CONDROSAN 400 mg HARD CAPSULES

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 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 Condrosan and what is it used for
2. Before taking Condrosan
3. How to take Condrosan
4. Possible side effects

5 Conservation of Condrosan

1. Additional information

1. What is Condrosan and what is it used for

Condrosan is presented in the form of hard capsules for oral administration, available in packs of 60 capsules. It belongs to the group of other anti-inflammatory and antirheumatic non-steroidal 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 have any serious kidney, liver, or heart disease. Consult your doctor.

Use of other medicines

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

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

Taking Condrosan with food and drinks

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

Pregnancy and breastfeeding

Do not take Condrosan if you are pregnant, as there is not enough 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 if you are breastfeeding, as there is not enough data on the effect this medication may have on your baby's health.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

3. How to take Condrosan

Follow the administration instructions of Condrosan indicated by your doctor exactly.

Consult your doctor or pharmacist if you have any doubts.

Adults and the elderly

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.

Condrosan will be administered for a minimum of 3 months, after which a 2-month rest period may be carried out, 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.

Children and adolescents under 18 years

Condrosan is not recommended for use in children and adolescents under 18 years due to the 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 will probably not experience any symptoms. However, you should inform your doctor or pharmacist.

If you forget to take Condrosan

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

If you stop taking Condrosan

The symptoms may reappear.

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

4. Possible side effects

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

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

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

Very rarely (in less than 1 in every 10,000 patients), some allergic reactions have been reported.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Conservation of Condrosan

Keep in the original package to protect it from moisture.

Keep out of the reach and sight of children.

Do not use Condrosan 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. Additional information

Composition of Condrosan

• The active ingredient 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 packaging content

Condrosan is presented in the form of hard gelatin capsules.

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 last revision of this leaflet:May 2019

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