CONDROSAN 400 MG HARD CAPSULES

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Condrosan 400 mg hard capsules

Chondroitin sulfate

Read all of this 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 you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What Condrosan is and what it is used for

Condrosan is presented in the form of hard capsules for oral administration, available in
containers of 60 capsules. It belongs to the group of other non-steroidal anti-inflammatory and
anti-rheumatic agents.

Condrosan is indicated for the symptomatic treatment of osteoarthritis.

2. Before taking Condrosan

Do not take Condrosan

• If you are hypersensitive to chondroitin sulfate or to any of the other components of
  Condrosan.

Take special care with Condrosan

• If you suffer from severe kidney, liver, or heart disease. Consult your
  physician.

Use of other medicines

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

Administration of Condrosan at doses much higher than recommended, together with antiplatelet agents used to prevent thrombosis, such as
acetylsalicylic acid, dipyridamole, clopidogrel, diltiazem, triflusal, or ticlopidine, could slightly increase
the effect of the aforementioned medicines.

Taking Condrosan with food and drinks

You may take Condrosan before, during, or after meals. However, if you frequently
experience stomach discomfort when taking medicines, it is advisable to take
Condrosan after meals.

Pregnancy and breastfeeding

Do not take Condrosan if you are pregnant, as there are insufficient data on its use
in pregnant women.

It is unknown whether the active ingredients of Condrosan pass into breast milk. Therefore, do not take Condrosan during breastfeeding, as there are insufficient data on the potential effects this medicine may have on the health of your baby.

Consult your physician or pharmacist before using any medicine.

Driving and operating machinery

It is not expected that Condrosan will affect the ability to drive vehicles or operate machinery.

3. How to take Condrosan

Follow exactly the administration instructions for Condrosan provided by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Adults and elderly

The usual dose is 2 capsules (total daily dose: 800 mg) per day, preferably taken as a single dose (2 capsules at once) for at least 3 months. However, if considered appropriate by the physician, treatment may be initiated with a dose of 1,200 mg (3 capsules per day, taken as a single dose or in 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.

Condrosan should be administered for a minimum of 3 months, after which a 2-month break may be taken, due to the product's residual effect, before restarting treatment following the same cycle.

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

Children and adolescents under 18 years of age

Condrosan is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

If you take more Condrosan than you should

If you have taken more Condrosan than you should, you are unlikely to experience any symptoms. Nevertheless, you should inform your doctor or pharmacist.

If you forget to take Condrosan

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

If you stop taking Condrosan

Symptoms may reappear.

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

4. Possible adverse effects

Like all medicines, Condrosan may produce adverse effects, although not all people will experience them.

Rarely (in 1 to 10 out of 10,000 patients), cases of nausea and/or gastrointestinal disturbances have been reported, which generally do not require discontinuation of treatment.

Very rarely (in less than 1 out of 10,000 patients), cases of edema and/or water retention have been reported.

Very rarely (in less than 1 out of 10,000 patients), allergic-type reactions have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Condrosan

Do not store above 30°C. Keep in the original container to protect from moisture.

Keep out of the reach and sight of children.

Do not use Condrosan after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Information provided

Composition of Condrosan

• The active substance is chondroitin sulfate 400 mg.
• The other component is magnesium stearate. Capsule composition: gelatin, titanium dioxide, quinoline yellow (E-104), indigotine (E-132).

Appearance of the product and contents of the pack

This medicine is presented as hard gelatin capsules of size 0, with a greenish-blue body and a blue cap. Capsule contents: white or almost white powder.

Condrosan is packaged in a cardboard box containing 60 capsules in blisters.

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 most recent review of this leaflet: May 2019

Detailed information about this medicine is available on the website of the Spanish Medicines Agency: http://www.aemps.gob.es