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Almiral – dragees, capsules, solution, suppositories, tablets

From the digestive organs. More often than 1% - abdominal pain or spasm, bloating, diarrhea, dyspepsia, nausea, constipation, flatulence, increased activity of liver transaminases, peptic ulcer, incl. with complications (perforation, bleeding), gastrointestinal bleeding without ulcer.

Less often than 1% - vomiting, jaundice, melena, blood in the stool, damage to the esophagus, aphthous stomatitis, dry mucous membranes (including the oral cavity), hepatitis, hepatonecrosis, cirrhosis, hepatorenal syndrome, changes in appetite, pancreatitis (including .ch. with concomitant hepatitis), colitis.

From the nervous system. More often than 1% - headache, dizziness.

Less often than 1% - sleep disturbance, drowsiness, depression, diplopia, anxiety, irritability, aseptic meningitis, convulsions, weakness.

From the senses. More often than 1% - tinnitus.

Less often than 1% - blurred visual perception, taste disturbance, hearing loss (including irreversible), scotoma.

From the side of the skin. More often than 1% - skin rash, itchy skin.

Less commonly 1% - alopecia, urticaria, eczema, toxic dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

From the genitourinary system. More often than 1% is fluid retention.

Less often than 1% - nephrotic syndrome, proteinuria, oliguria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.

From the hematopoietic organs. Less often than 1% - anemia (including hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

From the respiratory system. Less often than 1% - cough, bronchospasm, laryngeal edema.

From the SSS side. Less often than 1% - increased blood pressure, congestive heart failure.

Allergic reactions. Less often than 1% - swelling of the lips and tongue, anaphylactoid reactions, anaphylactic shock (usually develops rapidly). Overdose. Symptoms: dizziness, headache, hyperventilation, clouding of consciousness, in children - myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.

Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating increased blood pressure, renal dysfunction, convulsions, gastrointestinal irritation, respiratory depression. Forced diuresis and hemodialysis are ineffective.

Almiral instructions for use

INSTRUCTIONS for using the product

Almiral

Release form

Solution, ampoules

Pharmacological properties

Almiral is a non-steroidal drug with pronounced analgesic/anti-inflammatory properties. It is a prostaglandin synthetase (COX) inhibitor. Diclofenac sodium in vitro

in concentrations equivalent to those achieved in humans, does not inhibit the biosynthesis of proteoglycans in cartilage tissue. If the drug is used simultaneously with opioids to relieve postoperative pain, Almiral significantly reduces the need for opioids.

Indications

When administered, the drug is intended for the treatment of:

· inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism;

acute attacks of gout

· renal and biliary colic;

· pain and swelling after injuries and operations;

· severe migraine attacks.

The drug, when administered as an intravenous infusion, is intended for the treatment or prevention of postoperative pain.

Contraindications

Hypersensitivity to the active substance, sodium metabisulfite or to any other components of the drug

History of gastrointestinal bleeding or perforation associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs)

Active peptic ulcer/bleeding or history of recurrent peptic ulcer/bleeding (two or more separate episodes of established ulcer or bleeding)

· III trimester of pregnancy;

· Like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis;

· Inflammatory bowel diseases (such as Crohn's disease or ulcerative colitis);

· Liver failure

· Kidney failure

Congestive heart failure (NYHA II -IV)

· High risk of developing postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding;

· Treatment of PERIOPERATIVE pain during coronary artery bypass surgery (or use of a heart-lung machine)

Coronary heart disease in patients with angina pectoris or previous myocardial infarction

· Cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks;

· Peripheral arterial diseases.

In this dosage form, the drug is contraindicated for children.

For intravenous use only

· Concomitant use of NSAIDs or an anticoagulant (including low doses of heparin).

· A history of hemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding.

· Surgeries associated with a high risk of bleeding.

· History of bronchial asthma.

Moderate or severe renal impairment (serum creatinine > 160 µmol/l).

· Hypovolemia or dehydration for any reason.

Use during pregnancy and breastfeeding

Diclofenac suppresses the production of prostaglandins, so it can negatively affect the course of pregnancy and fetal development. Therefore, the drug should not be prescribed during pregnancy.

The active substance can be excreted in small quantities in breast milk, so it should not be used during breastfeeding.

Compound

Active substance:

3 ml of solution (1 ampoule) contains diclofenac sodium 75 mg.
Excipients
: propylene glycol, benzyl alcohol, sodium formaldehyde sulfoxylates, sodium metabisulfite (E 223), sodium hydroxide, water for injection.

Directions for use and doses

The drug should be used in the minimum effective doses for the shortest period of time, taking into account the treatment objectives of each individual patient.

Adults. The drug Almiral, solution for injection, should not be used for more than 2 days. If necessary, treatment can be continued with diclofenac tablets or suppositories.

IM injection

. In order to prevent damage to nerves or other tissues at the injection site, the following rules must be observed.

The dose is usually 75 mg (1 ampoule) per day, which is administered by deep injection into the upper outer quadrant of the gluteus maximus muscle. In severe cases (for example, colic), the daily dose can be increased to 2 injections of 75 mg, between which an interval of several hours is maintained (1 injection in each buttock). Alternatively, 75 mg injection can be combined with other dosage forms of diclofenac (eg tablets or suppositories) up to a maximum total daily dose of 150 mg diclofenac sodium.

In the setting of a migraine attack, clinical experience is limited to cases with initial use of 1 ampoule of 75 mg, the dose is administered, if possible, immediately after the use of 100 mg suppositories on the same day (if necessary). The total daily dose should not exceed 175 mg on the first day.

There are no available data on the use of Almiral for the treatment of migraine attacks lasting more than 1 day.

