CONDROSULF 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Condrosulf 400 mg Hard Capsules

Chondroitin sulfate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, 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, do not pass it on to others, as 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.

Contents of the Package Leaflet

1. What is Condrosulf and what is it used for
2. Before taking Condrosulf
3. How to take Condrosulf
4. Possible side effects
5. Storage of Condrosulf
6. Further information

1. What is Condrosulf and what is it used for

The active ingredient of this medicine is chondroitin sulfate, which is a non-steroidal anti-inflammatory and antirheumatic drug.

This medicine is used in the symptomatic treatment of osteoarthritis.

2. Before taking Condrosulf

Do not take Condrosulf

• If you are allergic (hypersensitive) to chondroitin sulfate or any of the other ingredients of Condrosulf.

Special warnings and precautions

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

Using other medicines

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

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

Taking Condrosulf with food and drinks

They can be taken before, during, or after meals, with a sufficient amount of liquid.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

It is unknown whether the active ingredients of Condrosulf pass into breast milk. Therefore, do not take Condrosulf if you are breastfeeding, as there is not enough data on the effect this medicine may have on your baby's health.

Driving and using machines

It is not expected that Condrosulf will affect your ability to drive vehicles and use machines.

Condrosulf 400 mg hard capsules contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

3. How to take Condrosulf

Follow the administration instructions of Condrosulf exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is 2 capsules per day (total daily dose: 800 mg), preferably in one intake (2 capsules at a time) for at least 3 months.

However, in patients with significant inflammatory symptoms, and as long as the doctor considers it appropriate, treatment may be started with a dose of 1,200 mg (3 capsules per day, in one intake or in 2 intakes) for the first 4 or 6 weeks, followed by 800 mg (2 capsules per day, preferably in one intake) until the administration period of at least 3 months is completed.

Condrosulf will be administered for a minimum of 3 months, after which a 2-month rest period will be carried out, and then the treatment will be restarted following the same cycle.

Method of administration:

This medicine is used orally.

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 Condrosulf than you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Condrosulf

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

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

4. Possible side effects

Like all medicines, Condrosulf can cause side effects, although not everyone gets them.

• Rare (at least 1 in 10,000 patients): Nausea and/or gastrointestinal disorders, which generally do not require the suspension of treatment.
• Very rare (less than 1 in 10,000 patients): edema and/or water retention in patients with renal (kidney) and/or cardiac (heart) insufficiency, allergic reactions.

Reporting side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Condrosulf

Keep out of the reach and sight of children.

Store in the original package, protected from moisture.

Do not use Condrosulf after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Condrosulf

The active ingredient is chondroitin sulfate.

The other ingredients are: magnesium stearate.

The composition of the capsule is: gelatin, quinoline yellow (E-104), indigotine (E-132).

Appearance of the product and packaging contents

Condrosulf is presented in the form of hard capsules for oral administration, blue-green transparent in color, containing a white or ivory powder. Each package contains 60 capsules.

Marketing authorization holder and manufacturer

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2 – 26900 Lodi (Italy)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

Planta 8, Local 1,

08028 Barcelona (Spain)

Date of the last revision of this leaflet:March 2024

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