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Adcal-D3 Lemon Chewable Tablets

Package leaflet: Information for the patient    KYOWAKIRIN

Adcal-Ds® Lemon Chewable Tablets

Calcium carbonate (1500 mg) and Vitamin D3 (400 I.U.)


What is in this leaflet

1.    What Adcal-D3 Lemon is and what it is used for

2.    What you need to know before you take Adcal-DLemon

3.    How to take Adcal-D3 Lemon

4.    Possible side effects

5.    How to store Adcal-D3 Lemon

6.    Contents of the pack and other information


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 or pharmacist.

-    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 or pharmacist. This includes any possible side effects not listed in this leaflet.


1.    What Adcal-D3 Lemon is and what it is used for

Adcal-D3 Lemon contains calcium and vitamin D3 which are both essential for healthy bones and teeth.

Adcal-D3 Lemon provides extra calcium and vitamin D3 to your diet. It is therefore used in conditions where your body’s calcium and vitamin D levels need to be increased.

Adcal-D3 Lemon can be prescribed by doctors for certain bone conditions, for example, osteoporosis.

Studies show that taking calcium and vitamin D3 over a long time can prevent hip and other non-vertebral bone fractures in later life.

2.    What you need to know before you take Adcal-D3 Lemon Q Do not take Adcal-D3 Lemon:

if you are allergic to calcium carbonate, vitamin D3 or any of the other ingredients of this medicine (listed in section 6). if you are allergic to peanut or soya. Adcal-D3 Lemon contains soya oil.

Q Warnings and precautions:

Talk to your doctor or pharmacist before taking Adcal-D3 Lemon.

Tell your doctor or pharmacist if you:

Have high levels of calcium in your blood (hypercalcaemia) or high levels of calcium in your urine (hypercalciuria).

If you are unsure your doctor will advise you.

Have problems with your kidneys, for example kidney stones.

Have sarcoidosis (inflammation that produces lumps of cells in various organs in the body), your doctor will be able to tell you if you do.

Have previously been told by your doctor that you have an intolerance to some sugars.

Are taking any other medication, even those you may have bought for yourself without prescription.

|| Other medicines and Adcal-D3 Lemon

Tell your doctor if you are taking calcium supplements or antacids for indigestion, digitalis drugs (eg. Lanoxin), diuretics or corticosteroids.

If you are taking thyroxine, bisphosphonates, iron or fluoride medicines, tetracycline or quinolone antibiotics make sure your doctor knows this. When taking these medicines leave a period of about 4 hours before taking your Adcal-D3 Lemon tablets. Do not take them at the same time.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

In pregnancy or when breast feeding, Adcal-D3 Lemon should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.

Adcal-D3 Lemon with food

This medicine should not be taken within 2 hours of eating foods rich in oxalic acid (e.g. spinach and rhubarb), phosphate (e.g. bran), or phytic acid (e.g. whole cereals).

Important information about some of the ingredients of Adcal-D3 Lemon

Adcal-D3 Lemon contains a small amount of sugar and may be harmful to the teeth if used for a prolonged period. Adcal-D3 Lemon contains soya oil. If you are allergic to peanut or soya, do not use this medicine.

3.    How to take Adcal-D3 Lemon

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adults, elderly and children over 12 years of age:

2 tablets daily, ideally one tablet taken in the morning and one in the evening. Adcal-D3 Lemon tablets should be chewed. Do not swallow whole.

Q Children under 12:

Adcal-D3 Lemon must not be given to children under 12 years old.


If you take more Adcal-D3 Lemon than you should

You should only take what your doctor recommends. If you take too many Adcal-D3 Lemon tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Adcal-DLemon pack and remaining tablets with you.

If you forget to take Adcal-D3 Lemon

If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Adcal-D3 Lemon

Always talk to your doctor or pharmacist before stopping using Adcal-D3 Lemon.

B If you have any further questions on the use of this product, ask your doctor or pharmacist.

D 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (affecting fewer than 1 in 1,000 people)

-    Constipation, wind, feeling sick, stomach ache, diarrhoea.

-    Skin rash.

-    Hypercalcaemia (too much calcium in your blood) or hypercalciuria (too much calcium in your urine).

If you are on long term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine samples to monitor kidney function.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme:

Website: 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 Adcal-D3 Lemon

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton and blister strip has passed. 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 Adcal-D3 Lemon contains

The active substances are calcium carbonate (1500mg, equivalent to 600mg calcium) and vitamin D3 (400iu, equivalent to 10pg colecalciferol).

The other ingredients are xylitol (E967), modified maize starch, sodium saccharin (E954), magnesium stearate and lemon flavouring.

The vitamin D3 compound contains DLa-tocopherol, edible fats (including soya oil), gelatin, sucrose and corn starch. What Adcal-D3 Lemon looks like and contents of the pack

The tablets are white, flat faced and circular in shape.

Adcal-D3 Lemon tablets are provided in packs of 56 or 112 tablets.


Marketing Authorisation Holder:

Kyowa Kirin Limited

Galabank Business Park

Galashiels

Scotland

TD1 1QH

Tel.: 01896 664000 Fax.: 01896 664001


Manufacturer:

Biokirch GmbH 21220 Seevetal Germany


Other sources of information

If you have been prescribed Adcal-D3 Lemon Chewable Tablets for the treatment or prevention of osteoporosis and would like further information you should speak to your doctor or pharmacist.

This leaflet was last revised in 05/2016


LFT-ADL-GB-003


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