Solpaflex (Tablets) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Consumer Healthcare (United Kingdom)

ATC Code

M01AE01 (Ibuprofen)

Active Substance

Ibuprofen (Rec.INN registered by WHO)

Dosage Form

Solpaflex

Film-coated tablets, 200 mg: 6, 12, or 24 pcs.

Dosage Form, Packaging, and Composition

12 pcs. – blisters (1) – carton packs.
12 pcs. – blisters (2) – carton packs.
6 pcs. – blisters (2) – carton packs.
6 pcs. – blisters (1) – carton packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic, and antipyretic effects.

The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play a major role in the pathogenesis of inflammation, pain, and fever. The analgesic effect is due to both a peripheral mechanism (indirectly, through suppression of prostaglandin synthesis) and a central mechanism (by inhibiting the synthesis of prostaglandins in the central and peripheral nervous system). It suppresses platelet aggregation.

Pharmacokinetics

When taken orally, Ibuprofen is almost completely absorbed from the gastrointestinal tract. Simultaneous food intake slows down the rate of absorption. It is metabolized in the liver (90%). The half-life (T_1/2) is 2-3 hours. 80% of the dose is excreted in the urine, mainly as metabolites (70%), 10% is excreted unchanged; 20% is excreted through the intestines as metabolites.

Indications

Symptomatic treatment as an anti-inflammatory and antipyretic agent: inflammatory and degenerative diseases of the joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), joint syndrome in acute gout, psoriatic arthritis, tendinitis, bursitis, radiculitis, traumatic inflammation of soft tissues and the musculoskeletal system. Neuralgia, myalgia, pain syndrome in infectious and inflammatory diseases of the ENT organs, adnexitis, algodysmenorrhea, headache and toothache. Fever in infectious and inflammatory diseases, in childhood infections, in post-vaccination reactions in children (in appropriate dosage forms).

ICD codes

Dosage Regimen

It is taken orally. The individual dosage regimen depends on the indications, the severity of clinical manifestations, and the patient’s age.

A single dose for adults and children over 6 years of age is 200-400 mg. It can be taken 3-4 times a day.

The maximum daily dose for adults is 1200 mg; for children aged 12-17 years – 1000 mg; for children aged 6 to 12 years – 800 mg.

For children under 6 years of age, the dose depends on the child’s age and body weight. The maximum daily dose should not exceed 30 mg/kg of body weight with intervals between doses of 6-8 hours.

Adverse Reactions

From the hematopoietic system: very rarely – blood disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).

From the immune system infrequently – hypersensitivity reactions – nonspecific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, angioedema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely – severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

From the digestive system infrequently – abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely – diarrhea, flatulence, constipation, vomiting; very rarely – peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis; frequency unknown – exacerbation of colitis and Crohn’s disease.

From the liver and biliary tract: very rarely – impaired liver function, increased activity of liver transaminases, hepatitis and jaundice.

From the urinary system: very rarely – acute renal failure (compensated and decompensated), especially with long-term use, in combination with an increase in plasma urea concentration and the appearance of edema, hematuria and proteinuria; nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

From the nervous system infrequently – headache; very rarely – aseptic meningitis.

From the cardiovascular system: frequency unknown – heart failure, peripheral edema; with long-term use, increased risk of thrombotic complications (e.g., myocardial infarction, stroke), increased blood pressure.

From the respiratory system: frequency unknown – bronchial asthma; bronchospasm; shortness of breath.

From laboratory parameters: possible – decrease in hematocrit or hemoglobin, increased bleeding time, decrease in plasma glucose concentration, decrease in creatinine clearance, increase in plasma creatinine concentration, increase in liver transaminase activity.

Contraindications

Hypersensitivity to ibuprofen; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase or active peptic ulcer bleeding or history thereof (2 or more confirmed episodes of peptic ulcer or peptic ulcer bleeding); history of gastrointestinal bleeding or perforation provoked by the use of NSAIDs; severe heart failure (functional class IV according to NYHA classification); severe impairment of renal and/or liver function; optic nerve diseases, “aspirin triad”, blood disorders; period after coronary artery bypass surgery; intracranial or other bleeding; hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diatheses; third trimester of pregnancy.

