APO-MEBEVERINE mebeverine hydrochloride 135 mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

mebeverine hydrochloride, Quantity: 135 mg

Saatavilla:

Arrotex Pharmaceuticals Pty Ltd

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: lactose monohydrate; purified talc; microcrystalline cellulose; povidone; sodium starch glycollate type A; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose

Antoreitti:

Oral

Kpl paketissa:

30, 10, 90

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

APO-MEBEVERINE tablets are indicated in the management of the irritable bowel syndrome ('irritable colon', 'spastic colon', 'functional bowel disorders', 'spastic constipation', 'nervous diarrhoea'). APO-MEBEVERINE is used to treat the symptoms of this condition - i.e. abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

Tuoteyhteenveto:

Visual Identification: White, round, biconvex, film coated tablets and plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2018-04-03

Pakkausseloste

1
AUSTRALIAN PRODUCT INFORMATION
APO-MEBEVERINE
Mebeverine hydrochloride
1
NAME OF THE MEDICINE
Mebeverine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-MEBEVERINE tablet contains mebeverine hydrochloride 135 mg.
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-MEBEVERINE tablets are white, round, biconvex, film coated and
plain on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-MEBEVERINE tablets are indicated in the management of the
irritable bowel syndrome
('irritable colon', 'spastic colon', 'functional bowel disorders',
'spastic constipation', 'nervous
diarrhoea'). APO-MEBEVERINE is used to treat the symptoms of this
condition - i.e. abdominal pain
and cramps, persistent, non-specific diarrhoea (with or without
alternating constipation) and
flatulence.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult dose is one APO-MEBEVERINE mebeverine
hydrochloride 135 mg (1 tablet)
three times daily, preferably before or with food. In case one or more
doses are missed, the patient
should continue with the next dose as prescribed, the missed doses are
not to be taken in addition
to the regular dose.
After a period of several weeks when the desired effect has been
obtained, the dosage may be
gradually reduced.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to any component of the product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Although not reported, APO-MEBEVERINE tablets should be used with
caution in patients with the
following conditions on the basis of potential clinical significance:
Cardiac dysrhythmia; in particular patients with partial or complete
atrioventricular heart block,
and/or angina or severe ischaemic heart disease.
2
Pharmaceutical Precaution - APO-MEBEVERINE tablets contain lactose
monohydrate and
consideration should be given to patients with a potential diagnosis
of lactose intolerance simulating
irritable bowel syndrome. Patients with rare heredi

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
APO-MEBEVERINE
Mebeverine hydrochloride
1
NAME OF THE MEDICINE
Mebeverine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-MEBEVERINE tablet contains mebeverine hydrochloride 135 mg.
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-MEBEVERINE tablets are white, round, biconvex, film coated and
plain on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-MEBEVERINE tablets are indicated in the management of the
irritable bowel syndrome
('irritable colon', 'spastic colon', 'functional bowel disorders',
'spastic constipation', 'nervous
diarrhoea'). APO-MEBEVERINE is used to treat the symptoms of this
condition - i.e. abdominal pain
and cramps, persistent, non-specific diarrhoea (with or without
alternating constipation) and
flatulence.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult dose is one APO-MEBEVERINE mebeverine
hydrochloride 135 mg (1 tablet)
three times daily, preferably before or with food. In case one or more
doses are missed, the patient
should continue with the next dose as prescribed, the missed doses are
not to be taken in addition
to the regular dose.
After a period of several weeks when the desired effect has been
obtained, the dosage may be
gradually reduced.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to any component of the product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Although not reported, APO-MEBEVERINE tablets should be used with
caution in patients with the
following conditions on the basis of potential clinical significance:
Cardiac dysrhythmia; in particular patients with partial or complete
atrioventricular heart block,
and/or angina or severe ischaemic heart disease.
2
Pharmaceutical Precaution - APO-MEBEVERINE tablets contain lactose
monohydrate and
consideration should be given to patients with a potential diagnosis
of lactose intolerance simulating
irritable bowel syndrome. Patients with rare heredi