TAZOKAP 20 mg hard gastro-resistant capsules

Ülke: Malta

Dil: İngilizce

Kaynak: Malta Medicines Authority

Aktif bileşen:

ESOMEPRAZOLE MAGNESIUM, DIHYDRATE

Mevcut itibaren:

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

ATC kodu:

A02BC05

INN (International Adı):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg

Farmasötik formu:

GASTRO-RESISTANT HARD CAPSULE

Kompozisyon:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg

Reçete türü:

POM

Terapötik alanı:

DRUGS FOR ACID RELATED DISORDERS

Ürün özeti:

Licence number in the source country: NOT APPLICAPABLE

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2021-08-17

Bilgilendirme broşürü

Page 1 of 8
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAZOKAP 20 MG HARD GASTRO-RESISTANT CAPSULES
TAZOKAP 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 TAZOKAP is and what it is used for
2.
What you need to know before you take TAZOKAP
3.
How to take TAZOKAP
4.
Possible side effects
5.
How to store TAZOKAP
6.
Contents of the pack and other information
1.
WHAT TAZOKAP IS AND WHAT IT IS USED FOR
TAZOKAP contains the active substance called 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.
TAZOKAP 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).
TAZOKAP 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).
-
Prolonged treatment after prevention of re

Ürün özellikleri

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TAZOKAP 20 mg hard gastro-resistant capsules
TAZOKAP 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
TAZOKAP 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
Page 2 of 15
TREATMENT OF ZOLLINGER ELLISON SYNDROME
TAZOKAP capsules are indicated in adolescents from the age of 12 years
for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients