This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
OSTEOFOS D3 1200 mg/ 800 I.U. powder for oral suspension
Calcium and Colecalciferol
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are similar to yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Osteofos D3 is and what it is used for 2. Before you take Osteofos D3 3. How to take Osteofos D3 4. Possible side effects 5. How to store Osteofos D3 6. Further information
Osteofos D3 is a calcium and vitamin D3 supplement for the treatment of certain bone conditions in the elderly.
Both calcium and vitamin D are found in the diet and vitamin D is also produced in the skin following exposure to the sun.
A lack of vitamin D and calcium may lead to reduced bone density and bone fractures. Osteofos D3 may be taken to make up for this deficiency of calcium and vitamin D.
Please tell your doctor if you are taking or have recently taken any other medicines (including medicines obtained without a prescription), especially:
Medicines that decrease the absorption or effect of Osteofos D3:
Medicines that increase the absorption or effect of Osteofos D3:
Medicines whose absorption is decreased by Osteofos D3:
Medicines whose effect is increased by Osteofos D3:
Tell your doctor and ask for his/her advice before taking any other product containing vitamin D or its derivatives while taking Osteofos D3.
Take Osteofos D3 preferably with your evening meal.
Tell your doctor if you usually eat food that contains oxalic acid (e.g. spinach and rhubarb), phosphates (especially from food additives) or phytinic acid (whole cereals), since these may reduce the absorption of calcium contained in Osteofos D3.
Tell your doctor and ask for his/her advice before taking foodstuffs which may be fortified with vitamin D.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Osteofos D3 if you are pregnant or breastfeeding.
Osteofos D3 is not recommended for children under 12 years old.
Osteofos D3 has no influence on your ability to drive or use machines.
Osteofos D3 contains the colouring agent sunset yellow (E 110) which may cause allergic reactions.
Osteofos D3 contains sucrose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Osteofos D3 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take 1 sachet of Osteofos D3 once a day, preferably during the evening meal.
Pour the contents of the sachet into a glass of non-carbonated water. Stir with a spoon to obtain a pleasant-tasting suspension. Drink the suspension immediately after mixing.
Contact your doctor or go to the nearest hospital emergency department if you or someone near you has taken too much Osteofos D3. Remember to take with you any remaining sachets and the box or this leaflet so that doctors know what has been taken.
If you forget to take Osteofos D3, take it as soon as you remember. In any case, you should never take a double dose in the same day to make up for forgotten sachets.
Like all medicines, Osteofos D3 can cause side effects, although not everybody gets them.
Stop taking Osteofos D3 and contact a doctor immediately if you experience any of the following:
Tell your doctor promptly if you experience the following side effects, which may indicate that calcium levels in your blood or urine are too high:
In addition, the following side effects may occur with the use of Osteofos D3:
Keep out of the reach and sight of children.
Store Osteofos D3 in the original package. Do not store above 25°C.
Do not use Osteofos D3 after the expiry date which is stated on the sachet and carton.
The expiry date [“EXP”] refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substances are: calcium and colecalciferol
Each sachet contains calcium 1200 mg (as calcium phosphate) and colecalciferol (Vitamin D3) 20 micrograms (equivalent to 800 I.U).
The other ingredients are: propylene glycol, sunset yellow FCF (E110), lemon flavouring (containing: natural flavourings, maltodextrin, gum arabic), saccharin sodium, anhydrous citric acid, microcrystalline cellulose and carmellose sodium, monopalmitate sucrose, silica colloidal anhydrous, mannitol, α-tocopherol, edible fats, gelatin, sucrose and maize starch (see Section 2 'Important information about some of the ingredients of Osteofos D3').
Osteofos D3 sachets contains white or slightly orange, granular powder for oral suspension. The obtained suspension is an orange opaque liquid containing white granules.
The sachets are packaged in cardboard boxes containing 2, 30 or 60 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names :
United Kingdom Osteofos D3
Austria Osteofos
Denmark Osteofos D3
Finland Osteofos D3
Germany Osteofos D3
Greece Caldesil
Luxembourg Osteofos D3
Ireland Osteofos D3
Spain Metafisol
Sweden Osteofos D3
This leaflet was last approved in 05/2010.
Link to this document from your website:http://www.medicines.ie/medicine/7920/XPIL/Osteofos+D3/