PACKAGE LEAFLET: INFORMATION FOR THE USER

NATECAL D3 C Chiesi

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.

•    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 Cfe). 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:

-    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 D3 or to any of the other ingredients of Natecal D3 (in particular soya bean oil);

•    If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria);

•    If you are suffering from kidney failure;

•    If you have kidney stones

•    If you have high levels of vitamin D in your blood (hypervitaminosis D)

Warnings and precautions

•    If you have had kidney stones or other kidney problems (your doctor will need to monitor your treatment carefully if your kidneys are not working properly to make sure you do not build up too much calcium in your blood);

•    If you stay in bed for a long period (months) and if you have osteoporosis (brittle bones) because you may have high levels of calcium in your blood;

•    If you are taking any other medicines containing calcium or vitamin D (your doctor or your pharmacist will be able to tell you if you do);

•    If you have sarcoidosis (your doctor will be able to tell you if you do);

Other medicines and Natecal D3.

Do not take the product without talking to your doctor or pharmacist if you are taking:

•    Any other medicine containing vitamin D;

•    The following heart medicines: digoxin or other cardiac glycosides;

•    Tetracycline and fluoroquinolone antibiotics; it is recommended that you wait at least 3 hours after taking these medicines

before taking Natecal D3 chewable tablets.

•    Thiazide diuretics;

•    If you take other drugs used to treat bone disorders, such as biphosphonates or sodium fluoride, it is recommended

that a period of at least 3 hours has to pass before taking Natecal D3 chewable tablets.

•    Phenytoin (a medicine for epilepsy) and barbiturates (medicines which are used for epilepsy or which help you sleep), as they may make the vitamin 63 less effective.

•    Rifampicin, makes the vitamin D3 less effective.

•    Orlistat (a medicine used to treat obesity), cholestyramine, laxatives such as paraffin oil, as they may reduce the amount

of vitamin D3 you absorb.

•    Estramustin (a medicine used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed may be reduced. They should be taken at least 2 hours before or after Natecal D3.

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)

•    hypercalcaemia (too much calcium in your blood) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, needing to pass urine more often, muscle weakness, drowsiness and confusion

•    hypercalciuria (too much calcium in your urine)

The following effects are rare: (occur in between 1 and 10 out of every 10,000 patients)

• nausea    • stomach ache • constipation    • diarrhoea

• flatulence    • itching    • rash    • hives

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.

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 YellowCaid 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

•    Keep out of the sight and reach of children.

•    Store in the original package in order to protect from moisture.

•    Do not take Natecal D3 after the expiry date which is stated on the box after “exp”.The expiry date refers to the last day of that month.

•    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 to protect the environment.

6.    Contents of the pack and other information What Natecal D3 contains

•    Each tablet contais the active substances: calcium carbonate (1500 mg equivalent to 600 mg calcium) and cholecalciferol (vitamin D3) (400 I.U equivalent to 0,01 mg).

•    The other ingredients are: sorbitol (E 420), maltodextrin, croscarmellose sodium (E 468), aspartame (E 951), saccharin sodium (E 954), lactose monohydrate, aniseed flavour, peppermint flavour, molasses flavour, magnesium stearate, DL-a-tocopherol (E 307), hydrogenated soya bean oil, gelatine, sucrose, maize starch.

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

Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK.

Manufacturer - ITALFARMACO S.p.A. - Viale F Testi, 330-20126 Milano.

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