Condrosulf

Package leaflet: Information for the patient

CONDROSULF 400 mg hard capsules, 400 mg granules for oral solution

sodium chondroitin sulfate
Please read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor. This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor. See section 4.

Contents of this leaflet:

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

1. What CONDROSULF is and what it is used for

CONDROSULF is a medicine used for the treatment of deformities resulting from joint degradation (osteoarthritis) of the knee and hip; its active ingredient is chondroitin sulfate, which is the main component of cartilage.
CONDROSULF relieves joint pain and improves joint mobility.

2. What you need to know before taking CONDROSULF

Do not take CONDROSULF if:

• you are allergic to the active substance or to other substances chemically related to it, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
CONDROSULF should be used with caution in individuals particularly at risk of allergies.
Inform your doctor or pharmacist before taking this medicine if you suffer from allergies.
CONDROSULF oral granules for solution contain:

• 1335 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before taking this medicine.
• Yellow Orange S (E 110). May cause allergic reactions.
• 38 mg of sodium (main component of table salt) per sachet. This corresponds to 1.9% of the maximum daily recommended dietary intake for an adult.

CONDROSULF hard capsules contain 36.5 mg of sodium (main component of table salt) per capsule. This corresponds to 1.8% of the maximum daily recommended dietary intake for an adult.
Children and adolescents
CONDROSULF is not recommended for children and adolescents under 18 years of age.
Other medicines and CONDROSULF
No interactions between CONDROSULF and other medicinal drugs are known. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
This medicine should be used during pregnancy or breastfeeding only when clearly necessary and under strict medical supervision.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, who will evaluate the benefits and risks of treatment with CONDROSULF.
Driving and using machines
CONDROSULF does not impair the ability to drive vehicles or operate machinery.

3. How to take CONDROSULF

Take this medicine exactly as prescribed by your doctor, who will determine the dose and duration of treatment. If you have any doubts, consult your doctor or pharmacist.
Adults
If not otherwise directed by your doctor, the usual dose is:
2 - 3 capsules or sachets per day, for at least 3 weeks.
Take CONDROSULF by mouth:

• if using CONDROSULF capsules, swallow the capsules with water;
• if using CONDROSULF granules, dissolve the contents of the sachets in water before taking.

Do not alter the dose recommended or prescribed by your doctor. If you do not notice any improvement or if your symptoms worsen, inform your doctor or pharmacist.
If you take more CONDROSULF than you should
Cases of overdose are not known. It is advisable not to exceed the recommended dosage.
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with CONDROSULF:

Rare adverse reactions (may affect up to 1 in 1,000 people):

• gastrointestinal disorders, abdominal pain, nausea, diarrhoea;
• sudden or gradual onset of skin lesions, such as discoloured spots or widespread rash (maculopapular exanthema, erythema, skin eruption);
• dizziness.

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• skin redness (eczema), urticaria, pruritus;
• swelling (oedema).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store CONDROSULF

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or as household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CONDROSULF contains
The active substance is: sodium chondroitin sulfate.
CONDROSULF hard capsules
Each capsule contains 400 mg of sodium chondroitin sulfate.
The other components are: magnesium stearate, gelatin, quinoline yellow (E104), indigo carmine (E132).
CONDROSULF granules for oral solution
Each sachet of granules contains 400 mg of sodium chondroitin sulfate.
The other components are: citric acid, orange flavour, sodium saccharin, orange yellow S (E110),
sorbitol, anhydrous colloidal silica (Aerosil 200).

Description of the appearance of CONDROSULF and contents of the pack
CONDROSULF hard capsules are available in packs containing 20 capsules.
CONDROSULF granules for oral solution are available in packs containing 20 sachets.

Marketing Authorization Holder and Manufacturer
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi