NOTICE
ANSM - Updated on : 09/05/2025
Product name
OSAFLEXAN 1178 mg, powder for oral solution in dose sachet
Glucosamine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Talk to your doctor or pharmacist if you experience any of these side effects. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 30 days.
What does this leaflet contain?
1. What is OSAFLEXAN 1178 mg, powder for oral solution in a sachet and what is it used for?
2. What do I need to know before taking OSAFLEXAN 1178 mg, powder for oral solution in a sachet?
3. How should I take OSAFLEXAN 1178 mg, powder for oral solution in a sachet?
4. What are the possible side effects?
5. How to store OSAFLEXAN 1178 mg, powder for oral solution in a sachet?
6. Package contents and other information.
1. WHAT IS OSAFLEXAN 1178 mg, powder for oral solution in a sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: M01AX05
OSAFLEXAN contains glucosamine, which belongs to the group of drugs known as other non-steroidal anti-inflammatory and anti-rheumatic agents.
OSAFLEXAN is used to relieve symptoms associated with mild to moderate osteoarthritis of the knee.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING OSAFLEXAN 1178 mg, powder for drinkable solution in a sachet?
Never take OSAFLEXAN 1178 mg, powder for oral solution in a sachet:
- if you are allergic to glucosamine or to any of the other components of this medicine listed in section 6.
- if you are allergic to shellfish, as the active substance, glucosamine, is extracted from them.
Warnings and precautions
Talk to your doctor or pharmacist before taking OSAFLEXAN 1178 mg, powder for oral solution in a sachet if you :
- have diabetes or impaired glucose tolerance. More frequent blood glucose checks may be necessary when you start taking OSAFLEXAN.
- have a known risk factor for cardiovascular disease (e.g. hypertension, diabetes, hypercholesterolemia or smoking); abnormal hypercholesterolemia has been observed in some patients treated with glucosamine.
- suffer from asthma. When you start taking OSAFLEXAN, you should be aware that symptoms may worsen.
You should immediately stop taking OSAFLEXAN and consult your doctor if you develop symptoms of angioedema: sudden swelling of the face, tongue and/or pharynx, difficulty swallowing, or allergic reactions accompanied by breathing difficulties.
Children and teenagers
Not applicable.
Other medicinal products and OSAFLEXAN 1178 mg, powder for drinkable solution in sachet-dose
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Precautions should be taken if OSAFLEXAN is to be taken in combination with other drugs, in particular:
- Certain types of medication used to prevent blood clotting (e.g. warfarin, dicoumarol, phenprocoumon, lacenocoumarol and fluindione). The effect of these drugs may be stronger when used with glucosamine. Patients on such concomitant therapy should therefore be monitored very closely when starting or stopping glucosamine therapy.
- tetracycline (antibiotic).
Nonsteroidal anti-inflammatory drugs (NSAIDs) may be administered with glucosamine sulfate.
OSAFLEXAN 1178 mg, powder for oral solution in dose sachet with food, drink and alcohol
OSAFLEXAN should be taken with meals.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
OSAFLEXAN should not be used during pregnancy.
OSAFLEXAN should not be used during breast-feeding.
Sportsmen
Not applicable.
Driving and use of machinery
The effects on the ability to drive vehicles and use machines have not been studied.
If you experience dizziness or drowsiness during treatment with OSAFLEXAN, you should not drive or operate machinery.
OSAFLEXAN 1178 mg, powder for oral solution in a sachet, contains laspartame, sodium and sorbitol.
- OSAFLEXAN contains 2.5 mg daspartam (E951) in each sachet. Laspartam contains a source of phenylalanine. This can be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by an accumulation of phenylalanine that cannot be eliminated properly by the body.
- OSAFLEXAN contains 2029 mg sorbitol (E420) in each sachet. Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medication.
- This medicine contains 151 mg sodium (the main component of table salt) in each sachet. This is equivalent to 7.6% of the maximum recommended daily allowance of sodium for an adult.
3. HOW DO I TAKE OSAFLEXAN 1178 mg, powder for oral solution in a sachet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The usual dose is 1 sachet (1178 mg glucosamine) once a day, orally, with meals.
Dissolve the sachet powder in a glass of water (250 ml) and drink.
Glucosamine is not indicated for the treatment of acute pain symptoms. Symptoms (particularly pain) may not be relieved for several weeks, or even longer. If there is no relief after 2 or 3 months, further treatment with OSAFLEXAN should be reconsidered.
Use in children and adolescents
OSAFLEXAN should not be used in children and adolescents under 18 years of age.
If you have taken more OSAFLEXAN 1178 mg, powder for oral solution in a sachet, than you should have :
Consult your doctor or pharmacist immediately.
If you have taken large amounts of OSAFLEXAN, you should consult your doctor or hospital. Signs and symptoms of glucosamine overdose may include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea or constipation. Stop taking glucosamine as soon as these signs appear.
If you forget to take OSAFLEXAN 1178 mg, powder for oral solution in a sachet:
Do not take a double dose to make up for the one you forgot to take. If it is almost time for your next dose, disregard the missed dose and continue taking OSAFLEXAN as scheduled.
If you stop taking OSAFLEXAN 1178 mg, powder for oral solution in a sachet:
Talk to your doctor if a change in your treatment could be considered.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone. Stop taking this medicine and contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, hives and difficulty breathing.
The following adverse reactions have been reported:
Common (up to 1 in 10 people):
o Headache,
o Fatigue,
o Nausea,
o Abdominal pain,
o Indigestion,
o Diarrhea,
o Constipation
o Flatulence
o Drowsiness
Uncommon (up to 1 in 100 people):
o Rash
o Erythema
o Pruritus
o Reddening.
Undetermined frequency (frequency cannot be estimated on the basis of available data):
o Allergic reactions (Hypersensitivity)
o Swelling of legs, feet and ankles,
o Poorly controlled diabetes
o Dizziness,
o Asthma/Worsened asthma
o Vomiting
o Fluctuation in International Normalized Ratio (INR) and elevation of liver enzymes.
o Jaundice.
Hypercholesterolemia has been reported, but no causal link has been demonstrated.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE OSAFLEXAN 1178 mg, powder for oral solution in a sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the case and sachet after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What OSAFLEXAN 1178 mg, powder for oral solution in a sachet, contains
- The active substance is :
glucosamine sulfate.
Each sachet contains 1884 mg of glucosamine hydrochloride and anhydrous sodium sulfate, equivalent to 1500 mg glucosamine sulfate or 1178 mg glucosamine.
- Other ingredients include
aspartam (E951), sorbitol (E420), citric acid (E330), macrogol 4000.
What is OSAFLEXAN 1178 mg, powder for oral solution in a sachet, and what does it contain?
This medicine comes in the form of a white, crystalline powder for oral solution.
Each box contains 30 or 90 sachets.
Not all presentations may be marketed.
Marketing authorization holder
COOPER CONSUMER HEALTH B.V.
VERRIJN STUARTWEG 60
1112AX DIEMEN
NETHERLANDS
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77000 MELUN
Manufacturer
ROTTAPHARM LTD
DAMASTOWN INDUSTRIAL PARK
MULHUDDART
DUBLIN 15
IRELAND
or
SIGMAR ITALIA S. P.A
VIA SOMBRENO 11
24011 ALME
ITALY
Drug names in member states of the European Economic Area
[to be completed subsequently by the owner].
The last date on which this leaflet was revised was :
[to be completed at a later date by the owner].
Other
Detailed information on this product is available on the ANSM (France) website.
Dizziness and drowsiness may occur. Make sure you tolerate this drug before driving or operating hazardous machinery.
