CONDROITIN SULFATE KERN PHARMA 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Chondroitin Sulfate Kern Pharma 400 mg Hard Capsules EFG

Chondroitin sulfate sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Chondroitin Sulfate Kern Pharma and what is it used for

The active substance of this medicine is chondroitin sulfate sodium, which is a non-steroidal anti-inflammatory and antirheumatic drug.

This medicine is used for the symptomatic treatment of osteoarthritis.

2. What you need to know before you take Chondroitin Sulfate Kern Pharma

Do not take Chondroitin Sulfate Kern Pharma

• If you are allergic (hypersensitive) to chondroitin sulfate sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• If you have or have had any serious kidney, liver, or heart disease; consult your doctor.

Using Chondroitin Sulfate Kern Pharma with other medicines

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

The administration of chondroitin sulfate sodium, at doses much higher than recommended, together with some antiplatelet medication used to prevent thrombosis (such as acetylsalicylic acid, dipyridamole, clopidogrel, ditazol, triflusal, and ticlopidine) could slightly increase the effect of these medicines.

Taking Chondroitin Sulfate Kern Pharma with food and drinks

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

However, if you often experience stomach upset when taking medicines, it is advisable to take Chondroitin Sulfate Kern Pharma after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 kidney and heart problems in your fetus.

It is not known whether chondroitin sulfate sodium passes into breast milk. Therefore, do not take this medicine if you are breastfeeding, as there is not enough data on the effect it may have on your baby's health.

Driving and using machines

It is unlikely that Chondroitin Kern Pharma will affect your ability to drive or use machines.

Chondroitin Sulfate Kern Pharma contains sodium:

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

3. How to take Chondroitin Sulfate Kern Pharma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults and elderly:

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

However, in patients with significant inflammatory symptoms, and provided that 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 the administration period of at least 3 months is completed.

Treatment will be administered for a minimum of 3 months, after which a 2-month rest period will be carried out, and then the same cycle will be repeated.

Children and adolescents under 18 years:

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

Method of administration:

This medicine is for oral use.

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 Chondroitin Sulfate Kern Pharma than you should

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

If you forget to take Chondroitin Sulfate Kern Pharma

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

If you stop taking Chondroitin Sulfate Kern Pharma

Do not stop treatment before, as its efficacy may be reduced.

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

4. Possible side effects

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

• Rare (may affect up to 1 in 1,000 people): Nausea and/or gastrointestinal disorders, which generally do not require treatment suspension.
• Very rare (may affect up to 1 in 10,000 people): Edema and/or water retention in patients with renal (kidney) and/or cardiac (heart) insufficiency, allergic reactions.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Chondroitin Sulfate Kern Pharma

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

Store in the original package protected from moisture.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Chondroitin Sulfate Kern Pharma

• The active substance is chondroitin sulfate sodium. Each capsule contains 400 mg of chondroitin sulfate sodium.
• The other ingredients are: magnesium stearate. Capsule composition: gelatin, yellow iron oxide (E-172), indigo carmine (E-132), titanium dioxide (E-171), and printing inkof black color (which contains Shellac lacquer (E-904), propylene glycol (E-1520), concentrated ammonia solution, potassium hydroxide (E-525), and black iron oxide (E-172)).

Appearance of the product and contents of the pack

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

Each pack contains 60 capsules in blisters.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/