CO-TRIMOXAZOLE PHARMC TABLET

Negara: Afrika Selatan

Bahasa: Inggris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Beli Sekarang

Selebaran informasi Selebaran informasi (PIL)
01-01-2024
Karakteristik produk Karakteristik produk (SPC)
01-01-2024

Tersedia dari:

Pharmacorp (Pty) Ltd

Dosis:

See ingredients

Bentuk farmasi:

TABLET

Komposisi:

EACH TABLET CONTAINS SULFAMETHOXAZOLE 400 mg TRIMETHOPRIM 80 mg

Status otorisasi:

Registered

Tanggal Otorisasi:

1992-04-01

Selebaran informasi

                                CO-TRIMOXAZOLE PHARMC
Patient Information Leaflet
Page 1 of 14
SCHEDULING STATUS
CO-TRIMOXAZOLE DS PHARMC, 160 MG/800 MG, TABLETS
CO-TRIMOXAZOLE PHARMC, 80 MG/400 MG, TABLETS
CO-TRIMOXAZOLE PAED PHARMC, 40 MG/200 MG, SUSPENSION
TRIMETHOPRIM AND SULFAMETHOXAZOLE
CO-TRIMOXAZOLE DS PHARMC IS SUGAR FREE
CO-TRIMOXAZOLE PHARMC IS SUGAR FREE
CO-TRIMOXAZOLE PAED PHARMC CONTAINS:
SUGAR AS SUCROSE 2 500 MG/5 ML
SWEETENER AS SODIUM SACCHARIN 20 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
CO-TRIMOXAZOLE PHARMC
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
CO-TRIMOXAZOLE PHARMC 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 CO-TRIMOXAZOLE PHARMC is and what it is used for
2.
What you need to know before you take/give CO-TRIMOXAZOLE PHARMC
S4
CO-TRIMOXAZOLE PHARMC
Patient Information Leaflet
Page 2 of 14
3.
How to take/give CO-TRIMOXAZOLE PHARMC
4.
Possible side effects
5.
How to store CO-TRIMOXAZOLE PHARMC
6.
Contents of the pack and other information
1. WHAT CO-TRIMOXAZOLE PHARMC IS AND WHAT IT IS USED FOR
CO-TRIMOXAZOLE DS PHARMC, CO-TRIMOXAZOLE PHARMC and CO-TRIMOXAZOLE
PAED PHARMC (called CO-TRIMOXAZOLE PHARMC in this leaflet) contains
two different
antibiotics called sulfamethoxazole and trimethoprim, which is used to
treat infections caused
by certain bacteria. As CO-TRIMOXAZOLE PHARMC only works against some
types of
bacteria, it is only suitable for treating some types of infections.
It is used for:
1.
Upper and lower lung infections
2.
Urinary bladder or urinary tract infections
3.
Gastrointestinal
tract
(your
mouth,
oesophagus
(gullet),
stomach
and
intestines)
infections
4.
Genital tract (reproductive track including sexually transferred
diseases) infections
5.
Skin infections
6.
Other infections caused by bacteria that CO-TRIMOXAZOL
                                
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Karakteristik produk

                                CO-TRIMOXAZOLE PHARMC
Professional Information
Page 1 of 22
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
CO-TRIMOXAZOLE DS PHARMC, 160 mg/800 mg, tablets
CO-TRIMOXAZOLE PHARMC, 80 mg/400 mg, tablets
CO-TRIMOXAZOLE PAED PHARMC, 40 mg/200 mg, suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CO-TRIMOXAZOLE DS PHARMC
Each tablet contains:
Trimethoprim
160 mg
Sulfamethoxazole
800 mg
Sugar free
Preserved with Nipastat
0,025 % _m/m_
For full list of excipients, see section 6.1.
CO-TRIMOXAZOLE PHARMC
Each tablet contains:
Trimethoprim
80 mg
Sulfamethoxazole
400 mg
Sugar free
Preserved with Nipastat
0,025 % _m/m_
For full list of excipients, see section 6.1.
CO-TRIMOXAZOLE PHARMC
Professional Information
Page 2 of 22
CO-TRIMOXAZOLE PAED PHARMC
Trimethoprim
40 mg/5 mL
Sulfamethoxazole
200 mg/5 mL
Contains sugar as sucrose
2 500 mg/5 mL
Contains sweetener as Sodium Saccharin
20 mg/5 mL
Preserved with Nipastat
15 mg/5 mL (0,5 % _w/v_)
Alcohol 96 %
0,025 mL/5 mL (0,5 % _v/v_)
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CO-TRIMOXAZOLE DS PHARMC
Tablets
White, capsule-shaped, biconvex bisected tablets.
The tablet can be divided into equal halves.
CO-TRIMOXAZOLE PHARMC
Tablets
White, flat, bisected, bevelled edged tablets
The tablet can be divided into equal halves.
CO-TRIMOXAZOLE PAED PHARMC
Suspension
A smooth, white suspension with a characteristic aniseed odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CO-TRIMOXAZOLE PHARMC
Professional Information
Page 3 of 22
Co-trimoxazole is effective against a wide range of Gram-positive and
Gram-negative
organisms.
IT IS INDICATED FOR:
1.
Upper
and
lower
respiratory
tract
infections
e.g.,
acute,
and
chronic
bronchitis,
bronchiectasis,
tonsillitis,
sinusitis
and
pharyngitis,
otitis
media,
pneumonia
and
pneumocystis
carinii
pneumonitis
(see
also
section
4.8
Pneumocystis
jirovecii
Pneumonitis (PJP)).
2.
Renal and urinary tract infections e.g., pyelitis, pyelonephritis,
urethritis, acute and
chronic cystitis and cystopyelitis, including prostatitis
                                
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