Cartexan

Package Leaflet: Information for the User

Cartexan, 400 mg, Hard Capsules

Sodium Chondroitin Sulfate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Cartexan and What is it Used For
• 2. Important Information Before Taking Cartexan
• 3. How to Take Cartexan
• 4. Possible Side Effects
• 5. How to Store Cartexan
• 6. Contents of the Pack and Other Information

1. What is Cartexan and What is it Used For

The active substance of Cartexan, sodium chondroitin sulfate, is a substance that occurs naturally in the human body. It is one of the structural elements of joint cartilage.
Cartexan is used for the symptomatic treatment of osteoarthritis of the knee and hip joints. The drug is characterized by a slow onset of action, which occurs within 6 to 8 weeks, therefore, for the treatment of acute and short-term pain, it is recommended to use other medications. The effects of treatment usually last for 2 to 3 months after discontinuation of treatment.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important Information Before Taking Cartexan

When Not to Take Cartexan

• if the patient is allergic to chondroitin sulfate or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting treatment with Cartexan, the patient should discuss it with their doctor or pharmacist.

• if the patient has heart disease (heart failure) or kidney failure. Cartexan may cause fluid accumulation in the body and swelling.
• if the patient has liver failure.
• if the patient is taking medications that affect blood clotting (such as acetylsalicylic acid, dipyridamole, or clopidogrel).
• if the patient is taking painkillers, as the use of chondroitin sulfate may reduce the need for painkillers.

Children

Cartexan is not recommended for use in children.

Cartexan and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. This is especially important for medications that affect blood clotting (such as warfarin, acetylsalicylic acid, dipyridamole, or clopidogrel).
If the patient is taking warfarin, after starting or stopping Cartexan, the doctor may order more frequent INR checks.

Cartexan with Food and Drink

Cartexan can be taken before, during, or after meals. If the patient is prone to stomach problems, the medication should be taken after a meal.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
There is no data on the use of Cartexan during pregnancy or breastfeeding, and therefore, the medication should not be taken during pregnancy or breastfeeding.

Driving and Operating Machinery

It has not been shown that Cartexan affects the ability to drive or operate machinery.

3. How to Take Cartexan

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The capsules should not be chewed, they should be swallowed whole, with a sufficient amount of liquid (e.g., a glass of water).
The recommended dose is 800 mg, i.e., 2 capsules in one daily dose taken for three months.
In more severe cases, the recommended dose is 1200 mg, i.e., 3 capsules per day for the first 4 to 6 weeks of treatment, and then 800 mg in one daily dose until the end of the three-month treatment period. The daily dose of 1200 mg can be taken once or divided into three doses, i.e., 1 capsule three times a day.
Treatment consists of repeated periods of three-month treatment with two-month breaks without taking the medication.

Use in Children

Cartexan is not recommended for children.

Overdose of Cartexan

One report of unintentional or intentional overdose without consequences for the patient (no vomiting, nausea, or changes in blood electrolyte levels occurred) has been received. Based on studies, no harmful effects or symptoms are expected. In case of overdose, the patient should always contact the Toxicological Information Center (tel. 607 218 174).

Missed Dose of Cartexan:

No special effects are expected. The patient should not take a double dose to make up for the missed dose, they should continue treatment by taking the normal dose the next day.

Stopping Cartexan Treatment

No special effects are expected.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Cartexan can cause side effects, although not everybody gets them.

Uncommon Side Effects (affecting up to 1 in 1,000 users):

Gastrointestinal Disorders: Gastrointestinal disorders (such as upper abdominal pain, nausea, or diarrhea).
Skin and Subcutaneous Tissue Disorders:Redness, papular rash, irritating dermatitis.

Rare Side Effects (affecting up to 1 in 10,000 users):

Skin and Subcutaneous Tissue Disorders:eczema, itching, urticaria.
General Disorders:Edema.

Reporting Side Effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the national reporting system:
Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Cartexan

The medication should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Do not use this medication after the expiry date stated on the carton and blister pack after "Expiry Date:". The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Cartexan Contains

• The active substance of Cartexan is Sodium Chondroitin Sulfate. Each capsule contains 400 mg of sodium chondroitin sulfate.
• Other ingredients: magnesium stearate. The excipients in the capsule shell are gelatin, titanium dioxide (E171), indigo carmine (E132), quinoline yellow (E104).

What Cartexan Looks Like and Contents of the Pack

Cartexan capsules are available in packs of 24, 60, and 180 capsules. The bulk pack contains 180 (3 packs of 60) capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

REIG JOFRE Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
Poland

Manufacturer

NOUCOR HEALTH, S.A.
Avda. Camí Reial, 51-57.
08184 Palau-Solità i Plegamans. Barcelona
Spain

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Countries:

Austria, Finland, Hungary, and Poland - Cartexan
Czech Republic - Condrodin

Date of Last Revision of the Leaflet: 10/2024