Package leaflet: Information for the user

Cartexan, 400 mg, hard capsules
Sodium chondroitin sulfate
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Cartexan is and what it is used for
Important information before taking Cartexan
How to take Cartexan
Possible side effects
How to store Cartexan
Contents of the pack and other information

1. What Cartexan is and what it is used for

The active substance in Cartexan, sodium chondroitin sulfate, is a naturally occurring substance in
the human body. It is one of the structural components of joint cartilage.
Cartexan is used in the symptomatic treatment of osteoarthritis of the knee and hip joints.
The effect of the medicine develops slowly, usually becoming apparent within 6 to 8 weeks. Therefore, for the treatment of acute or short-term pain, other medicines are recommended.
The beneficial effects of treatment typically persist for 2 to 3 months after discontinuation of therapy.
If no improvement occurs or if the patient feels worse, medical advice should be sought.

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 medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Cartexan, discuss this with your doctor or pharmacist.

if the patient suffers from heart disease (heart failure) or kidney failure. Cartexan may cause fluid retention and oedema.
if the patient suffers from liver failure.
if the patient is taking medicines affecting blood clotting (such as acetylsalicylic acid, dipyridamole or clopidogrel).
if the patient is taking painkillers, because the use of chondroitin sulfate may reduce the need for painkilling medicines.

Children
Cartexan is not recommended for use in children.
Cartexan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This particularly applies to medicines affecting blood clotting (such as warfarin, acetylsalicylic acid, dipyridamole or clopidogrel).
If the patient is taking warfarin, the doctor may recommend more frequent INR monitoring after starting or stopping treatment with Cartexan.
Cartexan with food and drink
Cartexan may be taken before, during or after meals. If the patient is prone to gastrointestinal discomfort, the medicine should be taken after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There is no data available on the use of Cartexan during pregnancy or breastfeeding, and therefore the medicine should not be used 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 medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.
Do not chew the capsules; swallow them whole with an adequate amount of liquid (e.g., a glass of water).

The recommended dose is 800 mg, i.e. 2 capsules taken as a single daily dose 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, followed by 800 mg as a single daily dose until the end of the three-month treatment period. The daily dose of 1200 mg may be taken either as a single dose or divided into three doses, i.e. 1 capsule three times a day.

Treatment consists of repeated three-month treatment periods with two-month breaks during which the medicine is not taken.

Use in children
Cartexan is not recommended for children.

Accidental or intentional overdose of Cartexan
One report has been received regarding accidental or intentional overdose with no consequences for the patient (no vomiting, nausea, or changes in blood electrolyte concentrations). Based on studies, harmful effects or symptoms are not expected. In case of overdose, always contact the Toxicology Information Centre (telephone: 607 218 174).

Missed dose of Cartexan
No specific adverse effects are expected. Do not take a double dose to make up for a missed dose; continue treatment by taking the next normal dose the following day.

Discontinuation of Cartexan
No specific adverse effects are expected.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Adverse reactions occurring rarely (in up to 1 user per 1,000):
Gastrointestinal disorders: Gastrointestinal disturbances (such as upper abdominal pain, nausea, or
diarrhea).
Skin and subcutaneous tissue disorders: Erythema, papular skin eruptions, irritant dermatitis.
Adverse reactions occurring very rarely (in up to 1 user per 10,000):
Skin and subcutaneous tissue disorders: Eczema, skin itching, urticaria.
General symptoms: Swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the national reporting system:
Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions may also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Cartexan

Keep this medicine 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 medicine after the expiry date stated on the carton and blister after "Expiry date:". The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Cartexan contains

The active substance is Chondroitin Sodium Sulfate. Each capsule contains 400 mg of chondroitin sodium sulfate.
Other components: magnesium stearate. The capsule shell contains the following excipients: gelatin, titanium dioxide (E171), indigotine (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 outer pack contains 180 capsules (3 packs of 60 capsules).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
REIG JOFRE Sp. z o.o.
Ostródzka Street 74N
03-289 Warsaw
Poland

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

This medicinal product is authorised in the following European Economic Area countries under the following names:
Austria, Finland, Hungary and Poland - Cartexan
Czech Republic - Condrodin