With caution simultaneous use of other NSAIDs; history of a single episode of gastric and duodenal ulcer or gastrointestinal ulcer bleeding; gastritis, enteritis, colitis, presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute phase or history thereof; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis; chickenpox; renal failure, including with dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, hepatic failure, liver cirrhosis with portal hypertension; hyperbilirubinemia; arterial hypertension and/or heart failure; cerebrovascular diseases; blood diseases of unknown etiology (leukopenia and anemia); severe somatic diseases; dyslipidemia/hyperlipidemia; diabetes mellitus; peripheral arterial diseases; smoking; frequent alcohol consumption; simultaneous use of drugs that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); first and second trimester of pregnancy; breastfeeding period; elderly age.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction. Use with caution in concomitant liver diseases.

Use in Renal Impairment

Contraindicated in severe renal dysfunction. Use with caution in concomitant kidney diseases.

Pediatric Use

Can be used according to indications in recommended doses.

Geriatric Use

Should be prescribed with caution to elderly patients to avoid worsening of concomitant diseases.

Elderly patients have an increased frequency of adverse reactions against the background of NSAID use, especially gastrointestinal bleeding and perforations, in some cases fatal.

Special Precautions

It is recommended to prescribe Ibuprofen for the shortest possible course and at the minimum effective dose necessary to relieve symptoms. If systemic use is necessary for more than 10 days, it is necessary to consult a doctor.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. If symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), stool test for occult blood.

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid the use of ibuprofen for chickenpox.

Ibuprofen suppresses COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

Effect on the ability to drive vehicles and mechanisms

Patients who experience dizziness, drowsiness, lethargy, or visual disturbances when taking ibuprofen should avoid driving vehicles and other activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, Ibuprofen reduces the effect of antihypertensive agents (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).

With simultaneous use with anticoagulants, their effect may be enhanced.

With simultaneous use with corticosteroids, the risk of developing adverse effects from the gastrointestinal tract increases.

With simultaneous use, Ibuprofen may displace from plasma protein binding indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), oral hypoglycemic drugs sulfonylurea derivatives.

With simultaneous use with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid – the concentration of ibuprofen in plasma decreases; with baclofen – a case of increased toxic effect of baclofen has been described.

With simultaneous use with warfarin, an increase in bleeding time is possible, microhematuria and hematomas have also been observed; with captopril – a decrease in the antihypertensive effect of captopril is possible; with cholestyramine – a moderately pronounced decrease in the absorption of ibuprofen.

With simultaneous use with lithium carbonate, the concentration of lithium in plasma increases.

With simultaneous use with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate – the toxicity of methotrexate increases.

Simultaneous use of NSAIDs and cardiac glycosides may lead to worsening of heart failure, decreased glomerular filtration rate, and increased plasma concentration of cardiac glycosides.

There is evidence of the likelihood of an increase in the plasma concentration of methotrexate against the background of NSAID use.

With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.

NSAIDs may reduce the effectiveness of mifepristone, so NSAIDs should be started no earlier than 8-12 days after the end of mifepristone use.

With simultaneous use of NSAIDs and tacrolimus, an increased risk of nephrotoxicity is possible.

Simultaneous use of NSAIDs and zidovudine may lead to increased hematotoxicity. There are data on an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia receiving combined treatment with zidovudine and ibuprofen.

In patients receiving combined treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.

In patients receiving NSAIDs and myelotoxic drugs simultaneously, hematotoxicity is enhanced.

With simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the frequency of development of hypoprothrombinemia increases.

With simultaneous use of ibuprofen and drugs that block tubular secretion, a decrease in excretion and an increase in plasma concentration of ibuprofen are noted.

With simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), an increase in the production of hydroxylated active metabolites occurs, increasing the risk of developing severe intoxications.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.