Package Insert: Information for the User

XICIL 1500 mg Powder for Oral Solution EFG

Glucosamine Sulfate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

XICIL belongs to the group of medications known as other nonsteroidal anti-inflammatory and antirheumatic compounds.

XICIL is indicated to relieve symptoms caused by mild to moderate knee arthritis.

Do not take XICIL

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

Warnings and precautions

• if you have impaired glucose tolerance. Frequent blood sugar level checks may be necessary when starting treatment with glucosamine.
• if you have any risk factors for heart or artery disease, as in some cases, increased cholesterol levels have been observed in 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 another treatment should be considered.

Children and adolescents

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

Other medications and XICIL

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

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

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

- Antibiotics such as tetracycline

XICIL with food and beverages

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.

Glucosamine is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on how XICIL affects the ability to drive and operate machinery. However, if you experience dizziness or drowsiness when taking XICIL, do not drive or operate machinery (see section 4 "Possible side effects").

XICIL contains sodium, sorbitol, and aspartame

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

This medication contains 2028.5 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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 (or your child) before taking this medication.

This medication contains 2.5 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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 adjust the dosage according to your condition.

Administration Method and Dosage

The usual starting dose is one packet (dissolved in a glass of water) once a day, preferably with meals.

For oral use.

Treatment Duration

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be appreciated 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 medication, inform 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 first sign of the mentioned symptoms.

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

If You Forget to Take XICIL

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

If You Interrupt Treatment with XICIL

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

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

You should interrupt the treatment of glucosamine and immediately go to your doctor or the nearest hospital if you experience any of the following symptoms:

• Swelling of the lips, face, tongue, or throat
• Difficulty swallowing or breathing
• Skin rash or urticaria

These symptoms may indicate that you are suffering from a severe allergic reaction to this medication. The most frequently observed adverse effects are:

Frequent (may affect up to 1 in 10 people)

• Headache
• Fatigue
• NauseaAbdominal pain
• Indigestion
• Diarrhea
• Constipation

Rare(may affect up to 1 in 100 people)

• Skin rash
• Itching
• Redness
• Vomiting

Unknown frequency (cannot be estimated from available data)

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 national notification system "Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es". By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging and label after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of XICIL

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

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

Appearance of the product and contents of the packaging

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

Each package contains 20 or 30 single-dose sachets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

Rottapharm, Ltd.

Damastown Industrial Park

Mulhuddart, Dublin 15

Ireland

or

SIGMAR ITALIA S.r.l.

Vía Sombrero, 11

24011 – Almè (Bergamo) - Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Last review date of this leaflet:October 2022

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