Package leaflet: Information for the user

STRUCTUM, 500 mg, capsules
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 as yours.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Structum is and what it is used for

This medicine is used as an adjunctive treatment for the symptoms of osteoarthritis.
Chondroitin sulfate is one of the main structural components of cartilage and bone.
It provides cartilage with its mechanical and elastic properties. The mechanism of action of chondroitin sulfate, the salt which is the active ingredient in Structum, involves inhibition of the activity of lysosomal enzymes within cartilage and stimulation of proteoglycan biosynthesis.

2. Important information before using Structum

When not to use Structum
Do not use this medicine if the patient is allergic to chondroitin sulphate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Structum, please discuss it with your doctor or pharmacist.

Children and adolescents
This medicine is intended for adults (aged over 18 years).
There are no data on the use of chondroitin sulphate in children and adolescents aged 0 to 18 years. Therefore, use of this medicine is not recommended in children and adolescents.

Structum with other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, use of Structum during pregnancy is not recommended.
Structum must not be used during breastfeeding.

Driving and using machines
There are no data available on the influence of this medicine on the ability to drive and use machines.

Structum contains:

7.5 mg of alcohol (ethanol) in each capsule, equivalent to 0.11 mg/kg. The amount of alcohol in one capsule of this medicinal product is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause any noticeable effects.
54.6 mg of sodium (the main component of table salt) in each capsule, corresponding to 3% of the recommended maximum daily dietary intake of sodium for adults.
indigo carmine, which may cause allergic reactions.

3. How to use Structum

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor.
The usual recommended dose is 1 capsule of 500 mg twice daily (1 g daily).
Structum should only be used in adults (aged over 18 years).
For oral use.
The capsules should be swallowed whole with a glass of water.
Taking more Structum than recommended
Seek immediate advice from your doctor or pharmacist.
Symptomatic treatment should be administered.
If you miss a dose of Structum
Do not take a double dose to make up for the missed dose.
If you have any further doubts 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 everyone will experience them.
Adverse reactions observed frequently (may occur in 1 out of 10 patients) include: dizziness,
diarrhea, abdominal pain, nausea.
Adverse reactions observed less frequently (may occur in 1 out of 100 patients) include:
rash with burning and itching sensation (urticaria), pruritus, rash, facial swelling.
Adverse reactions observed rarely (may occur in 1 out of 1000 patients) include: vomiting,
skin redness (erythema), sudden swelling of the face, tongue, and (or) throat, arms, and (or) legs (angioedema).
Swelling of the oral cavity or throat may interfere with breathing. If such symptoms occur, discontinue taking the medicine immediately. Emergency medical assistance may be required (serious allergic reaction causing swelling of the face or throat).
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Structum

Keep the medicine out of sight and reach of children.
Store below 25°C.
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 stated month.
Do not use this medicine if you notice any visible signs of damage.
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 pack and other information

What Structum contains
The active substance is sodium chondroitin sulfate.
Other ingredients of the medicine are*: talc, gelatin, titanium dioxide (E 171), indigo carmine.
* see section 2 "Structum contains"

What Structum looks like and contents of the pack
Opaque blue capsules.
Structum is available in packs containing 60 capsules.

Marketing Authorisation Holder
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycee,
45500 Gien
France

For further information, please contact the local representative of the Marketing Authorisation Holder:
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
Poland
tel.: 22 559 63 00