ESOMEPRAZOLE INOVAMED 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE

Available from:

INOVAMED LTD

ATC code:

A02BC05

Pharmaceutical form:

GASTRO RESISTANT TABLETS

Composition:

ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

JUBILANT GENERICS LTD., INDIA

Therapeutic area:

ESOMEPRAZOLE

Therapeutic indications:

Esomeprazole Inovamed tablets 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 an appropriate antibacterial therapeutic regimen 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 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.Esomeprazole Inovamed 20 mg tablets are indicated in adolescents from the age of 12 years forGastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophgeal reflux disease (GERD)In combination with antibiotics in treatment of duodenal ulcer caused by Helicobactor pylori

Authorization date:

2023-12-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
This medicine is dispensed with a doctor’s prescription only
ESOMEPRAZOLE
INOVAMED 20 MG
Gastro-resistant tablets
COMPOSITION
Each tablet contains:
Esomeprazole 20 mg )as magnesium trihydrate(
ESOMEPRAZOLE
INOVAMED 40 MG
Gastro-resistant tablets
COMPOSITION
Each tablet contains:
Esomeprazole 40 mg )as magnesium trihydrate(
For the list of inactive and allergenic ingredients in this
preparation,
see section 6 “Further information” and section 2 “Important
information about some of the ingredients in this medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not
pass it on to others. It may harm them even if it seems to you that
their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
FOR ADULTS, ESOMEPRAZOLE INOVAMED 20 MG AND 40 MG ARE
INTENDED:
For treatment of heartburn, with or without inflammation of the
gullet, caused by reflux of acid from the stomach.
Esomeprazole Inovamed reduces the production of acid and helps
heal the gullet by reducing pain and inflammation.
Treatment of ulcers in the upper gut or stomach caused by
Helicobacter pylori
bacteria. Esomeprazole Inovamed, in
combination with suitable antibiotics, treats the infection and leads
to healing of the ulcer and prevention of recurrence.
Healing of gastric ulcer caused by use of nonsteroidal anti-
inflammatory drugs )NSAIDs(, such as preparations to treat
arthritis.
Prevention of formation of gastric ulcers, if you may develop them
due to use of NSAIDs, such as preparations to treat arthritis.
Prolonged treatment with Esomeprazole Inovamed tablets to
prevent recurrent bleeding of a gastric or duodenal ulcer, after
primary intravenous esomeprazole treatment.
IN ADOLESCENTS, E