Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Arthryl (Viartril-S)
1500 mg, powder for oral solution
Glucosamini sulfas
Arthryl and Viartril-S are different trade names of the same medicine.
Please read this leaflet carefully before using 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 to glucosamine sulphate 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 shellfish,
in patients with phenylketonuria, because the medicine contains aspartame.

Warnings and precautions

Exercise caution when administering this medicine to patients with asthma, as symptoms of the disease may worsen.
Special caution is required when using this medicine in patients with severe liver or kidney impairment.
Caution is advised in patients with diabetes; close monitoring of blood glucose levels may be necessary at the beginning of treatment.

Children and adolescents
Arthryl must not be used in children and adolescents under 18 years of age.
Arthryl with other medicines
Inform your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or might take in the future, including those available without a prescription.
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 certain types of anticoagulants (e.g. warfarin, dicumarol, phenprocoumon, acenocoumarol and fluindione). The effect of these medicines may be enhanced when used simultaneously with glucosamine. Patients receiving such combinations should be monitored very carefully when starting and stopping glucosamine treatment.
Non-steroidal anti-inflammatory and analgesic medicines may be used concomitantly during treatment with glucosamine sulphate.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your 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 women or in breastfeeding women.
The use of this medicine is not recommended 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 if headache, drowsiness, fatigue, dizziness or visual disturbances occur.

Arthryl contains aspartame, sorbitol and sodium

Arthryl contains aspartame
The medicine contains 2.5 mg of aspartame 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 impaired excretion.

The medicine contains sorbitol
The medicine contains 2028.5 mg of sorbitol per sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or with hereditary fructose intolerance—a rare genetic disorder in which the body cannot metabolize fructose—the patient should consult a doctor before taking this medicine.

The medicine contains sodium
The medicine contains 150.98 mg of sodium (the main component of table salt) per sachet. This corresponds to 7.5% of the maximum recommended daily dietary intake of sodium for adults. 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 a doctor or pharmacist.
The contents of 1 sachet should be dissolved in a glass of water and taken once daily, preferably with food.
Use of a higher than recommended dose of Arthryl
Cases of overdose have not been reported so far. Results of animal studies indicate that toxic effects are unlikely, even after administration of very high doses of the medicine.
Missed dose
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Arthryl treatment
Do not discontinue treatment without consulting your doctor. If you have any further questions regarding 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.
Clinical studies have shown that the medicine is well tolerated. Adverse reactions were observed in
a small number of patients. They were usually transient and mild in intensity.
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
patients treated):
Gastrointestinal disorders: abdominal pain, nausea, bloating, constipation, diarrhoea or dyspepsia.
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 patients treated):
Skin and subcutaneous tissue disorders: rash, pruritus, 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 patients with
diabetes.
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: oedema or peripheral oedema.
Investigations: increased liver enzyme activity, increased blood glucose concentration, fluctuations
in INR (international normalized ratio used to assess blood coagulation).

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can 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 .
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Arthryl

Keep this medicine out of sight and reach of children.
Store below 25 o C.
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.
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 packaging and other information

What Arthryl contains
The active substance is glucosamine sulfate (Glucosamini sulfas) in the form of glucosamine sulfate with sodium chloride.
One sachet contains 1884 mg of glucosamine sulfate with sodium chloride, corresponding to 1500 mg of glucosamine sulfate (Glucosamini sulfas) and 384 mg of sodium chloride – see also section “The medicine contains sodium” in section 2.
Other ingredients are: aspartame (see also section “Arthryl contains aspartame” in section 2), sorbitol (see also section “The medicine contains sorbitol” in section 2), macrogol 4000, citric acid.

What Arthryl looks like and contents of the pack
White, crystalline, odourless powder for oral solution in a single-dose sachet.
The cardboard package 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:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands

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

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego Street 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa Forteczna Street 35-37 Tymiankowa Street 24/28
Działkowa Street 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 2799286
Parallel Import Licence Number: 397/25