ARTRON A

• Short description
• How to use

• • 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.

• General information
• Ingredients

• 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 is a medicinal product that contains glucosamine sulfate and belongs to a group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroidal.

  ARTRON A is used to treat the symptoms of osteoarthritis, e.g. pain, stiffness and limitation of joint functions. It protects the surface of the joints from destruction and improves their elasticity and mobility. Glucosamine sulfate also has a pain-relieving effect.

   

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

   Do not take ARTRON A if you are allergic to:

  - active substance (glucosamine) or any of the other ingredients of this medicine (listed in section 6);

  -    crustaceans, as the active substance (glucosamine) is obtained from crustaceans..

   

  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 is a source of fructose. If you have been told by your doctor that you or your child have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which people cannot break down fructose, talk to your doctor before you take or You will be given this medicine.

  • 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. This should be taken into account in patients who are on a low salt (sodium) diet.

   

  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 pharmacist 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 October 2022.

   

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

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