Esomeprazole 40mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole

Available from:

Cipla EU Ltd

ATC code:

A02BC05

INN (International Name):

Esomeprazole

Dosage:

40mg

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: 8901117074071

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 gastro-resistant tablets 20mg & 40mg 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.
This medicine 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). This
medicine can also be used to stop stomach ulcers from forming if you
are taking NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
•
Prol

Summary of Product characteristics

OBJECT 1
Esomeprazole 40 mg Gastro-
resistant Tablets
Summary of Product Characteristics Updated 18-Oct-2021 | Cipla EU 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
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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
Esomeprazole 40 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Esomeprazole 20 mg gastro-resistant tablets
Each gastro-resistant tablet contain 20 mg esomeprazole (as magnesium
dihydrate).
Excipients with known effect:
Each tablet contains sucrose 43.7 mg and lactose (as lactose
monohydrate 67.5 mg).
Each tablet contains 0.03 mg of sodium
Esomeprazole 40 mg gastro-resistant tablets
Each gastro-resistant tablet contain 40 mg esomeprazole (as magnesium
dihydrate).
Excipients with known effect:
Each tablet contains sucrose 87.4 mg and lactose (as lactose
monohydrate 100.125 mg).
Each tablet contains 0.06 mg of sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
Esomeprazole 20 mg gastr