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OSTEOFOS D3 1200MG/800 I.U. POWDER FOR ORAL SUSPENSION

Active substance(s): CALCIUM PHOSPHATE / COLECALCIFEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OSTEOFOS D3 1200 mg/ 800 I.U. powder for oral suspension
Calcium and Colecalciferol
Read all of this leaflet carefully before you start taking this medicine.
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.
In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Osteofos D3 is and what it is used for
Before you take Osteofos D3
How to take Osteofos D3
Possible side effects
How to store Osteofos D3
Further information

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
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.
2.

BEFORE YOU TAKE OSTEOFOS D3

Do not take Osteofos D3 if you:
• have an allergy (hypersensitivity) to calcium, colecalciferol or any of the other ingredients of
Osteofos D3 (see "Important information about some of the ingredients" section below and Section
6)
• are inactive and have high levels of calcium in your blood (hypercalcaemia) or urine
(hypercalciuria)
• have calcium deposits in the tissues of your body
• have serious kidney problems
• have kidney stones or calcium stones in general
• have abnormally high levels of vitamin D.
• are pregnant or breast feeding
• if you are less than 12 year of age

Take special care with Osteofos D3 if you:
• have kidney problems, or a tendency to form urinary stones. Your doctor will check your blood
and urine calcium levels to make sure they do not get too high
• are currently being treated for heart problems. You will be closely supervised by your doctor if you
take cardiac glycosides (e.g. digitalis), since their effect may be enhanced by taking Osteofos D3
• suffer from sarcoidosis (an immune system disorder of inflamed lesions of liver, lung, skin or
lymph nodes).Your doctor will monitor your blood and urine calcium levels, which may increase
due to a possible increased Vitamin D activity
Taking other medicines
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:
• colestyramine (used to treat high blood cholesterol levels), steroids (such as cortisone), mineral
oils (such as paraffin oil used as a laxative or stool softener): these medicines may decrease the
absorption of the vitamin D3
• phenytoin and barbiturates (e.g. phenobarbital), which are used to treat epilepsy: they may
decrease the activity of vitamin D3
• some diuretics (water pills e.g. furosemide and ethacrynic acid), antacids (used for indigestion)
that contain aluminium salts and thyroid hormones: these medicines can decrease the
absorption of calcium and increase its elimination in the stools or urine
Medicines that increase the absorption or effect of Osteofos D3:
• some other diuretics (of the thiazide kind, e.g. hydrochlorothiazide) can decrease the
elimination of calcium in the urine and thus cause too high calcium levels in the blood
• antibiotic drugs, such as penicillin, neomycin and chloramphenicol can increase the absorption
of calcium: your doctor may tell you to check your blood calcium during prolonged treatment
with Osteofos D3 and any of these drugs
Medicines whose absorption is decreased by Osteofos D3:
• tetracycline antibiotics: when taking these leave at least three hours before taking Osteofos D3.
Do not take them at the same time
• bisphosphonates (medicines used to treat or prevent osteoporosis) and sodium fluoride: when
taking these leave at least three hours before taking Osteofos D3
Medicines whose effect is increased by Osteofos D3:
• digitoxin (e.g. Lanoxin) or other cardiac glycosides used to treat heart disorders: calcium may
increase their effect on the heart

Tell your doctor and ask for his/her advice before taking any other product containing vitamin D or its
derivatives while taking Osteofos D3.
Taking Osteofos D3 with food and drink
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Osteofos D3 if you are pregnant or breastfeeding.
Children
Osteofos D3 is not recommended for children under 12 years old.
Driving and using machines
Osteofos D3 has no influence on your ability to drive or use machines.
Important information about some of the ingredients of Osteofos D3
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.
3.

HOW TO TAKE OSTEOFOS D3

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.
If you take more Osteofos D3 than you should
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
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.

4.

POSSIBLE SIDE EFFECTS

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:




swelling of face, lips and throat
sudden difficulty breathing
severe itching and/or rash (hives).

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:



anorexia, nausea (feeling sick), vomiting, headache, weakness, apathy and drowsiness;
thirst, dehydration, passing water frequently throughout the day or night, abdominal pain, lack
of bowel movement, irregular heart beat.

In addition, the following side effects may occur with the use of Calfovit D3:
• skin allergy
• constipation
• diarrhoea
• nausea (feeling sick) or vomiting
• stomach ache.
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.
5.

HOW TO STORE 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.
6.

FURTHER INFORMATION

What Osteofos D3 contains
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').
What Osteofos D3 looks like and contents of the pack
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 and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.,
1, Avenue de la Gare
L-1611 Luxembourg
Manufacturer
A Menarini Manufacturing Logistics and Services s.r.l.
Florence - Italy
or
Sigmar Italia S.r.l. Almé (Bg) - Italy

This medicinal product is authorised in the Member States of the EEA under the following
names :
United Kingdom

Osteofos D3

Greece

Caldesil

Austria

Osteofos

Luxembourg

Osteofos D3

Denmark

Osteofos D3

Ireland

Osteofos D3

Finland

Osteofos D3

Spain

Metafisol

Germany

Osteofos D3

Sweden

Osteofos D3

This leaflet was last approved in 02/2010.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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