Natecal D3 600mg/400unit chewable tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Calcium carbonate; Colecalciferol

Beszerezhető a:

Chiesi Ltd

ATC-kód:

A12AX

INN (nemzetközi neve):

Calcium carbonate; Colecalciferol

Adagolás:

1.5gram ; 400unit

Gyógyszerészeti forma:

Chewable tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 09060400; GTIN: 5028613002780

Betegtájékoztató

NATECAL D3
ISTRUZIONE
VENDITA
UK
NERO
1
150 x 200/34
Tipo di materiale
Descrizione
Formato
N. colori
Colore 2
Colore 3
Colore 4
Colore 5
TACCHE LAETUS
Corpo
Colore 1
PELLICOLA DI PROPRIETÀ
VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA
03-03-16
Cod. 01090/27
Destinazione
Paese
Codice
PK81032
606
8
NUOVO TESTO
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine is for use in Adults only
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in
this leaflet. See section 4.
In this leaflet:
1. What Natecal D3 is and what it is used for.
2. What you need to know before you take Natecal D3.
3. How to take Natecal D3.
4. Possible side effects.
5. How to store Natecal D3.
6. Contents of the pack and other information.
1. What Natecal D3 is and what it is used for
Natecal D3 chewable tablets contain two active substances, calcium
carbonate and cholecalciferol (vitamin D
3
). Both calcium
and vitamin D
3
are found in the diet and vitamin D is also produced in the skin after
exposure to the sun. Natecal D3 chewable
tablets may be prescribed by doctors to treat and prevent vitamin
D/calcium deficiency.
Natecal D
3
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.
2. What you need to know before you take Natecal D3
Do not take Natecal D3
•
If you are hypersensitive to calcium, vitamin D
3
or to any of the other ingredients of Natecal D3 (in particular soya
bean oil)

Termékjellemzők

OBJECT 1
NATECAL D3 CHEWABLE TABLETS
Summary of Product Characteristics Updated 07-Mar-2016 | Chiesi
Limited
1. Name of the medicinal product
NATECAL D3 600 mg + 400 I.U. chewable tablets
2. Qualitative and quantitative composition
One tablet contains:
Calcium carbonate
1500 mg (equivalent to 600 mg calcium)
Cholecalciferol (Vitamin D
3
)
400 I.U. (equivalent to 0.01 mg)
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 WOMEN_
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 (nephrolithiasis, 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