Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Arthryl (VIARTRIL-S)
1500 mg, powder for oral solution
Glucosamine sulfate
Arthryl and VIARTRIL-S are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

What Arthryl is and what it is used for
Important information before taking Arthryl
How to take Arthryl
Possible side effects
How to store Arthryl
Contents of the pack and other information

1. WHAT ARTHRYL IS AND WHAT IT IS USED FOR

Arthryl is used in the treatment of symptoms of mild to moderate osteoarthritis
of the knee joints.

2. IMPORTANT INFORMATION BEFORE USING ARTHRYL

When not to use Arthryl

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

Warnings and precautions

Caution is advised when administering Arthryl to patients with asthma, as symptoms may worsen.
Particular caution should be exercised when using the medicine in patients with severe hepatic or renal insufficiency.
Caution is recommended in patients with diabetes; close monitoring of blood glucose levels may be necessary at the beginning of treatment.

Children and adolescents
Arthryl should not be used in children.

Arthryl and other medicines
Inform your doctor about all medicines currently taken or recently used, including those obtained without a prescription, as well as any medicines planned for use.
No interactions between glucosamine sulphate and other medicines have been observed in clinical studies.
Caution is advised when Arthryl must be used concomitantly with other medicines, particularly with certain types of anticoagulants (e.g. warfarin, dicoumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be enhanced during concomitant use with glucosamine. Patients receiving such combinations should be monitored particularly carefully when starting and stopping glucosamine treatment.
Nonsteroidal anti-inflammatory and analgesic medicines may be used simultaneously during treatment with glucosamine sulphate.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Data from animal studies on the effects of glucosamine sulphate on fertility and lactation are insufficient. There are no adequate data on the use of glucosamine in pregnant or breastfeeding women.
Arthryl should not be used during pregnancy.
Use during breastfeeding is not recommended due to lack of safety data in newborns.

Driving and operating machinery
Arthryl has no significant influence on the ability to drive or operate machinery. However, caution is advised in cases of headache, drowsiness, fatigue, dizziness, or visual 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, a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

The medicine 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 certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—the patient should consult a doctor before taking this medicine.

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

3. HOW TO USE ARTHRYL

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor or pharmacist.
The contents of 1 sachet should be dissolved in a glass of water and taken once daily, preferably with
a meal.
Use of a higher than recommended dose of Arthryl
There have been no reported cases of overdose with this medicine. Animal study results indicate
that toxic effects are unlikely even after administration of very high doses.
Missed dose
Do not take a double dose to make up for a missed dose. Take the next dose at the regular time.
Discontinuation of Arthryl treatment
Do not discontinue treatment without consulting your doctor. If you have any further
questions regarding 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 everyone experiences them.
Clinical studies have shown that the medicine is well tolerated. Adverse reactions were observed in a small number of patients. These were mostly transient and mild in intensity.
The observed adverse reactions have been classified according to the following frequency:

Common adverse reactions (occurring in fewer than 1 in 10 but more than 1 in 100 treated patients):
Gastrointestinal disorders: abdominal pain, nausea, bloating, constipation, diarrhoea, or indigestion.
Nervous system disorders: headache, drowsiness.
Vascular disorders: sudden flushing, especially of the face.
General disorders and administration site conditions: fatigue.

Uncommon adverse reactions (occurring in fewer than 1 in 100 but more than 1 in 1000 treated patients):
Skin and subcutaneous tissue disorders: rash, itching, skin eruption.

Adverse reactions with unknown frequency (cannot be estimated from available data):
Immune system disorders: allergic reactions (hypersensitivity).
Metabolism and nutrition disorders: inadequate control of blood glucose levels in diabetic patients.
Psychiatric disorders: insomnia.
Nervous system disorders: dizziness.
Eye disorders: visual disturbances.
Cardiac disorders: heart rhythm disturbances, e.g. tachycardia (increased 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: swelling or peripheral oedema.
Investigations: increased liver enzyme activity, increased blood glucose concentration, fluctuations in INR (International Normalized Ratio for assessing blood coagulation system).

Cases of hypercholesterolemia have been reported; however, a causal relationship with the use of the medicine has not been established.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 ARTHRYL

Keep the medicine out of sight and reach of children.
Store 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 indicated.
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 PACKAGE AND OTHER INFORMATION

What Arthryl contains
The active substance 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.
Other components of the medicine are: aspartame (see also section "Arthryl contains aspartame" in
point 2), sorbitol (see also section "Arthryl contains sorbitol" in point 2), macrogol 4000, citric acid.

What Arthryl looks like and contents of the pack
White, crystalline, odourless powder for oral solution in a sachet containing a single dose of the medicine.
The cardboard pack contains 20 or 30 sachets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda., Av. D. João II, Edifício Atlantis, nº 44C – 7.3 and 7.4, 1990-095
Lisbon, Portugal

Manufacturer:
Rottapharm Ltd.
Damastown, Industrial Park, Mulhuddart, Dublin 15, Ireland

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Portugal, country of export: 2799286
Parallel Import Licence Number: 30/18