Darunavir Clonmel 800 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Darunavir

Available from:

Clonmel Healthcare Ltd

ATC code:

J05AE; J05AE10

INN (International Name):

Darunavir

Dosage:

800 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Protease inhibitors; darunavir

Authorization status:

Marketed

Authorization date:

2017-06-02

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR CLONMEL 800MG FILM-COATED TABLETS
Darunavir
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 Darunavir Clonmel is and what it is used for
2.
What you need to know before you take Darunavir Clonmel
3.
How to take Darunavir Clonmel
4.
Possible side effects
5.
How to store Darunavir Clonmel
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR CLONMEL IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR CLONMEL?
Darunavir
Clonmel
contains
the
active
substance
darunavir.
Darunavir
Clonmel
is
an
antiretroviral medicine used in the treatment of Human
Immunodeficiency Virus (HIV)
infection. It belongs to a group of medicines called protease
inhibitors. Darunavir Clonmel
works by reducing the amount of HIV in your body. This will improve
your immune system
and reduces the risk of developing illnesses linked to HIV infection.
WHAT IT IS USED FOR?
Darunavir Clonmel 800mg is used to treat adults and children (3 years
of age and above, at least
40 kg body weight) who are infected by HIV and
•
who have not used antiretroviral medicines before.
•
in certain patients who have used antiretroviral medicines before
(your doctor
will determine this).
Darunavir Clonmel must be taken in combination with a low dose of
ritonavir and other
anti-HIV medicines. Your doctor will discuss with you which
combination of medicines is best
for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR CLONMEL
DO NOT TAKE DARUNAVIR CLONMEL
•
if you are
ALLERGIC

Summary of Product characteristics

Health║Products║Regulatory║Authority
02║November║2023
CRN00DSHR
Page║1║of║34
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Darunavir║Clonmel║800║mg║film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║film‑coated║tablet║contains║800 mg║of║darunavir.
For║the║full║list║of║excipients,║see║section║6.1.
3 PHARMACEUTICAL FORM
Film‑coated║tablet.
Dark║redo║val║shaped║film-coated║tablets,║debossed║with║‘800’║on║one║side║and║plain║on║the║other║side,║with║dimensions║of║
approximately║20.2║mm║x║10.1║mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Darunavir║ Clonmel,║ co‑administered ║ with║ low║ dose║
ritonavir║ is║ indicated║ in║ combination║ with║ other║
antiretroviral║ medicinal║
products║for║the║treatment║of║patients║with║human║immunodeficiency║virus║(HIV‑1)║infection.
Darunavir║Clonmel║800
mg║tablets║may║be║used║to║provide║suitable║dose║regimens║for║the║treatment║of║HIV‑1
║infection║in║adult║
and║paediatric║patients║from║the║age║of║3
years║and║at║least║40 kg║body║weight║who║are:
●
║antiretroviral║therapy║(ART)‑naïve║(see║section║4.2).
● ║ART‑experienced
║with║no║darunavir║resistance║associated║mutations║(DRV‑RAMs)
║and║who║have║plasma║HIV‑1 ║RNA║< 100║
000 copies/ml║ and║ CD4+║ cell║ count║ ≥ 100 cells x 10║
6║
/l.║ In║ deciding║ to║ initiate║ treatment║ with║
Darunavir║ Clonmel║ in║ such║
ART‑experienced║patients,║genotypic║testing║should║guide║the║use║of║Darunavir║Clonmel║(see║sections║4.2,║4.3,║4.4║and║5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy║ should║ be║ initiated║ by║ a║ health║ care║
provider║ experienced║ in║ the║ management║ of║ HIV║
infection.║ After║