Medicinal Products

DOLENIO 1 178 mg Film-coated tablet (with splitter bar) Box of 30

Generic drug of the therapeutic class: Rheumatology
active ingredients: Glucosamine
laboratory: Biocodex

Film-coated tablet (with splitter bar)
All forms

Indication

Relief of symptoms of mild to moderate osteoarthritis of the knee.

Dosage DOLENIO 1, 178 mg Film-coated tablet (with splitter bar) Box of 30

adults

One tablet a day.

Glucosamine is not indicated for the treatment of acute pain symptoms. Relief of symptoms (especially pain) may not appear until after several weeks of treatment, or even longer in some cases. In the absence of any relief after 2 or 3 months, continued glucosamine treatment should be reconsidered.

The tablets can be taken during or outside meals.

Additional information on special populations

The elderly

No specific studies have been conducted in the elderly, but based on clinical experience, no dosage adjustment is necessary for the treatment of otherwise healthy elderly patients.

Children and adolescents

DOLENIO should not be used in children and adolescents under 18 years of age due to insufficient data on its tolerance and effectiveness.

Patients with renal and / or hepatic impairment

In patients with renal and / or hepatic impairment, no dose recommendation can be made as no studies have been performed in this patient population.

Against indications

· Since the active substance has been obtained from crustaceans, DOLENIO should not be administered to patients who are allergic to crustaceans.

· Hypersensitivity to the active substance or to any of the components.

· Children under 2 years old.

Dolenio side effects

The most common side effects associated with glucosamine therapy are nausea, abdominal pain, digestive upset, constipation, and diarrhea. Headache, fatigue, skin rash, pruritus and flushing have also been reported. The reported side effects are usually mild and transient.

The table below shows all related adverse events by organ class and frequency (very common ≥ 1/10, frequent ≥ 1/100, <1/10, infrequent ≥ 1000, <1/100, rare ≥ 1/10 000, <1/1 000, very rare <1/10 000, frequency not known (can not be estimated from the available data)).

MedDRA of organ system classes

Frequent

(≥ 1/100, <1/10)

Rare

(≥ 1/1000, <1/100)

Not known frequency

(can not be estimated from the available data)

Nervous system disorders

Headache

Tired

Dizziness

Respiratory, thoracic and mediastinal disorders

Asthma / Aggravation of asthma

Gastrointestinal disorders

nausea

Abdominal pain

Difficult digestion

Diarrhea

Constipation

vomiting

Skin and subcutaneous tissue disorders

Skin rash

itching

Flushing

Angioedema

Urticaria

Metabolism and nutrition disorders

Poorly controlled diabetes

hypercholesterolemia

General disorders and administration site conditions

Edema / peripheral edema

Cases of hypercholesterolemia, worsening of asthma and uncontrolled diabetes have been reported, but no causal relationship has been established.

Dolenio can induce elevated liver enzymes and, in rare cases, jaundice.

Diabetic patients

Deterioration of glycemic control in diabetic patients, whose frequency is not known.

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