PRIMODIUM CAPSULES 2MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE

Available from:

PRIME PHARMACEUTICAL SDN. BHD.

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Units in package:

1000 Capsules; 1000 Capsules

Manufactured by:

PRIME PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET(RIMUP) _
_ _
PRIMODIUM CAPSULES 2MG
Loperamide hydrochloride (2mg)
1
WHAT IS IN THIS LEAFLET
1. What Primodium is used for
2. How Primodium works
3. Before you use Primodium
4. How to use Primodium
5. While you are using it
6. Side effects
7. Storage and Disposal of Primodium
8. Product description
9. Manufacturer and Product
Registration Holder
10.Date of revision
WHAT PRIMODIUM_ _IS USED FOR
For control and symptomatic relief of short
and long term diarrhoea associated with
inflammatory bowel disease.
HOW PRIMODIUM WORKS
Loperamide inhibits movement of the
intestines by direct effect on the muscles of
the intestinal wall.
BEFORE YOU USE PRIMODIUM
_- When you must not use it _
- you are allergic to loperamide or any
of the other ingredients of Primodium.
- you are constipating.
_ _
_- Before you start to use it _
Please inform your doctor/pharmacist if:
- you have lost body fluids and salts
through diarrhoea especially in young
children with severe diarrhoea.
- you have very smelly stools, blood or
pus in your stools, stomach pain, or a
fever.
- you have liver disease.
- you have inflammation of the intestines
(ulcerative colitis).
- you are pregnant and breastfeeding.
_ _
_- Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE PRIMODIUM
_- How much to use_
_ _
Adults: 4mg, initially, followed by 2mg
after each loose stool, not exceeding
16mg daily. Long term diarrhoea: initial:
4mg followed by 2mg after each loose
stool until diarrhoea is controlled.
Maintenance: 4 – 8 mg a day in single or
divided daily doses as needed. Children:
as directed by physician. Follow all
directions given to you by your doctor and
pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the label,
ask your doctor or pharmacist for help.
_ _
_- When to use it _
Use as directed by yo

Summary of Product characteristics

®
PRIMODIUM CAPSULES 2MG
_Description:_ _Sz 4: Green opaque/grey opaque capsules. _
CONTENT:
Loperamide hydrochloride 2mg/capsule
INDICATION:
For control and symptomatic relief of acute non-specific diarrhoea and
of chronic diarrhoea associated with inflammatory bowel disease.
PHARMACOLOGY:
Loperamide inhibits intestinal peristalsis by direct effect on the
muscles of the intestinal wall.
Oral absorption is incomplete and elimination half-life ranges from
9.1 to 14.4 hours. It is mainly excreted in the feces.
ADVERSE EFFECTS
Abdominal pain, constipation, dizziness, dry mouth, tiredness, nausea
and vomiting and hypersensitivity reactions may occur occasionally.
Post-
marketing Experience - Cardiac Disorders: QT/QTc interval
prolongation, Torsades de Pointes, other ventricular arrhythmias,
cardiac arrest, syncope,
and death (see Warning and Precautions)
WARNINGS AND PRECAUTIONS
Caution in patients with dehydration, diarrhoea caused by infectious
organisms, and hepatic function impairment. It should be discontinued
if abdominal
distention occurs or if other untoward symptoms develop in patients
with ulcerative colitis. In acute diarrhoea, treatment should be
discontinued after 48
hours if improvement does not occur. In chronic diarrhoea, if no
improvement has occurred after 10 days of treatment with the maximum
dose,
loperamide is unlikely to be effective.
Appropriate fluid and electrolyte therapy should be given to protect
against dehydration in all cases of diarrhoea. Oral rehydration
therapy which is the
use of appropriate fluids including oral rehydration salts remains the
most effective treatment for dehydration due to diarrhoea. The intake
of as much of
these fluids as possible is therefore imperative. Drug-induced
inhibition of peristalsis may result in fluid retention in the
intestine, which may aggravate
and mask dehydration and depletion of electrolytes. If severe
dehydration or electrolyte imbalance is present. Loperamide should be
withheld until
appropriate corrective therapy has been initiated.
The use