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  Artron A

20 sachets
The contents of a sachet dissolved in a glass of water are taken once a day, preferably during a meal.
GENERAL INFORMATION

Package Leaflet: Patient Information

ARTRON A 1500 mg powder for oral solution in sachet
ARTRON A 1500 mg powder for oral solution in sachet

Глюкозаминов сулфат
Glucosamine sulfate

Read all of this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may have to read it again.
  • If you need more information or advice, ask your pharmacist.
  • Ако получите някакви нежелани реакции, уведомете Вашия лекар или фармацевт. Това включва и всички възможни нежелани реакции, неописани в тази листовка. Вижте точка 4.
  • If after 2-3 months you do not feel better or your condition gets worse, you should seek medical attention.

What this leaflet contains

  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. Packaging content and additional information

 

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

ARTRON A contains glucosamine sulphate, which belongs to non-steroidal anti-inflammatory and anti-rheumatic drugs.

АРТРОН А се използва за лечение на симптомите на остеоартрит, напр. болка и ограничение
of the joints functions.

If after 2-3 months you do not feel better or your condition gets worse, you should seek medical attention.

 

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

Do not take ARTRON A if you are allergic to:

  • глюкозамин или към някоя от останалите съставки на това лекарство (изброени в точка 6);
  • черупки от мекотели, тъй като активното вещество (глюкозамин) представлява екстракт от черупки от мекотели.

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

  • страдате от астма. Приемането на глюкозамин може да влоши симптомите на астма;
  • страдате от нарушен глюкозен толеранс (състояние, предшестващо захарен диабет). Препоръчително е да следите нивата на кръвната си захар преди започване на лечението и на редовни интервали по време на лечението с глюкозамин;
  • имате намалена чернодробна и/или бъбречна функция.

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

It is especially important to tell your doctor or pharmacist if you are taking:

  • антикoaгyланти (лекарства за разреждане на кръвта), като варфарин и аценокумарол. Действието на антикоагулантите може да се засили, когато те се прилагат едновременно с глюкозамин;
  • тетрациклинови антибиотици.

Steroidal, non-steroidal painkillers or anti-inflammatory medicinal products may be taken together with ARTRON A.

ARTRON A with food, beverages and alcohol

  • ARTRON A is recommended to be taken during meals.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

ARTRON A should not be taken during pregnancy and lactation.

Driving and using machines
No significant effects are found to reduce the ability to drive and use machines. If you experience headaches, drowsiness, tiredness, dizziness or visual disturbances, you should not drive or operate machinery.

ARTRON A contains:

  • сорбитол (E 420). Сорбитолът може да причини стомашно-чревно неразположение и слабо изразено слабително действие;
  • натрий. Това лекарство съдържа 161 mg натрий (основна съставка на готварската/трапезната сол) във всяко саше. Това количество е еквивалентно на 8 % от препоръчителния максимален дневен хранителен прием на натрий за възрастен.
  1. How to take ARTRON A

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

Adults
The contents of a sachet dissolved in a glass of water are taken once a day, preferably during a meal.

Glucosamine is not indicated for the treatment of acute pain. Relief of symptoms (especially pain relief) is not expected sooner than a few weeks of application and in some cases even more. If there is no relief of symptoms after 2-3 months, continued treatment with glucosamine should be rethought.

Elderly patients
No dose adjustment is required.

Patients with impaired renal and / or hepatic function
No dosage recommendation can be given in patients with impaired renal and / or hepatic function as no clinical studies have been performed.

Use in children and adolescents
ARTRON A should not be taken by children and adolescents under 18 years of age.

If you take more ARTRON A than you should
If you take more ARTRON A than you prescribed, you should contact your doctor or pharmacist immediately.

If you forget to take ARTRON A.
Do not take a double dose to make up for the missed dose. Accept the next dose as planned.

