Loperamide 2mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Flamingo 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: 5060464500459 5060464500800

Patient Information leaflet

LOPERAMIDE 2 MG CAPSULES (POM)
LEAFLET SIZE : 150 X 285 MM
MPLLLOP0002CPCOMFPLXXX071V05
FONTS SIZE :
Generic Name font size : 11 pt.
Composition fonts size : 9 pt.
FONTS : Arial
285 mm
285 mm
150 mm
150 mm
WHAT IS IN THIS LEAFLET:
1.
What Loperamide Capsule is and what it is used for
2.
What you need to know before you take Loperamide Capsules
3.
How to take Loperamide Capsules
4.
Possible side effects
5.
How to store Loperamide Capsules
6.
Contents of the pack and other information
1. WHAT LOPERAMIDE CAPSULE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE CAPSULES
3. HOW TO TAKE LOPERAMIDE CAPSULES
4. POSSIBLE SIDE EFFECTS
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPERAMIDE 2 MG CAPSULES, HARD
(loperamide hydrochloride)
LOPERAMIDE CAPSULE IS USED
• To treat sudden short-lived (acute) attacks of
diarrhoea in adults and in children over 9 years
of age.
• To treat long lasting (chronic) diarrhoea in adults
REPLACING FLUID AND SALTS
Loperamide capsules only treats the symptoms of
diarrhoea. Your body can lose large amounts of
fluids and salts when you have diarrhoea. You need
to replace the fluid by drinking more liquid than
usual. This is especially important for children.
Your doctor may also give you a special powder
containing sugar and salts (known as oral
rehydration therapy) to help your body replace the
fluid and salts lost during diarrhoea. The prevention
of fluid depletion (dehydration) is particularly
important in infants, children, and frail and elderly
people with acute diarrhoea.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, think you may be pregnant or
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
Do not drive if you feel dizzy, tired or sleepy. You
may feel less alert, feel faint or pass out. If you're
affected do not drive or use machines.
LOP

Summary of Product characteristics

OBJECT 1
Loperamide 2 mg Capsules
Summary of Product Characteristics Updated 16-Jun-2021 | Flamingo
Pharma (UK) 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 Capsules, hard
2. Qualitative and quantitative composition
Each capsule contains 2mg loperamide hydrochloride.
Excipient(s) with known effect:
Each capsule contains 109.00 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard (Capsule)
Size '4' (about 14 mm in length) Hard gelatin capsule with Green cap
imprinted with 'L' in black ink & grey
body imprinted with '2mg' in black ink, containing white to off-white
powder.
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 over 9
years. For the symptomatic treatment of
chronic diarrhoea in adults.
4.2 Posology and method of admin