Duartron 625 mg hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Duartron 625 mg hard capsules
Glucosamine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects 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 throughout the text of this leaflet.
Contents of the package leaflet
- What Duartron is and what it is used for
- What you need to know before taking Duartron
- How to take Duartron
- Possible side effects
- How to store Duartron
- Contents of the pack and other information
1. What Duartron is and what it is used for
Duartron belongs to the group of medicines known as other non-steroidal anti-inflammatory and anti-rheumatic agents.
Duartron contains the active substance glucosamine.
Duartron is indicated for the relief of symptoms caused by mild to moderate knee osteoarthritis.
2. What you need to know before taking Duartron
Do not take Duartron:
- if you are allergic to glucosamine or to any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to shellfish, because glucosamine is derived from shellfish.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Duartron:
- if you have glucose intolerance. More frequent monitoring of blood glucose levels may be required 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 therefore dosage recommendations cannot be given.
Other medicines and Duartron
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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, dicoumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be enhanced when used together with glucosamine. Therefore, patients receiving these combinations should be monitored more carefully when starting or stopping glucosamine treatment.
- Tetracyclines (antibiotics used to treat infections).
Taking Duartron with food and drink
Duartron may 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Duartron should not be used during pregnancy.
Use of Duartron is not recommended during breastfeeding.
Driving and use of machines
No studies have been conducted on the effects of Duartron on the ability to drive or operate machinery.
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 instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 2 capsules per day as 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. Symptom relief (especially pain relief) may not become apparent until 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 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 at all. In any case, inform your doctor.
If you forget to take Duartron
If you forget to take a dose, simply take the next dose according to your usual schedule. Do not take a double dose to make up for the missed dose.
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 condition may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These are usually mild and temporary.
Serious adverse effects
You must stop treatment with glucosamine and go immediately to your doctor or the nearest hospital if you experience any of the following symptoms, as these may indicate you are having a severe allergic reaction to this medicine:
- Swelling of the face, tongue, or throat
- Difficulty swallowing or breathing
- Skin rash or hives
Other adverse effects
Common (may affect up to 1 in 10 people):
Headache, fatigue, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Uncommon (may affect up to 1 in 100 people):
Rash, itching, redness.
Frequency not known (cannot be estimated from available data):
Vomiting, urticaria, dizziness, swelling of feet or ankles, angioedema. Worsening of pre-existing asthma; in diabetic patients, worsening of blood glucose control.
Elevated cholesterol levels have also been reported. It has not been possible to determine whether these effects are directly related to glucosamine.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Duartron
Keep this medicine out of sight and reach of children.
Store below 30°C. Keep 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Duartron
- The active substance is glucosamine. Each capsule contains 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride).
- The other component is magnesium stearate.
Capsule composition: gelatin, iron oxide (E172), titanium dioxide (E171), black iron oxide (E172).
Appearance of the product and contents of the container
Duartron is presented as brown hard gelatin capsules.
Duartron is packaged in a cardboard box containing 60 and 180 capsules in blisters.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 the most recent review of this leaflet
April 2018
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.gob.es.