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

  1. Possible side effects

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

Нежеланите реакции се класифицират по системо-органни класове и по честота по следния начин: много чести (≥1/10), чести (≥ 1/100 до < 1/10), нечести (≥ 1/1 000 до < 1/100), редки (≥1/10 000 до <1/1000), много редки (≤ 1/10 000), с неизвестна честота (от наличните данни не може да бъде направена оценка).

Чести: главоболие, сомнолентнocт, умора, диария, запек, гадене, коремна болка, нарушено храносмилане.

Uncommon: еритема (зачервяване на кожата), сърбеж, кожен обрив.

 Not known: алергични реакции, замайване, зрителни нарушения, косопад.

Reporting of side effects

Ако получите някакви нежелани лекарствени реакции, уведомете Вашия лекар или фармацевт. Това включва всички възможни неописани в тази листовка нежелани реакции. Можете също да съобщите нежелани реакции директно чрез Изпълнителната агенция по лекарствата, ул. Дамян Груев № 8, 1303 София: тел. +359 2 8903417, уебсайт: www.bda.bg. Като съобщавате нежелани реакции, можете да дадете своя принос за получаване на повече информация относно безопасността на това лекарство.

  1. How to store ARTRON A

Keep out of the reach and sight of children.

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

Do not use this medicine if you notice visible signs of product quality impairment.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

  1. Packaging content and additional information

What ARTRON A contains

  • Активното вещество е: глюкозаминов сулфат 1500 mg. Едно саше съдържа глюкозаминов сулфат – натриев хлорид 1884 mg, еквивалентно на глюкозаминов сулфат 1500 mg и натриев хлорид 384 mg.
  • Excipients are: сорбитол (Е 420), лимонена киселина, натриев цикламат, аромат малина (ароматизиращи вещества, царевичен малтодекстрин, арабска гума).

What ARTRON A looks like and contents of the pack
ARTRON A is a white to off-white powder with raspberry flavor in a sachet containing 1 dose.

Each pack contains 20 sachets and a leaflet for the patient. 1 dose.

Marketing Authorization Holder and Manufacturer

Fortex Nutraseuticals Ltd.,
10 Prohladen kut street,
1362 Sofia, Bulgaria

Date of the last review of the package leaflet
Август 2018

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 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 days.

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

 Do not take ARTRON A:

–        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;
–        if you have  intolerance to certain carbohydrates;

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;
  • if you are on controlled sodium diet(reduced sodium intake);
  • if 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;
  • if 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.

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.

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.

Important information about some of the ingredients of ARTRON A
ARTRON A contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Each sachet contains 158mg sodium. To be taken into consideration by patients on a controlled sodium diet.

  1. 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
Your symptoms may re-occur.

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

  1. Possible side effects

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

The following side- effects have been reported:

Common side effects (occurring in less than 1 in every 10 patients)
Nervous system disorders: headache, somnolence,tiredness;
Problems of a digestive system: diarrhea, constipation, nausea, flatulence, abdominal pain, indigestion.

Uncommon side effects( occurring in less than 1 in every 100 patients)
Problems with skin and hypodermic tissue:redness of a skin(erythema), pruritus( itching),
skin inflammation( cutaneous rashes).

Other side effects( with unknown frequency)
Allergic reactions, dizziness, visual disturbances, hair loss.

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 Bulgarian Drug Agency, Address: 8, Damyan Gruev Str. 1303 Sofia; Country Bulgaria; Phone: +359 2 8903 555; Fax: +359 2 8903 434; Email: bda@bda. By reporting side effects you can help provide more information on the safety of this medicine.

  1. 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.

  1. 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 of glucosamine sulfate 1500 mg and sodium chloride 384 mg.
  • Excipients are: sorbitol, citric acid, sodium cyclamate, raspberry flavour.

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.
Sachets made of composite foil (C/PAP/ALU) containing the following layers (paper, aluminium, polyethylene).
Each pack contains 20 sachets and package leaflet.

Marketing Authorisation Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10, Prohladen kat str., Suhodol Distr.,
1362 Sofia, Bulgaria

This leaflet was last revised in
August 2016

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