Arthril

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Arthryl (Glucosamine Mylan)

1500 mg, powder for oral solution

Glucosamine sulfate
Arthryl and Glucosamine Mylan are different trade names for the same drug.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Arthryl and what is it used for
• 2. Important information before taking Arthryl
• 3. How to take Arthryl
• 4. Possible side effects
• 5. How to store Arthryl
• 6. Package contents and other information

1. WHAT IS ARTHRYL AND WHAT IS IT USED FOR

Arthryl is used to treat symptoms of mild or moderate knee osteoarthritis.

2. IMPORTANT INFORMATION BEFORE TAKING ARTHRYL

When not to take Arthryl

• if the patient is allergic (hypersensitive) to glucosamine sulfate or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to shellfish, as glucosamine is obtained from shellfish,
• in patients with phenylketonuria, as the medicine contains aspartame.

Warnings and precautions

• Caution should be exercised when taking the medicine by patients with asthma, as it may worsen the symptoms of the disease.
• Particular caution should be exercised when taking the medicine by patients with severe liver or kidney failure.
• Cautions are advised for patients with diabetes; at the beginning of treatment, close monitoring of blood glucose levels may be necessary.

Children and adolescents

The medicine should not be taken by children.

Arthryl and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines they plan to take.
During clinical trials, no interactions were observed between glucosamine sulfate and other medicines.
Cautions should be exercised when taking Arthryl in combination with other medicines, particularly with certain types of medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindion). The effect of these medicines may be stronger when taken with glucosamine. Patients treated with such combinations of medicines should be closely monitored during the start and end of glucosamine treatment.
During glucosamine sulfate treatment, non-steroidal anti-inflammatory and pain-relieving medicines can be taken at the same time.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Data on the effects of glucosamine sulfate on fertility and lactation from animal studies are insufficient. There are no adequate data on the use of glucosamine in pregnant or breastfeeding women.
The medicine should not be taken during pregnancy.
Taking the medicine during breastfeeding is not recommended, as there are no data on the safety of its use in newborns.

Driving and using machines

Arthryl does not significantly affect the ability to drive or operate machines. However, caution is advised in case of headache, drowsiness, fatigue, dizziness, or vision disturbances.

Arthryl contains aspartame, sorbitol, and sodium

Arthryl contains aspartame

The medicine contains 2.5 mg of aspartame (E 951) per sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Arthryl contains sorbitol

The medicine contains 2028.5 mg of sorbitol (E 420) per sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine.

Arthryl contains sodium

The medicine contains 6.6 mmol (151 mg) of sodium (the main component of common salt) per sachet.
This corresponds to 7.6% of the maximum recommended daily intake of sodium in the diet for adults. Patients controlling their sodium intake should take this into account.

3. HOW TO TAKE ARTHRYL

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The contents of one sachet dissolved in a glass of water should be taken once a day, preferably with a meal.

Taking a higher dose of Arthryl than recommended

No cases of overdose have been reported so far. The results of animal studies indicate that the occurrence of toxic effects is unlikely even after taking very high doses of the medicine.

Missing a dose of Arthryl

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the normal time.

Stopping Arthryl treatment

Treatment should not be stopped without consulting a doctor. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Arthryl can cause side effects, although not everybody gets them.
Clinical trials have shown that the medicine is well-tolerated. Side effects were observed in a small number of patients. They were usually transient and mild.
The observed side effects are divided according to the following frequency:

Common side effects (occurring in less than 1 in 10 but more than 1 in 100 treated patients):

Gastrointestinal disorders:abdominal pain, nausea, bloating, constipation, diarrhea, or indigestion.
Nervous system disorders:headache, drowsiness.
Vascular disorders:flushing, especially of the face.
General disorders and administration site conditions:fatigue.

Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1000 treated patients):

Skin and subcutaneous tissue disorders:rash, itching, urticaria.

Side effects with unknown frequency (cannot be estimated from the available data):

Immune system disorders:allergic reactions (hypersensitivity).
Metabolism and nutrition disorders:inadequate control of blood glucose levels in patients with diabetes.
Psychiatric disorders:insomnia.
Nervous system disorders:dizziness.
Eye disorders:vision disturbances.
Cardiac disorders:arrhythmias, e.g., tachycardia (accelerated heart rate).
Respiratory, thoracic, and mediastinal disorders:asthma or worsening of asthma.
Gastrointestinal disorders:vomiting.
Hepatobiliary disorders:jaundice.
Skin and subcutaneous tissue disorders:angioedema, urticaria.
General disorders and administration site conditions:edema or peripheral edema.
Investigations:increased liver enzyme activity, increased blood glucose levels, fluctuations in the INR (International Normalized Ratio) value.
Cases of hypercholesterolemia have been reported, but their relationship to the use of the medicine has not been demonstrated.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
e-mail: ndl@urpl.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. HOW TO STORE ARTHRYL

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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. PACKAGE CONTENTS AND OTHER INFORMATION

What Arthryl contains

The active substance of the medicine is glucosamine sulfate.
One sachet contains 1500 mg of glucosamine sulfate (Glucosamini sulfas) in the form of 1884 mg of glucosamine sulfate with sodium chloride (containing 384 mg of sodium chloride) - see also the subsection "Arthryl contains sodium" in section 2.
The other ingredients of the medicine are: aspartame (see also the subsection "Arthryl contains aspartame" in section 2), sorbitol (see also the subsection "Arthryl contains sorbitol" in section 2), macrogol 4000, citric acid.

What Arthryl looks like and what the package contains

White, crystalline, odorless powder for oral solution in a sachet containing one dose of the medicine.
A cardboard box contains 20, 30, or 90 sachets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Mylan, Lda.
Avenida D. João II, Edifício Atlantis, N.° 44C - 7.3 e 7.4
1990-095 Lisbon
Portugal

Manufacturer:

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese export license number:
5932884
5932983
5219613

Parallel import license number: 46/20

Date of leaflet approval: 04.02.2025

[Information about the trademark]