BUSCOPAN PLUS

País: Indonésia

Língua: indonésio

Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes ativos:

HYOSCINE BUTYLBROMIDE; PARACETAMOL

Disponível em:

AVENTIS PHARMA - Indonesia

DCI (Denominação Comum Internacional):

HYOSCINE BUTYLBROMIDE; PARACETAMOL

Dosagem:

500/10 MG

Forma farmacêutica:

TABLET SALUT SELAPUT

Unidades em pacote:

DUS, 25 STRIP @ 4 TABLET SALUT SELAPUT

Fabricado por:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

Data de autorização:

2018-10-05

Características técnicas

COMPANY CORE DATA SHEET
Version 1
BUSCOPAN
® PLUS *
COMPOSITION
1 film-coated tablet contains:
Hyoscine butylbromide
10 mg
Paracetamol
500 mg
excipients**:
silica colloidal anhydrous, microcrystalline cellulose, sodium
carboxymethylcellulose, maize starch,
ethylcellulose, magnesium stearate, polyacrylate dispersion 30%
(eudragit NE 30D), polyethylenglycol
6000, talc, titanium dioxide, simethicone, hypromellose
INDICATIONS
Paroxysmal pain in diseases of the stomach or intestine spastic pain
and functional disorders
in the biliary and urinary tracts and female genital organs (e.g.
dysmenorrhoea).
DOSAGE AND ADMINISTRATION
BUSCOPAN
®
PLUS should not be taken over prolonged period of time (for more than
3 days)
without a prescription from the physician, The following doses are
recommended:
TABLETS
Adults: 1 - 2 tablets 3 times daily.
The total daily dose should not exceed 6 tablets.
The tablets should not be chewed, but swallowed in whole with a
sufficient amount of water.
_PAEDIATRIC POPULATION_
The film coated tablets is not suitable for children under 10 years of
age.
CONTRAINDICATIONS
BUSCOPAN
®
PLUS must not be used in
•
Mechanical-stenosis of gastrointestinal tract, achalasia, paralytic or
obstructive ileus,
intestinal atony, prostatic hypertrophy with urinary retention,
myasthenia gravis,
glaucoma, pathological tachyarrhythmia, mega colon and known
hypersensitivity to
hyoscine butylbromide, or paracetamol.
•
Patients with porphyria, as according to a single report, it has been
said to exacerbate
the disease
•
Patients with hepatic dysfunction.
DISETUJUI OLEH BPOM: 28/07/2021
ID REG: EREG10002212100006
•
severe hepatocellular insufficiency (Child - Pugh C).
In case of rare hereditary conditions that may be incompatible with an
excipient of the
product (see section Special warnings and precautions) the use of
BUSCOPAN
®
PLUS is
contraindicated.
SPECIAL WARNINGS AND PRECAUTIONS
In case severe, unexplained abdominal pain persists or worsens, or
occurs together with
symptoms like fever, nausea, vomiting