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ARTRON A

    • ARTRON A contains glucosamine sulfate, which belongs to a group of medicines called nonsteroidal anti-inflammatory agents
    • ARTRON A is used for the treatment of pain symptoms of osteoarthritis and improvement of joint mobility.
  • CONTENT

    What ARTRON A looks like and contents of the pack ARTRON A is white to almost white powder with raspberry odour contained in single-dose sachet. Each pack contains 20 sachets and package leaflet

    Method of use

    The recommended dose is: Adults including the elderly: The dose is the content of one sachet (1500mg glucosamine sulfate) daily, preferably at meals. Dissolve the powder from the sachet in a glass of water and drink. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment or sometimes even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment of glucosamine should be re-evaluated by your doctor. ARTRON A should not be used in children and adolescents below the age of 18 years. Patients with impaired renal and/or liver function No dose recommendation can be given since no studies have been performed.

  • Package leaflet: Information for the patient

    ARTRON A 1500 mg powder for oral solution in sachet

    Glucosamine sulfate

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

    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse 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 30-60 days.

    What is in this leaflet

     1. What ARTRON A is and what it is used for  

    2. What you need to know before you take ARTRON A  

    3. How to take ARTRON A  

    4. Possible side effects  

    5. How to store ARTRON A

    6. Contents of the pack and other information

     1. What ARTRON A is and what it is used for

     ARTRON A contains glucosamine sulfate, which belongs to a group of medicines called nonsteroidal anti-inflammatory agents.

    ARTRON A is used for the treatment of pain symptoms of osteoarthritis and improvement of joint mobility.

    You must talk to a doctor if you do not feel better or if you feel worse after 30-60 days.

    2. What you need to know before you take ARTRON A  

     Do not take ARTRON A if you are allergic to:

    - if you are allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6);

    -    if you are allergic to shellfish because glucosamine is derived of shellfish.

     Warnings and precautions  

    Talk to your doctor or pharmacist before taking ARTRON A if:

    - you suffer from asthma: when you starting glucosamine, you should be aware of potential worsening of symptoms;

    - you are on controlled sodium diet (reduced sodium intake);

    - you have impaired glucose tolerance (a pre-diabetic state): in this case closer monitoring of blood sugar levels may be necessary at the beginning and at the end of the treatment;

    - you have serious liver and/or kidney problems.

     Children and adolescents

    ARTRON A should not be used in children and adolescents below the age of 18 years.

     Other medicines and ARTRON A

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.  

    Tell your doctor before you take ARTRON A if you are taking some of these medicines:    

    - drugs used to prevent blood clotting (anticuagulants such as warfarin and acenocoumarol);

    - tetracyclines antibiotics.

    Steroidal and nonsteroidal anti-inflammatory drugs or painkillers can be taken together with ARTRON A.      

    ARTRON A with food, drink and alcohol

    ARTRON A should be taken preferably at meals.

     Pregnancy and, breast-feeding and fertility

    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.

    ARTRON A should not be taken during pregnancy and breast-feeding.  

    Driving and using machines    

    No studies of the effects on the ability to drive and use machines have been performed. However, if headache, somnolence, tiredness, dizziness or visual disturbances are experienced, driving a car or operating machinery is not recommended.    

    ARTRON A contains:

    • sorbitol (E420). Sorbitol can cause gastrointestinal malaise and poorly laxative effect.  

    • sodium. This medicine contains 161 mg sodium (the main ingredient in the cooking / table salt) in each sachet. This quantity is equivalent to 8% of the recommended maximum daily dietary intake of sodium per adult.

     3. How to take ARTRON A

     Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.  

     The recommended dose is:

    Adults including the elderly: The dose is the content of one sachet (1500mg glucosamine sulfate) daily, preferably at meals. Dissolve the powder from the sachet in a glass of water and drink.

    Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment or sometimes even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment of glucosamine should be re-evaluated by your doctor.

     Use in children and adolescents

    ARTRON A should not be used in children and adolescents below the age of 18 years.

    Patients with impaired renal and/or liver function

    No dose recommendation can be given since no studies have been performed.

    If you take more ARTRON A than you should

    If you take more ARTRON A than you should, you must consult your doctor or pfarmacist immediately.

    If you forget to take ARTRON A

    Do not take double dose to make up for a forgotten one.

    If you stop taking ARTRON A

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

     4. Possible side effects

     Like all medicines, this medicine can cause side effects, although not everybody gets them.

    The adverse events are presented according to MedDRA system organ classification within each frequency area and after decreasing degree of severity: Very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

     Common: headache, somnolence, fatigue, diarrhea, constipation, nausea, abdominal pain, indigestion

    Uncommon: erythema (redness of the skin), itching, skin rash.

    Not known: allergic reactions, dizziness, visual disturbances, hair loss.

    Reporting of side effects

    If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects, not listed in this leaflet. You can also report adverse events directly through the national system for reporting directly to

    Bulgarian Drug Agency,  

    Damyan Gruev Str., No 8, 1303 Sofia, Bulgaria

    tel. +359 2 8903417,  

    website www.bda.bg.  

    Reporting adverse reactions, you can do your bit to obtain more information on the safety of this medicine.

     

    5. How to store ARTRON A

     Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton or on the sachet. The expiry date refers to the last day of that month.

    Do not use this medicine if you notice any visible signs of deterioration.

    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 ARTRON A contains  

    - The active substance is: Glucosamine sulfate (1500 mg). Each sachet contains glucosamine sulfate sodium chloride 1884 mg, which is equivalent to glucosamine sulfate 1500 mg and sodium chloride 384 mg.

    - Excipients are: sorbitol (E 420), citric acid, sodium cyclamate, raspberry flavour (flavoring agents, corn maltodextrin, gum arabic).

     What ARTRON A looks like and contents of the pack

    ARTRON A is white to almost white powder with raspberry odour contained in single-dose sachet.

    Each pack contains 20 sachets and package leaflet.  

     Marketing Authorisation Holder and Manufacturer

    Fortex Nutraceuticals Ltd.,

    10, Prohladen kat street,  

    1362 Sofia, Bulgaria

     

    This leaflet was last revised in  

    August 2018

     

  • ARTRON A 1500 mg powder for oral solution in sachet Glucosamine sulfate