GLUCOSAMINE CINFA 1500 mg POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

glucosamine cinfa 1500 mg powder for oral solution EFG

Glucosamine sulfate

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

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

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

Package Leaflet Contents

1. What is glucosamine cinfa and what is it used for
2. What you need to know before taking glucosamine cinfa
3. How to take glucosamine cinfa
4. Possible side effects
5. Storage of glucosamine cinfa
6. Package Contents and Additional Information

1. What is glucosamine cinfa and what is it used for

Glucosamine cinfa belongs to the group of medications called other anti-inflammatory and antirheumatic non-steroidal compounds.

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

2. What you need to know before taking glucosamine cinfa

Do not take glucosamine cinfa

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take glucosamine cinfa.

Be particularly careful:

• If you have altered sugar tolerance (glucose). More 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 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 conducted in these conditions and, therefore, no dosage recommendations can be given. Administration in these patients should always be under medical supervision.

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 glucosamine if you are under 18 years old.

Other Medications and Glucosamine Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

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

• Certain types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, fenprocoumon, acenocoumarol, and fluindione). The effect of these medications may be enhanced if used with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of glucosamine treatment.
• With other medications such as tetracycline.

Consult your doctor for proper advice.

Taking Glucosamine Cinfa 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Glucosamine should not be used during pregnancy.

The use of glucosamine is not recommended during breastfeeding.

Driving and Using Machines

No studies have been conducted on how glucosamine affects the ability to drive and use machines. However, if you experience headache, fatigue, dizziness, drowsiness, or vision problems while taking glucosamine, you should not drive or operate machines (see section 4 "Possible Side Effects").

Glucosamine Cinfa Contains Aspartame (E-951)

This medication contains 2.5 mg of aspartame in each sachet.

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

Glucosamine Cinfa Contains Sodium

This medication contains 151 mg of sodium (a major component of table/cooking salt) in each sachet. This is equivalent to 7.5% of the maximum recommended daily sodium intake for an adult.

3. How to Take Glucosamine Cinfa

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

Your doctor will adjust the dose according to your condition.

The recommended 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 from symptoms in 2-3 months, consult your doctor to reconsider continuing treatment with glucosamine.

If You Take More Glucosamine Cinfa 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 glucosamine 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 medication and the amount ingested. It is recommended to bring the packaging and package leaflet to the healthcare professional.

If You Forget to Take Glucosamine Cinfa

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You should interrupt glucosamine treatment and consult 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:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Hot flashes
• Rash
• Itching
• Redness

Frequency Not Known (cannot be estimated from available data)

• Insomnia
• Dizziness
• Cardiac arrhythmia of the tachycardia type
• Vomiting
• Asthma and worsening of asthma symptoms
• Yellowing of the skin
• Swelling in the ankles, legs, and feet
• Hives
• Increased liver enzyme levels and worsening of blood sugar (glucose) levels in diabetes mellitus
• Allergic reactions
• Vision changes
• Increased blood pressure

A case of elevated cholesterol has been reported, but its relationship to the medication has not been demonstrated.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Glucosamine Cinfa

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glucosamine Cinfa

• The active ingredient 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: mannitol (E-421), aspartame (E-951), and citric acid monohydrate.

Appearance of the Product and Package Contents

White or yellowish fine powder with possible brownish granules for oral solution.

It is presented in single-dose sachets of a metal complex (Alu/PE/Coated Paper).

Each package contains 20, 30, or 500 (clinical package) single-dose sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:October 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68105/P_68105.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68105/P_68105.html