Loperamide 2mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Strides Pharma UK Ltd

ATC code:

A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 5031676004394

Patient Information leaflet

140 x 280 mm
Front Page
Home Health - SPUK
Front & Back Printing. To be supplied in the unfolded size.
Record Number: 342576
60 GSM Paper.
Pack Insert
140 X 280 MM
1047223
1040944
--
3
3.0
LOPERAMIDE 2 MG CAPSULES
Pantone Reflex Blue U
Pantone 536 U
Black
Printing clarity to be clear & sharp.
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you
.
●
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more
information or advice.
●
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
●
You must talk to your doctor if you do not feel
better or if you feel worse.
WHAT IS IN THIS LEAFLET
1. What Loperamide is and what it is used for
2.
What you need to know before you take Loperamide
3. How to take Loperamide
4.
Possible side effects
5.
How to store Loperamide
6. Contents of the pack and other information
1. WHAT LOPERAMIDE IS AND WHAT IT IS
USED FOR
Loperamide contains the active substance
loperamide hydrochloride which helps reduce
diarrhoea by slowing down an overactive bowel.
This medicine is used to treat
TWO DIFFERENT TYPES
of
diarrhoea. The two types have different age limits.
SHORT-TERM DIARRHOEA
•
For adults and children
AGED 12 AND OVER
•
To treat attacks that last
UP TO 48 HOURS
•
If your attack lasts longer than 48 hours
TALK
TO YOUR DOCTOR
IBS DIARRHOEA
•
For adults and young people
AGED 18 AND
OVER
who have been diagnosed with IBS
(Irritable Bowel Syndrome)
•
To treat attacks that last
UP TO 48 HOURS
•
You can use this medicine
FOR UP TO 2 WEEKS
for repeated attacks, but if any one attack lasts
continuously
FOR LONGER THAN 48 HOURS, TALK
TO YOUR DOCTOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE LOPERAMIDE
DO NOT TAKE LOPERAMIDE
IF YOU:
●
are allergic to loperamide hydrochloride or any
of t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Loritax 2mg Capsules
Loperamide 2mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide hydrochloride 2mg per capsule
Excipients with known effect: Contains lactose 100mg per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
Size 4, green opaque cap and a mauve opaque body, hard gelatin
capsule.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loperamide is indicated for the symptomatic treatment of acute
diarrhoea in adults and children aged
12 years and over.
Loperamide is also indicated for the symptomatic treatment of acute
episodes of diarrhoea associated
with Irritable Bowel Syndrome (IBS) in adults aged 18 years and over
following initial diagnosis by a
doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Loperamide hydrochloride 2mg capsules are for oral administration. The
capsules should be taken
with liquid.
_Adults and children aged 12 years and over _
_ _
_Acute diarrhoea:_
Two capsules initially (4mg), followed by 1 capsule (2mg) after every
loose stool. The maximum
daily dose should not exceed 6 capsules (12 mg).
_Symptomatic treatment of acute episodes of diarrhoea associated with
irritable bowel syndrome in _
_adults aged 18 years and over _
Two capsules (4 mg) to be taken initially, followed by 1 capsule (2
mg) after every loose stool, or as
previously advised by your doctor. The maximum daily dose should not
exceed 6 capsules (12 mg).
_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, this medicine
should be used with caution in such patients because of reduced first
pass metabolism (see section
4.4).
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
Loperamide hydrochloride 2mg capsule is contraindicated:
•
in patients with known hypersensitivity to loperamide hydr