Leaflet: information for the user

Glucosamine cinfa 1500 mg powder for oral solution EFG

Glucosamine sulfate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

glucosamine cinfais indicated to relieve symptoms caused by mild to moderate knee osteoarthritis.

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 seafood, as glucosamine is derived from seafood.

Warnings and precautions

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

Be especially careful:

• 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 any kidney or liver impairment, as no studies have been conducted in these conditions and therefore no dosage recommendations can be made. 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 another treatment should be considered.

Children and adolescents

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

Other medications and glucosamine cinfa

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

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

• 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 with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.
• With other medications such as tetracycline.

Consult your doctor for proper advice.

Glucosamine cinfa with food and beverages

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be 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 lactation.

Driving and operating machinery

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

Glucosamine cinfa contains aspartame (E-951)

This medication contains 2.5 mg of aspartame in each packet.

Aspartame contains a source of phenylalanine that 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 correctly.

Glucosamine cinfa contains sodium

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

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.

The recommended 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 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 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 ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forgot to take Glucosamine Cinfa

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You should stop treatment with glucosamine and immediately see 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 side effects are:

Frequent (may affect up to 1 in 10 people)

-Headache

-Drowsiness

-Fatigue

-Diarrhea

-Constipation

-Nausea

-Flatulence

-Abdominal pain

-Indigestion

Less frequent (may affect up to 1 in 100 people)

• Hot flashes
• Rash
• Itching
• Redness

Unknown frequency (cannot be estimated from available data)

• Insomnia
• Dizziness
• Arrhythmia of the type tachycardia
• Vomiting
• Asthma and worsening of asthma symptoms
• Yellow discoloration of the skin
• Swelling in ankles, legs, and feet
• Urticaria
• Increased levels of liver enzymes and worsening of blood sugar levels in diabetes mellitus
• Allergic reactions
• Visual disturbances
• Increased blood pressure

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

Reporting of side effects

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

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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Glucosamine sulfate composition

• The active principle is glucosamine. Each sachet contains 1,500 mg of sodium chloride glucosamine sulfate, equivalent to 1,178 mg of glucosamine.
• The other components are: mannitol (E-421), aspartame (E-951), and citric acid monohydrate.

Appearance of the product and contents of the packaging

Fine, white or yellowish powder with possible brownish granules for oral solution.

Presented in single-dose sachets of a metal complex (Alu/PE/Paper-coated).

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: October 2021

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your 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