Arthryl

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Arthryl (Glucosamina Mylan), 1500 mg, powder for oral solution
Glucosamini sulfas
Arthryl and Glucosamina Mylan 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, so you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Arthryl is and what it is 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 Arthryl is and what it is used for
Arthryl is used in the treatment of symptoms of mild to moderate knee osteoarthritis.

2. Important information before taking Arthryl

When not to take Arthryl:

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

Warnings and precautions

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

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age.
Arthryl with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
No interactions between glucosamine sulfate and other medicines have been observed in clinical studies.
Exercise caution when Arthryl must be used concomitantly with other medicines, particularly certain types of anticoagulants (e.g. warfarin, dicoumarol, phenprocoumon, acenocoumarol and fluindione). The effect of these medicines may be enhanced when taken together with glucosamine. Patients receiving such combinations should be monitored particularly carefully when starting and stopping glucosamine treatment.
Non-steroidal anti-inflammatory and analgesic drugs may be used concomitantly during treatment with glucosamine sulfate.
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 sulfate on fertility and lactation are insufficient. There are no adequate data on the use of glucosamine in pregnant or breastfeeding women.
Do not use this medicine during pregnancy.
Use during breastfeeding is not recommended, as there are no safety data available for newborns.
Driving and operating machinery
Arthryl has no significant influence on the ability to drive or operate machinery. However, caution is advised if you experience headache, drowsiness, fatigue, dizziness or visual disturbances.
Arthryl contains aspartame, sorbitol and sodium
Arthryl contains aspartame
Each sachet contains 2.5 mg of aspartame. 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 improper excretion.
Arthryl contains sorbitol
Each sachet contains 2028.5 mg of sorbitol. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking this medicine.
Arthryl contains sodium
Each sachet contains 6.6 mmol (151 mg) of sodium (the main component of table salt). This corresponds to 7.6% of the maximum recommended daily dietary sodium intake for adults. Patients who are monitoring their sodium intake should take this into account.
3. How to take Arthryl
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Dissolve the contents of one sachet in a glass of water and take once daily, preferably with food.
Taking more Arthryl than prescribed
Cases of overdose have not been reported. Animal studies indicate that toxic effects are unlikely, even after administration of very high doses.
If you miss a 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 stop treatment without consulting your doctor. If you have any further doubts 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 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):
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):
Skin and subcutaneous tissue disorders: rash, itching, erythema.
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: cardiac 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, a measure of 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 effects occur, including any not listed in this leaflet, inform your doctor or
pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 to provide more information on the safety of this medicine.

5. How to store Arthryl

Keep this 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 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 PACK AND OTHER INFORMATION

What Arthryl contains
The active substance is glucosamine sulfate (Glucosamini sulfas) in the form of glucosamine sulfate with sodium chloride.
Each sachet contains 1884 mg of glucosamine sulfate with sodium chloride, equivalent to 1500 mg of glucosamine sulfate (Glucosamini sulfas) and 384 mg of sodium – see also section "Arthryl contains sodium" in section 2.
The other ingredients are: aspartame (see also section "Arthryl contains aspartame" in section 2), sorbitol (see also section "Arthryl 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 single-dose sachets.
The cardboard box contains 20, 30 or 90 sachets.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Portugal, country of export:
Mylan, Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 and 7.4
1990-095 Lisbon, Portugal

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 5219613
Parallel Import Licence Number: 252/20