PRODUCT INFORMATION FOR THE USER

Condrodin 400 mg Hard Capsules

Sodium Chondroitin Sulfate

Read this leaflet carefully before you start taking this medicinal product.

• Keep this leaflet, as you may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the following happen to you, tell your doctor or pharmacist. For full details, see section 4.

1. What Condrodin is and what it is used for

2. What you need to know before you start taking Condrodin

3. How to use Condrodin

4. Possible side effects

5. Storage of Condrodin

6. Contents of the pack and additional information

Chondroitin belongs to the group of other nonsteroidal anti-inflammatory and antirheumatic agents.

This medication is used in the symptomatic treatment of osteoarthritis.

Do not take Condrodin

- If you are allergic (hypersensitive) to chondroitin sulfate or to any of the other components of this medication.

Warnings and precautions

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

- Be cautious if you have a severe kidney, liver, or heart disease.

Other medications and Condrodin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The administration of chondroitin sulfate, at very high doses above the recommended, along with some antiplatelet medication to prevent thrombosis, such as acetylsalicylic acid, dipiridamol, clopidogrel, ditiazol, triflusal, and ticlopidina, may slightly increase the effect of the aforementioned medications.

Taking Condrodin with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. The passage of chondroitin sulfate into breast milk is unknown. Therefore, do not take this medication if you are breastfeeding, as there is not enough data on the effect this medication may have on the health of the infant.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Condrodin contains sodium

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

Follow exactly the administration instructions for this medication 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 taken all at once (2 capsules at a time) for at least 3 months. However, and whenever the doctor considers it appropriate, 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.

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

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

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

If you take more Condrodin than you should

If you have taken more Condrodin than you should, it is likely that you will not experience any symptoms. However, you should inform your doctor or pharmacist.

If you forgot to take Condrodin

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

If you interrupt treatment with Condrodin

Symptoms may reappear.

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

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

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

In very rare occasions (may affect 1 in 10,000 patients) some cases of edema and/or water retention have been described.

In very rare occasions (may affect 1 in 10,000 patients) some allergic reactions have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep in the original packaging to protect it from moisture.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears 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 unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Condrodin

-The active ingredient is chondroitin sulfate. Each capsule contains 400 mg of sodium chondroitin sulfate.

- The other component is magnesium stearate.Composition of the capsule: gelatin, titanium dioxide, quinoline yellow (E-104), indigotin (E-132).

Appearance of the product and content of the packaging

This medication is presented in the form of hard gelatin capsules. Each package contains 60 hard capsules conditioned in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona) Spain.

Responsible for manufacturing:

Noucor Health., S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona) - Spain

Last review date of this leaflet September 2022

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