Numark Diarrhoea Relief Instants 2mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Numark Ltd

ATC code:

A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 5010441013229

Patient Information leaflet

Numark Diarrhoea Relief Instants
2mg Orodispersible Tablets
Loperamide Hydrochloride
PATIENT INFORMATION LEAFLET
Further information overleaf
➥
If you take other medicines:
Talk to your pharmacist before taking
this medicine if you are taking any other
medicines, particularly the following:
• ritonavir_ _(used to treat HIV),
• quinidine_ _(used to treat abnormal
heart rhythms or malaria),
• oral desmopressin (used to treat
excessive urination),
• itraconazole or ketoconazole (used to
treat fungal infections),
• gemfibrozil_ _(used to treat high
cholesterol).
If you are unsure about any of the
medicines you are taking, talk to your
pharmacist.
3. HOW TO TAKE THE MEDICINE
Rehydration sachets are available
separately.
If you take more medicine than you
should
If you have taken too much of this
medicine, immediately contact a doctor
or hospital for advice. Symptoms may
include: increased heart rate, irregular
heartbeat, changes to your heartbeat
(these symptoms can have potentially
serious, life-threatening consequences),
muscle stiffness, uncoordinated
movements, drowsiness, difficulty
urinating, or weak breathing.
Children react more strongly to large
amounts of this medicine than adults. If
a child takes too much or shows any of
the above symptoms, call a doctor
immediately.
4. POSSIBLE SIDE EFFECTS
Most people take the tablets without
any problems, but as with all medicines,
side effects may occur occasionally.
Stop taking the medicine and
contact your doctor immediately if
you notice:
Rare: (affects less than 1 in 1,000
but 1 or more in 10,000 people)
• Allergic reactions including
unexplained wheezing, shortness of
breath, or swelling of the face and
throat.
• Skin rashes, which may be severe
and include blistering or peeling skin.
• Loss of consciousness or reduced
level of consciousness (passing out,
feeling faint or less alert),
uncoordinated movements.
Not known: (frequency cannot be
estimated from the available data)
• Upper abdominal pain, abdominal
pain that radiates to back,
tenderne

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Asda Anti-Diarrhoea Instants 2 mg Orodispersible Tablets
Boots Diarrhoea Relief Instant-Melts 2 mg Orodispersible Tablets
Entrocalm Instants Diarrhoea Relief 2 mg Orodispersible Tablets
Galpharm Diarrhoea Relief Instants 2 mg Orodispersible Tablets
Superdrug Diarrhoea Relief Instant-Melts 2 mg Orodispersible Tablets
Tesco Anti-Diarrhoea Instants 2 mg Orodispersible Tablets
Numark Diarrhoea Relief Instants 2 mg Orodispersible Tablets
Sainsbury’s Healthcare Anti-Diarrhoea Instants 2 mg Orodispersible
Tablets
Co-Op Diarrhoea Relief Instants 2mg Orodispersible Tablets
Morrisons Acute Diarrhoea Relief 2mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide hydrochloride 2 mg per orodispersible tablet.
For excipients see Section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible Tablet
Flat round white, uncoated, orodispersible tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged 12 years
and over.
For the symptomatic treatment of acute episodes of diarrhoea
associated with Irritable
Bowel Syndrome in adults aged 18 years and over following initial
diagnosis by a
doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The orodispersible tablets should be placed on the tongue. The tablet
will
dissolve and is to be swallowed with saliva. No liquid intake is
needed for the
orodispersible tablet.
Acute Diarrhoea:
_Adults and children 12 years and over: _
2 tablets initially followed by 1 tablet after every loose stool. The
maximum
daily dose should not exceed 6 tablets
Symptomatic treatment of acute episodes of diarrhoea associated with
irritable
bowel syndrome:
_Adults aged 18 years and over: _
Two tablets initially, followed by 1 tablet after every loose stool,
or as
previously advised by your doctor. The maximum daily dose should not
exceed 6 tablets.
_Elderly: _
No dose adjustment is required for the elderly.
_Renal impairment: _
No dose adjustment is require