Package Insert: Information for the User

Glucosamine Normon 1,500 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 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..

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

This medicine is used to relieve symptoms caused by mild to moderate knee arthritis.

• Do not take Glucosamina Normon

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

• Warnings and precautions

Consult your doctor or pharmacist before starting to take Glucosamina Normon

• If you have impaired glucose tolerance. Frequent monitoring of blood sugar levels may be necessary when starting treatment with glucosamine.
• If you have any risk factors for heart or artery diseases, as in some cases, increases in 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 any kidney or liver impairment, as no investigations have been conducted in these conditions and therefore no recommendations can be given on dosage.

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

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

• Other medications and Glucosamina Normon

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

Be careful if you take glucosamine simultaneously with other medications, especially with warfarin and tetracycline. Consult your doctor for proper advice.

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

• Glucosamina Normon intake with food and beverages

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

• Pregnancy and breastfeeding

Glucosamina Normon should not be used during pregnancy.

Do not take glucosamine in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take glucosamine during the first 6 months of pregnancy unless clearly necessary and as advised 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 time possible. From week 20 of pregnancy, glucosamine may cause renal problems in your fetus if taken for more than a few days, which may cause 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 a period longer than a few days, your doctor may recommend additional monitoring.

Glucosamina Normon is not recommended for use during breastfeeding.

Consult your doctor or pharmacist before using any medication.

• Driving and operating machinery

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

Glucosamina Normon contains sodium and sorbitol (E-420)

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

This medication contains 1006 mg of sorbitol (E-420) 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.

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

• Administration Mode and Dosage

The usual starting dose is one packet (dissolved in a glass of water) taken 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 evident until after several weeks of treatment, and in some cases even longer. If you do not experience symptom relief after 2-3 months, reconsider continuing treatment with glucosamine.

• 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 medication, inform your doctor or pharmacist.

Signs and symptoms of glucosamine overdose include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea, or constipation. Do not continue taking the medication 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. Phone: 91 562 04 20, indicating the medication and the amount taken.

• If You Forget to Take Glucosamine Normon

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

If you have any other questions about using this product, 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 glucosamine treatment and immediately consult your doctor if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Urticaria 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.

• Rare(may affect up to 1 in 100 people)

• 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store in the original packaging to protect it from moisture.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Glucosamina Normon

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

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

Appearance of Glucosamina Normon and contents of the packaging

White powder in single-dose sachets.

Each package contains 20 or 30 sachets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:April 2023