CONDROITIN SULFATE ABAMED 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Chondroitin Sulfate Abamed 400 mg Hard Capsules EFG

Chondroitin sulfate sodium

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Chondroitin Sulfate Abamed and what is it used for

The active substance of this medication is chondroitin sulfate sodium and belongs to the group of other non-steroidal anti-inflammatory and antirheumatic agents.

This medication is indicated for the symptomatic treatment of osteoarthritis.

2. What you need to know before taking Chondroitin Sulfate Abamed

Do not take Chondroitin Sulfate Abamed

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

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

Other medications and Chondroitin Sulfate Abamed

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

The administration of this medication, at doses much higher than recommended, together with some antiplatelet medication used to prevent thrombosis (such as acetylsalicylic acid, dipyridamole, clopidogrel, ditazol, triflusal, and ticlopidine) could slightly increase the effect of these medications.

Taking Chondroitin Sulfate Abamed with food and drinks

You can take Chondroitin before, during, or after meals.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

It is unknown whether this medication passes into breast milk. Therefore, do not take Chondroitin Sulfate if you are breastfeeding, as there is not enough data on the effect it may have on your baby's health.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It is not expected that Chondroitin Sulfate Abamed will affect your ability to drive vehicles or use machines.

Chondroitin Sulfate Abamed contains sodium:

This medication contains 36.56 mg of sodium (main component of table/cooking salt) in each capsule (as part of the active substance). This is equivalent to 1.87% of the maximum recommended daily sodium intake for an adult.

3. How to take Chondroitin Sulfate Abamed

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of 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 in a single dose (2 capsules at once), for at least 3 months.

However, and always if the doctor considers it appropriate, treatment may be started with a dose of 1,200 mg (3 capsules per day, in a single dose or in 2 doses) for the first 4 or 6 weeks, followed by 800 mg (2 capsules per day, preferably in a single dose) until completing the administration period of at least 3 months.

Treatment will be administered for a minimum of 3 months, after which a 2-month rest period may be taken, given the residual effect of the product, and then the treatment can be restarted following the same cycle.

Children and adolescents under 18 years:

This medication is not recommended for use in children and adolescents under 18 years, due to the lack of data on safety and efficacy.

Method of administration:

The capsules should 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 will probably not experience any symptoms. However, you should inform your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 stop treatment before, as symptoms may reappear.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects:

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

Very rare (may affect up to 1 in 10,000 people): some cases of edema and/or water retention have been described. Additionally, some allergic reactions have been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Chondroitin Sulfate Abamed

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

Do not use this medication after the expiration date shown on the packaging and blister, after "EXP". The expiration date is the last day of the month indicated.

Store in the original package, protected from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Chondroitin Sulfate Abamed

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

Composition of the capsule: gelatin, quinoline yellow (E-104), indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

This medication is presented in the form of hard gelatin capsules, size 0, blue-green in color, containing a white 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 last revision of this package leaflet: July 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/