

The product contains: aspartame (E951), lactose, hydrogenated soya bean oil, sucrose.

The product contains aspartame, which is a source of phenylalanine. Phenylalanine may be harmful for people with phenylketonuria.

The product contains lactose and sucrose, 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 soya oil that may rarely cause severe allergic reactions in patients suffering from allergy to peanut or soya.

Natecal D3 with food and drinks: This product is likely to interact with some foods, for example those containing oxalic acid (like spinach, rhubarb, sorrel, cocoa, tea…), phosphate (e.g. ham, sausages, cheese spread…) or phytic acid (e.g. pulses, whole cereals, chocolate…). Therefore it is recommended to take Natecal D3 2 hrs before or after meals containing this kind of food.

Drug interactions

Natecal D3 must be used with caution in patients taking any other medicines or other products containing calcium or vitamin D, digoxin or other cardiac glycosides, and thiazide diuretics.

In patients taking tetracycline and fluoroquinolone antibiotics; it is recommended that you wait at least 3 hrs after taking these medicines before taking Natecal D3 orodispersible tablets.

In patients taking biphosphonates or sodium fluoride, it is recommended that a period of at least 3 hrs has to pass before taking Natecal D3 orodispersible tablets.

Phenytoin and barbiturates may make the vitamin D3 less effective.

Orlistat, cholestyramine, laxatives such as paraffin oil, may reduce the absorbed amount of vitamin D3.

Estramustin, thyroid hormones or medicines containing iron, zinc or strontium, as their absorbed amount may be reduced. They should be taken at least 2 hrs before or after Natecal D3.

Pregnancy and lactation

Natecal D3 orodispersible tablets should only be used in pregnancy and breast-feeding under medical supervision.

Side effects

Uncommon: hypercalcaemia, hypercalciuria.

Rare: nausea, stomach ache, constipation, diarrhoea, flatulence, itching, rash, hives.

Frequency not known (cannot be estimated from the available data):  hypersensitivity reactions such as swelling of the face, lips or tongue.

Dosage and administration

The usual dose for adults and elderly is 1 tablet twice a day (e.g. one in the morning and one in the evening) preferably after meals.

The tablets may be put in the mouth without any water and sucked, they must not be swallowed whole.

Storage conditions

Do not store above 25° C.  Store in the original package in order to protect from moisture.

 

Origin: Italy

Laboratories: Italfarmaco SPA

Distributor: Droguerie Phenicia

Registration Number: 166947/2011