Omeprazol Medical Valley 40 mg Enterokapsel, hård

País: Suecia

Idioma: sueco

Fuente: Läkemedelsverket (Medical Products Agency)

Ingredientes activos:

omeprazol

Disponible desde:

Medical Valley Invest AB

Código ATC:

A02BC01

Designación común internacional (DCI):

omeprazole

Dosis:

40 mg

formulario farmacéutico:

Enterokapsel, hård

Composición:

mannitol Hjälpämne; natriumlaurilsulfat Hjälpämne; sockersfärer Hjälpämne; omeprazol 40 mg Aktiv substans

tipo de receta:

Receptbelagt

Resumen del producto:

Förpacknings: Blister, 100 kapslar (Al); Blister, 100 kapslar (Plast/Al); Blister, 105 kapslar (Al); Blister, 105 kapslar (Plast/Al); Blister, 14 kapslar (Al); Blister, 14 kapslar (Plast/Al); Blister, 15 kapslar (Al); Blister, 15 kapslar (Plast/Al); Blister, 16 kapslar (Al); Blister, 16 kapslar (Plast/Al); Blister, 250 kapslar (Al); Blister, 250 kapslar (Plast/Al); Blister, 28 kapslar (Al); Blister, 28 kapslar (Plast/Al); Blister, 30 kapslar (Al); Blister, 30 kapslar (Plast/Al); Blister, 32 kapslar (Al); Blister, 32 kapslar (Plast/Al); Blister, 35 kapslar (Al); Blister, 35 kapslar (Plast/Al); Blister, 42 kapslar (Al); Blister, 42 kapslar (Plast/Al); Blister, 50 kapslar (Al); Blister, 50 kapslar (Plast/Al); Blister, 56 kapslar (Al); Blister, 56 kapslar (Plast/Al); Blister, 60 kapslar (Al); Blister, 60 kapslar (Plast/Al); Blister, 7 kapslar (Al); Blister, 7 kapslar (Plast/Al); Blister, 90 kapslar (Al); Blister, 90 kapslar (Plast/Al); Blister, 98 kapslar (Al); Blister, 98 kapslar (Plast/Al); Burk, 100 kapslar; Burk, 105 kapslar; Burk, 120 kapslar; Burk, 14 kapslar; Burk, 15 kapslar; Burk, 16 kapslar; Burk, 250 kapslar; Burk, 28 kapslar; Burk, 30 kapslar; Burk, 32 kapslar; Burk, 50 kapslar; Burk, 56 kapslar; Burk, 60 kapslar; Burk, 7 kapslar; Burk, 90 kapslar; Burk, 98 kapslar

Estado de Autorización:

Godkänd

Fecha de autorización:

2021-07-06

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOL MEDICAL VALLEY 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOL MEDICAL VALLEY 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOL MEDICAL VALLEY 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 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 Omeprazol Medical Valley is and what it is used for
2.
What you need to know before you take Omeprazol Medical Valley
3.
How to take Omeprazol Medical Valley
4.
Possible side effects
5.
How to store Omeprazol Medical Valley
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOL MEDICAL VALLEY IS AND WHAT IT IS USED FOR
Omeprazol Medical Valley 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.
Omeprazol Medical Valley is used to treat the following conditions:
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).
Omeprazol Medical Valley can al

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazol Medical Valley 10 mg gastro-resistant capsules, hard
Omeprazol Medical Valley 20 mg gastro-resistant capsules, hard
Omeprazol Medical Valley 40 mg gastro-resistant capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg: Each gastro-resistant capsule contains 10 mg of omeprazole.
20 mg: Each gastro-resistant capsule contains 20 mg of omeprazole.
40 mg: Each gastro-resistant capsule contains 40 mg of omeprazole.
Excipient with known effect
10 mg: Each gastro-resistant capsule contains approximately 6 mg of
sucrose.
20 mg: Each gastro-resistant capsule contains approximately 12 mg of
sucrose.
40 mg: Each gastro-resistant capsule contains approximately 23 mg of
sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard (gastro-resistant capsule)
Omeprazol Medical Valley 10 mg gastro-resistant capsules: Hard gelatin
capsule with green cap and
white body, size 14 mm x 5 mm, containing white to off-white spherical
pellets.
Omeprazol Medical Valley 20 mg gastro-resistant capsules: Hard gelatin
capsule with blue cap and
white body, size 14 mm x 5 mm, containing white to off-white spherical
pellets.
Omeprazol Medical Valley 40 mg gastro-resistant capsules: Hard gelatin
capsule with white cap and
grey body, size 16 mm x 6 mm, containing white to off-white spherical
pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Omeprazol Medical Valley gastro-resistant capsules 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 oesophagitis
•
Long-term management of patients wit