Rimactane 300mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Rifampicin

זמין מ:

Sandoz Ltd

קוד ATC:

J04AB02

INN (שם בינלאומי):

Rifampicin

כמות:

300mg

טופס פרצבטיות:

Oral capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05010900; GTIN: 05010678061208

עלון מידע

Page 1 of 2
CP00057
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIMACTANE
® 300MG CAPSULES
(rifampicin)
Your medicine is available using the name Rimactane 300mg
Capsules but will be referred to as Rimactane throughout this
leaflet.
Other strengths of this medicine are also available.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT
RIMACTANE

It is very important that you take Rimactane 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 Rimactane each day as you are told.

You must keep taking Rimactane 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.

Rimactane makes all your body fluids an orange or red
colour. Do not worry – this is normal and not harmful.

Take Rimactane on an empty stomach. This means at
least 30 minutes before food or 2 hours after food.

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.

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 on to others. It may harm them, even if their
signs of illness are the same as yours.

If you get any of the 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 Rimactane is and what it is used for
2.
What you need to know before you take Rimactane
3.
How to take Rimactane
4.
Possible side effects
5.
How to store Rimactane
6.
Contents of the pack and other information
1.
WHAT RIMACTANE IS AND WHAT IT IS USED FOR
Rimactane contains a medicine called rifampicin. It belongs to
a group of medicines called

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rimactane® 300 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl)
rifamycin SV.
One capsule contains 300 mg rifampicin Ph. Eur.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules.
Opaque, two-piece, hard gelatine capsule, reddish-brown in colour,
marked with
‘NG 300’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rifampicin is a major drug in the management of tuberculosis (all
forms) and
certain opportunistic mycobacterial infections. It is effective in
cases resistant
to other anti-tuberculosis agents and shows no cross-resistance
outside the
rifampycin group of drugs. In the treatment of tuberculosis Rifampicin
must
always be combined with other anti-tuberculosis agents. It is
effective in
combination with isoniazid, streptomycin, pyrazinamide, ethambutol and
the
majority of second line drugs.
Prophylaxis of meningococcal meningitis in close contact adult and
paediatric
patients
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_For the management of tuberculosis and certain opportunistic
mycobacterial _
_infections_:
Rifampicin must always be given in association with other
anti-tuberculosis
drugs, to prevent emergence of resistant strains.
_ Use in Adults_: 450-600mg daily as a single dose (based on
approximately
10mg per kg body weight). (Those patients 50kg (8 stone) and over
should take
600mg rifampicin daily, whilst patients under 50kg should take 450mg).
The following chemotherapeutic agents are employed today as combined
therapy for tuberculosis: rifampicin (Rimactane) (RMP), isoniazid
(INH),
pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM).
The dosages recommended by the Centres for Disease Control and
Prevention
are as follows:
DAILY
TWICE A WEEK
3 TIMES A WEEK
DRUG
MG/KG
MAX. MG
MG/KG
MAX. MG
MG/KG
MAX. MG
CHILDR
EN
ADUL
TS
CHILD
REN
ADULT
S
CHILD
REN
ADULT
S
RMP
10-20
10
600
10-20
10
600
10-20
10
600
INH
10-15
5
300
20-40
15
90