Imodium LiquiRelief 2mg Soft Capsules

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Loperamide hydrochloride

Boleh didapati daripada:

Johnson & Johnson (Ireland) Limited

Kod ATC:

A07DA; A07DA03

INN (Nama Antarabangsa):

Loperamide hydrochloride

Dos:

2 milligram(s)

Borang farmaseutikal:

Capsule, soft

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Antipropulsives; loperamide

Status kebenaran:

Marketed

Tarikh kebenaran:

2011-04-01

Risalah maklumat

■
If you have SEVERE DIARRHOEA as your body loses more fluid, sugars and
salts than normal.
■
Do not take this product for anything other than its intended use (see
section 1)
and never take more than the recommended amount (see section 3).
Serious heart problems (symptoms of which include fast or irregular
heartbeat) have been reported in patients who have taken too much
loperamide, the active ingredient in IMODIUM
®
LiquiRelief Capsules.
OTHER MEDICINES AND IMODIUM
® LIQUIRELIEF CAPSULES
■
If you are taking any OTHER MEDICINES, including:
■
_ritonavir_ (used to treat HIV) or quinidine (used to treat ABNORMAL
HEART
RHYTHMS or MALARIA).
■
_itraconazole_ or _ketaconazole_ (ANTIFUNGAL medicines)
■
_gemfibrozil_ (used to treat HIGH CHOLESTEROL)
■
_oral desmopressin_ (used to CONTROL THIRST and URINE PRODUCTION in
patients with diabetic insipidus)
If any of these bullet points apply to you now or in the past, TALK TO
A DOCTOR OR
PHARMACIST. If you are unsure about any of the medicines you are
taking, show
the bottle or pack to your pharmacist.
PREGNANCY AND BREAST-FEEDING
■
If you are pregnant or breast-feeding, think you may be pregnant or
are
planning to have a baby, ask your doctor or pharmacist for advice
before
taking this medicine.
■
Do not take this medicine if you are breast-feeding as small amounts
may
get into your milk. Talk to your doctor about a suitable treatment.
DRIVING AND USING MACHINES
■
This medicine may make you feel dizzy, tired or sleepy. If affected do
not
drive or operate machinery.
OTHER INFORMATION ABOUT THIS MEDICINE
■
IMODIUM
®
LiquiRelief Capsules only treat the symptoms of diarrhoea.
When you have diarrhoea, your body can lose large amounts of fluids
and
salts. You will need to replace the fluid by drinking more liquid than
usual.
Ask your pharmacist about special powders (known as ORAL REHYDRATION
THERAPY) which replace fluids and salts lost during diarrhoea. The
prevention
of fluid depletion (dehydration) is of particular importance in
infants, children
and fr

Ciri produk

Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium LiquiRelief 2mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg Loperamide hydrochloride.
Excipient with known effect – Each capsule contains 115.31 mg
Propylene Glycol which is equivalent to 0.65 mg/mg, also
contains trace amounts of soya lecithin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, soft (Capsules)
A clear blue size 2, oval soft gelatin capsule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged 12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ACUTE DIARRHOEA
Adults and children aged 12 years and over:
2 capsules initially followed by 1 capsule after every loose stool.
The capsules should be taken with water.
The maximum daily dose should not exceed 5 capsules.
USE IN 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, Imodium LiquiRelief should be used with
caution in such patients because of reduced first pass metabolism.
(see 4.4 Special warnings and special precautions for use).
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
Imodium LiquiRelief must not be used in:

Children less than 12 years of age

Patients with a known hypersensitivity (allergy) to any component of
the product

Acute dysentery, which is characterised by blood in stool and high
fever

Acute ulcerative colitis

Pseudomembranous colitis associated with broad spectrum antibiotics
Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 2 of 6

Patients with bacterial enterocolitis caused by invasive organisms
including Salmonella, Shigella and
Campylobacter

This product contains traces of soya lecithi