ARTHRYL PULV.ŠĶ.1.5G N20

ATC code: M01AX05 

Active substances: Glucosamini Sulfas

Vendor, principal: Rottapharm. 

 Prescription drug (℞) 

ARTHRYL 1200MG N20

Package leaflet: Information for the user

Arthryl 1.2 g powder for oral solution

Glucosamine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 30 days.

What is in this leaflet:

1.   What Arthryl is and what it is used for
2.   What you need to know before you use Arthryl
3.   How to use 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 indicated for the symptomatic treatment of mild to moderate osteoarthrosis. Osteoarthrosis is a non-inflammatory joint disease (worn joint).
The active substance glucosamine (in the form of glucosamine sulfate) is a salt of the naturally occurring amino monosaccharide glucosamine that is also found in the human organism. Glucosamine plays an important role in the biochemical composition of cartilage.
Usually, the starting compound for the synthesis of glucosamine is glucose, but in the case of osteoarthrosis, the biosynthesis of glucosamine and proteoglycans is disrupted. In this case, glucosamine received from an external source will compensate for the deficiency of the native substance, facilitate the biosynthesis of proteoglycans and nourish the articular cartilage.
In addition to participation in articular cartilage metabolism, glucosamine has the ability to inhibit the activity of enzymes responsible for cartilage degradation, such as collagenase and phospholipase A2. This activity may be related to the general characteristic of inhibiting other substances responsible for tissue degradation, as glucosamine also prevents the generation of superoxide radicals and inhibits the activity of lysosomal enzymes. Unlike other non-steroid anti-inflammatory substances, glucosamine does not cause stomach and duodenal ulcers. Glucosamine has no effect on cardiac circulation or the respiratory system, central nervous system or autonomous nervous system.

2. What you need to know before you use Arthryl Do not use Arthryl:

-   if you are allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6);
-   if you are allergic to crustaceans, since glucosamine is derived from crustaceans;
-   if you have phenylketonuria;
if you are intolerant to certain sugars.

Warnings and precautions

Ask your doctor or pharmacist for advice before using Arthryl:
-   if you have severe renal or hepatic failure, use Arthryl only under a doctor’s supervision;
-   if you have glucose intolerance (diabetes), starting treatment with Arthryl may necessitate more frequent blood sugar testing;
-   if you have a known risk factor for cardiovascular disease, since in some cases, the development of hypercholesterolemia has been reported in patients treated with glucosamine;
-   if you have asthma, you should be aware of the possible exacerbation of the symptoms before starting treatment with Arthryl;
-   if you are on a low-salt diet: one sachet contains 151 mg of sodium.
Tell your doctor about all the diseases you have before you start using Arthryl.

Children and adolescents

Arthryl is not used in children and adolescents under 18 years of age, since the safety and effectiveness of the medicine has not been proven.

Other medicines and Arthryl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Exercise caution when combining Arthryl with other medicines, especially:
-   certain blood thinning medicines (e.g. warfarin, dicoumarine, fenprocoumon, acenocoumarine and fluindione). The effect of these drugs can be enhanced by coadministration with glucosamine. Patients taking concomitantly any of these blood-thinning drugs should be closely monitored during initiation or discontinuation of glucosamine therapy.
-   tetracycline antibiotics (used for the treatment of infections).
Analgesics and non-steroid anti-inflammatory drugs can be used with glucosamine in case of the exacerbation of the symptoms of osteoarthrosis or at the start of the treatment, since the alleviation of the symptoms (especially pain) begins after 1...2 weeks of treatment at the earliest. Glucosamine treatment may reduce the necessity of using analgesics and non-steroid antiinflammatory drugs. In addition to Arthryl, physiotherapy can be used for treating osteoarthrosis.

Pregnancy, breast-feeding and fertility

Arthryl should not be taken during pregnancy and breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Arthryl has no influence on the ability to drive and use machines. Nevertheless, caution is advised in case of the occurrence of headache, sleepiness, fatigue, dizziness, or changes in vision.

Arthryl contains aspartame and sorbitol.

-   Arthryl contains aspartame, a source of phenylalanine; as a result, it should not be used by patients with phenylketonuria.
-   Arthryl contains sorbitol. If you have been told by your doctor that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. How to use Arthryl

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
The powder contained in one sachet should be dissolved in a glass of water and ingested 1 time per day, preferably during a meal.
Clinical trials have demonstrated the safety and efficacy of up to 3 years of treatment with glucosamine.

Use in children and adolescents

Glucosamine is not used in children and adolescents under 18 years of age.

If you use more Arthryl than you should

No cases of accidental or intentional overdose have been reported. Acute and chronic toxicity studies on animals have shown that a toxic effect is unlikely even in case of very large doses. If you have taken more Arthryl than you should, talk to your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects have occurred in a small number of patients and these effects have been mild to moderate and transient.
Common side effects can include headache, dizziness, fatigue, nausea or stomach ache, indigestion, distension, constipation, and diarrhoea.
Uncommon side effects include erythema, itching, and rash.
In rare cases, allergic reactions, dizziness, changes in vision, hair loss, and hypercholesterolemia (increased blood cholesterol) have been reported.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Arthryl

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Arthryl contains

-   The active substance is glucosamine.
The soluble powder in a single-dose package contains 1.2 g of glucosamine, corresponding to 1.5 g of glucosamine sulfate (in the form of 1.884 g of crystalline glucosamine sulfate, of which 384 mg is sodium chloride).
-   Other ingredients are aspartame, macrogol 4000, citric acid, sorbitol.

What Arthryl looks like and contents of the pack

The powder is cream-coloured, odourless and has a salty taste.
Poweder for solution in a single-dose package. One box contains 20 or 30 packages with powder.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Meda Pharma SIA Mūkusalas 101 Rīga LV-1004 Latvia
Manufacturer ROTTAPHARM Ltd.
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland
Or
SIGMAR ITALIA S.p.A.
Via Sombreno 11 24011 Alme (BG)
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Meda Pharma SIA Liivalaia 13/15 11018 Tallinn Phone: +372 6363 052

This leaflet was last revised in May 2018.