CONDRAL 400 mg Hard Capsule

Зміст інструкції

1. What is CONDRAL and what is it used for
2. What you need to know before taking CONDRAL
3. How to take CONDRAL
4. Possible side effects
5. How to store CONDRAL
6. Package Contents and Other Information
7. What is CONDRAL and what is it used for
8. What you need to know before you take CONDRAL
9. How to take CONDRAL
10. Possible side effects
11. How to store CONDRAL
12. Contents of the pack and other information

CONDRAL 400 mg hard capsules
Sodium chondroitin sulfate

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CONDRAL and what is it used for

What is CONDRAL
CONDRAL is a medicine based on Sodium Chondroitin Sulfate which belongs to the class of polysaccharides.
Chondroitin sulfate is an important component of cartilage, the supporting tissues present in the joints.

What is it used for
CONDRAL is indicated in adultsfor the treatment of symptoms of knee and hip osteoarthritis.

What is osteoarthritis?
Osteoarthritis is a very common disease, especially in adults, caused by an alteration of the tissue
cartilage in the joints.
The symptoms of osteoarthritis are: joint pain, stiffness after rest, reduced ability to
move the joints and in some cases deformation of the joints.

2. What you need to know before taking CONDRAL

Do not take CONDRAL:

• if you are allergic to sodium chondroitin sulfate or to chemically similar substances, or to any of the other ingredients of CONDRAL (see section 6 “What CONDRAL contains”).

Warnings and precautions
Talk to your doctor before taking CONDRAL

• if you suffer from any type of allergy.

Children and adolescents
The use of CONDRAL is not indicated in children and adolescents under 18 years of age because safety and efficacy
have not been established in this patient group.

Other medicines and CONDRAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
No interactions with other medicines are known to date.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under direct
medical supervision.

Driving and using machines
CONDRAL does not impair the ability to drive vehicles and operate machinery.

CONDRAL contains sodium
This medicine contains 37 mg of sodium (the main component of table salt) per capsule. This
is equivalent to 1.9% of the maximum recommended daily intake with the diet of an adult.

3. How to take CONDRAL

Take CONDRAL following the doctor's instructions exactly at all times. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose, unless otherwise prescribed by your doctor, is 2 to 3 capsules per day by mouth.
The duration of treatment should not be less than 3 weeks.

If you take more CONDRAL than you should
If you take more CONDRAL than you should, contact your doctor or go to the nearest hospital.

If you forget to take CONDRAL
Do not take a double dose to make up for a missed dose.

If you stop taking CONDRAL
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CONDRAL can cause side effects, although not everybody gets them.
Reactions such as nausea, diarrhoea, pain, abdominal discomfort and skin reactions may appear with the start of
therapy but are usually rare and mild.
The following side effects have been reported during treatment with CONDRAL, listed according to
frequency:

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

• dizziness
• pain in the upper abdomen
• diarrhoea
• nausea
• stomach and intestinal disorders
• redness of the skin (erythema)
• skin rash, including the appearance of red spots and blisters (rash and maculopapular rash). Very rare(less than 1 in 10,000):
• redness of the skin accompanied by itching (urticaria)
• skin inflammation accompanied by itching (eczema)
• itching
• swelling (edema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor.
You can also report side effects directly through the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store CONDRAL

Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after Expiry. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.

6. Package Contents and Other Information

What CONDRAL contains

• The active ingredient is sodium chondroitin sulfate. Each hard capsule contains 400 mg of sodium chondroitin sulfate.
• The other ingredients are: magnesium stearate, gelatin, indigotine (E132), quinoline yellow (E104).

Description of the appearance of CONDRAL and package contents
CONDRAL hard capsules are blue-green in color, packaged in blisters. They are available in a carton containing
20 hard capsules.

Marketing Authorisation Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 -20143 Milano

Manufacturer
DOPPEL Farmaceutici S.r.l. - Manufacturing facility at Via Volturno, 48 - 20089 Quinto De' Stampi – Rozzano (MI).
IBSA Farmaceutici Italia S.r.l. – Via Martiri di Cefalonia, 2 – 26900 Lodi.

