Rifater tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pyrazinamide; Rifampicin; Isoniazid

Available from:

Sigma Pharmaceuticals Plc

ATC code:

J04AM05

INN (International Name):

Pyrazinamide; Rifampicin; Isoniazid

Dosage:

300mg ; 120mg ; 50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 05010900

Patient Information leaflet

RIFATER
® TABLETS
(isoniazid, rifampicin, pyrazinamide)
PATIENT INFORMATION LEAFLET
IMPORTANT THINGS YOU NEED TO KNOW ABOUT RIFATER TABLETS
- It is very important that you take Rifater Tablets exactly as your
doctor
has told you
- 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
- Rifater Tablets make all your body fluids an orange or red colour.
Do
not worry - this is normal and not harmful
- Take Rifater Tablets on an empty stomach. This means at least
30 minutes before food or 2 hours after food
- While you are taking Rifater Tablets, you should not eat matured
cheese,
cured meat, some fish (like tuna, salmon and mackerel) or drink wine
and
beer (see ‘Taking Rifater 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 THE REST 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 your pharmacist. This medicine has been
prescribed for you. Do not pass it to others. It may harm them, even
if their
symptoms are the same as yours. If any of the side effects gets
serious, or if
you notice any side effects not listed in this leaflet, please tell
your doctor or
pharmacist.
Your medicine is available using the above name but will be referred
to as
Rifater Tablets throughout this leaflet
WHAT IS IN THIS LEAFLET
1. What Rifater Tablets are and what they are used for
2. What you need to know before you take Rifater Tablets
3. How to take Rifater Tablets
4. Possible side effects
5. How to store Rifater Tablets
6. Contents of the pack and other information
1. WHAT RIFATER TABLETS ARE AND WHAT THEY ARE USED FOR
Rifater Tablets contain three different medicines called isoniazid,
rifampicin
and pyrazinamide.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rifater Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin Ph Eur
120mg
Isoniazid Ph Eur
50mg
Pyrazinamide Ph Eur
300mg
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rifater is indicated in the treatment of pulmonary tuberculosis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Each Rifater tablet contains isoniazid (INH), pyrazinamide (Z) and
rifampicin
(RAMP) in such a ratio that the administration of 9-12mg/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.
Rifater should be given as a single dose and preferably on an empty
stomach at
least 30 minutes before a meal, or 2 hours after a meal to ensure
rapid and
complete absorption.
Once the initial intensive phase of treatment has been completed
treatment can
be continued with the combination rifampicin-isoniazid (Rifinah)
always on a
daily basis.
This regimen, if correctly applied, is 100% effective with very few,
if any,
relapses. The clinical evidence indicates that these occur generally
in the first
6 months after stopping treatment with bacilli fully sensitive to the
drugs
employed, so that changes in the drugs to be utilised for further
treatment are
not required. The regimen has been found to be fully effective also in
the
presence of a bacillary population resistant to isoniazid, to
streptomycin or to
both drugs.
_CHILDREN:_ The ratio of the three drugs in Rifater may not be
appropriate in
children (eg higher mg/kg doses of INH ar