Package leaflet: information for the user
OsteoEze 625 mg film-coated tablets
Glucosamine
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist
or nurse 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 tou 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 after 4 weeks.
In this leaflet:
1. What OsteoEze is and what it is used for.
2. What you need to know before you take OsteoEze.
3. How to take OsteoEze.
4. Possible side effects.
5. How to store OsteoEze.
6. Contents of the pack and other information.
1.
WHAT OSTEOEZE IS AND WHAT IT IS USED FOR
OsteoEze contains the active substance glucosamine, which belongs to a group of
medicines called other anti-inflammatory and anti-rheumatic agents, non-steroids.
Glucosamine is a substance naturally occurring in the human body and necessary for joint
fluid and cartilage.
OsteoEze is used for relief of symptoms associated with mild to moderate joint
degeneration (osteoarthritis) of the knee.
These symptoms could be: joint swelling, stiffness (after sleep or long rest), pain at rest or
pain at motion (e.g. when climbing the stairs or walking along uneven surfaces). If you
have other symptoms than those described, please consult your doctor who will rule out the
presence of joint diseases for which other treatment should be considered.
2.
What you need to know before you use OsteoEze
Do not take OsteoEze
- If you are allergic to glucosamine or to any of the other ingredients of this medicine, in
particular if you are allergic to peanut or soya, as OsteoEze contains soya derivatives.
- If you are allergic to shellfish, as the active ingredient, glucosamine, is extracted from
shellfish.
Warnings and precautions
Talk to a doctor or pharmacist before using OsteoEze:
- if you have diabetes or impaired glucose tolerance. More frequent controls of your blood
glucose levels may be necessary when starting treatment with glucosamine.
- if you have kidney or liver dysfunction, since no studies have been performed in such
patients dose recommendations cannot be given.
- if you have a known risk factor for cardiovascular disease, since hypercholesterolemia
has been observed in a few cases in patients treated with glucosamine.
- if you suffer from asthma. When starting on glucosamine, you should be aware of
potential worsening of symptoms.
Other medicines and OsteoEze
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
It is particularly important to tell your doctor or pharmacist if you are taking any of the
following medicines:


tetracyclines (antibacterials used against infection)
warfarin or similar type of products (anticoagulants used to prevent blood-clotting).
The effect of the anticoagulant may be intensified in association with glucosamine.
Patients treated with such combinations should therefore be monitored extra
carefully when initiating or ending glucosamine therapy.
OsteoEze with food and drink
The tablets should be swallowed with some liquid, and can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask you doctor or pharmacist for advice before taking this medicine.
OsteoEze should not be used during pregnancy.
The use of OsteoEze during breast-feeding is not recommended.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. If
you experience dizziness or drowsiness you should not be driving or operation machinery.
OsteoEze contains sunset yellow FCF aluminium lake (E110)
This medicinal product contains sunset yellow FCF aluminium lake (E110) which may
cause allergic reactions.
3.
How to take OsteoEze
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist
or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.
Use in adults:
The usual dose is 2 tablets once daily.
The tablet should be swallowed with some liquid and can be taken with or without a meal.
Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of
symptoms (especially pain relief) may not be experienced until after several weeks of
treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3
months, please tell your doctor because continued treatment with glucosamine should be
re-evaluated.
OsteoEze should not be used for more than 1 month without the advice of a doctor.
Use in elderly:
No dosage adjustment is required.
Patients with impaired renal and/or liver function:
No dose recommendations can be given, since no studies have been performed.
Use in children and adolescents:
OsteoEze should not be used in children and adolescents below the age of 18 years.
If you take more OsteoEze than you should
If you have taken too many OsteoEze tablets, consult your doctor or a hospital.
Signs and symptoms of overdose with glucosamine might include headache, dizziness,
confusion, joint pain, nausea, vomiting, diarrhoea or constipation. Stop taking glucosamine
at signs of overdose.
If you forget to take OsteoEze
You should not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking OsteoEze and see your doctor immediately if you experience
symptoms such as: swollen face, tongue and/or pharynx and/or difficulty to swallow or
hives together with difficulties to breath (angioedema).
Some side effects are common (may affect up to 1 in 10 people)
Headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Some side effects are uncommon (may affect up to 1 in 100 people)
Rash, itching, flushing.
Some side effects where the frequency are not known (frequency cannot be estimated
from the available data)
Blood glucose control worsened in diabetic patients, dizziness, aggravation of pre-existing
asthma, vomiting, elevated hepatic enzymes, jaundice (yellowing of the skin or whites of
the eyes), angioedema (swelling of the face, lips, tongue or throat), urticaria, swelling of
the feet or ankles, elevated cholesterol levels.
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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
5.
How to store OsteoEze
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
Do not store above 30°C.
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
protect the environment.
6.
Contents of the pack and other information
What OsteoEze contains
-
The active substance is: Glucosamine. Each film-coated tablet contains 625 mg of
glucosamine (as 750 mg glucosamine hydrochloride).
The other ingredients are:
Core: Povidone K30, calcium phosphate tribasic, microcrystalline cellulose,
crospovidone, magnesium stearate.
Coating: polyvinyl alcohol, talc, lecithin (soya) (E322), macrogol 4000/ macrogol
3000 and the colouring: Titanium dioxide (E171), sunset yellow FCF aluminium lake
(E110), quinoline yellow aluminium lake (E104), yellow iron oxide (E172).
What OsteoEze looks like and contents of the pack
The film-coated tablets are oblong, yellow, and embossed with V.
OsteoEze is supplied as film-coated tablets in 3 different pack sizes: 30 tablets
(Prescription status to be completed locally), 60 tablets (Prescription status to be
completed locally) and 180 tablets (Prescription status to be completed locally).
Marketing Authorisation Holder:
To be completed locally
For Sweden: Novartis Sweden AB, Box 1150, SE-183 11 Täby
Manufacturer:
To be completed locally:
The locally printed PL in each MS needs only to include the manufacturing site(s)
responsible for batch release specific to that MS.
 Novartis Consumer Health GmbH, Zielstattstraße 40, 81379 München, Germany
 Novartis Farma S.P.A, Via Provinciale Schito 131, Torre Annunziata, Italy
 Novartis Sverige AB, Kemistvägen 1, 183 11 TÄBY, Sweden
 Novartis (Hellas) S.A.C.I., National Road No1 (12th Km), Metamorphosis, 144 51
Athens, Greece
 Novartis Santé Familiale S.A.S., 10 rue Louis Blériot, 92500 Rueil-Malmaison,
France
This medicinal product is authorised in the Member States of the EEA under the
following names:
France: Voltaflex
Germany: Voltaflex Glucosaminhydrochlorid 750 mg
Greece: Voltaflex Glucosamine
Netherlands: Voltaflex Glucosamine
Sweden: OsteoEze
This leaflet was last approved in 2015-03-30