Strepfen^® (Tablets) Instructions for Use

Marketing Authorization Holder

Reckitt Benckiser Healthcare International, Ltd. (United Kingdom)

ATC Code

R02AX01 (Flurbiprofen)

Active Substance

Flurbiprofen (Rec.INN registered by WHO)

Dosage Form

Strepfen®

Lozenges 8.75 mg: 16 pcs.

Dosage Form, Packaging, and Composition

Lozenges round, white or almost white, made of semi-transparent caramel mass.

Excipients: sucrose, sugar syrup, calcium carbonate, cherry flavor, povidone, magnesium stearate, colloidal silicon dioxide, isopropyl alcohol.

8 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID. It has pronounced analgesic, anti-inflammatory, and antipyretic activity.

The mechanism of action is associated with inhibition of COX and suppression of prostaglandin synthesis. It inhibits platelet aggregation.

Pharmacokinetics

After oral administration, it is well and completely absorbed from the gastrointestinal tract.

C_max is reached within 1.5 hours. Plasma protein binding is more than 90%. It is metabolized in the liver. T_1/2 is about 6 hours. It is excreted by the kidneys: 20% unchanged, the rest as metabolites.

Indications

For oral administration: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute bursitis and tenosynovitis, soft tissue injuries; pain syndrome (mild to moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, dysmenorrhea, pain from injuries, burns; febrile syndrome in colds and infectious diseases.

For topical use: as a symptomatic agent to relieve sore throat in infectious and inflammatory diseases of the oral cavity and pharynx.

ICD codes

Dosage Regimen

For sore throat relief, dissolve one 8.75 mg lozenge in the mouth.

Repeat every 3 to 6 hours as needed for pain.

Do not exceed 5 lozenges in any 24-hour period.

The maximum duration of self-treatment is 3 days.

If symptoms persist or worsen, discontinue use and consult a physician.

For oral administration of other flurbiprofen formulations, follow the specific product instructions.

The dosage for oral tablets is indication-dependent and must be determined by a physician.

Take oral doses with a full glass of water.

To minimize gastrointestinal upset, take oral flurbiprofen with food or milk.

Avoid lying down for at least 10 minutes after taking an oral dose.

Do not crush or chew the lozenges; allow them to dissolve slowly in the mouth.

Do not use this product in children under 12 years of age for sore throat.

Oral administration of flurbiprofen is contraindicated in children under 15 years of age.

Use with caution in elderly patients and those with renal or hepatic impairment.

Adverse Reactions

From the digestive system dyspepsia (nausea, vomiting, heartburn, diarrhea), NSAID-gastropathy, abdominal pain, impaired liver function; with long-term use in high doses – ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, hemorrhoidal, from the gums).

From the cardiovascular system increased blood pressure, tachycardia, heart failure.

From the hematopoietic system rarely – anemia (iron deficiency, hemolytic, aplastic), agranulocytosis, leukopenia, thrombocytopenia.

From the central and peripheral nervous system headache, dizziness, drowsiness or insomnia, asthenia, depression, amnesia, tremor, agitation, rarely – ataxia, paresthesia, impaired consciousness.

From the urinary system tubulointerstitial nephritis, edematous syndrome, impaired renal function.

Allergic reactions skin rash, itching, urticaria, bronchospasm, photosensitization, angioedema, anaphylactic shock.

Other hearing loss, tinnitus, increased sweating.

Contraindications

Hypersensitivity to flurbiprofen and other NSAIDs; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad” (bronchial asthma, vasomotor rhinitis, intolerance to acetylsalicylic acid), gastrointestinal bleeding, cerebrovascular hemorrhage, heart failure, edema, arterial hypertension, hemostasis disorders (including hemophilia, hypocoagulation), severe hepatic failure, severe renal failure, confirmed hyperkalemia, treatment of postoperative pain after coronary artery bypass grafting, pregnancy, breastfeeding period; for oral administration – children under 15 years of age.

With caution

Anemia, bronchial asthma, hematopoietic disorders, chronic heart failure, arterial hypertension, coronary artery disease, edematous syndrome, hepatic and/or renal failure, chronic alcoholism, inflammatory bowel diseases, diverticulitis, erosive and ulcerative lesions of the gastrointestinal tract in remission, diabetes mellitus, conditions after extensive surgical interventions, inducible porphyria, elderly age.

Use in Pregnancy and Lactation

Flurbiprofen is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Oral administration is contraindicated in children under 15 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

During flurbiprofen administration, periodic monitoring of the peripheral blood picture and bleeding time is necessary.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Drug Interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

When used concomitantly, Flurbiprofen reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants (increases the risk of bleeding), antiplatelet agents, fibrinolytics, side effects of mineralocorticoids, corticosteroids, estrogens; reduces the effectiveness of antihypertensive and diuretic agents; enhances the hypoglycemic effect of sulfonylurea derivatives.

Acetylsalicylic acid increases the plasma concentration of the drug, ranitidine decreases it.

Antacids and cholestyramine reduce the absorption of flurbiprofen.

When used concomitantly, Flurbiprofen increases the blood concentration of lithium and methotrexate.

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.