Package leaflet: Information for the user

CONDROMED 800 mg tablet
Chondroitini natrii sulfas
Please read all of this leaflet carefully before 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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Condromed is and what it is used for
What you need to know before taking Condromed
How to take Condromed
Possible side effects
How to store Condromed
Contents of the pack and other information

1. What Condromed is and what it is used for

Condromed contains the active substance called chondroitin sodium sulfate.
Condromed belongs to other non-steroidal anti-inflammatory and anti-rheumatic drugs.
It is indicated for symptomatic treatment of osteoarthritis of the knee joint.
This medicine shows a delayed effect, which may persist after discontinuation of treatment.

2. Important information before taking Condromed

When not to take Condromed
If the patient is allergic to sodium chondroitin sulfate or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Condromed, consult a doctor or pharmacist if:

the patient currently has or has previously had liver, kidney or heart disorders or impairment.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.

Condromed and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially when using coumarin anticoagulants concomitantly.

Condromed with food and drink
See section 3. "How to take Condromed".

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines
Chondroitin sulfate may have a minor influence on the ability to drive and operate machinery.
Dizziness may occur after taking the medicine (see section 4). If this occurs, do not drive or operate machinery.

Condromed contains sodium
This medicine contains 73 mg of sodium (the main component of table salt) in each tablet. This corresponds to 3.8% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Condromed

This medicine should always be taken according to the instructions provided by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 1 tablet taken once daily.
Use in children and adolescents under 18 years of age
The use of this medicine is not recommended in children and adolescents under 18 years of age.
Elderly patients and patients with renal, hepatic or cardiac impairment
Treatment of patients with renal, hepatic or cardiac impairment requires special caution (see section "Warnings and precautions").
Instructions for use
The tablet may be taken before, during or after a meal.
Taking more than the recommended dose of Condromed
In case of taking more than the recommended dose of this medicine, contact your doctor immediately or go to the nearest hospital. Bring the medicine package with you.
Missing a dose of Condromed
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for a missed tablet.
Stopping treatment with Condromed
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
The adverse reactions listed below have been reported with the following frequency:
Rare (may occur in no more than 1 in 1,000 people)

Gastrointestinal disturbances such as abdominal pain, nausea, diarrhoea
Skin redness
Rash

Very rare (may occur in no more than 1 in 10,000 people)

Dizziness
Urticaria
Itching
Eruption
Allergic reaction
Swelling

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions enables more information on the safety of this medicine to be collected.

5. How to store Condromed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry
(Exp). The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine. Store in the original blister pack to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Condromed contains
The active substance is sodium chondroitin sulfate. Each tablet contains 800 mg of sodium chondroitin sulfate.
The other ingredient is magnesium stearate.
What Condromed looks like and contents of the pack
Condromed is a white or almost white, elongated, biconvex tablet with a diameter of approximately 21 mm.
Cartons contain 30 or 90 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy
tel.: +48 22 653 68 60