Esomeprazole TAD 20 mg hard gastro-resistant capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESOMEPRAZOLE MAGNESIUM, DIHYDRATE

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-08-17

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE TAD 20 MG HARD GASTRO-RESISTANT CAPSULES
ESOMEPRAZOLE TAD 40 MG HARD GASTRO-RESISTANT CAPSULES
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Esomeprazole TAD is and what it is used for
2.
What you need to know before you take Esomeprazole TAD
3.
How to take Esomeprazole TAD
4.
Possible side effects
5.
How to store Esomeprazole TAD
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE TAD IS AND WHAT IT IS USED FOR
Esomeprazole TAD contains the active substancecalled esomeprazole
magnesium dihydrate. This
belongs to a group of medicines called "proton pump inhibitors". They
work by reducing the amount
of acid that your stomach produces.
Esomeprazole TAD is used to treat the following conditions:
Adults
-
Gastro-esophageal 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 TAD 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 panc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Esomeprazole TAD 20 mg hard gastro-resistant capsules
Esomeprazole TAD 40 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 20 mg esomeprazole (as
esomeprazole magnesium
dihydrate).
Each hard gastro-resistant capsule contains 40 mg esomeprazole (as
esomeprazole magnesium
dihydrate).
Excipient (s) with known effect:
20 mg hard gastro-
resistant capsules
40 mg hard gastro-
resistant capsules
sucrose
28.46–32.56 mg
56.93–65.11 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule
20 mg: the body and the cap are slightly pink in colour; the capsules
contain white to almost white
pellets. Capsule size: no. 3.
40 mg: the body and the cap are off-pink in colour; the capsules
contain white to almost white pellets.
Capsule size: no. 1.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esomeprazole TAD capsules 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
-
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 IV INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS
TREATMENT OF ZOLLINGER ELLISON SYNDROME
Esomeprazole TAD capsules are indicated in adolescents from the age of
12 years for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management