Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL16508/0026.
Adcal-D3® Dissolve 1500 mg/400 IU Effervescent Tablets
Calcium carbonate and Vitamin-D3
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. See section 4.
What is in this leaflet
1. What Adcal-D3 Dissolve is and what it is used for
2. What you need to know before you take Adcal-D3 Dissolve
3. How to take Adcal-D3 Dissolve
4. Possible side effects
5. How to store Adcal-D3 Dissolve
6. Contents of the pack and other information
1. What Adcal-D3 Dissolve is and what it is used for
Adcal-D3 Dissolve contains calcium and vitamin D3 which are both essential for healthy bones and teeth. Adcal-D3 Dissolve 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 Dissolve 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 Dissolve
Do not take Adcal-D3 Dissolve:
if you are allergic to calcium carbonate, vitamin D3 or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Adcal-D3 Dissolve
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). If you are unsure your doctor will advise you
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 Dissolve
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 Dissolve 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 Dissolve should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.
Adcal-D3 Dissolve 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 Dissolve
The tablets contain a small amount of sugar and may be harmful to the teeth if used for a prolonged periodIf you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
This medicine contains 42.03 mg of sodium (main component of cooking/table salt) in each tablet. This is equivalent to 2.1% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Adcal-D3 Dissolve
Always take this medicine exactly as described in this leaflet or 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 taken in the morning and one tablet in the evening. Dissolve one tablet in a glass of water (approximately 200 ml) and drink immediately, do not chew or swallow the tablets whole.
Children under 12
Adcal-D3 Dissolve must not be given to children under 12 years.
If you take more Adcal-D3 Dissolve than you should
You should only take what your doctor recommends. If you take too many Adcal-D3 Dissolve tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Adcal-D3 Dissolve pack and remaining tablets with you.
If you forget to take Adcal-D3 Dissolve
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 Dissolve
Always talk to your doctor or pharmacist before stopping Adcal-D3 Dissolve.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):
Allergic reactions – symptoms include itching, wheezing, rash, swelling of the tongue or throat. If you have an allergic reaction stop taking the tablets and seek medical attention immediately.
Rare side effects (may affect up to 1 in 1,000 people):
Hypercalcaemia (too much calcium in your blood) and 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 theYellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Adcal-D3 Dissolve
Keep this medicine out of the sight and reach of children
Do not store above 30°C
Keep the container tightly closed
Do not use this medicine after the expiry date (Exp) which is stated on the tube and carton. 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 Dissolve contains
The active substances are 1500 mg calcium carbonate (equivalent to 600 mg calcium) and 400 IU vitamin D3 (equivalent to 10 μg).
The other ingredients are citric acid anhydrous, malic acid, sodium hydrogen carbonate (E500), sodium cyclamate (E953), lemon flavour (containing lemon oil, lime flavouring, sorbitol (E420), mannitol (E421), gluconolactone, maltodextrin, and acacia), sodium carbonate (E500), maltodextrin, and saccharin sodium (E954).
The vitamin D3 compound contains modified starch, sucrose, sodium ascorbate, medium chain triglycerides, colloidal anhydrous silica and all-rac-alpha-tocopherol.
What Adcal-D3 Dissolve looks like and contents of the pack
The tablets are white, round and lemon flavoured
Adcal-D3 Dissolve is provided in tubes containing 14 effervescent tablets and supplied in cartons of 4 tubes (total of 56 effervescent tablets).
Marketing Authorisation Holder:
Kyowa Kirin Limited Galabank Business Park Galashiels Scotland TD1 1QH
Hermes Pharma Ges.m.b.H Schwimmschulweg 1a 9400 Wolfsberg Austria
Other sources of information
If you have been prescribed Adcal-D3 Dissolve effervescent tablets for the treatment or prevention of osteoporosis and would like further information about osteoporosis, you should speak to your doctor or pharmacist.