Ritonavir 100 mg film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ritonavir

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

J05AE; J05AE03

INN (International Name):

Ritonavir

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Protease inhibitors; ritonavir

Authorization status:

Not marketed

Authorization date:

2017-04-07

Patient Information leaflet

NL/H/3149/001/IB/021- v00-06/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
RITONAVIR 100 MG FILM-COATED TABLETS
ritonavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU OR YOUR CHILD.
-
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 Ritonavir tablets is and what it is used for
2.
What you need to know before you or your child takes Ritonavir tablets
3.
How to take Ritonavir tablets
4.
Possible side effects
5.
How to store Ritonavir tablets
6.
Contents of the pack and other information
1.
WHAT RITONAVIR TABLETS IS AND WHAT IT IS USED FOR
Ritonavir tablets contains the active substance ritonavir. Ritonavir
is a protease inhibitor used to control HIV
infection. Ritonavir is used in combination with other anti-HIV
medicines (antiretrovirals) to control your HIV
infection. Your doctor will discuss with you the best combination of
medicines for you.
Ritonavir tablets is used by children 2 years of age or older,
adolescents and adults who are infected with HIV,
the virus which causes AIDS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES RITONAVIR TABLETS
DO NOT TAKE RITONAVIR TABLETS
-
if you are allergic to ritonavir or any of the other ingredients of
this medicine (see section 6).
-
if you have severe liver disease.
-
if you are currently taking any of the following medicines:
-
astemizole or terfenadine (commonly used to treat allergy symptoms –
these medicines may be available
without prescription);
-
amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone,
quinidine (used to correct
irregular heartbeats);
-
dihydroergot

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2024
CRN00F210
Page 1 of 75
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ritonavir 100 mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 100 mg of ritonavir.
For the Full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, capsule shaped, film-coated tablets, with a
dimension of approx. 17.1 mm in length and 9.1 mm in width,
debossed with 'H' on one side and 'R9' on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ritonavir is indicated in combination with other antiretroviral agents
for the treatment of HIV-1 infected patients (adults and
children of 2 years of age and older).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ritonavir should be administered by physicians who are experienced in
the treatment of HIV infection. Ritonavir film-coated
tablets are administered orally and should be ingested with food (see
section 5.2).
Ritonavir film-coated tablets should be swallowed whole and not
chewed, broken or crushed.
Posology
_Ritonavir dosed asa pharmacokineticenhancer_
When ritonavir is used as a pharmacokinetic enhancer with other
protease inhibitors (PI) the Summary of Product
Characteristics (SmPC) for the particular protease inhibitor must be
consulted.
The following HIV-1 protease inhibitors have been approved for use
with ritonavir as a pharmacokinetic enhancer at the noted
doses.
_Adults:_
Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily
Atazanavir 300 mg once daily with ritonavir 100 mg once daily
Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily
Lopinavir co-formulated with ritonavir (lopinavir/ritonavir) 400
mg/100 mg or 800 mg/200 mg
Saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily in
ART experienced patients. Initiate treatment with saquinavir
500 mg twice daily with ritonavir 100 mg twice daily for the first 7
days, then saquinavir 1000 mg twice daily with ritonavir 100
mg twice da