Chondroitin sulfate Kern Pharma 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Condroitín sulfato Kern Pharma 400 mg hard capsules EFG

Sodium chondroitin sulfate

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Condroitín sulfato Kern Pharma is and what it is used for
2. What you need to know before taking Condroitín sulfato Kern Pharma
3. How to take Condroitín sulfato Kern Pharma
4. Possible adverse effects
5. How to store Condroitín sulfato Kern Pharma
6. Contents of the pack and other information

1. What Condroitín sulfato Kern Pharma is and what it is used for

The active substance in this medicine is sodium chondroitin sulfate, which is a non-steroidal anti-inflammatory and anti-rheumatic agent.

This medicine is used for the symptomatic treatment of osteoarthritis.

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

Do not take Condroitin Sulfate Kern Pharma

• If you are allergic (hypersensitive) to sodium chondroitin sulfate or to any of the other components 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 ever had a serious kidney, liver, or heart disease; consult your doctor.

Use of Condroitin Sulfate Kern Pharma with other medicines

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

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

Taking Condroitin Sulfate Kern Pharma with food and drink

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It may cause kidney and heart problems in your fetus.

It is unknown whether sodium chondroitin sulfate passes into breast milk. Therefore, do not take this medicine while breastfeeding, as there are insufficient data on the potential effects of this medicine on your baby's health.

Driving and using machines

Condroitin Sulfate Kern Pharma is not expected to affect your ability to drive or operate machinery.

Condroitin Sulfate Kern Pharma contains sodium:

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

3. How to take Condroitín sulfato Kern Pharma

Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. If you have any doubts, 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 taken as a single dose (2 capsules at once) for at least 3 months.

However, in patients with significant inflammatory symptoms, and provided the physician considers it appropriate, treatment may be initiated with a dose of 1,200 mg (3 capsules per day, either as a single dose or divided into 2 doses) for the first 4 to 6 weeks, followed by 800 mg (2 capsules per day, preferably as a single dose) until completing a treatment period of at least 3 months.

Treatment should last for a minimum of 3 months, after which a 2-month break should be taken before restarting treatment, repeating the same cycle.

Children and adolescents under 18 years of age:

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

Method of administration:

This medicine is taken orally.

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

If you take more Condroitín sulfato Kern Pharma than you should

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

If you forget to take Condroitín sulfato Kern Pharma

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

If you stop taking Condroitín sulfato Kern Pharma

Do not discontinue treatment prematurely, as its effectiveness may be reduced.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

• Rare (may affect up to 1 in 1,000 people): nausea and/or gastrointestinal disturbances, which usually do not require discontinuation of treatment.
• 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-type reactions.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse 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 sight and reach of children.

Store in the original container, protected from moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Chondroitin Sulfate Kern Pharma

• The active substance is sodium chondroitin sulfate. Each capsule contains 400 mg of sodium chondroitin sulfate.
• The other components are: magnesium stearate. Capsule composition: gelatin, yellow iron oxide (E-172), indigotine (E-132), titanium dioxide (E-171), and printing ink black (containing shellac glaze (E-904), propylene glycol (E-1520), concentrated ammonium solution, potassium hydroxide (E-525), and black iron oxide (E-172)).

Appearance of the product and contents of the container

This medicine is presented as hard gelatin capsules with a blue cap and a blue-green 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 most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/