Amelotex, tablets 15 mg 20 pcs

Indications

Active ingredient

Composition

1 tablet contains meloxicam 15 mg.

How to take, the dosage

The drug is taken orally with meals once a day.

The recommended dosing regimen:

– Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect the dose can be reduced to 7.5 mg per day.
– Osteoarthritis: 7.5 mg per day. In case of ineffectiveness the dose can be increased up to 15 mg per day.
– Ankylosing spondylitis: 15 mg per day. Maximum daily dose should not exceed 15 mg.

In patients at increased risk of side effects, as well as in patients with significant renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg per day.

Interaction

Concomitant use with other nonsteroidal anti-inflammatory drugs (as well as with acetylsalicylic acid) increases the risk of erosive ulcerative lesions and bleeding from the gastrointestinal tract. When concomitant use with hypotensive drugs, the effectiveness of the latter may decrease.

Simultaneous use with lithium preparations may lead to cumulation of lithium and increase its toxic effects (it is recommended to control the lithium concentration in the blood).

In concomitant use with methotrexate there is an increased side effect of the latter on the hematopoietic system (risk of anemia and leukopenia, periodic control of total blood count is indicated).

Concomitant use with diuretics and with cyclosporine increases the risk of renal failure.

Concomitant use with intrauterine contraceptives may decrease the effectiveness of the latter.

In concomitant use with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase. fibrinolysin) the risk of bleeding increases (periodic control of blood clotting is necessary).

In concomitant use with colestiramine, as a result of binding meloxicam its excretion through the gastrointestinal tract is increased.

Concomitant use with selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Special Instructions

In case of peptic ulcers or gastrointestinal bleeding, development of side effects on the skin and mucous membranes the drug should be discontinued.

In patients with decreased volume of circulating blood and decreased glomerular filtration (dehydration, chronic heart failure, surgical operations) there may be clinically expressed chronic renal failure which is completely reversible after discontinuation of the drug (daily urine output and renal function should be monitored in such patients at the beginning of treatment).

In case of persistent and significant elevation of transaminases and changes in other liver function parameters the drug should be discontinued and control tests should be performed. In patients with increased risk of side effects, treatment should be started with 7.5 mg dose.

In end-stage chronic renal failure patients on dialysis, the dose should not exceed 7.5 mg/day.

During the treatment period caution should be exercised while driving motor transport and engaging in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (if dizziness and somnolence occur).

Contraindications

Hypersensitivity to the active substance or excipients;
Contraindicated in the period after coronary artery bypass grafting;
uncompensated heart failure;
complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (incl.ч. In anamnesis);
Erosive-ulcerative changes of the mucosa of the stomach or duodenum, active gastrointestinal bleeding;
Inflammatory bowel diseases (non-specific ulcerative colitis, Crohn’s disease);
Cerebrovascular bleeding or other bleeding;
Severe hepatic insufficiency or active liver disease;
Severe renal insufficiency in patients not undergoing dialysis (creatinine clearance less than 30 ml/min), progressive renal disease including.
Pregnancy, breastfeeding;
Childhood under 15 years old.

With caution
. In order to decrease the risk of the development of undesirable effects the minimal effective dose should be used in ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes, peripheral arterial disease, smoking, creatinine clearance less than 60 ml/min, anamnestic data on the development of gastrointestinal ulcers, the presence of Helicobacter pylori infection, the elderly, long-term use of nonsteroidal anti-inflammatory drugs, frequent use of alcohol, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Digestive system disorders: Nausea, vomiting, belching, abdominal pain, constipation or diarrhea, flatulence, increased activity of “liver” transaminases, hyperbilirubinemia, stomatitis, gastrointestinal erosive ulcerative lesions, esophagitis, gastritis, colitis, gastrointestinal organ perforation, gastrointestinal bleeding (hidden or overt), hepatitis.

Nervous system disorders: dizziness, vertigo, headache, tinnitus, confusion, drowsiness, disorientation, emotional lability.

Respiratory system: bronchospasm.

Hematopoietic disorders: anemia, leukopenia, thrombocytopenia.

Cardiovascular system disorders: peripheral edema, increased blood pressure, blood rushes to the face and upper chest, palpitations.

Urinary system disorders: edema, hypercreatininemia, increased concentration of urea in blood serum. In rare cases – acute renal failure, interstitial nephritis, albuminuria, hematuria.

Senses: conjunctivitis, visual impairment including blurred vision.

Skin disorders: itching, skin rash, urticaria, photosensitization, bullous rash, erythema multiforme, toxic epidermal necrolysis.

Allergic reactions: angioedema, anaphylactoid, anaphylactic reactions.

Overdose

Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, liver failure, respiratory arrest, asystole.

Treatment: there is no specific antidote; in case of overdose of the drug, gastric lavage, administration of activated charcoal (within the next hour), symptomatic therapy should be carried out. Colestiramine accelerates excretion of the drug from the body. Forced diuresis, hemodialysis are ineffective due to high binding of the drug to blood proteins.

Pregnancy use

It is contraindicated in pregnancy, during breastfeeding.

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