Ventra 40mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole magnesium dihydrate

Available from:

Ethypharm UK Ltd

ATC code:

A02BC05

INN (International Name):

Esomeprazole magnesium dihydrate

Dosage:

40mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral; Gastroenteral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5060078670135

Patient Information leaflet

ESOMEPRAZOLE 20 MG AND 40 MG, GASTRO-RESISTANT CAPSULES, HARD
1.3.1.2 – PACKAGE LEAFLET (ENGLISH VERSION)
EDITION 06/2018
1/8
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTRA 20 MG GASTRO-RESISTANT CAPSULES, HARD
VENTRA 40 MG GASTRO-RESISTANT CAPSULES, HARD
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VENTRA is and what it is used for
2.
What you need to know before you take VENTRA
3.
How to take VENTRA
4.
Possible side effects
5.
How to store VENTRA
6.
Contents of the pack and other information
1.
WHAT VENTRA IS AND WHAT IT IS USED FOR
Ventra contains a medicine called esomeprazole, which belongs to a
group of medicines called ’proton
pump inhibitors’. They work by reducing the amount of acid that your
stomach produces.
Ventra is used to treat the following conditions:
Adults and adolescents aged 12 years and above
-
‘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.
Adults
-
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Ventra can also be used to stop stomach ulcers from forming if you are
taking NSAIDs.
-
Too much acid i

Summary of Product characteristics

OBJECT 1
VENTRA 40 MG GASTRO-RESISTANT CAPSULES, HARD
Summary of Product Characteristics Updated 15-Jun-2017 | Ethypharm UK
Ltd
1. Name of the medicinal product
Ventra 40 mg gastro-resistant capsules, hard
2. Qualitative and quantitative composition
Each capsule contains 40 mg of esomeprazole (as magnesium dihydrate).
Excipients with known effect: each capsule contains 16.09 mg sucrose,
3.65 micrograms methyl-p-
hydroxybenzoate (E218) and 1.1 micrograms of propyl-p-hydroxybenzoate
(E216).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
Capsule with an opaque yellow cap and an opaque yellow body imprinted
in black with “40 mg” both on
the cap and on the body. The capsule contains off-white to greyish
spherical microgranules.
4. Clinical particulars
4.1 Therapeutic indications
Ventra capsules are indicated for:
ADULTS
Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent
relapse
- symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with appropriate antibacterial therapeutic regimens for
the eradication of
_Helicobacter _
_pylori _
_ _
_ _and
_ _
_ _
- healing of _Helicobacter pylori _associated duodenal ulcer and
- prevention of relapse of peptic ulcers in patients with
_Helicobacter pylori _associated ulcers
Patients requiring continued NSAID therapy
Healing of gastric ulcers associated with NSAID therapy.
Prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.
Prolonged treatment after i.v. induced prevention of rebleeding of
peptic ulcers.
Treatment of Zollinger Ellison Syndrome
ADOLESCENTS FROM THE AGE OF 12 YEARS
Gastro-oesophageal Reflux Disease (GERD)
- treatment of erosive reflux oesophagitis
- long-term management of patients with healed oesophagitis to prevent
relapse
- symptomatic treatment of gastro-oesophageal reflux disease (GERD)
In combination with antibiotics in treatment of duode