Glucosamine sulfate EG

Package leaflet: Information for the patient

GLUCOSAMINE SULFATE EG 1500 mg powder for oral solution

Equivalent medicine
Please read all of 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, ask 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GLUCOSAMINE SULFATE EG is and what it is used for
2. What you need to know before taking GLUCOSAMINE SULFATE EG
3. How to take GLUCOSAMINE SULFATE EG
4. Possible side effects
5. How to store GLUCOSAMINE SULFATE EG
6. Contents of the pack and other information

1. What GLUCOSAMINA SOLFATO EG is and what it is used for

GLUCOSAMINA SOLFATO EG contains the active substance glucosamine sulfate, which belongs to the 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 disease affecting the joints.

2. What you should know before taking GLUCOSAMINE SULFATE EG

Do not take GLUCOSAMINE SULFATE EG

• 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking GLUCOSAMINE SULFATE EG.
Consult your doctor to rule out the presence of other joint diseases that may require specific treatments.
Take this medicine with caution and consult 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 condition, may prescribe insulin;
• you have a predisposition 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 suffer from asthma, as this medicine may worsen your symptoms;
• you have severe kidney or liver problems (severe hepatic or renal insufficiency).

This medicine contains 151 mg of sodium per oral solution sachet. This should be taken into account for individuals on a low-sodium diet.
Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.
Other medicines and GLUCOSAMINE SULFATE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and consult your doctor if you are taking:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take GLUCOSAMINE SULFATE EG if you are pregnant, breastfeeding, have fertility problems, or are undergoing fertility testing.
Driving and using machines
If you experience dizziness or drowsiness after taking this medicine, avoid driving or operating machinery.
GLUCOSAMINE SULFATE EG contains sodium, aspartame and sorbitol
This medicine contains 151 mg of sodium (a main component of table salt) per sachet. This corresponds to 7.6% of the maximum recommended daily dietary intake for an adult.
This medicine contains 2.5 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body's inability to properly metabolize it.
This medicine contains 2,023.5 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before taking this medicine.

3. How to take GLUCOSAMINE SULFATE EG

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet (1500 mg) once daily for 6 weeks, unless otherwise
prescribed by your doctor. You may repeat the treatment cycle at intervals of 2 months.
The duration of treatment may be prolonged if necessary.
Take the contents of one sachet after dissolving it in a glass of water.
Use in the elderly
If you are an elderly person in good health, dose adjustment is not necessary.
Use in patients with impaired liver or kidney function
Careful medical monitoring is recommended.
If you take more GLUCOSAMINE SULFATE EG than you should
If you take or ingest an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to take GLUCOSAMINE SULFATE EG
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of 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 10 people)

• headache, fatigue 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 100 people)

• skin irritation, itching and skin redness.

Not known (frequency cannot be estimated from available data)

• allergic reaction;
• vision disorders;
• hair loss;
• bronchial asthma;
• increased blood sugar (glucose) levels;
• increased blood cholesterol levels (hypercholesterolemia).

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 the following website: 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 GLUCOSAMINE SULFATE EG

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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What GLUCOSAMINA SOLFATO EG 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, colloidal anhydrous silica.

Description of the appearance of GLUCOSAMINA SOLFATO EG and package contents
GLUCOSAMINA SOLFATO EG is a powder for oral suspension.
Pack size: 20 sachets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno, 48, 20089 Quinto de’ Stampi - Rozzano (Milan)