Arthryl

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Arthryl (Glucosamina Mylan)
1500 mg, powder for oral solution
Glucosamini sulfas
Arthryl and Glucosamina Mylan are different brand names of the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 USING ARTHRYL

When not to use 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 derived from shellfish,
• in patients with phenylketonuria, because the medicine contains aspartame.

Warnings and precautions

• Exercise caution when administering Arthryl to patients with asthma, as symptoms may worsen.
• Special caution is advised in patients with severe liver or kidney impairment.
• Caution is recommended for diabetic patients; 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 used or recently used, including those available without a prescription, as well as any medicines the patient intends to use.
No interactions between glucosamine sulfate 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, dicoumarol, phenprocoumon, acenocoumarol and fluindione). The effect of these medicines may be enhanced when used simultaneously 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 concurrently during treatment with glucosamine sulfate.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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.
Arthryl should not be used during pregnancy.
Use during breastfeeding is not recommended, as there are no data on safety for newborns.

Driving and operating machinery
Arthryl has no major 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 (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 impaired 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 certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot metabolize fructose—the patient should consult a doctor before taking this medicine.

Arthryl 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 the diet 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 the physician. In case of 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
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.
Discontinuation of Arthryl treatment
Do not discontinue 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 any medicinal product, this medicine may 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 and 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: erythema, pruritus, rash.

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 disorders, 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 coagulation system).

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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department for 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
E-mail: [email protected]

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 PACKAGE AND OTHER INFORMATION

What Arthryl contains
The active substance in Arthryl 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 section
"Arthryl contains sodium" in section 2.
Other ingredients of the medicine are: aspartame (see also the section "Arthryl contains aspartame" in
section 2), sorbitol (see also the 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 a sachet containing one dose of the medicine.
The cardboard package contains 20, 30 or 90 sachets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Mylan, Lda.
Av. D. João II, Edifício Atlantis, N.° 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:
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: 5932884
Parallel Import Licence Number: 46/20