ARTHRYL 400 mg/10 mg Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Arthryl Fast, (400 mg + 10 mg)/2ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Arthryl Fast and what is it used for
4. Important information before using Arthryl Fast
   1. When not to use Arthryl Fast
   2. Warnings and precautions
   3. Children and adolescents
   4. Arthryl Fast and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Arthryl Fast contains sodium
5. How to use Arthryl Fast
   1. Use in children and adolescents
   2. Use in the elderly
   3. Use in patients with renal and/or hepatic impairment
   4. Use of a higher dose of Arthryl Fast than recommended
   5. Missing a dose of Arthryl Fast
   6. Stopping the use of Arthryl Fast
6. Possible side effects
   1. Common (may affect up to 1 in 10 people):
   2. Uncommon (may affect up to 1 in 100 people):
   3. Frequency not known (cannot be estimated from the available data):
   4. Other side effects
   5. Reporting side effects
7. HOW TO STORE ARTHRYL FAST
8. Contents of the packaging and other information
   1. What Arthryl Fast contains
   2. What Arthryl Fast looks like and contents of the pack
   3. Manufacturer:
   4. Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------

Leaflet attached to the packaging: patient information

Arthryl Fast, (400 mg + 10 mg)/2ml, solution for injection

Glucosamine sulfate + Lidocaine hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Arthryl Fast and what is it used for
• 2. Important information before using Arthryl Fast
• 3. How to use Arthryl Fast
• 4. Possible side effects
• 5. How to store Arthryl Fast
• 6. Contents of the packaging and other information

1. What is Arthryl Fast and what is it used for

Arthryl Fast belongs to a group of medicines called other non-steroidal anti-inflammatory and anti-rheumatic medicines.
Arthryl Fast is used to treat symptoms of mild or moderate knee osteoarthritis in patients for whom oral administration of glucosamine is contraindicated.

2. Important information before using Arthryl Fast

When not to use Arthryl Fast

• if the patient is allergic to glucosamine or lidocaine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to shellfish-derived substances, as glucosamine is produced from them.

The solution for injection, due to the presence of lidocaine, is contraindicated in patients with arrhythmia, acute heart failure, and in patients with hypersensitivity to lidocaine.

Warnings and precautions

• if the patient has impaired glucose tolerance, the doctor may order laboratory tests at the beginning of treatment to determine blood glucose levels;
• if the patient has asthma, before starting treatment with glucosamine, the patient should be informed about the potential possibility of exacerbation of symptoms;
• if the patient has acute liver and kidney failure;
• if the patient is on a sodium-controlled diet.

Due to the presence of lidocaine, Arthryl Fast should be used with caution in people:

• with autoimmune diseases of the nervous system leading to severe muscle weakness and myasthenia or neurological disorders characterized by epileptic seizures;
• with heart failure (congestive heart failure) or slow heart rate (bradycardia) or respiratory failure;
• who have experienced blood volume loss due to bleeding or dehydration (hypovolemia) or in case of impaired venous return, e.g. in cases of significant fluid accumulation in the abdominal cavity (ascites) or the occurrence of a large abdominal tumor, as these patients may experience low blood pressure (hypotension);
• taking anti-arrhythmic drugs of class III (e.g. amiodarone), as the effect of lidocaine on the heart muscle may be enhanced during the administration of anti-arrhythmic drugs of class III. Then the patient will be closely monitored by the doctor.

Locally administered lidocaine may increase the activity of the creatine phosphokinase enzyme, which may make it difficult to diagnose a heart attack (acute myocardial infarction).
It is recommended to avoid using lidocaine in patients with disorders of certain enzymes involved in the production of pigments known as porphyrins, as it has been shown that lidocaine may cause porphyria in animals.
Injecting lidocaine into an area affected by inflammation or infection may cause a weakening of the effect of lidocaine.
It is recommended to avoid combining the medicine with other medicines administered in the form of a solution for injection.

Children and adolescents

Arthryl Fast should not be used in children and adolescents under 18 years of age. The safety and efficacy of glucosamine in this age group have not been established.

Arthryl Fast and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take.
Caution should be exercised when using Arthryl Fast in combination with other medicines, in particular with certain types of medicines used to prevent blood clotting (e.g. warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be stronger during concurrent use of glucosamine. Patients treated with such combinations of medicines should be closely monitored during the start and end of glucosamine treatment.
Also, tell your doctor about the concurrent use of tetracyclines (a group of antibiotics used to treat infections).
Due to the presence of lidocaine in Arthryl Fast, tell your doctor about the use of:

• medicines used to treat seizure attacks (hydantoin derivatives, such as phenytoin),
• medicines used to treat heart rhythm disorders (class III anti-arrhythmic drugs),
• cimetidine, mainly used to treat stomach ulcers,
• beta-adrenergic blocking agents, used to treat heart rhythm disorders, cardioprotection after a heart attack (myocardial infarction), and hypertension,
• muscle relaxants.

