REFITAL [Aceclofenac] 100 mg Film-coated tablets

REFITAL

instructions for medical use of the medicinal product

Tradename

Refital, Refital

International non-proprietary name

Aceclofenac, Aceclofenac

Composition

Each film-coated tablet contains:

active ingredient: aceclofenac CP   100 mg

excipients: microcrystalline cellulose, croscarmellose sodium, povidone K30, glyceryl palmitostearate, distilled water, ethyl alcohol; tablet coating: hypromellose (15 cps), macrogol 400, titanium dioxide.

Dosage form

Tablets.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs ( NSAIDs) .

Pharmacological properties

Refital is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. The active substance is aceclofenac.

Pharmacodynamics

Aceclofenac is a derivative of phenylacetic acid, inhibits cyclooxygenase types I and II, inhibits the synthesis of prostaglandins and thus affects the pathogenesis of inflammation, pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the patient.

Pharmacokinetics

After oral administration, the absorption of aceclofenac is high. _Cmax is achieved within 1.25-3 hours. It penetrates into the synovial fluid, where its concentration reaches 57% of the plasma concentration level and the time to reach _Cmax is 2-4 hours later than in plasma. V _d - 25 l. Plasma protein binding (albumin) - 99%. Aceclofenac circulates mainly unchanged, its main metabolite is 4'-hydroxyaceclofenac. T _1/2 is 4 hours. It is excreted by the kidneys, mainly in the form of hydroxy derivatives (about 2/3 of the administered dose).

Indications for use

Symptomatic treatment of diseases of the musculoskeletal system, including: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

For the relief of inflammation and pain syndrome: lumbago, humeroscapular periarthritis, rheumatic soft tissue damage, toothache.

Contraindications

·          erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; gastrointestinal bleeding or suspicion of it;

·          complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history);

·          hypersensitivity to aceclofenac;

·          the period after coronary artery bypass grafting;

·          severe liver failure or active liver disease;

·          severe renal failure (creatinine clearance less than 30 ml / min) progressive kidney disease hyperkalemia;

·          - inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;

·          - decompensated heart failure;

- disorders of hematopoiesis and coagulation;

- pregnancy and breastfeeding period;

- children's age up to 18 years.

Dosage and administration

inside. The tablets should be swallowed whole, without chewing, with a sufficient amount of liquid.

In order to minimize the risk of adverse reactions, the drug should be taken at the lowest effective dose for the shortest possible period of time.

Recommended dosage regimen: 100 ml 2 times a day, morning and evening.

The course of treatment is prescribed by the doctor individually.

In patients with hepatic insufficiency, the initial dose of Refital is 100 mg / day.

Special instructions and precautions

Use with caution in case of diseases of the liver, kidneys and gastrointestinal tract in history, bronchial asthma, arterial hypertension, ischemic heart disease, indications in the anamnesis of the development of ulcerative lesions of the gastrointestinal tract, in the presence of Helicobacter pylori infection, in cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial diseases , in smokers, in elderly patients, with long-term use of NSAIDs, with frequent alcohol use, with severe somatic diseases.

Prostaglandins play an important role in maintaining renal blood flow, so special care should be taken when prescribing to patients with heart or kidney failure, the elderly taking diuretics, and patients who, for any reason, have a decrease in BCC (for example, after major surgery) . In such cases, during treatment, it is recommended to monitor renal function as a precautionary measure. In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. During long-term therapy, it is necessary to monitor liver function, peripheral blood picture, fecal occult blood test.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, one should refrain from activities that require increased concentration of attention and speed of psychomotor reactions.

Use during pregnancy and during breastfeeding

Use during pregnancy and during breastfeeding is contraindicated.

Interaction with other drugs

If you are taking any other medicines, be sure to inform your doctor, and if you are self-treating, consult your doctor about the possibility of using the drug.

Digoxin, phenytoin, lithium preparations - it is possible to increase the concentration in the blood plasma of these drugs.

