GLUCOSAMINE NORMON 1500 mg POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Glucosamine Normon 1,500 mg Powder for Oral Solution EFG

Glucosamine, sulfate

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

• Keep this package leaflet, as 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What Glucosamine Normon is and what it is used for.
2. What you need to know before taking Glucosamine Normon.
3. How to take Glucosamine Normon
4. Possible side effects
5. Storage of Glucosamine Normon
6. Package contents and further information

1. What Glucosamine Normon is and what it is used for

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

This medicine is used to relieve the symptoms produced by mild to moderate knee osteoarthritis.

2. What you need to know before taking Glucosamine Normon

• Do not take Glucosamine Normon

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

• Warnings and precautions

Talk to your doctor or pharmacist before starting to take Glucosamine Normon

• If you have altered sugar tolerance (glucose). More frequent checks 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 any kidney or liver impairment, as no investigations have been carried out in these conditions and, therefore, no dosage recommendations can be given.

You should consult your doctor to rule out the presence of other joint diseases for which other treatments should be considered.

Do not take this medicine if you are under 18 years old.

• Other medicines and Glucosamine Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Be careful if you take glucosamine at the same time as other medicines, especially warfarin and tetracycline. Consult your doctor for proper advice.

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 together with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.

• Taking Glucosamine Normon with food and drinks

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

• Pregnancy and breastfeeding

Glucosamine Normon should not be used during pregnancy.

Do not take glucosamine if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take glucosamine during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, glucosamine may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

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

Glucosamine Normoncontains sodium and sorbitol (E-420)

This medicine contains 153 mg of sodium (main component of table/cooking salt) in each sachet. This is equivalent to 7.65% of the maximum recommended daily sodium intake for an adult.

This medicine contains 1006 mg of sorbitol (E-420) in each 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.

3. How to take Glucosamine Normon

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

• Administration method and dosage

The normal starting dose is one sachet (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 apparent until after several weeks of treatment, and in some cases even longer. If you do not experience relief of symptoms after 2-3 months, continuation of treatment with glucosamine should be reconsidered.

• If you take more Glucosamine Normon than you should

If you take more glucosamine than you should, or if another person or child takes this medicine, tell your doctor or pharmacist.

Signs and symptoms of overdose with glucosamine include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea, or constipation. Do not continue taking the medicine if you experience any of the above 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 Glucosamine Normon

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.

You should interrupt treatment with glucosamine and go immediately to your doctor if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

The most frequently observed are:

• Frequent(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)

• Rash.
• Itching.
• Redness.
• Vomiting.

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

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

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 package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosamine Normon

Keep in the original packaging to protect from moisture.

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

Do not use this medicine after the expiry date stated on the sachet and on the packaging after the abbreviation "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Glucosamine Normon

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

The other ingredients are: sorbitol (E-420), citric acid, macrogol 6000, and sodium saccharin.

Appearance of Glucosamine Normon and package contents

White powder in single-dose sachets.

Each package contains 20 or 30 sachets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last revision of this package leaflet:April 2023