Flexove tabletki 625 mg

Package Leaflet: Information for the User

Flexove, 625 mg, Tablets

Glucosamine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor or pharmacist.
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This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet

• 1. What is Flexove and what is it used for
• 2. Important information before taking Flexove
• 3. How to take Flexove
• 4. Possible side effects
• 5. How to store Flexove
• 6. Contents of the pack and other information

1. What is Flexove and what is it used for

Flexove belongs to a group of non-steroidal anti-inflammatory and anti-rheumatic medicines (NSAIDs).
Flexove is used to alleviate symptoms in cases of mild or moderate knee joint inflammation.

2. Important information before taking Flexove

When not to take Flexove:

• if the patient is allergicto glucosamineor any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergicto shellfish, as glucosamine is produced from them.

Warnings and precautions

Glucosamine is not indicated for the treatment of acute pain.

Before taking Flexove, the patient should discuss it with their doctor or pharmacist:

• if the patient has glucose tolerance disorders. At the beginning of glucosamine treatment, it may be necessary to monitor blood glucose levels more frequently.
• in case of identified risk factors for cardiovascular disorders, as in rare cases, an increase in blood cholesterol levels has been observed in patients treated with glucosamine.
• if the patient has asthma. Before starting glucosamine treatment, the possibility of worsening symptoms should be considered.

Children and adolescents

Flexove should not be used in children and adolescents under 18 years of age.

Flexove and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Caution should be exercised when using Flexove in combination with other medicines, particularly with:

• certain types of medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be stronger when taken with glucosamine. Patients treated with such combinations of medicines should be closely monitored when starting and stopping glucosamine treatment.
• tetracyclines (antibiotics used in infections).

Before taking Flexove, the patient should consult their doctor.

Pregnancy, breastfeeding, and fertility

Flexove should not be used during pregnancy.
It is not recommended to use Flexove during breastfeeding.
If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects of Flexove on the ability to drive and use machines. If the patient experiences dizziness or drowsiness after taking the tablets, they should not drive or operate machinery.

3. How to take Flexove

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

The recommended initial dose is 2 tablets (1250 mg of glucosamine) taken orally, once a day.
Relief of symptoms (especially pain) may not occur until after several weeks of treatment, and in some cases, even longer. If there is no relief of symptoms after 2-3 months, the doctor should reconsider further use of glucosamine.
No studies have been conducted in patients with renal and/or hepatic impairment. Therefore, there are no dosage recommendations for this group of patients.
For oral use.
The tablets should be swallowed with water or another suitable liquid.
The break line on the tablet only facilitates breaking the tablet to make it easier to swallow, and not to divide it into equal doses.

Overdose of Flexove

In case of taking large amounts of the medicine, the patient should contact their doctor or go to the hospital emergency department. Symptoms of glucosamine overdose may include: headache, dizziness, disorientation, joint pain, nausea, vomiting, diarrhea, or constipation. If symptoms of overdose occur, the patient should stop taking glucosamine.

Missing a dose of Flexove

The patient should not take a double dose to make up for a missed dose. If it is almost time for the next dose, the patient should skip the missed dose and continue taking Flexove according to the established schedule.

Stopping Flexove treatment

The patient should inform their doctor, as modification of the treatment of symptoms may be required.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flexove can cause side effects, although not everybody gets them.
The patient should stop taking Flexove and immediately call the emergency services or go to the hospital emergency department if they experience symptoms of angioedema, such as:
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swelling of the face, tongue, or throat,
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difficulty swallowing,

• hives and difficulty breathing.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

headache, fatigue, nausea, abdominal pain, indigestion, diarrhea, constipation.

Uncommon (may affect up to 1 in 100 people):

rash, itching, skin redness.

Frequency not known (frequency cannot be estimated from the available data):

hives, swelling/edema of the ankles, feet, and hands, dizziness, vomiting, worsening of glycemiain diabetic patients, increased liver enzyme activity, jaundice.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Flexove

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or packaging: EXP. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine if the patient notices any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Flexove contains

• The active substance of Flexove is glucosamine. Each tablet contains 750 mg of glucosamine hydrochloride, equivalent to 625 mg of glucosamine.
• The other ingredients are: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and magnesium stearate.

What Flexove looks like and contents of the pack

White to light beige, oval tablet, 10 mm x 18.75 mm, marked with the letter "G" on one side and a break line on the other side. The break line on the tablet only facilitates breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Blisters (PVC/PVDC/Aluminum) in a carton box.
Pack size: 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoires Expanscience

1 place des Saisons – 92048 Paris La Défense Cedex,
France

Manufacturer

Famar Italia S.p.A.,Via Zambeletti 25, 20021 Baranzate, Italy
Haupt Pharma Wülfing GmbH, Bethelner Landstr. 18, 31028 Gronau, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic
Flexove
France
Flexea
Iceland
Glucomed
Poland
Flexove
Portugal
Glucomed
Slovakia
Glucomed
Sweden
Glucomed
Date of last revision of the leaflet:06/2024