DUARTRON 625 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Duartron 625 mg Hard Capsules

Glucosamine

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

The name of this medicine is Duartron 625 mg Hard Capsules. However, the product will be referred to as Duartron in the package leaflet text.

Contents of the Package Leaflet

1. What is Duartron and what is it used for
2. What you need to know before you take Duartron
3. How to take Duartron
4. Possible side effects
5. Storage of Duartron
6. Contents of the pack and further information

1. What is Duartron and what is it used for

Duartron belongs to a group of medicines called other anti-inflammatory and anti-rheumatic non-steroidal compounds.

Duartron contains the active ingredient glucosamine.

Duartron is indicated for the relief of symptoms produced by mild to moderate knee osteoarthritis.

2. What you need to know before you take Duartron

Do not take Duartron:

• 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, as glucosamine is obtained from shellfish.

Warnings and precautions

Consult your doctor or pharmacist before taking Duartron.

• if you have glucose intolerance. More frequent monitoring of blood glucose levels may be necessary when starting treatment with Duartron.
• if you have any risk factors for heart disease, as an increase in cholesterol has been observed in some patients treated with glucosamine.
• if you have asthma. When starting treatment with glucosamine, you should be aware that symptoms may worsen.
• if you have kidney or liver problems, as no studies have been conducted in this group of patients, and dosage recommendations cannot be given.

Other medicines and Duartron

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Caution is recommended if Duartron is administered in combination with other medicines, especially:

• Certain types of medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be enhanced if used with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.

• Tetracyclines (antibiotics for treating infections).

Taking Duartron with food and drink

Duartron can be taken with food and drink, before, during, or after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Duartron should not be used during pregnancy.

The use of Duartron is not recommended during breastfeeding.

Driving and using machines

No studies have been conducted on how Duartron affects the ability to drive and use machines.

However, if you experience dizziness or drowsiness due to the capsules, you should not drive or operate machinery.

3. How to take Duartron

Follow exactly the administration instructions of the medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The recommended dose is 2 capsules per day in a single intake (1,250 mg of glucosamine).

Swallow the capsules with a sufficient amount of water. Do not chew the capsules.

Glucosamine is not indicated for the treatment of acute pain. Relief of symptoms (especially pain relief) may not be apparent until after several weeks of treatment, and sometimes even longer. If no improvement is observed after 2-3 months, please consult your doctor.

Use in children and adolescents

Duartron is not recommended for use in children or adolescents under 18 years of age.

If you take more Duartron than you should

If you have taken more Duartron capsules than you should, you may experience headache, dizziness, disorientation, joint pain, nausea, vomiting, or diarrhea, although you may not experience any symptoms. In any case, inform your doctor.

If you forget to take Duartron

If you forget to take a dose, simply take the next dose as scheduled. Do not take a double dose to make up for the forgotten doses.

If you stop taking Duartron

Continue taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking this medicine, your disease may recur.

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. These are usually mild and temporary.

Serious side effects

Stop taking glucosamine and seek immediate medical attention if you experience any of the following symptoms, as they may indicate a severe allergic reaction to this medicine:

• Swelling of the face, tongue, throat
• Difficulty swallowing or breathing
• Skin rash or hives

Other side effects

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

Headache, fatigue, nausea, abdominal pain, indigestion, diarrhea, constipation.

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

Rash, itching, redness.

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

Vomiting, hives, dizziness, swelling in feet or ankles, angioedema. Worsening of existing asthma, in diabetic patients worsening of blood glucose control.

High cholesterol levels have also been reported. It has not been possible to determine whether these effects are directly related to glucosamine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Duartron

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

Store below 30°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Duartron

• The active ingredient is glucosamine. Each capsule contains 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride).
• The other ingredient is magnesium stearate.

Composition of the capsule:gelatin, iron oxide (E172), titanium dioxide (E171), black iron oxide (E172).

Appearance and packaging of the product

Duartron is presented as hard gelatin capsules of brown color.

Duartron is packaged in a cardboard box containing 60 and 180 capsules in blisters.

Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

LABORATORIO REIG JOFRE, S.A.

C/Gran Capitán 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

Date of last revision of this package leaflet

April 2018

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products: http://www.aemps.gob.es.