Package leaflet: Information for the user
OSTEOFOS D3 1200 mg/ 800 I.U. powder for oral suspension
Calcium and Colecalciferol
1. What OSTEOFOS D3 is and what it is used for
2. What you need to know before you take OSTEOFOS D3
3. How to take OSTEOFOS D3
4. Possible side effects
5. How to store OSTEOFOS D3
6. Contents of the pack and other information
1. What OSTEOFOS D3 is and what it is used for
OSTEOFOS D3 is a calcium and vitamin D3 supplement for the treatment of certain bone conditions in adults and 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.
2. What you need to know before you take OSTEOFOS D3
Talk to your doctor before taking OSTEOFOS D3:
Do not give this medicine to children under 18 years of age because the safety and efficacy of OSTEOFOS D3 have not been established in children.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular you should tell your doctor if you are taking:
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.
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.
See also section 3 how to take OSTEOFOS D3.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
OSTEOFOS D3 should not be used during pregnancy or when breast-feeding.
OSTEOFOS D3 has no influence on your ability to drive or use machines.
Sunset yellow (E 110): May cause allergic reactions.
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.
3. How to take OSTEOFOS D3
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 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, do not take a double dose to make up for a forgotten sachet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking OSTEOFOS D3 and contact a doctor immediately if you experience any of the following symptoms:
Other side effects
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:
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store OSTEOFOS D3
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 sachet and carton.
The expiry date [“EXP”] refers to the last day of that month.
Do not throw away any medicine 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
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).
OSTEOFOS D3 sachets contain 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:
or
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom OSTEOFOS D3
Austria OSTEOFOS
Luxembourg OSTEOFOS D3
Ireland OSTEOFOS D3