Leaflet: information for the user

Duartron 625 mg hard capsules

Glucosamine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 text of the leaflet

1. What Duartron is and what it is used for

2. What you need to know before you start taking Duartron

3. How to take Duartron

4. Possible side effects

5. Storage of Duartron

6. Contents of the pack and additional information.

Duartron belongs to the group of medications known as other nonsteroidal anti-inflammatory and antirheumatic compounds.

Duartron contains the active ingredient glucosamine

Duartron is indicated to relieve symptoms caused by mild to moderate knee arthritis.

Do not take Duartron:

- if you are allergic to glucosamine or any of the other components of this medication (listed in section 6).

- if you are allergic to seafood, as glucosamine is derived from seafood.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Duartron.

- if you have glucose intolerance. 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, 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.

Patients with kidney or liver problems should not take Duartron.

Other medications and Duartron

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

- Some types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, fenprocumon, acenocumarol, and fluindione). The effect of these medications may be potentiated 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Duartron should not be used during pregnancy.

The use of Duartron during breastfeeding is not recommended.

Driving and operating machinery

No studies have been conducted on how Duartron affects the ability to drive and operate machinery.

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

Follow exactly the medication administration instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 2 capsules per day in a single dose (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 become apparent until after several weeks of treatment and sometimes, in some cases, 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 old.

If you take more Duartron than you should

If you have taken more Duartron capsules than you should consume,you may experience headache, dizziness, disorientation, joint pain, nausea, vomiting, or diarrhea, although it is possible that you will 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 doseaccording to your usual schedule.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Duartron

Continue taking this medication until your doctor tells you to stop. Do not stop taking itjust because you feel better. If you stop taking this medication, your condition may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. These are normally mild and transient.

Severe Adverse Effects

You should discontinue treatment with glucosamine and immediately seek medical attention or visit the nearest hospital if you experience any of the following symptoms, as these symptoms may indicate that you are suffering a severe allergic reaction to this medication:

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

Other Adverse Effects

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

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

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

Rash, itching, redness.

Unknown Frequency(cannot be estimated from available data):

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

Also, elevated cholesterol levels have been reported.It has not been possible to determine that these effects are directly related to glucosamine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Duartron

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

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

Appearance of the product and content of the packaging

Duartron is presented in the form of hard gelatin capsules of brown color.

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio Reig Jofre, S.A.

C/Gran Capitán 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

Date of the last review of this prospectus

April 2018

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.gob.es.