GLUFAN 625 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Glufan 625 mg film-coated tablets

glucosamine

Contents of the pack

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

1. What is Glufan and what is it used for

Glucosamine is a natural product produced from glucose (a sugar). Glucosamine facilitates the formation of cartilage and joints.

Glufan is indicated for the relief of symptoms produced by mild to moderate knee osteoarthritis.

2. What you need to know before you take Glufan

Do not takeGlufanif:

• You are hypersensitive (allergic) to glucosamine or any of the other components of this medicine (listed in section 6).
• You are allergic to shellfish, as the active ingredient, glucosamine, is obtained 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 necessary when starting treatment.
• If you have asthma. When starting treatment with Glufan, you should be aware that symptoms may worsen.

Stop taking Glufan and consult your doctor immediately 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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Glufan should not be administered during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Glufan does not affect the ability to drive or use machinery. However, if you feel tired or have a headache when taking Glufan, you should not drive or operate tools or machines.

Glufan contains yellow orange aluminium lake (E-110):

This medicine may cause allergic reactions because it contains yellow orange aluminium lake (E-110).

3. How to take Glufan

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the daily dose based on your individual characteristics.

The recommended dose is one tablet twice a day. Once symptom relief is achieved, the dose may be reduced to one tablet a day.

The tablets should be swallowed with a sufficient amount of liquid.

If you take more Glufan than you should

The signs and symptoms that may occur in case of overdose with glucosamine are 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Glufan

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

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

4. Possible side effects

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

The following side 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, diarrhea, nausea/vomiting, swelling of the face, tongue, or throat (angioedema, see "Warnings and precautions"), urticaria, worsening of glucose control in patients with diabetes mellitus, edema, e.g., of ankles, legs, and feet, liver failure (increased liver enzymes and jaundice).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 package.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

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 of Glufan

• The active substance is glucosamine hydrochloride, which corresponds to 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride).
• The other components (excipients) are:

Core of the tablet:povidone, calcium phosphate, microcrystalline cellulose, crospovidone, and magnesium stearate.

Coating:polyvinyl alcohol, talc, lecithin, macrogol, titanium dioxide (E-171), yellow orange aluminium lake (E-110), quinoline yellow (E-104), and iron oxide yellow (E-172).

Appearance and packaging of the product.

The tablets are yellow and oval.

Glufan is available in 4 different pack sizes: 20, 60, 90, and 180 tablets.

Not all pack sizes may be marketed.

Marketing authorisation 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 last revision of this leaflet:April 2021

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