Natecal D3 600 mg + 400 I.U. chewable tablets

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.

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 bisphosphonates 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 D₃ 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.

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.

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.

What Natecal D3 contains

• Each tablet contains 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-α-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.

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