Glufan 625 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Glufan 625 mg film-coated tablets
glucosamine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Package leaflet contents
- What Glufan is and what it is used for
- What you need to know before taking Glufan
- How to take Glufan
- Possible side effects
- Storage of Glufan
- Package contents and additional information
1. What Glufan is and what it is used for
Glucosamine is a natural product derived from glucose (a sugar). Glucosamine aids in the formation of cartilage and joints.
Glufan is indicated for the relief of symptoms caused by mild to moderate knee osteoarthritis.
2. What you need to know before starting to take Glufan
Do not take Glufan:
- If you are hypersensitive (allergic) to glucosamine or to any of the other components of this medicine (listed in section 6).
- If you are allergic to shellfish, since the active ingredient, glucosamine, is derived from shellfish.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Glufan.
- If you have diabetes, you should consult your doctor before taking Glufan. More frequent monitoring of blood sugar levels may be required when starting treatment.
- If you have asthma. When starting treatment with Glufan, you should be aware that symptoms may worsen.
Stop taking Glufan and seek immediate medical attention if you experience any of the following symptoms (angioedema):
- Swelling of the face, lips, tongue, or throat
- Difficulty swallowing
- Skin rash and difficulty breathing
Other medicines and Glufan
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some 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.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Glufan should not be administered during pregnancy or breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and use of machines
Glufan does not affect the ability to drive or operate machinery. However, if you experience tiredness or headache while taking Glufan, you should not drive or operate tools or machinery.
Glufan contains Orange Yellow S aluminium lake FCF (E-110):
This medicine may cause allergic reactions because it contains Orange Yellow S aluminium lake FCF (E-110).
3. How to take Glufan
Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine your daily dose based on your individual characteristics.
The recommended dose is one tablet twice daily. Once symptom relief has been achieved, the dose may be reduced to one tablet per day.
The tablets should be swallowed with a sufficient amount of liquid.
If you take more Glufan than you should
Signs and symptoms that may occur in case of an overdose with glucosamine include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhea, or constipation. In case of overdose, treatment with Glufan should be discontinued.
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 medication and the amount ingested.
If you forget to take Glufan
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The following adverse effects have been reported:
- Common (may affect up to 1 in 10 people): headache, somnolence, upper abdominal discomfort.
- Uncommon (may affect up to 1 in 100 people): skin rash, itching, redness of the skin.
-Frequency not known*(cannot be estimated from the available data):* dizziness, asthma or worsening of asthma, stomach pain, diarrhoea, nausea/vomiting, swelling of the face, tongue or throat (angioedema, see “Warnings and precautions”), urticaria, worsening of blood glucose control in patients with diabetes mellitus, oedema, e.g. of ankles, legs and feet, hepatic failure (increase in liver enzymes and jaundice).
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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Glufan.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original container.
Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Package contents and additional information
Composition of Glufan
- The active substance is glucosamine hydrochloride, corresponding to 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride).
- The other components (excipients) are:
Tablet core: povidone, calcium phosphate, microcrystalline cellulose, crospovidone, and magnesium stearate.
Coating: polyvinyl alcohol, talc, lecithin, macrogol, titanium dioxide (E-171), orange-yellow FCF aluminum lake (E-110), quinoline yellow (E-104), iron oxide yellow (E-172).
Appearance of the product and contents of the container.
The tablets are yellow and oval-shaped.
Glufan is available in 4 different package sizes: 20, 60, 90, and 180 tablets.
Only some of these package sizes may be commercially available.
Marketing Authorization Holder
Laboratorios Farmacéuticos ROVI, S.A.
Julián Camarillo, 35
28037 – Madrid
Spain
Manufacturer
ROVI Pharma Industrial Services, S.A.
Vía Complutense 140
28805 Alcalá de Henares (Madrid)
Spain
Or
Laboratorios Farmacéuticos ROVI, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
Date of the most recent review of this leaflet: April 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/