Flexove tablets 625 mg

Patient Information Leaflet: Instructions for the User

Warning! Keep this leaflet – the packaging information is in a foreign language!
Flexove tablets 625 mg (Glucomed)
Glucosaminum
Flexove tablets 625 mg and Glucomed are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Flexove is and what it is 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 Flexove is and what it is used for

Flexove belongs to the group of other non-steroidal anti-inflammatory and anti-rheumatic drugs (NSAIDs).
Flexove is used to relieve symptoms in cases of mild to moderate knee joint osteoarthritis.

2. Important information before using Flexove tablets

When not to use Flexove:

• if the patient is allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to shellfish, because glucosamine is derived from them.

Warnings and precautions
Glucosamine is not indicated for the treatment of acute pain.
Before starting to take Flexove, consult a doctor or pharmacist:

• if the patient has glucose intolerance disorders. At the beginning of glucosamine treatment, more frequent monitoring of blood glucose levels may be necessary.
• in case of established cardiovascular risk factors, because in rare cases an increase in blood cholesterol levels has been observed in patients treated with glucosamine.
• if the patient has asthma. The possibility of worsening symptoms should be considered before starting glucosamine.

Children and adolescents
Flexove tablets should not be used in children and adolescents under 18 years of age.
Interaction of Flexove with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Exercise caution when using Flexove together with:

• 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 during concomitant use of glucosamine. Patients receiving such combinations should be monitored particularly carefully when starting and stopping glucosamine treatment.
• tetracyclines (antibiotics used for infections).

Consult a doctor before using Flexove.
Pregnancy, breastfeeding and fertility
Do not use Flexove during pregnancy.
Use of Flexove is not recommended during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
No studies on the effects on the ability to drive or operate machinery have been performed. If dizziness or drowsiness occurs after taking the tablets, driving or operating machinery should be avoided.

3. How to use Flexove tablets 625 mg

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Dosage
The recommended initial dose is 2 tablets (1250 mg of glucosamine) taken orally once daily.
Symptom relief (especially pain) may not occur until several weeks of treatment have passed,
and in some cases even longer. If no symptom relief occurs after 2–3 months,
the doctor should reconsider further use of glucosamine.
Studies have not been conducted in patients with impaired renal and/or hepatic function.
Therefore, dosage recommendations for this patient group are not available.
For oral use.
The tablets should be swallowed whole with water or another suitable liquid.
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing and does not ensure equal division into doses.
Taking more Flexove tablets 625 mg than prescribed
In case of ingestion of a large amount of medicine, contact a doctor or go to a hospital emergency department immediately.
Symptoms of overdose with glucosamine may include: headache, dizziness, disorientation, joint pain, nausea, vomiting, diarrhoea, or constipation.
If symptoms of overdose occur, glucosamine should be discontinued immediately.
Missing a dose of Flexove tablets 625 mg
Do not take a double dose to make up for a missed dose. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule.
Stopping Flexove tablets 625 mg
Inform your doctor, as modification of treatment for symptoms may be required.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You must stop taking Flexove tablets and immediately call an ambulance or go to
a hospital emergency department if you experience symptoms of angioedema,
such as:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• hives and breathing difficulties.

The following adverse reactions have been reported:
Common (may occur in up to 1 in 10 people):
headache, fatigue, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Uncommon (may occur in up to 1 in 100 people):
rash, itching, skin redness.
Frequency not known (frequency cannot be estimated from the available data):
urticaria, oedema/swelling of ankles, legs and feet, dizziness, vomiting, increased glycaemia
in diabetic patients, increased liver enzyme activity, jaundice.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Flexove tablets

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

6. Contents of the pack and other information

What Flexove contains

• The active substance is glucosamine. Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride – 750 mg).
• The other ingredients are: microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

What Flexove looks like and contents of the pack
White to off-white, oval tablet 10 mm x 18.75 mm, marked with the letter "G" on one side and a score line on the other side. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not allow for division into equal doses.
PVC/PVDC-Aluminium blisters in a cardboard carton.
Pack size: 60 tablets.
For further information, contact the responsible party or the parallel importer.
Responsible party in Portugal, country of export:
Laboratoires Expanscience
1 place des Saisons
92048 Paris La Défense Cedex
France
Manufacturer:
Haupt Pharma Wülfing GmbH
Bethelner Landstr. 18
31028 Gronau
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, country of export: 5820386
Parallel import authorization number: 70/21
This medicinal product is authorized for marketing in the European Economic Area countries under the following names:
Czech Republic Flexove
France Flexea
Iceland Glucomed
Poland Flexove
Portugal Glucomed
Slovakia Glucomed
Sweden Glucomed