NOTICE
ANSM - Last updated: 05/03/2015
Name of the medicinal product
STRUCTOFLEX 625 mg capsule
glucosamine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 2 or 3 months.
Review summary
In this notice :
1. WHAT IS STRUCTOFLEX 625 mg, hard capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE STRUCTOFLEX 625 mg capsules?
3. HOW TO TAKE STRUCTOFLEX 625 mg capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE STRUCTOFLEX 625 mg capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS STRUCTOFLEX 625 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
STRUCTOFLEX contains glucosamine (as glucosamine hydrochloride 750 mg), which belongs to the group of medicines called other anti-inflammatory and antirheumatic, non-steroidal agents.
Therapeutic indications
STRUCTOFLEX is used to relieve symptoms associated with mild to moderate osteoarthritis of the knee.
2. BEFORE YOU TAKE STRUCTOFLEX 625 mg capsules?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take STRUCTOFLEX 625 mg capsule if:
· Allergy (hypersensitivity) to glucosamine or any of the other ingredients of STRUCTOFLEX;
· Allergy (hypersensitivity) to crustaceans, because the active substance, glucosamine, is extracted from them.
Precautions for use; special warnings
Take special care with STRUCTOFLEX 625 mg capsule:
If you have:
· diabetes or glucose intolerance. More frequent blood glucose monitoring may be required when you start treatment with glucosamine.
· renal or hepatic impairment; no studies have been conducted in this type of patient with glucosamine.
· presence of known cardiovascular disease (eg hypertension, diabetes, hypercholesterolemia or smoking). Abnormal hypercholesterolemia has been observed in some patients treated with glucosamine.
· asthma. When you start treatment with STRUCTOFLEX, it is important to know that the symptoms may worsen.
You should immediately stop taking STRUCTOFLEX and consult your doctor before symptoms of angioedema occur: abrupt swelling of the face, tongue and / or pharynx, difficulty swallowing, or allergic reactions with difficulty breathing.
Interaction with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Caution should be exercised when STRUCTOFLEX is combined with other medicinal products, in particular:
· warfarin (blood thinning medication, anticoagulant).
· tetracycline (antibiotic).
An increase in the effect of coumarin-type anticoagulants (eg warfarin or comparable drugs) was observed in concomitant glucosamine therapy. Patients treated with these combinations will be monitored with particular attention to the onset and termination of glucosamine therapy.
Interactions with food and beverages
Food and drinks
Capsules should be swallowed with water or other liquid and may be taken indifferently during or out of meals.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
STRUCTOFLEX should not be used during pregnancy as there are no data on its administration in pregnant women.
There are no data on the use of this medication in breast milk. Therefore, use of this medication is not recommended during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
The effects on the ability to drive and use machines have not been studied. If you experience dizziness or drowsiness during treatment with STRUCTOFLEX, you should not drive a vehicle or use a machine.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE STRUCTOFLEX 625 mg capsule?
Instructions for proper use
Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dose is 2 capsules, once a day.
Capsules should be swallowed with water or other liquid and may be taken indifferently outside or during meals.
Glucosamine is not indicated for the treatment of acute pain symptoms. Relief of symptoms (especially pain) may only occur after several weeks of treatment, and sometimes even longer. In the absence of any relief after 2 or 3 months, further treatment with STRUCTOFLEX should be reconsidered.
Children and Youth
STRUCTOFLEX should not be used in children and adolescents under 18 years of age.
Symptoms and Instructions for Overdose
If you take more STRUCTOFLEX 625 mg capsule than you should:
If you have taken large amounts, you should consult your doctor or a hospital. Signs and symptoms of overdose with glucosamine may result in headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea or constipation. Stop taking glucosamine at the onset of such signs.
Instructions for omission of one or more doses
If you forget to take STRUCTOFLEX 625 mg capsule:
Do not take a double dose to make up for the missed dose. If it is almost time for your next dose, skip the missed dose and continue with STRUCTOFLEX as directed.
Risk of withdrawal syndrome
If you stop taking STRUCTOFLEX 625 mg capsule:
Your symptoms may recur.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following adverse reactions have been reported:
Common (1 to 10 patients out of 100):
Headache, fatigue, nausea, abdominal pain, indigestion, diarrhea, constipation.
Uncommon (1 to 10 of 1000 patients):
Rash, pruritus, blushing.
Frequency not known (can not be estimated from the available data):
Swelling of the face, tongue or throat (angioedema, see "Take special care with STRUCTOFLEX 625 mg capsule" ), hives, swelling of the legs, swelling of the feet and ankles, dizziness, vomiting, deterioration of control blood glucose levels in diabetic patients, elevated liver enzymes and jaundice.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE STRUCTOFLEX 625 mg capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use STRUCTOFLEX after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 30 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does STRUCTOFLEX 625 mg contain, capsule?
The active substance is :
Glucosamine ................................................. .................................................. ............................... 625 mg
In the form of glucosamine hydrochloride ............................................ 750 mg
For a capsule.
The other components are :
Magnesium stearate.
Composition of the capsule shell : gelatin, red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172).
Pharmaceutical form and content
What is STRUCTOFLEX 625 mg capsule and contents of the pack?
This medication is in the form of capsules. Capsules are opaque, brown in color.
Box of 60 or 180 capsules in blister packs.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
exploiting
PIERRE FABRE MEDICAMENT
45 place Abel Gance
92100 BOULOGNE
Maker
LABORATORIOS J. URIACH Y COMPANIA SA
AVDA. CAMI REIAL 51-57
POL. IND. RIERA DE CALDES
08184 PALAU-SOLITA I PLEGAMANS (BARCELONA)
SPAIN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.