Diuretics, antihypertensives - possible weakening of the action of duretics and antihypertensives.

Potassium-sparing diuretics - hyperglycemia may develop. With this combination, it is necessary to control the level of potassium in the blood plasma.

Other NSAIDs, GCS for oral administration (prednisone) - increased risk of side effects from the gastrointestinal tract.

Selective serotonin reuptake inhibitors (eg citalopram, fluoxetine, paroxetine, sertraline) - increased risk of gastrointestinal bleeding.

Cyclosporine, tacrolimus - it is possible to increase the toxic effect of drugs on the kidneys.

Hypoglycemic agents - both hypoglycemia and hyperglycemia are possible. With this combination, it is necessary to control the content of glucose in the blood.

Methotrexate - taking aceclofenac within 24 hours before or after taking methotrexate can lead to an increase in its plasma concentration and increased toxic effects.

Acetylsalicylic acid - a decrease in the concentration of aceclofenac in the blood plasma.

Antiplatelet agents and anticoagulants (warfarin, clopidogrel) - increased risk of bleeding With this combination, regular monitoring of blood clotting is necessary.

Mifepristone - Do not take Refital within 8-12 days after taking mifepristone due to the risk of reducing its effect.

Antimicrobial agents of the fluoroquinolone group - an increase in the risk of seizures.

Zidovudine - increased risk of bleeding, hemarthrosis and hematomas may occur.

Side effect

Determining the frequency of adverse reactions: very often (≥ 1/10); often (from ≥ 1/100 to < 1/10); infrequently (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10,000 to < 1/1000), very rarely (< 1/10,000).

On the part of the blood and lymphatic system: rarely - anemia; very rarely - inhibition of bone marrow function, granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia.

From the immune system: rarely - anaphylactic reactions (including shock), hypersensitivity.

From the side of metabolism and nutrition: very rarely - hyperkalemia.

On the part of the psyche: very rarely - depression, unusual dreams, insomnia.

From the nervous system: often - dizziness; very rarely - paresthesia, tremor, drowsiness, headache, dysgeusia (taste perversion).

On the part of the organ of vision: rarely - visual impairment.

On the part of the organ of hearing and labyrinth disorders: very rarely - dizziness, ringing in the ears.

From the side of the cardiovascular system: rarely - increased blood pressure, worsening of the course of arterial hypertension, heart failure; very rarely - hyperemia, hot flashes, vasculitis, palpitations.

On the part of the respiratory system, chest organs and mediastinum: rarely - shortness of breath; very rarely - bronchospasm.

From the digestive system: often - dyspepsia, abdominal pain, nausea, diarrhea; infrequently - flatulence, gastritis, constipation, vomiting, ulcerative stomatitis; rarely - melena, the formation of ulcers of the stomach and intestines, hemorrhagic diarrhea, gastrointestinal bleeding; very rarely - stomatitis, blood vomiting, intestinal perforation, exacerbation of Crohn's disease and ulcerative colitis, pancreatitis.

From the side of the liver and biliary tract: often - increased activity of liver enzymes; very rarely - liver disease (including hepatitis), an increase in alkaline phosphatase activity.

From the skin and subcutaneous tissues: infrequently - itching, rash, dermatitis, urticaria; rarely - Quincke's edema; very rarely - purpura, eczema, severe mucocutaneous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

From the urinary system: infrequently - an increase in the concentration of urea in the blood serum, an increase in the concentration of creatinine in the serum; very rarely - nephrotic syndrome, renal failure.

General reactions: very rarely - swelling, weakness, muscle spasms.

Overdose

Symptoms: dizziness, headache, nausea, vomiting, abdominal pain.

Treatment: gastric lavage, activated charcoal, symptomatic therapy. There is no specific antidote.

Storage conditions

Store in a cool and dry place, at a temperature not exceeding 30º C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

10 tablets in an aluminum foil blister. 6 blisters with instructions for use in a cardboard box.