Omeprazole 10mg gastro-resistant capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Omeprazole

Beschikbaar vanaf:

DE Pharmaceuticals

ATC-code:

A02BC01

INN (Algemene Internationale Benaming):

Omeprazole

Dosering:

10mg

farmaceutische vorm:

Gastro-resistant capsule

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 01030500

Bijsluiter

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Details
OMEPRAZOLE 10MG & 20MG GASTRO-RESISTANT CAPSULES PIL- UK
Black
BBBA3101
R.Wrey
03/10/18
08/10/18
R.Wrey
140 x 540
8pt
Liconsa
03/10/18
04/10/18
3
Version 2
01.11.2017
OMEPRAZOLE 10 MG AND 20 MG
GASTRO-RESISTANT CAPSULES
BBBA3101
_Continued over page_
_Continued top of next column_
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 CAPSULES ARE
AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OMEPRAZOLE CAPSULES
3 HOW TO TAKE OMEPRAZOLE CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE OMEPRAZOLE CAPSULES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT OMEPRAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
Omeprazole capsules contain 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 used to treat the following
conditions:
In adults:
• ‘Gastro-oesophageal reflux disease’ (GORD).
This i

Productkenmerken

OBJECT 1
OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES
Summary of Product Characteristics Updated 25-Jul-2018 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Omeprazole 10mg Gastro-resistant Capsules
2. Qualitative and quantitative composition
Each capsule contains 10mg omeprazole.
Excipient with known effect:
Contains sucrose, see section 4.4.
Each 10mg omeprazole capsule contains 51 to 58mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
GASTRO-RESISTANT CAPSULES, HARD
Hard gelatine capsules of size 3, Opaque yellow cap and body
containing white to off-white spherical pellets.
4. Clinical particulars
4.1 Therapeutic indications
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-associ