Arthril

Package Leaflet: Information for the Patient

Arthryl, 1500 mg, Powder for Oral Solution

Glucosamine sulfate

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

• This leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 not listed in this leaflet, the doctor or pharmacist should be informed. 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. Contents of the pack 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 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 derived 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 impairment.
• Cautious use is recommended in patients with diabetes; close monitoring of blood glucose levels may be necessary at the start of treatment.

Children and adolescents

The medicine should not be taken by children and adolescents under 18 years of age.

Arthryl and other medicines

The doctor should be informed about all medicines taken by the patient, including those obtained without a prescription, and about any planned treatment.
During clinical trials, no interactions were observed between glucosamine sulfate and other medicines.
Cautious use is recommended when taking Arthryl in combination with other medicines, particularly certain types of anticoagulant medicines (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 should be closely monitored when starting or stopping glucosamine treatment.
Non-steroidal anti-inflammatory and pain-relieving medicines can be taken simultaneously with glucosamine sulfate treatment.

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 its safety in newborns.

Driving and using machines

Arthryl does not significantly affect the ability to drive or operate machinery. However, caution is recommended 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 in each 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 impaired excretion.

The medicine contains sorbitol

The medicine contains 2028.5 mg of sorbitol in each 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, they should consult their doctor before taking the medicine.

The medicine contains sodium

The medicine contains 6.6 mmol (151 mg) of sodium (the main component of common salt) in each 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 doctor or pharmacist should be consulted.
The contents of one sachet dissolved in a glass of water should be taken once a day, preferably with a meal.

Overdose of Arthryl

No cases of overdose have been reported so far. Animal studies suggest that the occurrence of toxic effects is unlikely even with very high doses of the medicine.

Missed 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 usual time.

Stopping treatment with Arthryl

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

4. Possible side effects

Like all medicines, this medicine 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.
Observed side effects were classified according to the following frequency:

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

Gastrointestinal disorders:abdominal pain, nausea, bloating, constipation, diarrhea, or dyspepsia.
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 patients):

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

Side effects of 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 diabetic patients.
Psychiatric disorders:insomnia.
Nervous system disorders:dizziness.
Eyes 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 INR (International Normalized Ratio, a measure of blood clotting).
Cases of hypercholesterolemia have been reported, but their relationship to the use of the medicine has not been established.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help gather more information 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 after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Arthryl contains

The active substance of the medicine 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, which corresponds to 1500 mg of glucosamine sulfate (Glucosamini sulfas) and 384 mg of sodium chloride - see also subsection "Arthryl contains sodium" in section 2.
The other ingredients of the medicine are: aspartame (see also subsection "Arthryl contains aspartame" in section 2), sorbitol (see also subsection "Arthryl contains sorbitol" in section 2), macrogol 4000, anhydrous citric acid.

What Arthryl looks like and contents of the pack

White, crystalline, odorless powder for oral solution in a sachet containing one dose of the medicine.
The carton contains 20, 30, or 90 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer:

Rottapharm Ltd.
Damastown, Industrial Park
Mulhuddart
Dublin 15
Ireland
For more detailed information, please contact:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00

Date of last revision of the leaflet: