Rifinah 300

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISONIAZID; RIFAMPICIN

Available from:

Sanofi Malta Limited

ATC code:

J04AM02

INN (International Name):

ISONIAZID; RIFAMPICIN

Pharmaceutical form:

COATED TABLET

Composition:

ISONIAZID 150 mg; RIFAMPICIN 300 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOBACTERIALS

Authorization status:

Authorised

Authorization date:

2007-08-08

Patient Information leaflet

TURN
OVER
_I_
IMPORTANT THINGS YOU NEED TO KNOW ABOUT
RIFINAH 300/150MG TABLETS
The name of your medicine is Rifinah 300/150mg Coated
Tablets (called Rifinah 300/150mg Tablets in this leaflet).
•
It is very important that you take Rifinah 300/150mg
Tablets exactly as your doctor has told you. There is a
chance of you having a severe and dangerous allergic
reaction if you do not take your tablets every day as you
are told
•
You must keep taking it until your doctor tells you to stop.
•
If you are taking any other medicines, including
medicines you have bought from the pharmacy or shop,
you must make sure your doctor knows
•
Rifinah 300/150mg Tablets makes all of your body fluids
an orange or red colour. Do not worry - this is normal
and not harmful
•
Take Rifinah 300/150mg Tablets on an empty stomach.
This means at least 30 minutes before food or 2 hours
after food
•
While you are taking Rifinah 300/150mg Tablets, you
should not eat cheese, skipjack tuna or drink red wine
(see ‘Taking Rifinah 300/150mg Tablets with food and
drink’)
•
If you get a temperature, are sick, begin to feel more
unwell, lose your appetite or have yellowing of the skin,
gums or eyes, you must talk to your doctor straight away
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 to
others. It may harm them, even if their symptoms 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 Rifinah 300/150mg Tablets are and what they are
used for
2.
What you need to know before you take Rifinah
300/150mg Tablets
3.
How to take Rifinah 300/150mg Tablets
4.
Possible side effects
5.
How to store Rifinah 300/150mg Tablets
6.
Cont

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rifinah 300/150mg Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances (per tablet):
Rifampicin 300mg
Isoniazid 150mg
Excipients (per tablet):
Sucrose 181.03mg
E110, Sunset yellow 1.37mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet
Orange, smooth, shiny capsule shaped sugar coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rifinah is indicated in the treatment of all forms of tuberculosis,
including fresh,
advanced and chronic cases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Another antituberculosis drug may be given concurrently with Rifinah
until the
susceptibility of the infecting organism to rifampicin and isoniazid
has been confirmed.
_Adults:_ Patients should be given the following single daily dose
preferably on an empty
stomach at least 30 minutes before a meal or 2 hours after a meal:
Rifinah 150: Patients weighing less than 50kg - 3 tablets.
Rifinah 300: Patients weighing 50kg or more - 2 tablets.
_Use in the elderly:_ Caution should be exercised in such patients
especially if there is
evidence of liver impairment.
4.3
CONTRAINDICATIONS
Rifinah is contraindicated in

patients who are hypersensitive to rifamycins or isoniazid or any of
the
excipients (see section 6.1);

the presence of jaundice;

concurrent treatment with the combination of saquinavir/ritonavir (see
section
4.5 Interaction with other medicinal products and other forms of
interaction).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Rifinah is a combination of 2 drugs, each of which has been associated
with liver
dysfunction.
All tuberculosis patients should have pre-treatment measurements of
liver
function.
Adults treated for tuberculosis with Rifinah should have baseline
measurements
of hepatic enzymes, bilirubin, serum creatinine, a complete blood
count and a
platelet count (or estimate).
Patients should be seen at least monthly during therapy and should be
quest