Rimactane 150mg capsules

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Rifampicin

থেকে পাওয়া:

Sandoz Ltd

এটিসি কোড:

J04AB02

INN (International Name):

Rifampicin

ডোজ:

150mg

ফার্মাসিউটিকাল ফর্ম:

Oral capsule

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 05010900

তথ্য লিফলেট

Proof no.
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05/12/2017
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ARTWORK PROOF BOX
Ref:
V046: Update to SPC + PIL to include PRAC reco Amplodine
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIMACTANE
®
150 MG CAPSULES
RIFAMPICIN
IMPORTANT THINGS YOU NEED TO KNOW ABOUT RIMACTANE 150 MG CAPSULES
•
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.
Rimactane Capsules contain a medicine called
rifampicin. It belongs to a group of medicines called
anti-bacterials. It works by killing the bacteria that
cause infections.
Rimactane Capsules are used to treat the following
bacterial infections:
•
In combination with other drugs for the treatment
and prevention of tuberculosis (also known as
TB), an infectious disease mainly affecting the
lungs, and some other infections
•
Prevention of meningococcal meningitis.
DO NOT TAKE RIMACTANE IF YOU:
•
are allergic to active substance or to any of the
other ingredients of this medicine (listed in
section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue.
•
have jaundice – yellowing of the skin or whites of
the eyes caused by liver or blood problems.
•
are taking saquinavir or ritonavir

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rimactane® 150 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl)
rifamycin SV.
One capsule contains 150 mg rifampicin Ph. Eur.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules.
Opaque, two-piece, hard gelatine capsules, reddish- brown in colour,
marked
with ‘NG 150’.
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
1