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viekirax ®
ombitasvir/ paritaprevir/
ritonavir tablets
SAFETY INFORMATION
NAME OF THE MEDICINAL PRODUCT: Viekirax 12.5 mg/75 mg/50 mg fi lm-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each fi lm-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and
50 mg of ritonavir.
THERAPEUTIC INDICATIONS: Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC)
in adults (see sections 4.2, 4.4, and 5.1 of the SmPC). For hepatitis C virus (HCV) genotype specifi c activity, see sections 4.4 and 5.1 of the SmPC.
CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the excipients. Patients with severe hepatic impairment
(Child-Pugh C). Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or
contraceptive vaginal rings. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are
associated with serious events must not be co-administered with Viekirax. Examples of CYP3A4 substrates are alfuzosin hydrochloride;
amiodarone; astemizole, terfenadine; cisapride; colchicine in patients with renal or hepatic impairment; ergotamine, dihydroergotamine,
ergonovine, methylergometrine; fusidic acid; lovastatin, simvastatin, atorvastatin; oral midazolam, triazolam; pimozide; quetiapine; quinidine;
salmeterol; sildenafi l (when used for the treatment of pulmonary arterial hypertension); ticagrelor. Co-administration of Viekirax with or
without dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease ombitasvir, paritaprevir,
and ritonavir plasma concentrations and reduce their therapeutic effect and must not be co-administered. Examples of contraindicated
strong or moderate enzyme inducers are carbamazepine, phenytoin, phenobarbital; efavirenz, nevirapine, etravirine; enzalutamide; mitotane;
rifampicin; St. John’s Wort (Hypericum perforatum). Co-administration of Viekirax with or without dasabuvir with medicinal products that
are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax.
Examples of contraindicated strong CYP3A4 inhibitors are cobicistat; indinavir, lopinavir/ritonavir, saquinavir, tipranavir; itraconazole,
ketoconazole, posaconazole, voriconazole; clarithromycin, telithromycin; conivaptan.
LIST OF EXCIPIENTS: Tablet core: Copovidone, Vitamin E polyethylene glycol succinate, Propylene glycol monolaurate, Sorbitan monolaurate,
Colloidal anhydrous silica (E551), Sodium stearyl fumarate. Film-coating: Polyvinyl alcohol (E1203), Polyethylene glycol 3350, Talc (E553b),
Titanium dioxide (E171), Iron oxide red (E172).
MARKETING AUTHORISATION HOLDER: AbbVie Ltd, Maidenhead, SL6 4XE, United Kingdom
PRESCRIPTION STATUS: restricted to medical prescription
PHARMACOTHERAPEUTIC GROUP: Antivirals for systemic use; direct-acting antivirals, ATC code not yet assigned
For information to special warnings and precautions for use, interaction with other medicinal products and other forms
of interaction, fertility, pregnancy and lactation and undesirable effects please refer to the published Summary of
Product Characteristics.
DATE OF INFORMATION: 01/2015
exviera ®
dasabuvir tablets
SAFETY INFORMATION
NAME OF THE MEDICINAL PRODUCT: Exviera 250 mg fi lm-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each fi lm-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Excipient with known effect: each fi lm-coated tablet contains 44.94 mg lactose (as monohydrate).
THERAPEUTIC INDICATIONS: Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC)
in adults (see sections 4.2, 4.4 and 5.1 of the SmPC). For hepatitis C virus (HCV) genotype specifi c activity, see sections 4.4 and 5.1. of the SmPC.
CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the excipients. Use of ethinylestradiol-containing medicinal
products such as those contained in most combined oral contraceptives or contraceptive vaginal rings. Co-administration of Exviera with
medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce
its therapeutic effect. Examples of contraindicated inducers are carbamazepine, phenytoin, phenobarbital; efavirenz, nevirapine, etravirine;
enzalutamide; mitotane; rifampicin; St. John’s Wort (Hypericum perforatum). Medicinal products that are strong CYP2C8 inhibitors may
increase dasabuvir plasma concentrations and must not be co-administered with Exviera. Example of contraindicated CYP2C8 inhibitors is
gemfi brozil. Exviera is administered with ombitasvir/ paritaprevir /ritonavir. For contra-indications with ombitasvir/ paritaprevir /ritonavir
refer to the Summary of Product Characteristics.
LIST OF EXCIPIENTS: Tablet core: Microcrystalline cellulose (E460(i)), Lactose monohydrate, Copovidone, Croscarmellose sodium,
Colloidal anhydrous silica (E551), Magnesium stearate (E470b). Film-coating: Polyvinyl alcohol (E1203), Titanium dioxide (E171),
Polyethylene glycol 3350, Talc (E553b), Iron oxide yellow (E172), Iron oxide red (E172), Iron oxide black (E172).
MARKETING AUTHORISATION HOLDER: AbbVie Ltd, Maidenhead, SL6 4XE, United Kingdom
PRESCRIPTION STATUS: restricted to medical prescription
PHARMACOTHERAPEUTIC GROUP: Antivirals for systemic use; direct-acting antivirals, ATC code not yet assigned
For information to special warnings and precautions for use, interaction with other medicinal products and other forms
of interaction, fertility, pregnancy and lactation and undesirable effects please refer to the published Summary of
Product Characteristics.
DATE OF INFORMATION: 01/2015
1693007
Item code: ATHCV150107, 23022015