PACKAGE LEAFLET: INFORMATION FOR THE USER
Osaflex 1178 mg powder for oral solution, sachet
Glucosamine
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 further questions, please 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 the same as 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. What Osaflex is and what it is used for
2. Before you take Osaflex
3. How to take Osaflex
4. Possible side effects
5. How to store Osaflex
6. Further information
1. WHAT OSAFLEX IS AND WHAT IT IS USED FOR
Osaflex contains glucosamine which belongs to a group of medicines called other anti-inflammatory
and anti-rheumatic agents, non steroids.
Osaflex is used for the relief of symptoms in mild to moderate osteoarthritis of the knee.
2. BEFORE YOU TAKE OSAFLEX
Do not take Osaflex if you:
-
are allergic (hypersensitive) to glucosamine or to any of the other ingredients of Osaflex
(listed in section 6).
are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from shellfish.
Take special care with Osaflex (and speak to your doctor) if you:
- suffer from diabetes mellitus or have impaired glucose tolerance. More frequent controls of
your blood glucose levels may be necessary when starting the treatment with Osaflex.
have impaired kidney or liver function, since no studies with glucosamine have been
performed in this patient group.
- have a known risk factor for cardiovascular (heart) disease (e.g. hypertension, diabetes
mellitus, hypercholesterolemia or if you smoke), since an abnormally high level of cholesterol
in the blood has been observed in a few cases in patients treated with glucosamine.
- suffer from asthma. When starting on Osaflex, you should be aware of potential worsening of
symptoms.
You should stop taking Osaflex and see your doctor immediately if you experience symptoms of
angioedema, such as: swollen face, tongue and/or pharynx and/or difficulty to swallow or hives
together with difficulties to breathe
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Caution should be exercised if Osaflex has to be combined with other medicines, especially:
-
warfarin (medicine to thin the blood, anticoagulant).
-
tetracycline (antibiotic).
Increased effect of coumarin anticoagulants (e.g. warfarin or similar drugs) during concomitant
treatment with glucosamine has been reported. Patients treated with such combinations should
therefore be monitored extra carefully when initiating or ending glucosamine therapy.
Please contact your doctor for medical advice.
Taking Osaflex with food and drink
You can take Osaflex with or without food.
Pregnancy and breast-feeding
Osaflex should not be used during pregnancy.
The use of Osaflex during breast-feeding is not recommended.
Ask your doctor or pharmacist for advice before taking any medicine.
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 while taking Osaflex, you should not drive or operate machinery.
Important information about some of the ingredients of Osaflex
-
Osaflex contains aspartame (E951), a source of phenylalanine, which may be harmful for
people with phenylketonuria.
-
Osaflex contains sorbitol (E420). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
-
One sachet contains 6.6 mmol (151 mg) sodium, which should be taken into consideration by
patients on a controlled sodium diet.
3. HOW TO TAKE OSAFLEX
Dosage
Always take Osaflex exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is one sachet (1178 mg of glucosamine) once daily, taken orally.
Dissolve the powder from the sachet in a glass of water (250 ml) and drink.
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
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cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with
Osaflex should be re-evaluated.
Children and adolescents
Use of Osaflex is not recommended in children and adolescents below the age of 18.
If you take more Osaflex than you should
If you have taken large quantities, you must consult your doctor or a hospital. Signs and symptoms of
overdose with glucosamine might include headache, dizziness, confusion, joint pain, feeling sick,
vomiting (being sick), diarrhoea or constipation. Stop taking glucosamine at signs of overdose.
If you forget to take Osaflex
Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose, skip
the forgotten dose and carry on taking Osaflex as scheduled.
If you stop taking Osaflex
Your symptoms may reoccur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Osaflex can cause side effects, although not everybody gets them.
The following have been reported:
Common (in less than 1 in 10 but more than 1 in 100 patients):
headache, tiredness, feeling sick, abdominal pain, indigestion, diarrhoea, constipation.
Uncommon (in less than 1 in 100 but more than 1 in 1,000 patients):
rash, itching, flushing.
Not known (cannot be estimated from the available data):
Swelling of face, tongue, or throat (angioedema, see Take special care with Osaflex), hives,
swelling/swelling of ankles, legs and feet, dizziness, vomiting (being sick), blood glucose control
worsened in patients with diabetes mellitus, hepatic enzyme elevation and jaundice..
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE OSAFLEX
Keep out of the reach and sight of children.
Do not use Osaflex after the expiry date which is stated on the carton and sachets after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. The measures will help to protect the environment.
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6. FURTHER INFORMATION
What Osaflex contains
The active substance is glucosamine. Each sachet contains 1884 mg mixture of glucosamine
hydrochloride and anhydrous sodium sulphate, corresponding to 1500 mg glucosamine sulphate or
1178 mg glucosamine.
The other ingredients are aspartame (E951), sorbitol (E420), citric acid anhydrous, macrogol 4000.
What Osaflex looks like and content of the pack
Osaflex is a white, crystalline powder for oral solution.
Each carton contains 30 or 90 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
To be completed nationally
For SE:
ROTTAPHARM Ltd
Damastown Indusstrial Park
Mulhuddart, Dublin 15
Ireland
Manufacturer
To be completed nationally
For SE:
ROTTAPHARM Ltd
Damastown Indusstrial Park
Mulhuddart, Dublin 15
Ireland
or
Sigmar Italia S.p.A.
Via Sombreno 11
24011 Almè
Italy
This medicinal product is authorized in the Member States of the EEA under the following
names:
Sweden: OSAFLEX
France: OSAFLEXAN
This leaflet was last approved in 2012-03-30
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