Omeprazole 20mg gastro-resistant capsules, hard

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

OMEPRAZOLE

MAH:

Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

ATC_code:

A02BC01

INN:

OMEPRAZOLE 20 mg

pharmaceutical_form:

GASTRO-RESISTANT HARD CAPSULE

composition:

OMEPRAZOLE 20 mg

prescription_type:

POM

therapeutic_area:

DRUGS FOR ACID RELATED DISORDERS

authorization_status:

Withdrawn

authorization_date:

2013-11-22

PIL

Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT USER
Omeprazole 20 mg Gastro-Resistant capsules, hard
Omeprazole 40 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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Omeprazole capsule is and what it is used for
2. What you need to know before you take Omeprazole capsule
3. How to take Omeprazole capsule
4. Possible side effects
5. How to store Omeprazole capsule
6. Contents of the pack and other information
1. WHAT OMEPRAZOLE CAPSULE IS AND WHAT IT IS USED FOR
Omeprazole capsule 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 capsule is used to treat the following conditions:
In 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 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 capsule 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

SPC

Page 1 of 15
1. NAME OF THE MEDICINAL PRODUCT
Omeprazole 20 mg gastro
‐
resistant capsules, hard
Omeprazole 40 mg gastro
‐
resistant capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole 20 mg: each gastro-resistant capsule, hard contains 20 mg
omeprazole.
Omeprazole 40 mg: each gastro-resistant capsule, hard contains 40 mg
omeprazole.
Excipients with known effect:
20 mg: each gastro-resistant capsule, hard contains 7,9 mg of lactose
anhydrous and approximate
149,6 mg of sucrose.
40 mg: each gastro-resistant capsule, hard contains 15,84 mg lactose
anhydrous and approximate
299,2 mg of sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Omeprazole 20 mg
Hard gelatine capsules nº 2 (length=18.0 mm), with green body and
cap, containing enteric coated
pellets of white or slightly yellow colour.
Omeprazole 40 mg
Hard gelatine capsules nº 0 (length=21.7mm), with blue purple body
and cap, containing enteric
coated pellets of white or slightly yellow colour.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Omeprazole is indicated in adults and children aged over 1 year of age
and ≥ 10 kg.
_ _
Omeprazole gastro-resistant capsules, hard are 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 esophagitis
•
Long-term management of patients with healed reflux esophagitis
•
Treatment of symptomatic gastro-esophageal reflux disease
•
Treatment of Zollinger-Ellison syndrome
Page 2 of 15
Paediatric population
_Children over 1 year of age and ≥ 10 kg _
•
Treatment of reflux esophagitis
•
Symptomatic treatment of heartburn and acid