Esomeprazole Tillomed 40 mg powder for solution for injection/infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Esomeprazole

Inapatikana kutoka:

Laboratorios Tillomed Spain, S.L.U.

ATC kanuni:

A02BC05

INN (Jina la Kimataifa):

Esomeprazole

Kipimo:

40 milligram(s)

Dawa fomu:

Powder for solution for injection/infusion

Eneo la matibabu:

esomeprazole

Idhini hali ya:

Marketed

Idhini ya tarehe:

2020-02-21

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE TILLOMED 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
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 Tillomed is and what it is used for
2.
What you need to know before Esomeprazole Tillomed is given to you
3.
How Esomeprazole Tillomed is given to you
4.
Possible side effects
5.
How to store Esomeprazole Tillomed
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE TILLOMED IS AND WHAT IT IS USED FOR
Esomeprazole Tillomed contains a medicine called esomeprazole. This
belongs to a group of
medicines called “proton pump inhibitors”. These work by reducing
the amount of acid your stomach
produces.
Esomeprazole Tillomed is used for the short-term treatment of certain
conditions, when you are unable
to have treatment by mouth. It is used to treat the following
conditions:
_ _
_ADULTS _
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach enters the
oesophagus (the passage between the throat and stomach) causing pain,
inflammation and
heartburn.
•
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole can also be used to prevent stomach ulcers from
developing if you are taking
NSAIDs.
•
Prevention of rebleeding following therapeutic endoscopy for acute
bleeding from gastric or
duodenal ulcers.
_CHILDREN AND ADOLESCENTS AGED 1-18 YEARS _
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach enters the
oesophagus (the passage between the throat and stomach) causing pain,
inflammation and
heartburn.
2.
WHAT YOU NEED TO

Tabia za bidhaa

Health Products Regulatory Authority
18 January 2023
CRN00D5C6
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Tillomed 40 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains esomeprazole 40 mg (as sodium salt).
One ml of reconstituted concentrate contains 8 mg
Excipient(s) with known effect
This medicinal product contains < 1 mmol sodium (23 mg) per 40 mg,
i.e. essentially sodium free.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White to off-white porous cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Tillomed is indicated in adults for:

Gastric antisecretory treatment when the oral route is not possible,
such as:
o
gastroesophageal reflux disease (GERD) in patients with esophagitis
and/or severe symptoms of reflux.
o
healing of gastric ulcers associated with Nonsteroidal
Anti-inflammatory drug (NSAIDs) therapy.
o
prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.

prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal ulcers.
Esomeprazole Tillomed is indicated in children and adolescents aged
1-18 years for:

Gastric antisecretory treatment when the oral route is not possible,
such as:
o
gastroesophageal reflux disease (GERD) in patients with erosive reflux
esophagitis and/or severe symptoms of
reflux.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
_Gastric antisecretory treatment when the oral route is not possible_
Patients who cannot take oral medication may be treated parenterally
with 20-40 mg once daily.
Patients with reflux oesophagitis should be treated with 40 mg once
daily. Patients treated symptomatically for reflux disease
should be treated with 20 mg once daily.
For healing of gastric ulcers associated with NSAID therapy, the usual
dose is 20 mg once daily. For prevention of gastric and
duodenal