Leaflet: information for the user

CARTISORB 1500 mg powder for oral solution

Glucosamine sulfate

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

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Cartisorb is and what it is used for

2. What you need to know before you start taking Cartisorb

3. How to take Cartisorb

4. Possible side effects

5. Storage of Cartisorb

6. Contents of the pack and additional information

Cartisorb belongs to the group of medications known as other nonsteroidal anti-inflammatory and antirheumatic compounds.

Cartisorb is indicated to relieve symptoms caused by mild to moderate knee arthritis.

Do not take Cartisorb:

-if you are allergic (hypersensitive) to glucosamine or to any of the other components of this medication (listed in section 6).

-if you are allergic (hypersensitive) to shellfish, as glucosamine is derived from shellfish

Warnings and precautions

-if you have impaired glucose tolerance. Frequent blood sugar level checks may be necessary when starting treatment with glucosamine.

-if you have any risk factors for heart or vascular diseases, as in some cases, increased cholesterol levels have been observed in patients treated with glucosamine.

-if you have asthma. When starting treatment with glucosamine, be aware that symptoms may worsen.

-if you have kidney or liver problems.

You should consult your doctor to rule out the presence of other joint diseases for which another treatment should be considered.

Children and adolescents

Do not take Cartisorb if you are under 18 years old.

Use of Cartisorb with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

Precaution is recommended if Cartisorb is administered in combination with other medications, especially with:

-Some types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medications may be potentiated if used with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.

-Antibiotics such as tetracycline.

Cartisorb intake with food and beverages

Dissolve the contents of the Cartisorb sachet in a glass of water and take it once a day, preferably with meals.

Pregnancy, breastfeeding, and fertility

Cartisorb should not be used during pregnancy.

Glucosamine is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on how Cartisorb affects the ability to drive and operate machinery. However, if you experience dizziness or drowsiness when taking Cartisorb, do not drive or operate machinery (see section 4 "Possible side effects").

Cartisorb contains sodium.This medication contains 151 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 7.6% of the recommended daily maximum sodium intake for an adult.

Cartisorb contains sorbitol. This medication contains 2,028.5 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has indicated that you have a condition of intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dosage according to your condition.

Administration Method and Dosage

The usual starting dose is one packet (dissolved in a glass of water) once a day, preferably with meals.

For oral use.

Treatment Duration

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be appreciated until after several weeks of treatment and, in some cases, even longer. If you do not experience relief of symptoms in 2-3 months, consult your doctor or pharmacist, as you may need to consider other treatments.

If You Take More Cartisorb Than You Should

If you take more Cartisorb than you should, or if another person or child takes this medication, inform your doctor or pharmacist.

The signs and symptoms of overdose with glucosamine include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea, or constipation. Do not continue taking Cartisorb at the first sign of the mentioned symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: (91) 562-04-20, indicating the medication and the amount taken.

If You Forget to Take Cartisorb

Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Cartisorb

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You should discontinue treatment with glucosamine and immediately seek medical attention at the nearest hospital if you experience any of the following symptoms:

-Lip, face, tongue, or throat swelling.

-Difficulty swallowing or breathing.

-Skin rash or urticaria.

These symptoms may indicate that you are experiencing a severe allergic reaction to this medicine.

The most frequently observed side effects are:

Frequent (may affect up to 1 in 10 people)

-Headache.

-Fatigue.

-Nausea.

-Abdominal pain.

-Indigestion.

-Diarrhea.

-Constipation.

Rare (may affect up to 1 in 100 people)

-Skin rash.

-Itching.

-Redness.

-Vomiting.

Unknown frequency (cannot be estimated from available data)

-Dizziness.

-Worsening of asthma symptoms.

-Swelling in ankles, legs, and feet.

-Urticaria.

-Increased cholesterol levels and worsening blood sugar levels in diabetes mellitus.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through Spain's national notification system "Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es". By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 30°C. Store in the original packaging to protect it from moisture. Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the overwrap and container after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cartisorb

-The active principle is glucosamine. Each Cartisorb sachet contains 1,500 mg of sodium chloride glucosamine sulfate, equivalent to 1,178 mg of glucosamine.

-The other components are: sucralose, sorbitol (E-420), sodium chloride, citric acid, macrogol 4000, and lemon aroma.

Appearance of the product and content of the packaging

Cartisorb is presented in sachets containing powder for oral solution.

Each package contains 30 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona) Spain.

Responsible for manufacturing:

SINCROFARM S.L.

C/Mercurio, 10. Pol. Ind. Almeda

08940 Cornellà de Llobregat(Barcelona) - Spain

Date of the last review of this leaflet:May 2019

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines:http://www.aemps.gob.es