Chondroitin sulfate Abamed 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Condroitina sulfato Abamed 400 mg hard capsules EFG

Chondroitin sulfate sodium

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Condroitina sulfato Abamed is and what it is used for
2. What you need to know before taking Condroitina sulfato Abamed
3. How to take Condroitina sulfato Abamed
4. Possible side effects
5. How to store Condroitina sulfato Abamed
6. Contents of the pack and other information

1. What Condroitina sulfato Abamed is and what it is used for

The active substance in this medicine is sodium chondroitin sulfate, which belongs to the group of other non-steroidal anti-inflammatory and anti-rheumatic agents.

This medicine is indicated for the symptomatic treatment of osteoarthritis.

2. What you need to know before starting to take Condroitina sulfato Abamed

Do not take Condroitina sulfato Abamed

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine.

• If you currently have or have previously had a serious kidney, liver, or heart disease; consult your doctor.

Other medicines and Condroitina sulfato Abamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Administration of this medicine at doses much higher than recommended, together with antiplatelet agents used to prevent thrombosis (such as acetylsalicylic acid, dipyridamole, clopidogrel, dipyridamol, triflusal, and ticlopidine) could slightly increase the effect of these medicines.

Taking Condroitina sulfato Abamed with food and drinks

You may take Condroitina before, during, or after meals.

However, if you often experience stomach discomfort when taking medicines, it is advisable to take this medicine after meals.

Pregnancy and breastfeeding

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.

Do not take chondroitin sulfate if you are pregnant, as there is insufficient data on its use in pregnant women.

It is unknown whether this medicine passes into breast milk. Therefore, do not take chondroitin sulfate during breastfeeding, as there is insufficient data on the potential effects of this medicine on your baby's health.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Condroitina sulfato Abamed is not expected to affect your ability to drive or operate machinery.

Condroitina sulfato Abamed contains sodium:

This medicine contains 36.56 mg of sodium (the main component of table/cooking salt) per capsule (as part of the active substance). This corresponds to 1.87% of the maximum daily sodium intake recommended for an adult.

3. How to take Chondroitin sulfate Abamed

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients:

The usual dose is 2 capsules per day (total daily dose of chondroitin sulfate: 800 mg), preferably taken as a single dose (2 capsules at once), for at least 3 months.

However, if considered appropriate by the physician, treatment may be initiated at a dose of 1,200 mg (3 capsules per day, taken as a single dose or in 2 doses) for the first 4 to 6 weeks, followed by 800 mg (2 capsules per day, preferably as a single dose) until completing a treatment period of at least 3 months.

Treatment should be administered for a minimum of 3 months. After this period, a 2-month break may be taken, due to the product's residual effect, before restarting treatment following the same cycle.

Children and adolescents under 18 years of age:

This medicine is not recommended for use in children and adolescents under 18 years of age due to the absence of data on safety and efficacy.

Method of administration:

The capsules must be taken without chewing. They can be taken before, during, or after meals, with a sufficient amount of liquid.

If you take more Chondroitin sulfate Abamed than you should

If you have taken more chondroitin sulfate than you should, you are unlikely to experience any symptoms. Nevertheless, you must inform your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Chondroitin sulfate Abamed

Do not take a double dose to make up for forgotten doses.

If you stop taking Chondroitin sulfate Abamed

Do not discontinue treatment prematurely, as symptoms may reappear.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects:

Rare (may affect up to 1 in 1,000 people): nausea and/or gastrointestinal disturbances, which generally do not require discontinuation of treatment.

Very rare (may affect up to 1 in 10,000 people): cases of oedema and/or water retention have been reported. In addition, some allergic-type reactions have been reported.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Chondroitin sulfate Abamed

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

Do not use this medicine after the expiry date stated on the container and blister pack, following "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging, protected from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point 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 package and other information

Composition of Condroitina sulfato Abamed

• The active substance is sodium chondroitin sulfate. Each capsule contains 400 mg of sodium chondroitin sulfate.
• The other components are: magnesium stearate.

Capsule composition: gelatin, quinoline yellow (E-104), indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the medicine and contents of the pack

This medicine is presented as hard gelatin capsules of size 0, blue-green in color, containing a whitish powder.

Each cardboard box contains 60 capsules in blisters.

Marketing Authorization Holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Manufacturer

Sincrofarm, S.L.

c/ Mercurio, 10

Pol. Ind. Almeda

08940 Cornellá de Llobregat

(Barcelona)

Spain

Date of the most recent revision of this package leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/