Rifinah 300 / 150 mg Film Coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Rifampicin; Isoniazid

Disponibil de la:

Sanofi-Aventis Ireland Limited T/A SANOFI

Codul ATC:

J04AM; J04AM02

INN (nume internaţional):

Rifampicin; Isoniazid

Dozare:

300mg/150 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Combinations of drugs for treatment of tuberculosis; rifampicin and isoniazid

Statutul autorizaţiei:

Marketed

Data de autorizare:

1977-04-01

Prospect

Internal
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.
Internal
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
n

Caracteristicilor produsului

Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifinah 300 / 150 mg 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
function 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 CONTRAINDICATIONS
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-aminosalicylic 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 p