Epimiraflu 75 mg 10 capsules

Epimiraflu 75 mg Oseltamivir 10 Hard gelatin capsules For the treatment and prevention of influenza virus infections.

Composition

Active ingredient: Oseltamivir – 75 mg per capsule.

Description

Epimiraflu is an antiviral drug that belongs to the class of neuraminidase inhibitors. It effectively blocks the spread of influenza A and B viruses in the body, reducing the severity and duration of the illness.

The drug is most effective when taken within the first 48 hours of symptom onset. Additionally, it is used for post-exposure prophylaxis in individuals who have been in contact with infected persons and for seasonal influenza prevention during outbreaks. Epimiraflu does not replace influenza vaccination but serves as an important treatment and preventive measure, particularly for high-risk groups such as children, the elderly, and people with chronic illnesses or weakened immune systems.

 Indications for Use

-Treatment of influenza

For patients aged 1 year and older with symptoms of influenza, provided that the influenza virus is circulating in the community.

Treatment should be started within 48 hours of symptom onset.

Indicated for the treatment of infants under 12 months during a pandemic influenza outbreak.

-Prevention of influenza

Post-exposure prophylaxis: For individuals aged 1 year and older who have been in close contact with a confirmed case of influenza.

Seasonal prevention: In special circumstances (e.g., a mismatch between circulating and vaccine strains or during a pandemic), Epimiraflu may be used for preventive purposes in individuals aged 1 year and older.

-Epimiraflu is not a substitute for influenza vaccination.

-The decision to use antiviral drugs for treatment or prevention should be based on official recommendations, taking into account the characteristics of the circulating influenza viruses, drug susceptibility patterns, and the disease impact in different regions and populations.

Dosage and Administration:

The decision to administer Epimiraflu to this group should be made by a physician.

-Treatment of influenza

Adolescents (13–17 years) and adults: 75 mg (one capsule) twice daily for 5 days.

Children over 40 kg who can swallow capsules: 75 mg twice daily for 5 days.

-Prevention of influenza

Adolescents (13–17 years) and adults: 75 mg once daily for 10 days after exposure.

Children over 40 kg who can swallow capsules: 75 mg once daily for 10 days.

Contraindications

Hypersensitivity to oseltamivir or any excipients in the formulation.

Precautions:

-Epimiraflu is only effective against influenza viruses and does not work against other infections.

-The safety and efficacy of the drug in patients with severe or unstable medical conditions requiring hospitalization have not been established.

-The efficacy of oseltamivir in immunocompromised patients, as well as those with chronic cardiac or respiratory conditions, has not been firmly established.

-Not recommended for premature infants (less than 37 weeks postmenstrual age) due to insufficient data.

-Epimiraflu is not a replacement for vaccination, and its use should not interfere with influenza immunization programs.

-Resistance patterns of circulating influenza strains should be considered when deciding to use oseltamivir.

Pregnancy and Lactation:

-Pregnancy: Limited data from post-marketing surveillance and animal studies suggest no harmful effects on pregnancy, fetal development, or postnatal growth. Pregnant women may take Epimiraflu after considering the benefits and risks.

-Lactation: Oseltamivir and its active metabolite are excreted in breast milk at low levels, resulting in a subtherapeutic dose for the infant. Epimiraflu may be used in breastfeeding mothers if the benefits outweigh the risks.

Side Effects:

Most common side effects in adults and adolescents:

Infections: Bronchitis, upper respiratory tract infections.

Nervous system: Headache, insomnia, convulsions (rare).

Respiratory: Cough, runny nose.

Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain, indigestion.

Skin: Rash, urticaria, eczema (rare).

General: Dizziness, fatigue, pain.

Most common side effects in children:

Infections: Pneumonia, sinusitis, bronchitis, otitis media.

Respiratory: Cough, nasal congestion, asthma, nosebleeds.

Gastrointestinal: Vomiting, diarrhea, nausea, abdominal pain.

Eye disorders: Conjunctivitis.

Skin: Dermatitis.

Serious but rare side effects (from post-marketing surveillance):

Immune system: Severe allergic reactions, including anaphylaxis.

Neurological and psychiatric: Hallucinations, delirium, abnormal behavior, confusion, nightmares, convulsions (mainly in children and adolescents).

Cardiac: Arrhythmias.

Gastrointestinal: Gastrointestinal bleeding, hemorrhagic colitis.

Liver: Hepatitis, elevated liver enzymes, fatal fulminant hepatic failure.

Skin: Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioedema).

Storage Conditions

Store in a dry place at a temperature not exceeding 30°C.

Packaging

Carton box containing: One blister pack of 10 hard gelatin capsules and an insert leaflet.