DERVATAN

Patient Information Leaflet

Dervatan, 400 mg, hard capsules
Sodium chondroitin sulfate
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dervatan is and what it is used for
2. Important information before taking Dervatan
3. How to take Dervatan
4. Possible side effects
5. How to store Dervatan
6. Contents of the pack and other information

1. What Dervatan is and what it is used for

The active substance in Dervatan, sodium chondroitin sulfate, is a naturally occurring substance in the human body. It is one of the structural components of joint cartilage.
Dervatan is used in the symptomatic treatment of osteoarthritis of the knee and hip joints. The effect develops slowly, usually becoming apparent within 6 to 8 weeks. Therefore, for the treatment of acute and short-term pain, other medications are recommended. The therapeutic effect usually persists for 2 to 3 months after discontinuation of treatment.
If there is no improvement in symptoms, or if the patient feels worse, consult a doctor.

2. Important information before taking Dervatan

When not to take Dervatan

• 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 treatment with Dervatan, discuss this with your doctor or pharmacist.

• if the patient has heart and/or kidney function disorders. Dervatan may cause fluid retention and oedema.
• if the patient has liver function disorders.
• if the patient is taking medicines affecting blood clotting (such as acetylsalicylic acid, dipyridamole, clopidogrel, ticlopidine).
• if the patient is taking painkillers, as treatment with sodium chondroitin sulfate may reduce the need for painkillers.

Children and adolescents
Dervatan is not recommended for use in children and adolescents.
Dervatan 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 applies in particular to medicines affecting blood clotting (such as warfarin, acetylsalicylic acid, dipyridamole, clopidogrel, ticlopidine).
If the patient is taking warfarin, the doctor may recommend more frequent INR monitoring after starting or stopping treatment with Dervatan.
Dervatan with food and drink
Dervatan may be taken before, during or after meals. If the patient is prone to gastrointestinal disturbances, the medicine should be taken after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data on the use of Dervatan during pregnancy or breastfeeding, and therefore the medicine should not be used during pregnancy or breastfeeding.
Driving and operating machinery
Dervatan has no effect or has a negligible effect on the ability to drive and operate machinery.
Dervatan contains sodium
The medicine contains 37 mg of sodium (the main component of table salt) in each hard capsule. This corresponds to 1.8% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Dervatan

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).

Adults (including elderly patients)
The recommended dose is 800 mg, i.e. 2 capsules as a single daily dose administered for a period
of three months. Treatment consists of repeated three-month treatment periods with two-month
interruptions without taking the medicine.
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.

Use in children and adolescents
Dervatan is not recommended for use in children and adolescents.

Taking more Dervatan than recommended
One case of accidental or intentional overdose has been reported, with no consequences
for the patient (no vomiting, nausea, or changes in blood electrolyte concentrations). Based on
available studies, harmful effects or symptoms of overdose are not expected with this medicine.
If you have taken more than the recommended dose of this medicine, contact your doctor
immediately or go to the nearest hospital.

Missed dose of Dervatan
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 on the following day.

Stopping Dervatan
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 will experience them.
Adverse reactions occurring rarely (in no more than 1 in 1,000 patients):
Gastrointestinal disorders: gastrointestinal disturbances, upper abdominal pain,
nausea, diarrhoea.
Skin and subcutaneous tissue disorders: erythema, pruritus, nodular skin eruptions.
Adverse reactions occurring very rarely (in no more than 1 in 10,000 patients):
Skin and subcutaneous tissue disorders: allergic reactions, urticaria, eczema.
General disorders and administration site conditions: swelling.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to:
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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dervatan

Keep this medicine out of sight and reach of children.
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 you no longer use. This will help protect
the environment.

6. Contents of the packaging and other information

What Dervatan contains

• The active substance is chondroitin sodium sulfate. Each capsule contains 400 mg of chondroitin sodium sulfate.
• Other ingredients: magnesium stearate. The excipients in the capsule shell are:
• Capsule cap: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
• Capsule body: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), erythrosine (E 127).

What Dervatan looks like and contents of the pack
Appearance of the capsule: the filling is a hygroscopic powder, white or almost white in colour,
while the capsule shell consists of an orange cap and a yellow body.
PVC/Aluminium blister pack in a cardboard box: each package contains 24 or 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
For Pharma Experts s.r.o.
U Hrnčíř 442
252 42 Jesenice
Czech Republic
Tel.: +420 777 760 812

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