Leaflet: information for the user

Chondroitin sulfate Kern Pharma 400 mg hard capsules EFG

Chondroitin sulfate sodium

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isChondroitin sulfate Kern Pharmaand what it is used for

2. What you need to know before starting to takeChondroitin sulfate Kern Pharma

3. How to takeChondroitin sulfate Kern Pharma

4. Possible side effects

5. Storage ofChondroitin sulfate Kern Pharma

6. Contents of the pack and additional information

The active ingredient of this medication is sodium chondroitin sulfate, which is a non-steroidal anti-inflammatory and anti-arthritic agent.

This medication is used for the symptomatic treatment of osteoarthritis.

Do not take Condroitín sulfato Kern Pharma

• If you are allergic (hypersensitive) to chondroitin sulfate sodium or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult a doctor or pharmacist or nurse before starting to take this medication.

• If you suffer from or have ever suffered from any serious kidney, liver, or heart disease; consult your doctor.

Use of Condroitín sulfato Kern Pharma with other medications

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

The administration of chondroitin sulfate sodium, at very high doses above those recommended, together with some antiplatelet medication used to prevent thrombosis (such as acetylsalicylic acid, dipiridamol, clopidogrel, ditazol, trifusal, and ticlopidina) may slightly increase the effect of these medications.

Taking Condroitín sulfato Kern Pharma with food and beverages

They can be taken before, during, or after meals, with a sufficient amount of liquid.

However, if you often experience stomach discomfort when taking medications, it is recommended to take Condroitín sulfato Kern Pharma 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.

Do not take chondroitin sulfate sodium if you are pregnant, as there is not enough data on its use in pregnant women.

It may cause renal and cardiac problems in your fetus.

The passage of chondroitin sulfate sodium into breast milk is unknown. Therefore, do not take this medication if you are breastfeeding, as there is not enough data on the effect it may have on the health of your baby.

Driving and operating machinery

It is not expected that Condroitín Kern Pharma will affect your ability to drive vehicles and operate machinery.

Condroitín sulfato Kern Pharma contains sodium:

This medication contains less than 36.63 mg of sodium (main component of table salt/for cooking) in each capsule. This is equivalent to 1.83% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.

Adults and elderly:

The recommended dose is 2 capsules per day (total daily dose of condroitin sulfate: 800 mg), preferably in a single dose (2 capsules at once) for at least 3 months.

However, in patients with significant inflammatory symptoms, and always at the discretion of the doctor, treatment may be initiated 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.

The treatment will be administered for at least 3 months, after which a 2-month rest period will be performed, and then the same cycle will be repeated.

Children and adolescents under 18 years:

This medication is not recommended for use in children and adolescents under 18 years, due to the absence of data on safety and efficacy.

Form of use: :

This medication is taken orally.

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

If you take more Condroitín Sulfate Kern Pharma than you should:

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Condroitín Sulfate Kern Pharma:

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

If you interrupt the treatment with Condroitín Sulfate Kern Pharma:

Do not suspend treatment beforehand, as its effectiveness may be reduced.

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

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

-Rare (may affect up to 1 in 1,000 people)Nausea and/or gastrointestinal disturbances, which generally do not require suspension of treatment.

-Very rare (may affect up to 1 in 10,000 people): edema and/or water retention in patients with renal (kidney) insufficiency and/or cardiac (heart) insufficiency, allergic reactions.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging protected from humidity.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Condroitín sulfato Kern Pharma

• The active ingredient is sodium chondroitin sulfate. Each capsule contains 400 mg of sodium chondroitin sulfate.
• The other components are: magnesium stearate.Composition of the capsule: gelatin, yellow iron oxide (E-172), indigotin (E-132), titanium dioxide (E-171) andprinting inkof black color (which contains Shellac (E-904), propylene glycol (E-1520), concentrated solution of ammonia, potassium hydroxide (E-525) and black iron oxide (E-172)).

Appearance of the product and content of the packaging

This medicine is presented in the form of hard gelatin capsules, with a blue-colored cap and a blue-green colored body, marked with “Kern Pharma” on the body of the capsule.

Each package contains 60 capsules in blisters.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:September 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/