What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL16508/0026.

Adcal-D3 Dissolve 1500mg/400IU Effervescent Tablets

PATIENT INFORMATION LEAFLET

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).
  • if you are allergic to peanut or soya. Adcal-D3 Dissolve contains soya oil.

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 period
  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
  • Adcal-D3 Dissolve contains soya oil. If you are allergic to peanut or soya, do not use this medicine.
  • This medicine contains 52 mg of sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

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):

  • Constipation, wind, feeling sick, stomach ache, diarrhoea
  • Skin rash
  • 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

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 25°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 anhydrous (E500), maltodextrin, and saccharin sodium (E954).
  • The vitamin D3 compound contains α-tocopherol, hydrogenated soyabean oil, gelatin, sucrose and maize starch.

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
Tel.: 01896 664000
Fax.: 01896 664001

Manufacturer:

Hermes Arzneimittel GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

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.

This leaflet was last revised in 02/2017