GO-PAIN P SYRUP

Negara: Afrika Selatan

Bahasa: Inggris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Beli Sekarang

Unduh Selebaran informasi (PIL)
04-03-2023
Unduh Karakteristik produk (SPC)
04-03-2023

Tersedia dari:

Pharmacorp (Pty) Ltd

Dosis:

See ingredients

Bentuk farmasi:

SYRUP

Komposisi:

EACH 5 ml SYRUP CONTAINS PARACETAMOL 120 mg

Status otorisasi:

Registered

Tanggal Otorisasi:

1990-06-11

Selebaran informasi

                                GO-PAIN P, paracetamol 120 mg per 5 ml syrup
Approved Patient Information Leaflet
04 March 2023
Page 1 of 9
SCHEDULING STATUS
S0
GO-PAIN P 120 MG/5 ML, SYRUP
PARACETAMOL
CONTAINS SUGARS AS
SUCROSE 1,565 G/5 ML
LIQUID GLUCOSE 2,0 G/5 ML
CONTAINS SWEETENERS AS
SODIUM CYCLAMATE 15 MG/5 ML
SACCHARIN SODIUM 5 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
GO-PAIN P is available without a doctor’s prescription, for your
child treat a mild illness.
Nevertheless, you still need to use GO-PAIN P carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share GO-PAIN P with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5 days for pain and
for fever 3 days.
WHAT IS IN THIS LEAFLET
1
What GO-PAIN P is and what it is used for
2. What you need to know before you give GO-PAIN P
3. How to give GO-PAIN P
4. Possible side effects
5. How to store GO-PAIN P
6. Contents of the pack and other information
GO-PAIN P, paracetamol 120 mg per 5 ml syrup
Approved Patient Information Leaflet
04 March 2023
Page 2 of 9
1. WHAT GO-PAIN P IS AND WHAT IT IS USED FOR
GO-PAIN P contains paracetamol. Paracetamol acts as an analgesic (to
relieve pain) and as an
antipyretic (to reduces fever).
GO-PAIN P can be used in children (3 months to 12 years of age) for
the treatment of mild or
moderate pain and feverishness.
2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE GO-PAIN P
DO NOT GIVE GO-PAIN P
•
If your child is hypersensitive (allergic) to paracetamol or any of
the other ingredients of GO-
PAIN P (listed in section 6).
•
If your child has serious problems with his/her liver.
WARNINGS AND PRECAUTIONS
GO-PAIN P contains paracetamol which may be fatal in overdose. In the
event of over dosage
or suspected overdose and notwithstanding the fact that the person may
be asymptomatic, the
nearest doctor, hospital or Poison Centre must
                                
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Karakteristik produk

                                GO-PAIN P, paracetamol 120 mg per 5 ml
Approved Professional Information
04 March 2023
Page 1 of 14
SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
GO-PAIN P 120 mg/5 mL Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL syrup contains:
Paracetamol
120 mg
Methyl hydroxybenzoate (Preservative)
0,12 % _m/v_
Propyl hydroxybenzoate (Preservative)
0,02 % _m/v_
Ethanol 96 % _v/v_
10,56 % _v/v_ ethanol
Contains sugar as
Sucrose
1,565 g/5 mL
Liquid glucose
2,0 g/5 mL
Contains sweetener as
Sodium cyclamate
15 mg/5 mL
Saccharin sodium
5 mg/5 mL
GO-PAIN P syrup contains TARTRAZINE.
For full list of excipients, see section 6.1.
GO-PAIN P, paracetamol 120 mg per 5 ml
Approved Professional Information
04 March 2023
Page 2 of 14
3. PHARMACEUTICAL FORM
Syrup
A green syrup
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GO-PAIN P is indicated for the symptomatic treatment of mild to
moderate pain and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DO NOT EXCEED THE RECOMMENDED DOSE.
Infants 3 to 12 months: 2,5 mL every six to eight hours
Children 1 to 6 years: 5 mL to 10 mL every six to eight hours
Children 7 to 12 years: 10 mL to 20 mL every six to eight hours
While symptoms persist, to be repeated every 4 hours if needed to a
maximum of 4 doses per
24 hours for not longer than 5 days.
METHOD OF ADMINISTRATION
Dose to be taken orally.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to paracetamol or to any of the excipients listed in
section 6.1
•
Severe liver function impairment.
GO-PAIN P, paracetamol 120 mg per 5 ml
Approved Professional Information
04 March 2023
Page 3 of 14
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GO-PAIN P contains paracetamol which may be fatal in overdose. In the
event of over
dosage or suspected overdose and notwithstanding the fact that the
person may be
asymptomatic,
the
nearest
doctor,
hospital
or
Poison
Centre
must
be
contacted
immediately.
•
Dosages of GO-PAIN P in excess of those recommended may cause severe
liver
damage.
•
Consult a medical practitioner if pain or fever persists o
                                
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