Leaflet: information for the user

Condrosulf 400 mg hard capsules

Chondroitin sulfate

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What isCondrosulfand what it is used for

2. Before takingCondrosulf

3. How to takeCondrosulf

4. Possible side effects

5. Storage ofCondrosulf

6. Additional information

The active ingredient of this medication is chondroitin sulfate, which is a nonsteroidal anti-inflammatory and antirheumatic agent.

This medication is used for the symptomatic treatment of osteoarthritis.

Do not take Condrosulf

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

Be especially careful with Condrosulf

• If you suffer or have ever suffered from any serious kidney, liver, or heart disease; consult your doctor.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

The administration of Condrosulf, at very high doses above the recommended levels, together with some antiplatelet medication used to prevent thrombosis (such as acetylsalicylic acid, dipiridamol, clopidogrel, ditazol, trifusal, and ticlopidine) may slightly increase the effect of these medications.

Taking Condrosulf with food and beverages

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 recommended 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 are not enough data on its use in pregnant women.

The active principles of Condrosulf are unknown to pass into breast milk. Therefore, do not take Condrosulf if you are breastfeeding, as there are not enough data on the effect it may have on the health of your baby.

Driving and operating machines

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

Condrosulf 400 mg hard capsules contain sodium

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

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

The usual dose is 2 capsules per day (total daily dose: 800 mg), preferably taken all at once (2 capsules at a time) for at least 3 months.

However, in patients with significant inflammatory symptoms, and always at the doctor's discretion, treatment may be initiated with a dose of 1,200 mg (3 capsules per day, taken all at once or in 2 doses) for the first 4 or 6 weeks, followed by 800 mg (2 capsules per day, preferably taken all at once) until the administration period of at least 3 months is completed.

Condrosulf should be taken for at least 3 months, after which a 2-month rest period will be performed, and then the treatment will be restarted following the same cycle.

Method of Use :

This medication is taken orally.

The capsules should be swallowed whole. 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, seek immediate medical attention or call the Toxicological 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 the missed dose.

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

Like all medications, Condrosulf may produce adverse effects, although not all people will experience them.

-Rare (in at least 1 in 10,000 patients): Nausea and/or gastrointestinal disturbances, which generally do not require 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the reach and sight of children.

Store in the original packaging protected from humidity.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Condrosulf

The active ingredient is chondroitin sulfate.

The other components are: magnesium stearate.

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

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

IBSA Farmaceutici Italia srl

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th Floor, Local 1,

08028 Barcelona (Spain)

Date of the last review of this prospectusor:March 2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/