Cartisorb 1500 mg powder for oral solution
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
CARTISORB 1500 mg powder for oral solution
Glucosamine sulphate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Cartisorb is and what it is used for
- What you need to know before taking Cartisorb
- How to take Cartisorb
- Possible side effects
- How to store Cartisorb
- Contents of the pack and other information
1. What Cartisorb is and what it is used for
Cartisorb belongs to the group of medicines known as other non-steroidal anti-inflammatory and anti-rheumatic agents.
Cartisorb is indicated for the relief of symptoms caused by mild to moderate knee osteoarthritis.
2. What you need to know before starting to take Cartisorb
Do not take Cartisorb:
- if you are allergic (hypersensitive) to glucosamine or to any of the other components of this medicine (listed in section 6).
- if you are allergic (hypersensitive) to shellfish, since glucosamine is derived from shellfish.
Warnings and precautions
- if you have impaired glucose tolerance. More frequent monitoring of blood sugar levels may be necessary when starting treatment with glucosamine.
- if you have any risk factors for heart or arterial diseases, as increases in cholesterol levels have been observed in some 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 alternative treatments should be considered.
Children and adolescents
Do not take Cartisorb if you are under 18 years of age.
Use of Cartisorb with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
Caution is recommended if Cartisorb is administered in combination with other medicines, especially:
- Certain types of medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be enhanced when used together with glucosamine. Therefore, patients receiving these combinations should be monitored more closely when starting or stopping treatment with glucosamine.
- Antibiotics such as tetracycline.
Taking Cartisorb with food and drinks
Dissolve the contents of the Cartisorb sachet in a glass of water and take once daily, preferably with meals.
Pregnancy, breastfeeding, and fertility
Cartisorb must not be used during pregnancy.
The use of glucosamine is not recommended during breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
No studies have been conducted on the effects of Cartisorb on the ability to drive or operate machinery. However, if you experience dizziness or drowsiness while taking Cartisorb, you should not drive or operate machinery (see section 4 “Possible side effects”).
Cartisorb contains sodium. This medicine contains 151 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 7.6% of the maximum daily recommended intake of sodium for an adult.
Cartisorb contains sorbitol. This medicine contains 2,028.5 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
3. How to take Cartisorb
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will adjust the dose according to your condition.
Method of administration and dosage
The usual starting dose is one sachet (dissolved in a glass of water) once daily, preferably with meals.
For oral use.
Duration of treatment
Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not occur until several weeks of treatment have passed, and in some cases even longer. If you do not experience symptom relief within 2–3 months, consult your doctor or pharmacist, as alternative treatments may need to be considered.
If you take more Cartisorb than you should
If you take more Cartisorb than you should, or if someone else or a child takes this medicine, inform your doctor or pharmacist.
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 any of the symptoms listed above.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562-04-20, indicating the medicine and the amount taken.
If you forget to take Cartisorb
Do not take a double dose to make up for missed doses.
If you stop treatment with Cartisorb
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You should stop taking glucosamine and go immediately to your doctor or nearest hospital if you experience any of the following symptoms:
- Swelling of lips, face, tongue or throat.
- Difficulty swallowing or breathing.
- Skin rash or hives.
These symptoms may indicate that you are experiencing a severe allergic reaction to this medicine.
The most commonly observed adverse effects are:
Frequent (may affect up to 1 in 10 people)
- Headache.
- Tiredness.
- Nausea.
- Abdominal pain.
- Indigestion.
- Diarrhoea.
- Constipation.
Uncommon (may affect up to 1 in 100 people)
- Skin rash.
- Itching.
- Redness.
- Vomiting.
Frequency not known (cannot be estimated from available data)
- Dizziness.
- Worsening of asthma symptoms.
- Swelling of ankles, legs and feet.
- Urticaria.
- Increased cholesterol levels and worsening of blood sugar (glucose) levels in diabetes mellitus.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through Spain’s national reporting system: “Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es”. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cartisorb
Store below 30°C. Keep in the original packaging to protect from moisture. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging following the abbreviation “EXP”. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cartisorb
- The active substance is glucosamine. Each sachet of Cartisorb contains 1,500 mg of glucosamine sulfate as glucosamine sulfate sodium chloride complex, equivalent to 1,178 mg of glucosamine.
- The other components are: sucralose, sorbitol (E-420), sodium chloride, citric acid, macrogol 4000 and lemon flavour.
Nature of the product and contents of the pack
Cartisorb is presented in sachets containing powder for oral solution.
Each pack contains 30 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LABORATORIO REIG JOFRE, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona), Spain.
Manufacturer:
SINCROFARM S.L.
C/Mercurio, 10. Pol. Ind. Almeda
08940 Cornellà de Llobregat (Barcelona) - Spain
Date of the most recent review of this leaflet: May 2019
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines: http://www.aemps.gob.es