LOMODIUM CAPSULE

国家: 马来西亚

语言: 英文

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

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资料单张 资料单张 (PIL)
10-11-2023
产品特点 产品特点 (SPC)
16-01-2024

有效成分:

LOPERAMIDE HYDROCHLORIDE

可用日期:

DYNAPHARM (M) SDN BHD

INN(国际名称):

LOPERAMIDE HYDROCHLORIDE

每包单位数:

10x10 Capsule Capsules; 1000 Capsule Capsules

厂商:

DYNAPHARM (M) SDN BHD

资料单张

                                Consumer Medication Information Leaflet (RiMUP)
LOMODIUM CAPSULE
Loperamide hydrochloride (2mg)
1
What is in this leaflet
1.
What Lomodium Capsule is used for
2.
How Lomodium Capsule works
3.
Before you use Lomodium Capsule
4.
How to use Lomodium Capsule
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lomodium
Capsule
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Lomodium Capsule is used for
For the control and symptomatic relief
pf diarrhoea associated with
inflammatory bowel disease, as well as
to reduce the volume of discharge from
surgery that make an opening in the
belly.
How Lomodium Capsule works
Loperamide exerts a direct effect on the
muscles of the intestine. It reduces the
intestinal motility and thus controls the
diarrhoea.
Before you use Lomodium Capsule
- When you must not use it
- If you are allergic to Loperamide or
any of the other ingredients.
- If you have constipation.
- If you have diarrhea caused by
infection.
Pregnancy and lactation
Do not take Lomodium Capsule if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Lomodium Capsule if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
- Before you start use it
This medicine is not recommended for
children under 6 years of age.
Tell your doctor / pharmacist if you have
inflammatory bowel disease.
- 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 Lomodium Capsule
- How much to use
Usual adult dose:
Acute diarrhoea: Oral, 2 capsules
initially, followed by 1 capsule after
each unformed stool.
Chronic diarrhoea: Initial: Oral 2
capsules, followed by 1 capsules after
each unformed stool until diarrhoea is
controlled.
Maintenance: Oral, 2 to 4 capsules a day
in single or divided daily doses as
needed.
Usual adult prescribing limits: 8
capsules per day.
Follow all di
                                
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产品特点

                                LOMODIUM CAPSULE
MAL19913258AZ
DESCRIPTION:
CAPSULE
Capsule Colour
: Green/Grey
Capsule Size
: # 4
Granules Colour
: White
EACH CAPSULE CONTAINS:
Loperamide Hydrochloride
................................................................ 2 mg
PHARMACODYNAMICS:
Loperamide exerts a direct effect on the muscles of the intestine. It
reduces the intestinal motility and thus controls the
diarrhoea.
PHARMACOKINETICS:
Loperamide is not well absorbed from the gastrointestinal tract. The
half-life is 9.1 hours to 14.4 hours (average 10.8 hours).
Protein binding is 97%. Excretion is by renal and also appeared in
faeces.
INDICATIONS:
For the control and symptomatic relief of acute non-specific diarrhoea
and of chronic diarrhoea associated with inflammatory
bowel disease, as well as to reduce the volume of discharge from
ileostomies.
RECOMMENDED DOSE:
Usual adult dose:
Acute diarrhoea: Oral, 4 mg initially, followed by 2 mg after each
unformed stool.
Chronic diarrhoea: Initial: Oral 4 mg, followed by 2 mg after each
unformed stool until diarrhoea is controlled.
Maintenance: Oral, 4 to 8 mg a day in single or divided daily doses as
needed.
Usual adult prescribing limits: 16 mg per day.
ROUTE OF ADMINISTRATION:
FOR ORAL USE ONLY
CONTRAINDICATIONS:
It is contraindicated in patients with known hypersensitivity to the
drug and in those in whom constipation must be avoided.
WARNINGS AND PRECAUTIONS:
Not recommended for children under 6 years of age.
Its use has been associated with fatal episodes of paralytic ileus in
infants and young children.
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 deplet
                                
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