Copegus® tablets are used to treat chronic hepatitis C (CHC) in combination with other preparations.
The active ingredient is ribavirin (one tablet contains 200 mg of ribavirin).
Excipients: pregelatinized starch, sodium starch glycolate (type A), microcrystalline cellulose, corn starch, magnesium stearate.
Film sheath: OPADRY® pink 03A14309 (hypromellose, talc, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)), ethylcellulose aqueous dispersion (solid), triacetin.
Hypersensitivity to ribavirin or to any of the excipients.
Pregnancy. Treatment with Copegus® can only be started after receiving a negative pregnancy test immediately before starting treatment.
Breastfeeding period.
History of severe heart disease, including unstable and uncontrolled heart disease during the previous 6 months.
Hemoglobinopathies (eg thalassemia, sickle cell disease).
You should also read the instructions for the use of preparations that are used in combination with Copegus®.
Treatment should be prescribed and monitored by a physician experienced in the treatment of chronic hepatitis C.
You should also read the instructions for the use of preparations that are prescribed in combination with Copegus® for the treatment of chronic hepatitis C.
Copegus® should be taken orally twice a day (morning and evening) with meals. Due to the teratogenic potential of ribavirin, tablets should not be crushed or crushed.
The dose of the Copegus® preparation depends on the patient's body weight, the genotype of the virus and the preparation with which the Copegus® preparation is used in combination.
The duration of treatment depends on which preparation Copegus® is used in combination with, and may depend on individual factors on the part of the patient and the virus, including genotype, presence or absence of coinfection, previous treatment, response during treatment.
The introductory part of the instructions is given, read the full instructions inside the package.
Children
Regarding the use of Copegus®, children need to assess the benefit-risk ratio in each individual case.
Drivers
The preparation "Copegus®" does not affect or has a slight effect on the ability to drive vehicles or work with other mechanisms. However, when used in combination with interferon alpha-2a or interferon alpha-2a, there may be some effect. For more information, see the instructions for medical use of medicines that are prescribed in combination with Copegus®.
In the course of clinical studies, there were no cases of overdose with Copegus®. When the maximum recommended dose was exceeded by more than 4 times, hypocalcemia and hypomagnesemia were observed. In many of these cases, ribavirin was administered intravenously. Due to the large volume of distribution, ribavirin is not significantly eliminated by hemodialysis.
A characteristic feature of the safety profile of ribavirin is hemolytic anemia, which occurs during the first weeks of therapy. Hemolytic anemia associated with the use of ribavirin can lead to deterioration of cardiac function and / or worsening of existing cardiac pathology. In some patients, an increase in the level of uric acid and indirect bilirubin associated with hemolysis was also observed.
The introductory part of the instructions is given, read the full instructions inside the package.
Store at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 4 years.
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