GLUCOSAMINE KERN PHARMA 1500 mg POWDER FOR ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosamine Kern Pharma 1,500 mg powder for oral solution EFG

Glucosamine sulfate

Read all of this leaflet carefully before you start taking this medicine.

• 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. 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.

Contents of the pack:

1. What Glucosamine Kern Pharma is and what it is used for.
2. Before taking Glucosamine Kern Pharma.
3. How to take Glucosamine Kern Pharma.
4. Possible side effects.
5. Storage of Glucosamine Kern Pharma.
6. Further information.

1. What Glucosamine Kern Pharma is and what it is used for

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

Glucosamine Kern Pharma is indicated to relieve symptoms caused by mild to moderate knee osteoarthritis.

2. Before taking Glucosamine Kern Pharma

Do not take Glucosamine Kern Pharma:

• if you are allergic (hypersensitive) to glucosamine or any of the other ingredients of Glucosamine Kern Pharma,
• if you are allergic (hypersensitive) to shellfish, as glucosamine is obtained from shellfish.

Take special care with Glucosamine Kern Pharma:

• if you have altered 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 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 treatment should be considered.

Do not take Glucosamine Kern Pharma if you are under 18 years old.

Using other medicines

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

Caution is recommended if Glucosamine Kern Pharma is administered simultaneously 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.

Consult your doctor for proper advice.

Taking Glucosamine Kern Pharma with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Glucosamine Kern Pharma should not be used during pregnancy. It may cause kidney and heart problems in your fetus.

The use of glucosamine during breastfeeding is not recommended.

Driving and using machines

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

Important information about some of the ingredients of Glucosamine Kern Pharma:

Patients on low-sodium diets should note that this medicine contains 151 mg (6.57 mmol) of sodium per sachet.

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking/using this medicine.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Glucosamine Kern Pharma

Follow the administration instructions of Glucosamine Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will adjust the dose according to your condition.

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.

Duration of treatment

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 relief of symptoms after 2-3 months, the continuation of treatment with glucosamine should be reconsidered.

If you take more Glucosamine Kern Pharma than you should

If you take more Glucosamine Kern Pharma 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 Glucosamine Kern Pharma 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 Kern Pharma

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

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

4. Possible side effects

Like all medicines, Glucosamine Kern Pharma can cause side effects, although not everybody gets them.

You should interrupt treatment with glucosamine and go to your doctor immediately 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 side effects are:

Frequent (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

• Rash.
• Itching.
• Redness.

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.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Glucosamine Kern Pharma

Keep below 25°C.

Keep out of the reach and sight of children.

Do not use Glucosamine Kern Pharma after the expiration date stated on the sachet and packaging after the abbreviation "Cad". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Glucosamine Kern Pharma:

• The active ingredient is glucosamine. Each Glucosamine Kern Pharma 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 (E951), sorbitol (E420), sodium, citric acid, and macrogol 4000.

Appearance of the product and packaging contents

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

Each package contains 20 or 30 sachets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder and manufacturer:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colon II

08228 Terrasa - Barcelona

Spain

Date of the last revision of this leaflet: September 2023.

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