Condrosulf 400 mg hard capsules

Spain
Brand name Condrosulf 400 mg hard capsules
Form capsules, hard
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 64547
Condrosulf 400 mg hard capsules capsules, hard

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Condrosulf 400 mg hard capsules

Chondroitin sulfate

Read the entire leaflet carefully before you start taking this medicine.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
  • If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What Condrosulf is and what it is used for

The active substance in this medicine is chondroitin sulfate, which is a non-steroidal anti-inflammatory and anti-rheumatic agent.

This medicine is used for the symptomatic treatment of osteoarthritis.

2. Before taking Condrosulf

Do not take Condrosulf

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

Take special care with Condrosulf

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

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

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

Taking Condrosulf with food and drinks

Condrosulf may be taken before, during, or after meals, with a sufficient amount of liquid.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not take Condrosulf if you are pregnant, as there are insufficient 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 during breastfeeding, as there are insufficient data on the potential effects of this medicine on your baby's health.

Driving and use of machines

It is not expected that Condrosulf affects the ability to drive vehicles or operate machinery.

Condrosulf 400 mg hard capsules contain sodium

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

3. How to take Condrosulf

Follow exactly the administration instructions for Condrosulf provided 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 as a single dose (2 capsules at once) for at least 3 months.

However, in patients with significant inflammatory symptoms, and only if considered appropriate by the physician, treatment may be initiated with a dose of 1,200 mg (3 capsules per day, either as a single dose or divided into two 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.

Condrosulf should be administered for a minimum of 3 months, after which a 2-month break should be taken before restarting treatment, following the same cycle.

Method of administration:

This medicine is taken orally.

The capsules should not be chewed. They may 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Condrosulf

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

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

4. Possible adverse effects

Like all medicines, Condrosulf may produce adverse effects, although not everyone experiences them.

  • Rare (at least 1 in 10,000 patients): Nausea and/or gastrointestinal disturbances, which generally do not require discontinuation 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-type reactions.

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 Medicines: https://www.notificaram.es.

By reporting adverse 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 container, protected from moisture.

Do not use Condrosulf after the expiry date stated on the container, after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Information for the user

Composition of Condrosulf

The active substance is chondroitin sulfate.

The other components are: magnesium stearate.

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

Appearance of the product and contents of the pack

Condrosulf is available as hard capsules for oral administration, transparent blue-green in colour, containing white or ivory-coloured powder. Each pack contains 60 capsules.

Marketing Authorization Holder and Manufacturer

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2 – 26900 Lodi (Italy)

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th floor, Local 1,
08028 Barcelona (Spain)

Date of the most recent review of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/