During treatment with glucosamine sulfate, non-steroidal anti-inflammatory and anti-pain medicines can be used concurrently.
During treatment, physiotherapy, physical therapy, and physical exercises can be performed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Arthryl Fast should not be used during pregnancy.
Using Arthryl Fast during breastfeeding is not recommended.

Driving and using machines

Caution is recommended in case of headache, drowsiness, fatigue, dizziness, or vision disturbances. Injecting lidocaine causes numbness of the body area related to driving and operating machines. Avoid driving and operating machines until the proper functioning of this body area is restored.

Arthryl Fast contains sodium

Arthryl Fast contains 40.3 mg of sodium (the main component of table salt) in each ampoule.
This corresponds to, depending on the number of ampoules administered: 2% (1 ampoule) or 4% (2 ampoules)
of the maximum recommended daily intake of sodium in the diet for adults. Patients on a sodium-controlled diet should take this into account.

3. How to use Arthryl Fast

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The contents of ampoule A (brown) should be combined in one syringe with the contents of ampoule B (colorless). The solution should be used immediately.
The yellowish color of the resulting solution does not affect the efficacy and safety of the medicine.
The recommended dosage is 1 or 2 ampoules intramuscularly, 3 times a week, for 4 to 6 weeks.
Arthryl Fast should not be used in the form of injections if oral administration of the medicine is possible.
Glucosamine is not indicated for the treatment of acute pain. Relief of symptoms (especially pain)
may occur after several weeks of treatment, and in some cases even after a longer period.

Use in children and adolescents

Arthryl Fast is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of glucosamine have not been established.

Use in the elderly

There are no special dosage recommendations.

Use in patients with renal and/or hepatic impairment

Due to the insufficient amount of data, there are no special dosage recommendations.

Use of a higher dose of Arthryl Fast than recommended

In case of using a higher dose of Arthryl Fast than recommended, consult a doctor or pharmacist or go to the hospital emergency department.

Missing a dose of Arthryl Fast

Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping the use of Arthryl Fast

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reported side effects were usually transient and mild. Systemic treatment with glucosamine is associated with the following side effects.
Specific to intramuscular administration are nausea and very rarely vomiting, which may occur due to the presence of lidocaine in the medicine. Additionally, administration in the form of a solution for injection may sometimes cause reactions at the injection site (e.g. abscess and inflammation of the subcutaneous tissue).
Observed side effects are divided according to the following frequency:

Common (may affect up to 1 in 10 people):

• headache, drowsiness
• diarrhea, constipation, nausea, bloating, abdominal pain, indigestion
• fatigue.

Uncommon (may affect up to 1 in 100 people):

• hot flashes (sudden feeling of heat, especially felt in the neck and head)
• flushing, itching, rash.

Frequency not known (cannot be estimated from the available data):

• allergic reactions (hypersensitivity), inadequate control of diabetes, insomnia, dizziness, vision disturbances, asthma or exacerbation of asthma, vomiting, jaundice, hair loss, angioedema, urticaria, reaction at the injection site (abscess and inflammation of the subcutaneous tissue), edema (excessive fluid accumulation in tissues) / peripheral edema (most commonly affecting the limbs - legs), increased activity of liver enzymes, increased blood glucose levels, fluctuations in international normalized ratio (INR) values used to determine the effect of anticoagulant medicines.

Other side effects

Nausea and very rarely vomiting may occur due to the presence of lidocaine.
Additionally, cases of hypercholesterolemia (elevated cholesterol levels in the blood) have been reported, but no link has been established between the use of the medicine and this disorder.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ARTHRYL FAST

Keep the medicine out of the 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 stated.
Medicines should 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 Fast contains

The active substances of the medicine are: glucosamine sulfate, lidocaine hydrochloride.
Each ampoule A (brown) contains: glucosamine sulfate 400 mg in the form of glucosamine sulfate sodium chloride 502.5 mg (see also subsection "Arthryl Fast contains sodium" in section 2), lidocaine hydrochloride 10 mg.
The other ingredients of the medicine are:
Ampoule A (brown): water for injections, sulfuric acid (for pH adjustment).
Ampoule B (colorless): diethanolamine, water for injections.

What Arthryl Fast looks like and contents of the pack

6 ampoules A made of orange type I glass, containing the solution for injection, and 6 ampoules B made of colorless type I glass, containing the diluent, placed in a PVC blister pack in a cardboard box.
Marketing authorization holder:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer:

Biologici Italia Laboratories S.r.l.
Via Filippo Serpero 2
20060 Masate (MI)
Italy
For more detailed information, please contact:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
Arthryl Fast, (400 mg + 10 mg)/2 ml, solution for injection
The contents of ampoule A (brown) should be combined in one syringe with the contents of ampoule B (colorless). From a microbiological point of view, the prepared solution should be used immediately.
The yellowish color of the resulting solution does not affect the efficacy and tolerability of the medicine.