CONDROITIN SULFATE REIG JOFRE 400 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Chondroitin Sulfate Reig Jofre 400 mg Hard Capsules EFG

chondroitin sulfate sodium

Read all of this 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 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 leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Chondroitin Sulfate Reig Jofre and what is it used for

The active substance of this medicine is chondroitin sulfate sodium and belongs to the group of other anti-inflammatory and anti-rheumatic non-steroidal agents. This medicine is indicated for the symptomatic treatment of osteoarthritis.

2. What you need to know before you take Chondroitin Sulfate Reig Jofre

Do not take Chondroitin Sulfate Reig Jofre

• If you are allergic (hypersensitive) to chondroitin sulfate sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be cautious if you have any serious kidney, liver, or heart disease.

Other medicines and Chondroitin Sulfate Reig Jofre

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

The administration of chondroitin sulfate sodium, at doses much higher than recommended, along with some antiplatelet medication to prevent thrombosis, such as acetylsalicylic acid, dipyridamole, clopidogrel, ditazol, triflusal, and ticlopidine, may slightly increase the effect of the aforementioned medications.

Taking Chondroitin Sulfate Reig Jofre with food and drinks

You can take this medicine before, during, or after meals. However, if you often experience stomach upset when taking medications, it is advisable to take this medicine 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 medicine.

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

It is unknown whether chondroitin sulfate sodium passes into breast milk. Therefore, do not take this medicine 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 medicine.

Driving and using machines

It is not expected that this medicine will affect your ability to drive vehicles or use machines.

Chondroitin Sulfate Reig Jofre contains sodium

This medicine contains 36.40 mg of sodium (the main component of table/cooking salt) in each capsule (as part of the active ingredient). This is equivalent to 1.82% of the maximum recommended daily sodium intake for an adult.

3. How to take Chondroitin Sulfate Reig Jofre

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly patients

The normal dose is 2 capsules (total daily dose: 800 mg) per day, preferably in a single dose (2 capsules at a time) 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 to continue with 800 mg (2 capsules per day, preferably in a single dose) until completing the administration period of at least 3 months.

This medicine will be administered for a minimum of 3 months, after which a 2-month rest period may be performed, given the residual effect of the product, to later restart treatment following the same cycle.

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

Use in children and adolescents

The use of this medicine is not recommended in children or adolescents under 18 years of age due to the lack of data on safety and efficacy.

If you take more Chondroitin Sulfate Reig Jofre 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 medicine and the amount ingested.

If you forget to take Chondroitin Sulfate Reig Jofre

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

If you stop taking Chondroitin Sulfate Reig Jofre

The symptoms may reappear.

If you have any other questions about 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.

In rare cases (between 1 and 10 out of every 10,000 patients), nausea and/or gastrointestinal alterations have been described, which generally do not require the suspension of treatment.

In very rare cases (in less than 1 out of every 10,000 patients), some cases of edema and/or water retention have been described.

In very rare cases (in less than 1 out of every 10,000 patients), some allergic reactions have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Chondroitin Sulfate Reig Jofre

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

Do not use this medicine after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

Store in the original package to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Chondroitin Sulfate Reig Jofre

• The active substance is chondroitin sulfate sodium. Each capsule contains 400 mg of chondroitin sulfate sodium.
• The other ingredient is magnesium stearate. Composition of the capsule: gelatin, titanium dioxide (E171), quinoline yellow (E-104), indigo carmine (E-132).

Appearance of the product and contents of the pack

This medicine is presented in the form of hard gelatin capsules, size 0, with a green-blue body and a bright blue head.

Contents of the capsules: white or off-white powder

Aluminum-PVC blisters packaged in cartons containing 60 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona).

Spain

Manufacturer:

NOUCOR HEALTH, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona).

Spain

Date of the last revision of this leaflet:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS).