Package leaflet: information for the patient

CONDROSULF UNIDIE 1200 mg oral gel

Sodium chondroitin sulfate
Please read this leaflet carefully before using this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

What CONDROSULF UNIDIE 1200 mg oral gel is and what it is used for
What you need to know before taking CONDROSULF UNIDIE 1200 mg oral gel
How to take CONDROSULF UNIDIE 1200 mg oral gel
Possible side effects
How to store CONDROSULF UNIDIE 1200 mg oral gel
Contents of the pack and other information

1. What CONDROSULF UNIDIE 1200 mg oral gel is and what it is used for

Pharmacotherapeutic category: Other non-steroidal anti-inflammatory and antirheumatic agents.
ATC code: M01AX25
This medicinal product contains chondroitin sulfate. It is recommended in adults (over 18 years of age) for the treatment of pain and functional impairment due to osteoarthritis of the hip and knee.
The medicine has a slow onset of action, with effects becoming apparent after approximately 2 months, and its effect may persist after discontinuation of treatment.

2. What you need to know before taking CONDROSULF UNIDIE 1200 mg oral gel

Do not take CONDROSULF UNIDIE 1200 mg oral gel:

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking CONDROSULF UNIDIE 1200 mg oral gel.
This medicine is not recommended during pregnancy or while breastfeeding (see section
"Pregnancy and breastfeeding").
Patients with heart and/or renal insufficiency:
In very rare cases (<1/10,000), these types of patients have experienced cases of edema and/or fluid
retention. This may be attributed to the osmotic effect of sodium chondroitin sulfate (see section 4).
If in doubt, please consult your doctor or pharmacist.
Children and adolescents:
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and CONDROSULF UNIDIE 1200 mg oral gel
No interaction studies have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
CONDROSULF UNIDIE 1200 mg oral gel with food and drink
Not applicable
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Due to lack of data, this medicine is not recommended during pregnancy or breastfeeding.
Pregnancy
There are no clinical data on the use of this product during pregnancy. Animal studies are insufficient to determine effects on pregnancy, the embryo, the fetus, and postnatal development. As a precautionary measure, it is advisable to avoid using CONDROSULF UNIDIE during pregnancy.
Breastfeeding
In the absence of clinical data on excretion in breast milk, the use of CONDROSULF UNIDIE is not recommended in breastfeeding women.
Fertility
Animal studies are insufficient to determine effects on male and female fertility.
Driving and using machines
The effects on the ability to drive and use machines have not been specifically studied.
However, chondroitin sulfate may slightly impair the ability to drive and use machinery. Dizziness may occur after taking the medicine (see section 4).
CONDROSULF UNIDIE 1200 mg oral gel contains 6 mg of sodium benzoate (E211) per sachet.
The medicine also contains 110 mg of sodium (the main component of table/cooking salt) per sachet. This amount corresponds to 5.5% of the maximum daily sodium intake recommended in an adult's diet.

3. How to take CONDROSULF UNIDIE 1200 mg oral gel

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For use in adults only (over 18 years of age).
The recommended dose is one sachet (1200 mg) taken once daily.
Tear open the sachet and squeeze to release the gel.
For oral use.
The contents of the sachet may be swallowed undiluted or diluted in half a glass of water, preferably taken with food.
The duration of treatment may be adjusted according to clinical response, bearing in mind that the medicine has a delayed effect of 2 months and that this effect may persist even after discontinuation of treatment.

Paediatric population
Due to lack of adequate studies, the use of CONDROSULF UNIDIE is not recommended in children and adolescents under 18 years of age.

Patients with renal, hepatic, and cardiac impairment
Experience with the use of sodium chondroitin sulfate in patients with renal, hepatic, or cardiac impairment is limited. Therefore, these patients should be treated with particular caution (see section "Warnings and precautions").

If you take more CONDROSULF UNIDIE 1200 mg oral gel than you should
Contact your doctor or pharmacist immediately.

If you forget to take CONDROSULF UNIDIE 1200 mg oral gel
Not applicable

If you stop taking CONDROSULF UNIDIE 1200 mg oral gel
Not applicable

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Within each system organ classification, adverse reactions are listed according to frequency, using the following categories: very common (>1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000).

System organ classification	Rare	Very rare
Nervous system disorders		Dizziness
Gastrointestinal disorders	Gastrointestinal disorder Epigastralgia Nausea Diarrhea
Skin and subcutaneous tissue disorders	Erythema Rash Maculopapular rash	Urticaria Eczema Pruritus Allergic reaction^1,2
General disorders and administration site conditions¹		Edema²

Cases of allergic reactions (e.g. angioedema) have been reported rarely.
See section "Warnings and precautions".
If you notice the appearance of any adverse reactions not listed in this leaflet, or if any of the listed adverse reactions worsen, consult your doctor or pharmacist.
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 through the national reporting system at the following website: 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 UNIDIE 1200 mg oral gel

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date (Exp.) stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or 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 UNIDIE 1200 mg oral gel contains
The active substance is:
sodium chondroitin sulfate…………………………………………………………………..1200 mg
The other ingredients are: xylitol, sodium benzoate (E211), potassium sorbate, microcrystalline cellulose, vanilla flavour, caramel flavour, purified water.
Description of the appearance of CONDROSULF UNIDIE 1200 mg oral gel and contents of the
pack
Each sachet contains an opalescent, viscous, amber-coloured gel with a characteristic aromatic taste for oral use.
Carton containing 14 sachets
Carton containing 30 sachets
Marketing Authorization Holder and Manufacturer
IBSA FARMACEUTICI ITALIA SRL
Via Martiri di Cefalonia 2
26900 Lodi,
ITALY