Patient Leaflet Updated 08-Mar-2016 | Chiesi Limited
Natecal D3 Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
600 mg + 400 I.U. chewable tablet
calcium + cholecalciferol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 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 chewable tablets may be prescribed by doctors to treat and prevent vitamin D/calcium deficiency.
Natecal D3 is used:
2. What you need to know before you take Natecal D3
Do not take Natecal D3
Warnings and precautions
Other medicines and Natecal D3.
Do not take the product without talking to your doctor or pharmacist if you are taking:
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 two hours before or after meals containing this kind of food.
Pregnancy and breast-feeding
Natecal D3 chewable tablets should only be used in pregnancy and breast-feeding when it has been recommended by a doctor.
Important information about some of the ingredients of Natecal D3
The product contains: sorbitol (E420), 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, sucrose and sorbitol therefore if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The product contains soya oil, therefore if you are allergic to peanut or soya, do not use this medicinal product.
3. How to take Natecal D3
Always take Natecal D3 exactly as your doctor has told you. You should check with your doctor if you are not sure.
The usual dose for adults and elderly is one tablet twice a day (e.g. one in the morning and one in the evening) preferably after meals. The tablets may be chewed or sucked, they must not be swallowed whole.
If you take more Natecal D3 than you should
Contact your doctor. If you cannot do this, go to your nearest hospital accident and emergency (casualty) department, taking any remaining tablets and the packaging with you.
If you forget to take Natecal D3
Take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Never take two doses at the same time.
4. Possible side effects
Like all medicines, Natecal D3 can cause side effects, although not everybody gets them.
The following effects are uncommon: (occur in between 1 and 10 out of every 1,000 patients)
The following effects are rare: (occur in between 1 and 10 out of every 10,000 patients)
The frequency of the following effects is not known (cannot be estimated from the available data): Serious allergic (hypersensitivity) reactions such as swelling of the face, lips or tongue.
Other special population
Patients with renal impairment could have a potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Natecal D3
6. Contents of the pack and other information
What Natecal D3 contains
What Natecal D3 looks like and contents of pack
This medicinal product is a chewable tablet.
The tablet has a round, bevelled edge shape and is white to almost white with the inscription “D” on one side.
Tablet container containing 12 or 60 tablets.
Marketing Authorisation Holder
This leaflet was last revised in December 2015
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PK81032 - CP0020/7
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
+44 (0) 161 488 5555