Rabeprazole 10mg gastro-resistant tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Rabeprazole sodium

Inapatikana kutoka:

Accord-UK Ltd

ATC kanuni:

A02BC04

INN (Jina la Kimataifa):

Rabeprazole sodium

Kipimo:

10mg

Dawa fomu:

Gastro-resistant tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01030500; GTIN: 5012617020796

Taarifa za kipeperushi

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RABEPRAZOLE ALL STRENGTHS GASTRO-RESISTANT TABLETS PIL - UK
Black
BBBB5611
M.Ellott
09/09/2022
190x600
10 pt
Teva Bulgaria
Dupnitsa
09/09/2022
09/09/2022
1
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
RABEPRAZOLE 10MG AND 20MG
GASTRO-RESISTANT TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BBBB5611
_Continued over page_
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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. See section 4.
•
The full name of the product is Rabeprazole 10mg
and 20mg Gastro-resistant Tablets but within the
leaflet it will be referred to as Rabeprazole tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT RABEPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RABEPRAZOLE TABLETS
3
HOW TO TAKE RABEPRAZOLE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RABEPRAZOLE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT RABEPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Rabeprazole tablets belong to a group of medicines
called Proton Pump Inhi

Tabia za bidhaa

OBJECT 1
RABEPRAZOLE 10MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 18-Oct-2022 | 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
Rabeprazole 10mg Gastro-resistant Tablets
2. Qualitative and quantitative composition
Rabeprazole 10mg gastro-resistant tablet contains rabeprazole sodium
10mg corresponding to 9.42mg
rabeprazole.
Excipients with known effect:
Sodium laurilsulfate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
10mg: Pink, coated, elliptical, biconvex tablet.
4. Clinical particulars
4.1 Therapeutic indications
Rabeprazole 10mg Gastro-resistant Tablets are indicated for the
treatment of:
• Active duodenal ulcer
• Active benign gastric ulcer
• Symptomatic erosive or ulcerative gastro-oesophageal reflux
disease (GORD).
• Gastro-Oesophageal Reflux Disease Long-term Management (GORD
Maintenance)
• Symptomatic treatment of moderate to very severe
gastro-oesophageal re