Rifater 50 mg/300 mg/120 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isoniazid; Pyrazinamide; Rifampicin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

J04AM; J04AM05

INN (International Name):

Isoniazid; Pyrazinamide; Rifampicin

Dosage:

50 /300 /120 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Combinations of drugs for treatment of tuberculosis; rifampicin, pyrazinamide and isoniazid

Authorization status:

Marketed

Authorization date:

1987-02-09

Patient Information leaflet

Internal
RIFATER
®
50MG/300MG/120MG TABLETS
_ _
_Isoniazid 50mg - Pyrazinamide 300mg -Rifampicin 120mg _
_Sanofi Logo _
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 Rifater is and what it is used for
2. What you need to know before you take Rifater
3. How to take Rifater
4. Possible side effects
5. How to store Rifater
6. Contents of the pack and other information
1. W
1. WHAT RIFATER IS AND WHAT IT IS USED FOR
AT RIFATER IS AND WHAT IT ISED FOR
Rifater is one of a group of medicines used to treat tuberculosis
(also known as TB) of the lung.
2. WHAT YOU NEED TO KNOW BEFOREYOU TAKE RIFATER
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFATER
DO NOT TAKE RIFATER IF:
• You are allergic (hypersensitive) to:
- isoniazid
- rifampicin
- pyrazinamide
- any of the other ingredients (see Section 6 Further information).
Signs of an allergic reaction include: rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
• You have yellowing of the skin and eyes (jaundice).
• You are taking saquinavir or ritonavir for HIV infection (see
‘Taking other medicines’ section below).
Severe skin reactions such as severe extensive skin damage (separation
of the epidermis and superficial mucous
membranes) (toxic epidermal necrolysis, TEN,), skin blistering,
red/purple rash, fever headache, cough and joint pain
(Stevens-Johnson syndrome, SJS) or large areas of red, swollen skin
with small pus-filled elevations (acute generalized
exanthematous pustulosis, AGEP) may occur. Treatment must be
immediately

Summary of Product characteristics

Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifater 50 mg/300 mg/120 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
Isoniazid. 50 mg
Pyrazinamide 300 mg
Rifampicin 120 mg
Excipient: Contains 104.99 mg sucrose
_For a full list of excipients, see section 6.1. _
3 PHARMACEUTICAL FORM
Coated tablet.
Smooth, circular, pink-beige sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications for use
In the treatment of pulmonary tuberculosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
For oral administration.
Adults:
Rifater is recommended in the initial intensive phase of the
short-course treatment of pulmonary tuberculosis. During this
phase, which lasts for 2 months, Rifater should be administered on a
daily continuous basis. The concomitant administration of
ethambutol or intramuscular streptomycin over the same period of time
is advised.
Rifater should only used under the supervision of specialists having
the appropriate facilities for clinical and laboratory
monitoring of effects.
Each Rifater tablet contains isoniazid (INH), pyrazinamide (Z) and
rifampicin (RAMP) in such a ratio that the administration of
9-12 mg/kg RAMP, 4-5mg/kg INH and 23-30mg/kg Z can be achieved by
giving 3 tablets daily to patients weighing less than
40kg, 4 tablets to patients weighing 40-49kg, 5 tablets to patients
weighing 50-64kg and 6 tablets to patients weighing 65kg
or more.
Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 2 of 15
Rifater should be given as a single dose 1-2 hours before a meal to
ensure rapid and complete absorption. Once the initial
intensive phase of treatment has been completed the treatment can be
continued with the combination rifampicin-isoniazid
(Rifinah) always on a daily basis.
Children:
There is insufficient experience of use in children.
Use in the elderly:
Caution should be exercised in such patients, in view of the possib