Pedippi 4 mg/ml, poeder voor orale suspensie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

OMEPRAZOL 360 mg/flacon

Beschikbaar vanaf:

Xeolas Pharmaceuticals Limited Hamilton Building, DCU, Glasnevin DUBLIN 9 (IERLAND)

ATC-code:

A02BC01

INN (Algemene Internationale Benaming):

OMEPRAZOL 360 mg/flacon

farmaceutische vorm:

Poeder voor orale suspensie

Samenstelling:

ARABISCHE GOM (E 414) ; KALIUMWATERSTOFCARBONAAT (E 501 (II)) ; MALTITOL (E 965) ; MANNITOL (D-) (E 421) ; MUNTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMBENZOAAT (E 211) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; PULEGON ; SUCRALOSE (E 955) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ARABISCHE GOM (E 414) ; KALIUMWATERSTOFCARBONAAT (E 501 (II)) ; MALTITOL (E 965) ; MANNITOL (D-) (E 421) ; MINTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMBENZOAAT (E 211) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; PULEGON ; SUCRALOSE (E 955) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Omeprazole

Autorisatie datum:

2019-11-25

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEDIPPI 4MG/ML, POEDER VOOR ORALE SUSPENSIE
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 Oral Suspension is and what it is used for
2. What you need to know before you take Omeprazole Oral Suspension
3. How to take Omeprazole Oral Suspension
4. Possible side effects
5. How to store Omeprazole Oral Suspension
6. Contents of the pack and other information
1.
WHAT OMEPRAZOLE ORAL SUSPENSION IS AND WHAT IT IS USED FOR
THE NAME OF YOUR MEDICINE IS OMEPRAZOLE 4MG/ML ORAL SUSPENSION (CALLED
OMEPRAZOLE ORAL
SUSPENSION IN THIS LEAFLET).
Omeprazole Oral Suspension 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 is commonly used to treat the following conditions:
In adults:
•
‘Gastro-oesophageal reflux disease’ (GORD). 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 can also
be used to stop ulc

Productkenmerken

Samenvatting van producteigenschappen 1. NAAM VAN HET MEDICINALE PRODUCT
PEDIPPI 4mg/ml, poeder voor orale suspensie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
4 mg/ml: After constitution, each ml of suspension contains 4mg of
omeprazole. Each constituted bottle
(90ml) contains 360mg of omeprazole.
Excipients with known effect:
Each ml of suspension contains sodium methyl parahydroxybenzoate
(E219) 2.3mg, maltitol (E965)
272mg, sodium benzoate (E211) 5mg, sodium 17.2mg and potassium 54.3
mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for Oral Suspension
Powder in Cap: White / off-white / slightly yellow powder.
Powder in Bottle: White / off-white / slightly yellow powder. May
contain dark specks due to sweetener.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS_
Omeprazole Oral Suspension 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 esophagitis
•
Long-term management of patients with healed reflux esophagitis
•
Treatment of symptomatic gastro-esophageal reflux disease
Paediatric use
_Children over 1 month of age _
•
Treatment of reflux esophagitis
•
Symptomatic treatment of heartburn and acid regurgitation in
gastro-esophageal reflux disease
_Children over 4 years of age_ _and adolescents _
In combination with antibiotics in treatment of duodenal ulcer caused
by _H. pylori_
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION_
OMEPRAZOLE 2MG/ML ORAL SUSPENSION IS SUITABLE FOR DOSES OF
 15MG. FOR DOSES OF 20MG OR
GREATER, OMEPRAZOLE 4MG/ML ORAL SUSPENSION IS SUITABLE.
Posology in adults
_Treatment of duodenal ulcers _
The recommended dose in patients with an