Loperamide 2mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Loperamide hydrochloride

Dostupné z:

Milpharm Ltd

ATC kód:

A07DA03

INN (Medzinárodný Name):

Loperamide hydrochloride

Dávkovanie:

2mg

Forma lieku:

Oral capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 01040200; GTIN: 08901175040704

Príbalový leták

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.
-
This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.
-
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.
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
This medicine contains Loperamide
which helps to stop diarrhoea by
making the stools more solid and
less frequent.
This medicine is used for the
treatment of sudden short-lived
(acute) attacks of diarrhoea in adults
and children over 12 years of age.
PLEASE NOTE THAT THIS MEDICINE
ONLY RELIEVES THE SYMPTOMS OF
DIARRHOEA AND IT IS IMPORTANT TO
DRINK SUFFICIENT FLUID TO REPLACE THE
WATER LOST IN THE LOOSE STOOLS.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE LOPERAMIDE
DO NOT TAKE LOPERAMIDE
-
You are allergic to loperamide or
to any of the other ingredients in
this medicine (listed in section 6).
-
You suffer from colitis
(inflammation of the colon) or
any other inflammatory bowel
disease, such as ulcerative
colitis.
-
You have severe diarrhoea after
taking antibiotics.
-
You have a swollen stomach or
tummy, and/or constipation.
-
You are suffering from acute
dysentery the symptoms of which
may include blood in your stools
and a high temperature.
-
if it is for a child aged below 12
If any of these apply to you, get
advice from a doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking Loperamide
-
If you have AIDS and your
stomach becomes swollen. Stop
taking t

Súhrn charakteristických

OBJECT 1
LOPERAMIDE 2MG CAPSULES
Summary of Product Characteristics Updated 03-Oct-2022 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Loperamide 2 mg Hard Capsules
2. Qualitative and quantitative composition
Each hard capsule contains 2 mg of loperamide hydrochloride.
Excipient with known effect:
Each hard capsule contains 144.6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule,
White opaque cap/White opaque body, size '4' hard gelatin capsule
shells, imprinted with '2'on cap and 'L' on
body with black ink filled with white to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
For symptomatic treatment of acute diarrhoea in adults and children
aged 12 years and over.
4.2 Posology and method of administration
_Posology_
_Adults and children over 12 years of age:_
Two capsules to be taken initially, followed by one capsule after each
loose motion, up to a