CONDRAL 400 mg granules for oral solution
CONDRAL 800 mg granules for oral solution
Sodium chondroitin sulfate

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet:

• 1. What CONDRAL is and what it is used for
• 2. What you need to know before you take CONDRAL
• 3. How to take CONDRAL
• 4. Possible side effects
• 5. How to store CONDRAL
• 6. Package Contents and Other Information

2. What is CONDRAL and what is it used for

What is CONDRAL
CONDRAL is a medicine based on Sodium Chondroitin Sulfate which belongs to the class of polysaccharides.
Chondroitin sulfate is an important component of cartilage, the supporting tissues present in the joints.

What is it used for
CONDRAL is indicated in adultsfor the treatment of symptoms of knee and hip osteoarthritis.

What is osteoarthritis?
Osteoarthritis is a very common disease, especially in adults, caused by an alteration of the
cartilaginous tissue in the joints.
The symptoms of osteoarthritis are: joint pain, stiffness after rest, reduced ability to
move the joints and in some cases deformation of the joints.

2. What you need to know before you take CONDRAL

Do not take CONDRAL:

• if you are allergic to sodium chondroitin sulfate or to substances with similar chemical structures, or to any of the other ingredients of CONDRAL (see section 6 “What CONDRAL contains”).

Warnings and precautions
Talk to your doctor before taking CONDRAL

• if you suffer from any type of allergy.

Children and adolescents
The use of CONDRAL is not indicated in children and adolescents under 18 years of age because safety and efficacy
have not been established in this patient group.

Other medicines and CONDRAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
No interactions with other medicines are known to date.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under direct
medical supervision.

Driving and operating machinery
CONDRAL does not impair the ability to drive vehicles and operate machinery.

CONDRAL contains:

• sorbitol.In particular the 400 mg granulescontain 1335 mg of sorbitol per sachet, while the 800 mg granulescontain 2670 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 a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before taking this medicine;
• sunset yellow (E110):may cause allergic reactions;
• sodium(main component of table salt). In particular the 400 mg granulescontain 38 mg of sodium per sachet, while the 800 mg granulescontain 76 mg of sodium per sachet. This corresponds to 1.9% and 3.8% respectively of the maximum daily intake recommended with the diet of an adult.

3. How to take CONDRAL

Take CONDRAL following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose, unless otherwise prescribed by your doctor, is:

• 400 mg sachets: 2 to 3 sachets per day by mouth
• 800 mg sachets: one sachet per day by mouth. The contents of the sachets should be dissolved in water before taking. The duration of treatment should not be less than 3 weeks.

If you take more CONDRAL than you should
If you take more CONDRAL than you should, contact your doctor or go to the nearest hospital.

If you forget to take CONDRAL
Do not take a double dose to make up for a missed dose.

If you stop taking CONDRAL
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CONDRAL can cause side effects, although not everybody gets them.
Reactions such as nausea, diarrhoea, pain, abdominal discomfort and skin reactions may appear with the start of
therapy but are usually rare and of modest severity.
During treatment with CONDRAL, the following side effects have been reported, listed according to
frequency:

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

• dizziness
• pain in the upper abdomen
• diarrhoea
• nausea
• stomach and intestinal disorders
• redness of the skin (erythema)
• skin rash, including the appearance of red spots and blisters (rash and maculopapular rash). Very rare(less than 1 in 10,000):
• skin redness accompanied by itching (urticaria)
• skin inflammation accompanied by itching (eczema)
• itching
• swelling (edema).
• Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CONDRAL

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

6. Contents of the pack and other information

What CONDRAL contains

• The active ingredient is sodium chondroitin sulfate. Each sachet contains 400 mg or 800 mg of sodium chondroitin sulfate.
• The other ingredients are: citric acid, sodiumsaccharin (see paragraph “CONDRAL contains sodium”), orange aroma, sunset yellow(E 110)(see paragraph “CONDRAL contains sunset yellow (E110)”), sorbitol(see paragraph “CONDRAL contains sorbitol”), anhydrous colloidal silica.

Description of the appearance of CONDRAL and contents of the pack
CONDRAL oral solution granules 400 mg is packaged in sachets. They are available in a carton
containing 20 sachets.
CONDRAL oral solution granules 800 mg is packaged in sachets. They are available in a carton
containing 20 or 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 -20143 Milano

Manufacturer
IBSA Farmaceutici Italia S.r.l. – Via Martiri di Cefalonia, 2 – 26900 Lodi.