Glucosamine sulfate Doc Generici

Package leaflet: Information for the patient

GLUCOSAMINA SOLFATO DOC Generici

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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GLUCOSAMINA SOLFATO DOC Generici is and what it is used for

GLUCOSAMINA SOLFATO DOC Generici 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 need to know before taking GLUCOSAMINA SOLFATO DOC Generici

Do not take GLUCOSAMINA SOLFATO DOC Generici

• 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 GLUCOSAMINA SOLFATO DOC Generici.
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 may prescribe insulin depending on your health condition;
• 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 fats;
• you suffer from asthma, as 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 administered to children and adolescents under 18 years of age.
Other medicines and GLUCOSAMINA SOLFATO DOC Generici
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 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, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant, breastfeeding, have fertility problems, or are undergoing fertility testing.
Driving and using machines
If you experience dizziness, drowsiness, headache, or visual disturbances after taking this medicine, avoid driving vehicles or operating machinery.
GLUCOSAMINA SOLFATO DOC Generici contains aspartame, sorbitol and sodium

• 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 2023.5 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• This medicine contains 151 mg of sodium (the main component of table salt) per sachet. This corresponds to 8% of the maximum recommended daily dietary intake for an adult.

3. How to take GLUCOSAMINA SOLFATO DOC Generici

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. The treatment course may
be repeated with intervals of 2 months.
Take the contents of one sachet after dissolving it in a glass of water.
If you take more GLUCOSAMINA SOLFATO DOC Generici than you should
If you take too much of this medicine, inform your doctor immediately or go to the nearest
hospital.
If you forget to take GLUCOSAMINA SOLFATO DOC Generici
Do not take a double dose to make up for the forgotten 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 will experience them.
The following side effects may occur:
Common (may affect up to 1 in 100 people)

• headache, fatigue and drowsiness;
• nausea, abdominal pain, indigestion, diarrhoea, constipation, increased passage of 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;
• visual disturbances;
• hair loss;
• breathing difficulties (bronchial asthma);
• increased blood sugar (glucose) levels;
• increased blood cholesterol levels (hypercholesterolaemia).

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 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 GLUCOSAMINA SOLFATO DOC Generici

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

6. Package contents and other information

What GLUCOSAMINA SOLFATO DOC Generici 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 components are aspartame, sorbitol, citric acid, macrogol 4000, colloidal anhydrous silica.

Description of the appearance of GLUCOSAMINA SOLFATO DOC Generici and package contents
The pack contains 20 sachets of oral solution powder.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno 48 - 20089 Quinto de’ Stampi - Rozzano (Milan) – Italy.