Document: OsteoEze 625 mg film-coated tablet ENG PL change

• OsteoEze 625 mg film-coated tablet ENG PL
• OsteoEze 625 mg film-coated tablet OTC ENG PL

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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.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

OsteoEze contains the active substance glucosamine, which belongs to a group of medicines called other anti-inflammatory and antirheumatic agents, non-steroids.

Glucosamine is a substance naturally occurring in the human body andnecessary 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.

Do not use 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.

Tell your doctor or pharmacist if any of the above apply because OsteoEze is not suitable for you in these circumstances.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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.

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 immediatelyif you experience symptoms such as: swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficulties to breathe (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 awayamedicines 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 Sverige AB, Box 1150, SE-183 11 Täby, Sweden

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