CONDRODIN 400 HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Condrodin 400 mg hard capsules

Chondroitin sulfate sodium

Read the entire package leaflet carefully before starting to take the medicine.

• Keep this package 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 only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience any side effects not mentioned in this package leaflet, see section 4.

Contents of the package leaflet

1. What Condrodin is and what it is used for
2. What you need to know before taking Condrodin
3. How to take Condrodin
4. Possible side effects
5. Storage of Condrodin
6. Contents of the pack and further information

1. What Condrodin is and what it is used for

Condrodin belongs to the group of other anti-inflammatory and antirheumatic non-steroidal agents.

This medicine is used for the symptomatic treatment of osteoarthritis.

2. What you need to know before taking Condrodin

Do not take Condrodin

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• Be cautious if you have any severe kidney, liver, or heart disease.

Other medicines and Condrodin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Taking Condrodin with food and drinks

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

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. It is unknown whether chondroitin sulfate passes into breast milk. Therefore, do not take this medicine if you are breastfeeding, as there is insufficient data on the effect it may have on the health of the infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Condrodin will affect your ability to drive vehicles or use machines.

Condrodin contains sodium

• Patient with low-sodium diets should note that this medicine contains 36.40 mg (1.58 mmol) of sodium per capsule.

3. How to take Condrodin

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

The recommended dose in adult patients is 2 capsules (total daily dose: 800 mg of chondroitin sulfate) per day, preferably in a single dose (2 capsules at once) for at least 3 months. However, and 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, followed by 800 mg (2 capsules per day, preferably in a single dose) until completing the administration period of at least 3 months.

Treatment will be administered for a minimum of 3 months, after which a 2-month rest period may be performed, given the residual effect of the product, to then restart treatment following the same cycle.

The capsules should be taken without chewing. They can be taken before, during, or after meals.

Use in children and adolescents: The use of the medicine is not recommended in children or adolescents under 18 years of age due to the lack of data on safety and efficacy.

If you take more Condrodin than you should

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

If you forget to take Condrodin

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

If you stop taking Condrodin

Symptoms may reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very rarely (may affect up to 1 in 10,000 patients), some cases of edema and/or water retention have been described.

Very rarely (may affect up to 1 in 10,000 patients), some allergic reactions have been reported.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not mentioned in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Condrodin

Keep the medicine in the original package to protect it from moisture.

Keep out of sight and reach of children.

Do not use this medicine 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 collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Condrodin

• The active ingredient is chondroitin sulfate. Each capsule contains 400 mg of chondroitin sulfate sodium.
• The other ingredient is magnesium stearate. Composition of the capsule: gelatin, titanium dioxide, quinoline yellow (E-104), indigo carmine (E-132).

Appearance of the product and contents of the pack

This medicine is presented in the form of hard gelatin capsules. Each pack contains 60 hard capsules packaged 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 package leaflet: September 2022

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