Esomeprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

A02BC05

INN (International Name):

Esomeprazole

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Gastroenteral; Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5015525051135

Patient Information leaflet

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Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
ESOMEPRAZOLE 40 MG GASTRO-RESISTANT TABLETS
esomeprazole
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 Esomeprazole is and what it is used for
2. What you need to know before you take Esomeprazole
3. How to take Esomeprazole
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information
1. WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR
Esomeprazole contains a medicine called esomeprazole. This belongs to
a group of medicines called ‘proton
pump inhibitors’. They work by reducing the amount of acid that your
stomach produces.
Esomeprazole is used to treat the following conditions:
Adults
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the gullet
(the tube which connects your throat to your stomach) causing pain,
inflammation and heartburn.
•
Ulcers in the stomach or upper part of the gut (intestine) that are
infected with bacteria called
‘
_Helicobacter pylori’_
. If you have this condition, your doctor may also prescribe
antibiotics to treat the
infection and allow the ulcer to heal.
•
Stomach
ulcers
caused
by
medicines
called
NSAIDs
(Non-Steroidal
Anti-Inflammatory
Drugs).
Esomeprazole can also be used to stop stomach ulcers or ulcers in the
upper part of the gut (intestine)
from forming if you are taking NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zol

Summary of Product characteristics

OBJECT 1
ESOMEPRAZOLE 20 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 02-Sep-2022 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
•
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
Esomeprazole 20 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Each tablet contains: 20 mg esomeprazole (as esomeprazole magnesium
amorphous).
Excipients with known effects:
Each tablet also contains not more than 27.45 mg Sucrose.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Gastro-resistant tablet
20 mg: Light brick red to brown coloured, oval, biconvex, film-coated
tablets with 'E5' debossed on one side
and plain on other side
4. Clinical particulars
4.1 Therapeutic indications
Esomeprazole Gastro-resistant tablets are indicated in adults for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
- Treatment of erosive reflux esophagitis.
- Long-term management of patients with healed esophagitis to prevent
relapse.
- Symptomat