Loperamid Brown 2 mg Kapsel, hård

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

loperamidhydroklorid

Tillgänglig från:

Brown & Burk IR Limited

ATC-kod:

A07DA03

INN (International namn):

loperamide hydrochloride

Dos:

2 mg

Läkemedelsform:

Kapsel, hård

Sammansättning:

azorubin Hjälpämne; laktosmonohydrat Hjälpämne; para-orange Hjälpämne; loperamidhydroklorid 2 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 18 kapslar; Blister, 60 kapslar; Blister, 6 kapslar; Blister, 10 kapslar; Blister, 12 kapslar; Blister, 30 kapslar; Blister, 40 kapslar; Blister, 100 kapslar; Burk, 250 kapslar

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-05-21

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPERAMID BROWN 2 MG CAPSULES, HARD
(LOPERAMIDE HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist or
nurse.
•
This medicine has prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are same as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is used:
• To treat sudden short-lived (acute) attacks of diarrhoea in adults
and children aged
12 years and above.
• To treat long-lasting (chronic) diarrhoea in adults
The capsules contain loperamide hydrochloride, a substance that helps
reduce diarrhoea by
slowing down an overactive bowel. This allows water and salts that are
usually lost in
diarrhoea to be absorbed by the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
• If you are allergic to loperamide hydrochloride, or any of other
ingredients of this medicine
(listed in section 6).
a. If it is for a child aged under 12.
b. If you have severe diarrhoea after taking antibiotics.
c. If you are having a flare-up of an inflammatory bowel condition
like ulcerative colitis.
d. If you are constipated, or your stomach appears swollen (especially
in children with
severe dehydration).
e. If you have acute dysentery, the symptoms of which may include
blood in your stools
and a high temperature.
If any of these applies to you, talk to a doctor or p

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Loperamid Brown 2 mg capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2mg Loperamide Hydrochloride.
Excipient with known effect:
Each tablet contains 132.00 mg lactose monohydrate, 0.0013 mg
carmoisine, and 0.0009 Sunset
yellow FCF.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard.
Green opaque cap, grey opaque body, size '4', hard gelatin capsules,
filled with white to off white
powder. Approximately 14 mm in length.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea of any aetiology
including acute exacerbations of
chronic diarrhoea for periods of up to 5 days in adults and children
aged 12 years and over. For the
symptomatic treatment of chronic diarrhoea in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ACUTE DIARRHOEA
Adults and children over 12:
Two capsules initially, followed by one capsule after each loose
stool. The usual dose is 3-4 capsules
a day. The total daily dose should not exceed 8 capsules.
CHRONIC DIARRHOEA
Studies have shown that patients may need widely differing amounts of
Loperamide. The starting
dose should be between two and four capsules per day in divided doses,
depending on severity. If
required, this dose can be adjusted according to result up to a
maximum of eight capsules daily.
Having established the patient's daily maintenance dose, the capsules
may be administered on a twice
daily regimen. Tolerance has not been observed and therefore
subsequent dosage adjustment should
be unnecessary.
_Paediatric population_
is contraindicated in children less than 12 years of
age.
_Elderly_
No dose adjustment is required for the elderly.
_Renal impairment_
No dose adjustment is required for patients with renal impairment.
_Hepatic impairment_
Although no pharmacokinetic data are available in patients with
hepatic impairment,
should be used with caution in such patient