JOFLEX (Glucosamine sulphate) capsules for joint health

JOFLEX is a dietary supplement, provides your body with glucosamine that boosts your bones strength. Glucosamine is a building block for cartilage and also helps to make the cushioning fluid between joints. It is a must for maintaining healthy joints.

Composition

Joflex capsules
Joflex capsules
  • Each one capsule contains 500 mg α- D – Glucosamine sulphate potassium chloride.
  • Pharmaceutical form: Hard gelatin capsule colored white and turquoise.

Therapeutic indications

Relief of symptoms of mild to moderate osteoarthritis.

Dose & Methods of administration

  • 1 capsule should be taken three times daily, preferably at meals.
  • Elderly: No adjustment of dose is required with the treatment of elderly patients.
  • Children: is not recommended for use in children or adolescents under the age of 18 years due to insufficient experience.
  • Reduced kidney and/or liver function: no recommendations regarding dose can be given.

Contraindications

  • Hypersensitivity to glucosamine.
  • Persons allergic to crab should not use Glucosamine sulphate.

Special warnings and Precautions for use

  • Exacerbation of asthma symptoms after initiation of glucosamine have been described. Therefore, asthmatic patients starting on glucosamine should be aware of potential worsening of symptoms.
  • Caution is advised in treatment of patients with impaired glucose tolerance. Closer monitoring of blood sugar levels and where relevant insulin requirements may be necessary in diabetics at the beginning of treatment and periodically during treatment.
  • If unusual signs or symptoms appear, or if any changes in the course of usual symptoms occur, the patient is recommended to consult the physician immediately.

Drug Interaction

  • The physico-chemical and pharrnacokinetic properties of glucosamine sulfate suggest a low potential for interactions however, Patients treated with coumarin anticoagulants should be monitored closely when initiating or ending glucosamine therapy.
  • Concurrent treatment with glucosamine may increase the absorption and serum concentration of tetracyclines, but the clinical relevance of this interaction is probably limited.

Pregnancy and lactation

Glucosamine sulphate should not be used during pregnancy or lactation.

Possible side effects

The most common adverse reactions associated with oral administration are usually mild and transitory.

  • Common: nausea, abdominal pain, indigestion, constipation, diarrhea, headache, tiredness and somnolence.
  • Uncommon : rash, itching, and flushing.
  • Unknown frequency of occurrence: Allergic reaction, dizziness, visual disturbances, asthma , hair loss & elevated hepatic enzymes and jaundice.

Pharmacodynamic properties

Product for the treatment of osteoarthritis.

Glucosamine sulfate, the active ingredient of JOFLEX is a chemically well defined and pure compound and is the salt of the natural amino-monosaccharide glucosamine which is physiologically present in the human body.

The mechanism of action of glucosamine sulfate in osteoarthritis is unknown. However, glucosamine is a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans.

Glucosamine sulfate has also been shown to inhibit the activity of cartilage-destroying enzymes such as collagenase and phospholipase A2, as well as the generation of other tissue-damaging substances such as superoxide radicals, or the activity of lysosomal enzymes. These activities may contribute to the mild anti-inflammatory effects observed.

Unlike NSAIDs, glucosamine sulfate does not inhibit the synthesis of prostaglandins. No effects on the cardiovascular and respiratory systems, on the CNS, or the autonomic nervous system, have been shown in safety pharmacology studies.

Analgesics and NSAIDs may be used concomitantly with glucosamine sulfate, either for rescue analgesia during possible flares of the disease, or in the initial period of treatment, when the symptomatic effects of glucosamine sulfate may be delayed for 1-2 weeks. Physical therapy programs can be used concomitantly with glucosamine sulfate in the overall management of ostecarthritis.

Pharmacokinetic properties

After oral administration, radiolabelled glucosamine is rapidly and almost completely absorbed. The absolute bioavailability in man after a single oral dose of radiolabelled glucosamine was 25%, due to the first-pass effect in the liver in which more than 70% of glucosamine is metabolized. The gastrointestinal absorption is close to 90%, since only 11% of the administered radioactivity is excreted in faeces.

Overdose

if overdose occurs treatment should be symptomatic and standard supportive measures should be adopted as required.

Storage and packing

  • Store at temperature not exceeding 30°C in a dry place.
  • Package: Carton box containing 3 (AL/PVC) strips, each strip contains 10 capsules and an inner insert.
  • Manufacturing by: Pharaonia Pharmaceuticals (Pharo Pharma) for EMA Pharm Pharmaceuticals. Head office: Pharma Plaza Building, Asma Fahmy st.. El Nozha, Nasr City, Egypt www.emapharm.com.
Glucosamine M01AX05 antiinflammatory and antirheumatic agents, non-steroids EMA Pharm Pharmaceuticals

JOFLEX capsules – Information Leaflet

AR- Patient_Information_Leaflet
JOFLEX capsules – AR- Patient_Information_Leaflet
ENG-Patient-Information-Leaflet
JOFLEX capsules – ENG-Patient-Information-Leaflet
Council of Arab Health Ministers and Union of Arab pharmacists
Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.
The doctor and the pharmacist are experts in medicine, its benefits and risks.
Do not by yourself intenupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep medicament out of children reach.

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