XICIL 1500 MG ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

XICIL 1500 mg Powder for Oral Solution EFG

Glucosamine Sulfate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is XICIL and what is it used for
2. What you need to know before you take XICIL
3. How to take XICIL
4. Possible side effects
5. Storage of XICIL

1. Contents of the pack and further information

1. What is XICIL and what is it used for

XICIL belongs to the group of medicines called other anti-inflammatory and anti-rheumatic non-steroidal compounds.

XICIL is indicated to relieve symptoms produced by mild to moderate knee osteoarthritis.

2. What you need to know before you take XICIL

Do not take XICIL

• if you are allergic (hypersensitive) to glucosamine or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to shellfish, as glucosamine is obtained from shellfish.

Warnings and precautions

• if you have altered sugar (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 artery disease, as increased cholesterol levels have been observed in some patients treated with glucosamine.
• if you have asthma. When starting treatment with glucosamine, keep in mind 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 other treatments should be considered.

Children and adolescents

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

Other medicines and XICIL

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Caution is recommended if XICIL is administered in combination with other medicines, especially with:

• 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 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

Taking XICIL with food and drinks

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

Pregnancy, breastfeeding, and fertility

XICIL should 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 how XICIL affects the ability to drive and use machines. However, if you experience dizziness or drowsiness when taking XICIL, do not drive or use machines (see section 4 "Possible side effects").

XICIL contains sodium, sorbitol, and aspartame

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

This medicine contains 2028.5 mg of sorbitol per sachet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or 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 medicine.

This medicine contains 2.5 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

3. How to take XICIL

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

Your doctor will adjust the dose according to your condition.

Method of administration and dosage

The normal starting dose is one sachet (dissolved in a glass of water) once a day, 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 be noticed 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 XICIL than you should

If you take more XICIL than you should, or if another person or child takes this medicine, tell 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 XICIL at the slightest presence of the aforementioned 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 medicine and the amount taken.

If you forget to take XICIL

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

If you stop taking XICIL

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

4. Possible side effects

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

You must stop the treatment with glucosamine and go immediately to your doctor or the 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 suffering a severe allergic reaction to this medicine. The most frequently observed side effects are:

Common (may affect up to 1 in 10 people)

• Headache
• Fatigue
• Nausea
• Abdominal pain
• Indigestion
• Diarrhea
• Constipation

Uncommon (may affect up to 1 in 100 people)

• Skin rash
• Itching
• Redness
• Vomiting

Frequency not known (cannot be estimated from the available data)

• Dizziness
• Worsening of asthma symptoms
• Swelling in ankles, legs, and feet
• Hives
• Increased cholesterol levels and worsening of blood sugar (glucose) levels in patients with diabetes mellitus

If you consider that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

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 them directly through the Spanish national reporting system "Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es". By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of XICIL

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton after CAD or EXP. The expiry date is the last day of the month stated.

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 XICIL

The active substance is glucosamine. Each XICIL sachet contains 1,500 mg of glucosamine sulfate as glucosamine sulfate sodium chloride, equivalent to 1,178 mg of glucosamine.

The other ingredients are: aspartame (E-951), sorbitol (E-420), sodium, citric acid, and macrogol 4000.

Appearance of the product and pack contents

The powder is white crystalline and odorless and is packaged in single-dose sachets.

Each pack contains 20 or 30 single-dose sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

Rottapharm, Ltd.

Damastown Industrial Park

Mulhuddart, Dublin 15

Ireland

or

SIGMAR ITALIA S.r.l.

Via Sombrero, 11

24011 – Almè (Bergamo) - Italy

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 – Barcelona

Spain

Date of the last revision of this leaflet:October 2022

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