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

Active substance(s): CALCIUM PHOSPHATE / COLECALCIFEROL / CALCIUM PHOSPHATE / COLECALCIFEROL / 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 because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 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.
 You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

1.

What OSTEOFOS D3 is and what it is used for
What you need to know before you take OSTEOFOS D3
How to take OSTEOFOS D3
Possible side effects
How to store OSTEOFOS D3
Contents of the pack and other 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 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

Do not take OSTEOFOS D3:
 if you are allergic to calcium, colecalciferol or any of the other ingredients of this medicine (listed in section
6)
 if you are inactive and have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
 if you have calcium deposits in the tissues of your body
 if you have serious kidney problems
 if you have kidney stones or calcium stones in general
 if you have abnormally high levels of vitamin D.
 if you are pregnant or breast feeding
 if you are less than 18 years of age

Warning and precautions
Talk to your doctor before taking 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




if you 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
if you 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.

Children
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.
Other medicines and OSTEOFOS D3
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:
 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.
OSTEOFOS D3 with food and drink

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.

Pregnancy and breast-feeding
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.
Driving and using machines
OSTEOFOS D3 has no influence on your ability to drive or use machines.
OSTEOFOS D3 contains the colouring agent sunset yellow (E 110) and sucrose.
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 or pharmacist have 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 pleasanttasting 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, 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:





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

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:



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 OSTEOFOS D3:
 constipation
 diarrhoea
 nausea (feeling sick) or vomiting
 stomach ache.
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 the Yellow 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 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

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, -tocopherol, edible fats,
gelatin, sucrose and maize starch (see Section ').
What OSTEOFOS D3 looks like and contents of the pack
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 and Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.,
1, Avenue de la Gare
L-1611 Luxembourg

Manufacturer:
Sigmar Italia S.p.A.
Via Sombreno, 11
Almé 24011-BG-Italy
or
A. Menarini Manufacturing Logistics and Services s.r.l.
Via Sette Santi, 3
Florence-Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom

OSTEOFOS D3

Luxembourg

OSTEOFOS D3

Austria

OSTEOFOS

Ireland

OSTEOFOS D3

This leaflet was last revised in 02/2017.

Expand Transcript

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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