Omeprazole Pinewood 20 mg gastro-resistant capsules, hard

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Omeprazole

Saatavilla:

Pinewood Laboratories Ltd

ATC-koodi:

A02BC; A02BC01

INN (Kansainvälinen yleisnimi):

Omeprazole

Annos:

20 milligram(s)

Lääkemuoto:

Gastro-resistant capsule, hard

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Proton pump inhibitors; omeprazole

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2003-11-18

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE PINEWOOD 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Omeprazole Pinewood is and what it is used for
2.
What you need to know before you take Omeprazole Pinewood
3.
How to take Omeprazole Pinewood
4.
Possible side effects
5.
How to store Omeprazole Pinewood
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE PINEWOOD IS AND WHAT IT IS USED FOR
Omeprazole Pinewood contains the active substance omeprazole. It
belongs to a group of
medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your
stomach produces.
Omeprazole Pinewood is used to treat the following conditions:
In adults:
•
‘Gastro-oesophageal 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 upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).
•
Ulcers which 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.
•
Ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Omeprazole Pinewood can also be used to stop ulcers from forming if
you are taking
NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison
syndrome

Valmisteyhteenveto

Health Products Regulatory Authority
25 May 2023
CRN00DHD7
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Pinewood 20 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole Pinewood 20 mg capsules: one capsule contains 20 mg of
omeprazole.
Excipient(s) with known effect:Each 20mg omeprazole capsule contains
102 to 116mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard
Omeprazole Pinewood 20mg capsules : opaque yellow capsule containing
off-white to cream-white enteric coated spherical
microgranules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Pinewood is indicated for:
Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, _Helicobacter pylori
_(_H. pylori_) eradication in peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in
patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
_Children over 1 year of age and _≥ _10 kg_
• Treatment of reflux oesophagitis
• Symptomatic treatment of heartburn and acid regurgitation in
gastro-0esophageal reflux disease
_Children and adolescents over 4 years of age _
• In combination with antibiotics in treatment of duodenal ulcer
caused by _H. pylori _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is
Omeprazole Pinewood 20 mg once daily. In most patients
healing occurs within two weeks. For those patients who may not be
fully healed after the initial course, healing usually o