Rifinah 300/150mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISONIAZID, RIFAMPICIN

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

J04AM02

INN (International Name):

ISONIAZID 150 mg RIFAMPICIN 300 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ISONIAZID 150 mg RIFAMPICIN 300 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOBACTERIALS

Authorization status:

Withdrawn

Authorization date:

2007-08-08

Patient Information leaflet

RIFINAH® 300/150MG FILM-COATED TABLETS
_RIFAMPICIN 300MG _
_ISONIAZID 150MG _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
Read all of this leaflet carefully before you start taking this
medicine.
- 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.
Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any side effects gets serious, or if you notice any side effect
not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Rifinah is and what it is used for
2. What you need to know before you take Rifinah
3. How to take Rifinah
4. Possible side effects
5. How to store Rifinah
6. Contents of the pack and other information
1. WHAT RIFINAH IS AND WHAT IT IS USED FOR
Rifinah 300/150mg Film-Coated Tablets is one of a group of medicines
used to treat tuberculosis
(also known as TB) of the lung and other mycobacterial infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFINAH
DO NOT TAKE RIFINAH IF:
- You are allergic (hypersensitive) to the active ingredients
(isoniazid or rifampicin) or to any of the
other ingredients.
- You have yellowing of the skin and eyes (jaundice).
- You are taking saquinavir or ritonavir for HIV infection (see
‘Taking other medicines’ section below).
Do not take if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking Rifinah.
WARNINGS AND PRECAUTIONS
INFORM YOUR DOCTOR IMMEDIATELY WHILE TAKING THIS MEDICINE
• If your symptoms of tuberculosis return or get worse (see 4.
Possible side effects)
• If you develop new or sudden worsening of shortness of breath,
possibly with a dry cough
or fever not responding to antibiotic treatment. These could be
symptoms of lung
inflammation (interstitial lung disease/pneumonitis) and can lead to
serious breathing
problems due to collection of fluid in the lungs and interfere with
normal breathing wh

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Rifinah 300/150mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Rifampicin and 150mg Isoniazid.
Excipients:
Sucrose 181.03mg
Sodium 1.3mg
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Film-coated Tablets (tablets).
Orange, smooth, shiny, capsule-shaped, sugar-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of tuberculosis, and other mycobacterial infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Rifinah should be given at least 30 minutes before a meal or 2 hours
after a meal.
_Adults Only: _
Rifampicin 450-600mg (10mg/kg b.w.) daily as a single dose combined
with
Isoniazid 5mg/kg b.w.
_Use _
_in _
_the _
_elderly:_
Caution
should
be
exercised
in
using
rifampicin
in
such
patients
especially if there is evidence of liver impairment.
_Use in impaired liver function: _
A daily dose of 8mg/kg/day should not be exceeded in patients
with impaired liver function.
4.3
CONTRA-INDICATIONS
Use in patients with jaundice.
Use
in
patients
with
known
hypersensitivity
to
the
rifamycins,
isoniazid
or
any
of
the
components
Rifinah
use
is
contra-indicated
when
given
concurrently
with
the
combination
of
saquinavir/ritonavir (See Section 4.5).
Administration at the same time as some formulations of
para-aminosalicyclic acid, since such
a combination will not permit adequate blood levels of either. Dosage
of each should be
separated by at least eight hours, unless the formulation of PAS has
been shown not to inhibit
absorption.
Use in patients with manic or hypomanic psychoses.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Rifinah
is
a
combination
of
two
drugs,
each
of
which
has
been
associated
with
liver
dysfunction.
Patients with impaired liver function or chronic alcoholism should
only be given Rifinah in
cases of necessity and then with caution and under strict medical
supervision. In these patients,
careful monitoring of liver function, especially serum alanine
aminotransferase (ALT) and
serum as