Darunavir Accord Tablet, film coated 600mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DARUNAVIR PROPYLENE, GLYCOLATE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

J05AE10

INN (International Name):

DARUNAVIR PROPYLENE GLYCOLATE 600 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DARUNAVIR PROPYLENE GLYCOLATE 600 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2019-02-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR ACCORD 600MG 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Darunavir Accord is and what it is used for
2.
What you need to know before you take Darunavir Accord
3.
How to take Darunavir Accord
4.
Possible side effects
5.
How to store Darunavir Accord
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR ACCORD IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR ACCORD?
Darunavir Accord contains the active substance darunavir. Darunavir
Accord is an antiretroviral
medicine used in the treatment of Human Immunodeficiency Virus (HIV)
infection. It belongs to a
group of medicines called protease inhibitors. This medicine 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 Accord is used to treat adults and children of 3 years of
age and above, and at least
15 kilogram body weight who are infected by HIV and who have already
used other antiretroviral
medicines.
Darunavir Accord 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 ACCORD
DO NOT TAKE DARUNAVIR ACCORD
-
if you are
ALLERGIC
to darunavir or any of the other ingredients of this medicine (listed
in section
6) or to ritonavir.
-
if you have

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Accord 600mg Film–coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Accord 600 mg film-coated tablets
Each film-coated tablet contains 600 mg of darunavir (as propylene
glycolate).
_Excipients with known effect _
Each film-coated tablet contains 2.88 mg of Sunset Yellow FCF Aluminum
Lake (E110).
Each film-coated tablet contains 113.90 mg of lactose monohydrate.
Each film-coated tablet contains 83.33 mg of propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Darunavir Accord 600 mg
Orange oval shaped tablet, debossed with “600” on one side with
dimensions: Length: 20.2±0.2 mm,
Width: 10.2 ± 0.2 mm and Thickness: 6.8±0.4mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir Accord 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 (see section 4.2).
Darunavir Accord 600 mg tablets may be used to provide suitable dose
regimens (see section 4.2):
•
For the treatment of HIV-1 infection in antiretroviral treatment
(ART)-experienced adult
patients, including those that have been highly pre-treated.
•
For the treatment of HIV-1 infection in paediatric patients from the
age of 3 years and at least
15 kg body weight.
In deciding to initiate treatment with Darunavir Accord
co-administered with low dose ritonavir,
careful consideration should be given to the treatment history of the
individual patient and the patterns
of mutations associated with different agents. Genotypic or phenotypic
testing (when available) and
treatment history should guide the use of Darunavir Accord (see
sections 4.2, 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 therapy with Darunavir Accord has been initiated,
patients should be advised not