Esomeprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole

Available from:

DE Pharmaceuticals

ATC code:

A02BC05

INN (International Name):

Esomeprazole

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral; Gastroenteral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500

Patient Information leaflet

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Details
ESOMEPRAZOLE 20MG & 40MG 28 TABLETS (BLISTER CARTON) PIL - UK
Black
BBBA5211
RH
10-06-18
01-10-19
RH
190x600
11pt
Teva Bulgaria
Dupnitsa
10-06-19
10-06-19
02
Version 2
01.11.2017
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 and adolescents aged 12 years and above
• ‘Gastrooesophageal reflux disease’ (GORD). This
is where acid from the stomach escapes into the
gullet (the tube which connects your throat to
your stomach) causing pa

Summary of Product characteristics

OBJECT 1
ESOMEPRAZOLE 20MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 05-Dec-2019 | Accord-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
Esomeprazole 20mg Gastro-resistant Tablets
2. Qualitative and quantitative composition
One gastro-resistant tablet contains 20mg of esomeprazole
(corresponding to 21.75mg esomeprazole
magnesium dihydrate).
Excipient with known effect:
Each tablet contains no more than 5.65 mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
20mg: A light pink, elliptically shaped, biconvex film-coated tablet,
6.55 x 13.6 mm.
4. Clinical particulars
4.1 Therapeutic indications
_Adults_
Esomeprazole 20mg tablets are indicated in adults for:
Gastro-oesophageal Reflux Disease (GORD)
- treatment of erosive reflux oesophagitis
- long-term management of patients with healed oesophagitis to prevent
relapse
- symptomatic treatment of gastro-oesophageal reflux disease (