COLOFAC 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:

Viatris Pty Ltd

Lääkemuoto:

Tablet, sugar coated

Koostumus:

Excipient Ingredients: purified talc; Acacia; Gelatin; povidone; magnesium stearate; Carnauba Wax; potato starch; sucrose; lactose monohydrate

Antoreitti:

Oral

Kpl paketissa:

30, 10 sample pack, 90

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

COLOFAC tablets are indicated in the management of the irritable bowel syndrome ( 'irritable colon', 'spastic colon', 'functional bowel disorders', 'spastic constipation', 'nervous diarrhoea'). COLOFAC 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 sugar-coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2001-08-28

Pakkausseloste

COLOFAC
®
C
O
L
O
F
A
C
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING COLOFAC?
COLOFAC contains the active ingredient mebeverine hydrochloride.
COLOFAC is taken to relieve the symptoms of irritable bowel
syndrome, which can include, abdominal pain and cramps, bowel spasm,
diarrhoea and flatulence.
For more information, see Section 1. Why am I taking COLOFAC? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE COLOFAC?
Do not take if you have ever had an allergic reaction to COLOFAC or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
COLOFAC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with COLOFAC and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE COLOFAC?
•
Take COLOFAC at about the same time each day. The usual dose is one
tablet three times a day.
•
Take COLOFAC immediately before or during a meal. Swallow the tablets
with a glass of water.
More instructions can be found in Section 4. How do I take COLOFAC? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING COLOFAC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
COLOFAC.
•
If you become pregnant while you are taking COLOFAC, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take COLOFAC to treat any other complaints unless your doctor
or pharmacist tells you to.
•
Do not give COLOFAC to anyone else, even if they have the same
condition as you.
•
Do not stop taking COLOFAC, or lower the dosage, without checking with
your doctor.
DRIVING
OR USING
MACHINES
•
Be careful before you drive

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
COLOFAC
®
_mebeverine hydrochloride tablet _
1
NAME OF THE MEDICINE
Mebeverine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COLOFAC tablet contains 135 mg of mebeverine hydrochloride as the
active ingredient.
Excipients with known effect: lactose, sugars and traces of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COLOFAC tablets are sugar-coated, white, round, biconvex, and 11 mm in
diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COLOFAC tablets are indicated in the management of the irritable bowel
syndrome ('irritable colon', 'spastic
colon', 'functional bowel disorders', 'spastic constipation', 'nervous
diarrhoea'). COLOFAC 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
DOSE AND METHOD OF ADMINISTRATION
The recommended adult dose is one COLOFAC 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
CONTRAINDICATIONS
Hypersensitivity to any component of the product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although not reported, COLOFAC tablets should be used with caution in
patients with the following
conditions on the basis of potential clinical significance:
PHARMACEUTICAL PRECAUTION
COLOFAC tablets contain lactose monohydrate (80 mg per tablet) and
consideration should be given to
patients with a potential diagnosis of lactose intolerance simulating
irritable bowel syndrome. Patients with
rare
hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-galactose
malabsorption should not take this medicine.
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