DUOPIC 150/75 TABLET

Ülke: Güney Afrika

Dil: İngilizce

Kaynak: South African Health Products Regulatory Authority (SAHPRA)

Mevcut itibaren:

Adcock Ingram Limited

Doz:

Not Indicated

Farmasötik formu:

TABLET

Kompozisyon:

None

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

Date of approval: 31 May 2022
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
DUOPIC 150/75, 150 MG AND 75 MG, FILM-COATED TABLETS
RIFAMPICIN/ ISONIAZID
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DUOPIC
150/75
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor, pharmacist, nurse or
other health care
provider.
•
DUOPIC 150/75 has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What DUOPIC 150/75 is and what it is used for
2.
What you need to know before you take DUOPIC 150/75
3.
How to take DUOPIC 150/75
4.
Possible side effects
5.
How to store DUOPIC 150/75
6.
Contents of the pack and other information
1. WHAT DUOPIC 150/75 IS AND WHAT IT IS USED FOR
DUOPIC 150/75 contains two different medicines called rifampicin and
isoniazid. They both
belong to a group of medicines called anti-tuberculous medicines. They
work by killing the
bacteria that cause tuberculosis. DUOPIC 150/75 tablets are used to
treat tuberculosis (also
known as TB).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUOPIC 150/75
DO NOT TAKE DUOPIC 150/75:
•
if you are hypersensitive (allergic) to rifampicin, isoniazid, or to
any other ingredients of
DUOPIC 150/75 (listed in section 6).
•
if you have yellowing of the skin and eyes (jaundice).
•
if you have liver damage.
•
If you are taking saquinavir or ritonavir for an HIV infection (see
‘Other medicines and
DUOPIC 150/75’ section below).
Date of approval: 31 May 2022
PATIENT INFORMATION LEAFLET
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH DUOPIC 150/75:
Talk to your doctor or pharmacist before taking DUOPIC 150/75 tablets
if:
•
You have liver problems.
•
You have any kidney problems and if you are having more than 600 mg
rifampicin per day.
•
You inject yourself with drugs.
•
You are a black or Hispanic woman.
•
The person taking this medicine is a child.
•
You

Ürün özellikleri

Date of approval: 31 May 2022
PROFESSIONAL INFORMATION
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
DUOPIC 150/75, 150 mg and 75 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains150 mg rifampicin and 75 mg isoniazid.
Sugar free.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Brick red coloured capsule shaped biconvex film coated tablets, break
line on one side and
plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pulmonary tuberculosis for adults in the continuous phase of
treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
DUOPIC 150/75 tablets are recommended in the continuation phase of the
treatment of
pulmonary tuberculosis. During this phase, which lasts for 4 months,
this medicine should be
administered on a continuous daily basis.
THE TOTAL DOSAGE REQUIREMENT IS AS FOLLOWS:
_DAILY (DOSE RANGE)_
_RIFAMPICIN _ 10 mg/kg maximum 600 mg per day
(8 mg to 12 mg)
_ISONIAZID_
5 mg/kg maximum 300 mg per day
(4 mg to 6 mg)
Date of approval: 31 May 2022
PROFESSIONAL INFORMATION
_THE DAILY DOSAGE IS AS FOLLOWS:_
_PATIENT BODY MASS (KG) _
_AMOUNT OF TABLETS (DAILY) _
30 to 37*
2
38 to 54
3
55 to 70
4
71 and more*
5
* In practice, most patients taking rifampicin containing FDC tablets
will receive either 3 or 4
tablets daily. Only a small proportion of adult TB patients will fall
into the categories with a
body-mass from 30 to 37 kg or body-mass above 70 kg. This might
necessitate the maximum
dose of rifampicin of 600 mg per day to be exceeded; however, the dose
limit of 12 mg/kg will
still be observed which does not pose an additional risk.
METHOD OF ADMINISTRATION
DUOPIC 150/75 tablets should be taken orally, as a single dose and
should be swallowed
whole with water.
4.3 CONTRAINDICATIONS
DUOPIC 150/75 is contraindicated
•
in patients with a hypersensitivity to rifamycins or isoniazid or any
of the excipients of
DUOPIC 150/75 (see section 6.1);
•
in the presence of jaundice;
•
in pat