Efavirenz Rowex 600mg Film-coated Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Efavirenz

Pieejams no:

Rowex Ltd

ATĶ kods:

J05AG; J05AG03

SNN (starptautisko nepatentēto nosaukumu):

Efavirenz

Deva:

600 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Non-nucleoside reverse transcriptase inhibitors; efavirenz

Autorizācija statuss:

Marketed

Autorizācija datums:

2013-10-25

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ ROWEX 600 MG FILM-COATED TABLETS
efavirenz
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Efavirenz Rowex is and what it is used for
2.
What you need to know before you take Efavirenz Rowex
3.
How to take Efavirenz Rowex
4.
Possible side effects
5.
How to store Efavirenz Rowex
6.
Contents of the pack and other information
1
WHAT EFAVIRENZ ROWEX IS AND WHAT IT IS USED FOR
Efavirenz Rowex, which contains the active substance efavirenz,
belongs to a class of antiretroviral
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). It is an
ANTIRETROVIRAL
MEDICINE THAT FIGHTS HUMAN IMMUNODEFICIENCY VIRUS
(HIV) infection by reducing the amount of the
virus in blood. It is used by adults, adolescents and children
weighing ≥40 kg.
Your doctor has prescribed Efavirenz Rowex for you because you have
HIV infection. Efavirenz Rowex
taken in combination with other antiretroviral medicines reduces the
amount of the virus in the blood. This
will strengthen your immune system and reduce the risk of developing
illnesses linked to HIV infection.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFAVIRENZ ROWEX
DO NOT TAKE EFAVIRENZ ROWEX
•
IF YOU ARE ALLERGIC
to efavirenz or any of the other ingredients of this medicine (listed
in section 6).
Contact your doctor or pharmacist for advice.
•
IF YOU HAVE SEVERE LIVER DISEASE.
•
IF YOU HAVE A HEART CONDITION, SUCH AS CHANGES IN THE RHYTHM OR RATE
OF THE HEARTBEAT, A SLOW
HEARTBEAT, OR SEVE

Produkta apraksts

Health Products Regulatory Authority
25 July 2022
CRN00CWN9
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efavirenz Rowex 600mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz.
Excipient with known effect
Each film-coated tablet contains 95.29 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow film-coated tablet of capsule shape (9.6 x 19.2 mm) with a
break line on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Efavirenz Rowex is indicated in antiviral combination treatment of
human immunodeficiency virus-1 (HIV-1) infected adults,
adolescents and children weighing ≥ 40 kg.
Efavirenz Rowex has not been adequately studied in patients with
advanced HIV disease, namely in patients with CD4 counts <
50 cells/mm3, or after failure of protease inhibitor (PI) containing
regimens. Although cross-resistance of efavirenz with PIs has
not been documented, there are at present insufficient data on the
efficacy of subsequent use of PI based combination therapy
after failure of regimens containing Efavirenz Rowex.
For a summary of clinical and pharmacodynamic information, see section
5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
Efavirenz Rowex must be given in combination with other antiretroviral
medicines (see section 4.5).
In order to improve the tolerability of nervous system adverse
reactions, bedtime dosing is recommended (see section 4.8).
_Adults and adolescents over 40 kg: _the recommended dose of Efavirenz
Rowex in combination with nucleoside analogue
reverse transcriptase inhibitors (NRTIs) with or without a PI (see
section 4.5) is 600 mg orally, once daily.
Efavirenz film-coated tablets are not suitable for children weighing
less than 40 kg. Other efavirenz formulations are av