Pantoprazole 20mg gastro-resistant tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Pantoprazole sodium sesquihydrate

Διαθέσιμο από:

DE Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

A02BC02

INN (Διεθνής Όνομα):

Pantoprazole sodium sesquihydrate

Δοσολογία:

20mg

Φαρμακοτεχνική μορφή:

Gastro-resistant tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01030500

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
pantoprazole
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 Pantoprazole is and what it is used for
2.
What you need to know before you take Pantoprazole
3.
How to take Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Contents of the pack and other information.
1.
WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
Pantoprazole is a selective “proton pump inhibitor”, a medicine
which reduces the amount of acid
produced in your stomach. It is used for treating acid-related
diseases of the stomach and intestine.
PANTOPRAZOLE IS USED FOR:
_Adults and adolescents 12 years of age and above:_
-
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to
gastro-oesophageal reflux disease cause by reflux of acid from the
stomach.
-
Long-term management of reflux oesophagitis (inflammation of the
oesophagus accompanied
by the regurgitation of stomach acid) and preventing its return.
_Adults: _
_ _
-
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs
(NSAIDs, for example ibuprofen) in patients at risk who need to take
NSAIDs continuously.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE
DO NOT TAKE PANTOPRAZOLE
-
if you are allergic to pantoprazole or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to medicines containing other proton pump
inhibitors.
-
if you are taking medicines for the

Αρχείο Π.Χ.Π.

OBJECT 1
PANTOPRAZOLE 20MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 26-Mar-2020 | 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
Pantoprazole 20 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 20 mg pantoprazole
(as pantoprazole sodium sesquihydrate 22.58 mg)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
Elliptical, biconvex, light yellow gastro-resistant tablet
4. Clinical particulars
4.1 Therapeutic indications
Pantoprazole is indicated for use in adults and adolescents 12 years
of age and above for:
• Symptomatic gastro-oesophageal reflux disease.
• Long-term management and prevention of relapse in reflux
oesophagitis.
Pantoprazole is indicated for use in adults for:
• Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs
(NSAIDs) in patients at risk with a need for