Package leaflet: Information for the patient

GLEXAR 1500 mg powder for oral solution

Glucosamine sulfate
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What GLEXAR is and what it is used for
What you need to know before taking GLEXAR
How to take GLEXAR
Possible side effects
How to store GLEXAR
Contents of the pack and other information

1. What GLEXAR is and what it is used for

GLEXAR contains the active substance glucosamine sulphate, which belongs to a group of medicines called non-steroidal anti-inflammatory and anti-rheumatic agents.
This medicine is used to relieve the symptoms of osteoarthritis (primary and secondary), a type of joint disease.

2. What you need to know before taking GLEXAR

Do not take GLEXAR

if you are allergic to glucosamine or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to shellfish, as glucosamine is derived from shellfish;
if you have a condition called phenylketonuria, because this medicine contains aspartame (a source of phenylalanine).

Warnings and precautions
Talk to your doctor or pharmacist before taking GLEXAR.
Consult your doctor to rule out the presence of other joint diseases that may require specific treatments.
Take this medicine with caution and speak to your doctor if:

you have glucose intolerance, a type of sugar intolerance; your doctor will monitor your blood sugar levels and, depending on your health status, may prescribe insulin;
you are predisposed to heart and artery diseases (cardiovascular diseases); your doctor should monitor your blood lipid levels, as this medicine may cause an increase in blood lipids;
you have asthma, because this medicine may worsen your symptoms;
you have severe kidney or liver problems (severe hepatic or renal insufficiency).

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and GLEXAR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise caution if GLEXAR is to be taken together with other medicines, especially:

certain types of medicines used to prevent blood clotting (e.g. warfarin, dicoumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be enhanced when used with glucosamine. Therefore, patients receiving such combinations must be closely monitored when starting or stopping glucosamine therapy.
tetracyclines, medicines used to treat bacterial infections.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take GLEXAR if you are pregnant, breastfeeding, have fertility problems, or are undergoing fertility testing.
Driving and using machines
If after taking this medicine you experience dizziness, drowsiness, headache or visual disturbances, avoid driving or operating machinery.
GLEXAR contains aspartame
This medicine contains a source of phenylalanine (aspartame). It may be harmful if you have phenylketonuria.
GLEXAR contains sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
GLEXAR contains 151 mg of sodium per sachet of oral solution powder. This should be taken into consideration in patients with impaired renal function or those following a low-sodium diet.

3. How to take GLEXAR

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is not suitable for treating occasional joint problems (acute symptoms).
The effect of GLEXAR is not immediate. Improvement in symptoms may take several weeks or longer
after starting treatment. If you do not notice an improvement in your health condition after 2-3 months of treatment with this medicine, consult your doctor.
The recommended dose is 1 sachet (1500 mg) once daily. Take the contents of one sachet dissolved
in a glass of water.
Use in elderly patients
If you are elderly and do not suffer from any particular disorders, dose adjustment is not necessary.
If you take more GLEXAR than you should
If you take/ingest an excessive dose of this medicine, inform your doctor immediately or go to the
nearest hospital.
If you forget to take GLEXAR
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur.

Common (may affect up to 1 in 100 people)

headache, tiredness and drowsiness;
nausea, abdominal pain, indigestion, diarrhoea, constipation, increased intestinal gas (flatulence), stomach pain and heaviness, difficulty in digestion (dyspepsia).

Uncommon (may affect up to 1 in 1,000 people)

skin irritation, itching and skin redness.

Not known (frequency cannot be estimated from the available data)

allergic reaction;
vision disorders;
hair loss;
breathing difficulties (bronchial asthma);
increased blood sugar (glucose) levels;
isolated cases of increased blood cholesterol levels (hypercholesterolemia) have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLEXAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GLEXAR contains

The active substance is glucosamine sulfate sodium chloride. One sachet contains 1884 mg of glucosamine sulfate sodium chloride, equivalent to 1500 mg of glucosamine sulfate and 384 mg of sodium chloride.
The other ingredients are aspartame, sorbitol, citric acid, macrogol 4000, anhydrous colloidal silica.

Description of the appearance of GLEXAR and contents of the pack
GLEXAR is an oral suspension powder.
Pack size: 20 sachets.
Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (Potenza)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 20089 Quinto de’ Stampi - Rozzano (Milan)