Rifinah 150

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 100 mg; RIFAMPICIN 150 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOBACTERIALS

Authorization status:

Authorised

Authorization date:

2011-03-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Rifinah 150/100mg
Coated Tablets
rifampicin - isoniazid
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IMPORTANT THINGS YOU KNOW NEED TO ABOUT RIFINAH 150/100MG TABLETS
The name of your medicine is Rifinah 150/100mg Coated Tablets (called
Rifinah 150/100mg Tablets
in this leaflet).
• It is very important that you take Rifinah 150/100mg 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 150/100mg Tablets makes all of your body fluids an orange
or red colour. Do not worry -
this is normal and not harmful
• Take Rifinah 150/100mg Tablets on an empty stomach. This means at
least 30 minutes before food
or 2 hours after food
• While you are taking Rifinah 150/100mg Tablets, you should not eat
cheese, skipjack tuna or drink
red wine (see ‘Taking Rifinah 150/100mg 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 150/100mg Tablets are and what they are used for
2. What you need to know before you take Rifi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rifinah 150/100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances (per tablet):
Rifampicin 150mg
Isoniazid 100mg
Excipients with known effect (per tablet):
Sucrose 110.06mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet
Cyclamen, smooth, shiny, round, curved 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
questioned