Leaflet: information for the user

Glufan 625 mg film-coated tablets

glucosamine

1. What isGlufanand what it is used for

2. What you need to know before starting to takeGlufan

3. How to takeGlufan

4. Possible side effects

5. Storage ofGlufan

6. Contents of the pack and additional information

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

Glufanis indicated for the relief of symptoms produced by mild to moderate knee arthritis.

Do not takeGlufan:

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

- If you are allergic to seafood, as the active ingredient, glucosamine, is obtained from seafood.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glufan.

- If you have diabetes, you should consult with your doctor before taking Glufan. You may need more frequent checks of your blood sugar levels when starting treatment.

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

Stop taking Glufan and see your doctor immediately if you experience any of the following symptoms (angioedema).

• Swelling in the face, lips, tongue, or throat
• Difficulty swallowing
• Rash on the skin and difficulty breathing

Other medications and Glufan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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 monitored more closely at the start or end of treatment with glucosamine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Glufan should not be administered during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Glufan does not affect the ability to drive or operate machinery. However, if you feel tired or experience headaches while taking Glufan, you should not drive or handle tools or machinery.

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

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

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 inform you of the daily dose based on your individual characteristics.

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

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 areheadache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhea, or constipation. In case of overdose, treatment withGlufan should be discontinued.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Glufan

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been described:

-Frequent(may affect up to 1 in 10 patients):headache, drowsiness, upper abdominal discomfort.

-Rare(may affect up to 1 in 100 patients):skin rash, itching, skin redness.

-Unknown frequency(cannot be estimated from available data):dizziness, asthma or worsening of asthma, stomach pain, diarrhea, nausea/vomiting, facial, tongue, or throat swelling (angioedema, see “Warnings and precautions”),hives,worsening of blood glucose control in patients with diabetes mellitus, edema, e.g. of ankles, legs, and feet, liver failure (elevated liver enzymes and jaundice).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

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

Unused medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Glufan

• The active ingredient is hydrochloride of glucosamine, which corresponds to 625 mg of glucosamine (equivalent to 750 mg of hydrochloride of glucosamine).
• 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), yellow-orange aluminum lake FCF S (E-110), yellow quinoline (E-104), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging.

The tablets are yellow and oval-shaped.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder.

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 – Madrid

Spain

Responsible for Manufacturing

ROVI Pharma Industrial Services, S.A.

Vía Complutense 140

28805 Alcalá de Henares (Madrid)

Spain

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Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Last review date of this leaflet:April 2021

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/