IV infusion

. Immediately before starting the IV infusion, Almiral should be diluted in 100–500 ml of 0.9% sodium chloride solution or 5% glucose solution. Both solutions must be buffered with sodium bicarbonate solution (0.5 ml of 8.4% solution or 1 ml of 4.2%). Only transparent solutions can be used.

Almiral, solution for injection, should not be administered as a bolus injection.

Recommended alternative dosage regimens for the drug Almiral, solution for injection:

for the treatment of
moderate to severe postoperative pain, 75 mg should be administered continuously over 30 minutes to 2 hours; if necessary, treatment can be repeated after 4–6 hours, but the dose should not exceed 150 mg/day;
To prevent
postoperative pain, a loading dose of 25–50 mg should be administered 15 minutes to 1 hour after surgery, followed by a continuous infusion of approximately 5 mg/hour up to a maximum daily dose of 150 mg.

Elderly patients.

Although the pharmacokinetics of Almiral do not deteriorate to any clinically significant extent in elderly patients, NSAIDs should be used with extreme caution in such patients, who are generally more likely to develop adverse reactions. In particular, in frail elderly patients or patients with low body weight, it is recommended to use the lowest effective doses (see SPECIAL INSTRUCTIONS); Patients should also be monitored for gastrointestinal bleeding when treated with NSAIDs.

The recommended maximum daily dose of Almiral is 150 mg.

Children.

Diclofenac in dosage form for injection is contraindicated for use in children.

Side effects

Nervous system disorders:

anxiety, cephalalgia (headaches), sleep disturbances, drowsiness, aseptic meningitis, depression, convulsions, nightmares.

Digestive system disorders:

bloating, abdominal pain, dry mouth, diarrhea/constipation, jaundice, esophageal damage, nausea, peptic ulcers, hepatitis, cirrhosis, blood in the stool, liver necrosis, colitis, pancreatitis.

Perception disorders:

blurred vision, tinnitus, double vision, hearing loss, taste disturbance.

Disorders of the genitourinary system: oliguria (decreased amount of urine), edema, protein in the urine, kidney failure, blood in the urine, nephritis.

Skin changes:

toxic dermatitis, rash, eczema, alopecia (hair loss), urticaria, increased photosensitivity (sun intolerance), itching, pinpoint hemorrhages.

Hematopoietic disorders:

thrombocytopenic purpura, agranulocytosis, eosinophilia, anemia, leukopenia, thrombocytopenia.

Cardiac disorders: increased blood pressure, heart failure (congestive), extrasystole, chest pain, heart attack.

Breathing disorders:

pneumonitis, bronchospasm, cough, laryngeal edema.

Allergy:

swelling of the lips, tongue, vasculitis (inflammation of blood vessels).

Local reactions:

necrosis (tissue breakdown) of adipose tissue, burning, infiltration (dense formation), aseptic necrosis.

Interaction with other drugs

The drug helps to increase plasma concentrations of digoxin, indirect anticoagulants, oral hypoglycemic drugs and quinol derivatives. In addition, the drug helps to increase the concentration of lithium in the blood.

Diclofenac sodium increases the toxicity of cyclosporine and methotrexate.

When used simultaneously, it increases the risk of developing undesirable effects of glucocorticosteroids.

The drug increases the risk of developing hyperkalemia when taken simultaneously with potassium-sparing diuretics.

Acetylsalicylic acid, when used simultaneously, helps to reduce plasma concentrations of diclofenac sodium.

Overdose

An overdose is manifested by dizziness, headache, clouding of consciousness, vomiting, and breathing problems. Children may experience myoclonic convulsions, liver/kidney dysfunction, vomiting, abdominal pain, and bleeding.

In case of overdose, you must stop using the medicine and seek medical help.

Storage conditions

Almiral in a dry place away from direct sunlight at a temperature of 8 to 25 degrees Celsius .

Best before date

3 years.

Kalmirex®

Frequency of side effects: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from available data).

Disorders of the blood and lymphatic system: very rarely - anemia, lymphadenopathy.

Immune system disorders: rarely - hypersensitivity reactions, anaphylactic reactions; very rarely - anaphylactic shock.

Metabolic and nutritional disorders: infrequently - anorexia; very rarely - polydipsia.

Mental disorders: infrequently - insomnia, sleep disorders; rarely - loss of activity, depression.

Nervous system disorders: uncommon - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, loss of sensitivity, sensory disorders, lethargy.

Violations of the organ of vision: rarely - disturbances of visual perception.

Hearing and labyrinthine disorders: rarely - tinnitus, vertigo.

Cardiac disorders: rarely - angina pectoris, tachycardia, rapid heartbeat; very rarely - bradycardia.

Vascular disorders: infrequently - arterial hypotension; rarely - flushes of blood.

Disorders of the respiratory system, chest and mediastinal organs: rarely - shortness of breath, nosebleeds, rapid breathing.

Gastrointestinal disorders: uncommon - gastrointestinal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely - epigastric pain, constipation, flatulence, vomiting.

Disorders of the liver and biliary tract: rarely - liver dysfunction.

Disorders of the skin and subcutaneous tissues: rarely - allergic dermatitis, sweating, itching, urticaria, skin rash.

Musculoskeletal and connective tissue disorders: uncommon - muscle weakness, myalgia, pain in the extremities; rarely - discomfort in the limbs; very rarely - osteopenia.

Renal and urinary tract disorders: rarely - enuresis, proteinuria.

General disorders and disorders at the injection site: often - redness of the injection site; infrequently - asthenia (weakness), malaise, fatigue; rarely - a feeling of intoxication, a feeling of heat, irritability, thirst; very rarely - a feeling of discomfort in the chest.

Laboratory and instrumental data: rarely - decreased blood pressure, increased bilirubin concentration, impaired liver function tests, decreased platelet count, increased leukocyte count; very rarely - increased creatinine levels.