CONDROITIN SULFATE ABAMED 400 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Chondroitin Sulfate Abamed 400 mg Granules for Oral Solution

Sodium Chondroitin Sulfate

Read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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 harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Chondroitin Sulfate Abamed is and what it is used for
2. What you need to know before you take Chondroitin Sulfate Abamed
3. How to take Chondroitin Sulfate Abamed
4. Possible side effects
5. Storing Chondroitin Sulfate Abamed
6. Contents of the pack and further information

1. What Chondroitin Sulfate Abamed is and what it is used for

This medicinal product is indicated for the symptomatic treatment of osteoarthritis. It belongs to the group of non-steroidal anti-inflammatory and antirheumatic drugs.

2. What you need to know before you take Chondroitin Sulfate Abamed

Do not takeChondroitin Sulfate Abamed

• If you are allergic (hypersensitive) to sodium chondroitin sulfate or any of the other ingredients of this medicinal product.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicinal product.

• Be cautious if you have any serious kidney, liver, or heart disease.

UsingChondroitin Sulfate Abamedwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The administration of sodium chondroitin sulfate at doses much higher than recommended, along with some antiplatelet medication to prevent thrombosis, such as acetylsalicylic acid, dipyridamole, clopidogrel, ditazole, triflusal, and ticlopidine, may slightly increase the effect of the aforementioned medications.

Pregnancy, breastfeeding, and fertility

It is not recommended to take this medicinal product during pregnancy or breastfeeding.

Driving and using machines

It is not expected that sodium chondroitin sulfate will affect the ability to drive vehicles and use machines.

Chondroitin Sulfate Abamed contains orange yellow S (E-110), sodium, and sorbitol (E-420):

This medicinal product may cause allergic reactions because it contains orange yellow S (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

This medicinal product contains sorbitol (E-420). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicinal product.

Patients with low-sodium diets should be aware that this medicinal product contains 37.97 mg (1.65 mmol) of sodium per dose.

3. How to take Chondroitin Sulfate Abamed

Follow exactly the administration instructions of this medicinal product as indicated by your doctor. Your doctor will indicate the duration of your treatment with sodium chondroitin sulfate.

In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine.

The recommended dose is 2 sachets (total daily dose of sodium chondroitin sulfate: 800 mg) per day, preferably in a single dose (2 sachets at a time) for at least 3 months. However, in patients with significant inflammatory symptoms, and provided that the doctor considers it appropriate, treatment may be started with a dose of 1,200 mg (3 sachets per day, in a single dose or in 2 doses) for the first 4 or 6 weeks, followed by 800 mg (2 sachets per day, preferably in a single dose) until the administration period of at least 3 months is completed.

Treatment will be administered for a minimum of 3 months, after which a 2-month rest period will be carried out, and then the treatment will be restarted following the same cycle.

Pour the contents of the sachets into a glass and dissolve them in a little water before administration. The dose can be taken before, during, or after meals.

If you take moreChondroitin Sulfate Abamed than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicinal product and the amount ingested.

If you forget to takeChondroitin Sulfate Abamed

Do not take a double dose to make up for forgotten doses.

If you stop takingChondroitin Sulfate Abamed

Do not stop treatment beforehand, as its efficacy may be reduced.

If you have any further questions on the use of this medicinal product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 10,000 people), nausea and/or gastrointestinal disorders have been described, which generally do not require the suspension of treatment.

Very rarely (may affect up to 1 in 10,000 people), in patients with renal and/or cardiac insufficiency, some cases of edema and/or water retention have been described.

Very rarely (may affect up to 1 in 10,000 people), some allergic reactions have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storing Chondroitin Sulfate Abamed

Keep this medicinal product out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicinal product after the expiry date which is stated on the packaging after “EXP:”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofChondroitin Sulfate Abamed

• The active substance is sodium chondroitin sulfate. Each sachet contains 400 mg of sodium chondroitin sulfate.
• The other ingredients (excipients) are: anhydrous citric acid, orange flavor, sodium saccharin, orange yellow S (E110), anhydrous colloidal silica, and sorbitol.

Appearance and packaging of the product

This medicinal product is presented as an orange granulate for oral solution. Each pack contains 60 sachets (contains 2 boxes of 30 sachets).

Marketing authorization holder and manufacturer

Marketing authorization holder

Qualix Pharma, S.L.

C/ Botánica 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Manufacturer

Kern Pharma S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa

(Barcelona)

Date of last revision of this leaflet:November 2015.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/