Pantoprazole 40mg gastro-resistant tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Pantoprazole sodium sesquihydrate

Διαθέσιμο από:

Sandoz Ltd

Φαρμακολογική κατηγορία (ATC):

A02BC02

INN (Διεθνής Όνομα):

Pantoprazole sodium sesquihydrate

Δοσολογία:

40mg

Φαρμακοτεχνική μορφή:

Gastro-resistant tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01030500; GTIN: 5050650057034

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
PANTOPRAZOLE 40 MG GASTRO-RESISTANT TABLETS
pantoprazole (as sodium sesquihydrate)
The name of this medicine is Pantoprazole 40 mg Gastro-Resistant
Tablets, which will be
referred to
as Pantoprazole Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or your pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others; it may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Pantoprazole Tablets are and what they are used for
2. Before you take Pantoprazole Tablets
3. How to take Pantoprazole Tablets
4. Possible side effects
5. How to store Pantoprazole Tablets
6. Further information
1.
WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE 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 TREATING:

_Adults and adolescents 12 years of age and above:_

Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your
throat to your stomach) accompanied by the regurgitation of stomach
acid.
_Adults_:

An infection with a bacterium called _Helicobacter pylori _in patients
with duodenal ulcers
and stomach ulcers in combination with two antibiotics (Eradication
therapy). The aim is
to get rid of the bacteria and so reduce the likelihood of these
ulcers returning.

Stomach and duodenal ulcers.

Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stomach.
2.
BEFORE YOU TAKE PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU:

ARE ALLERGIC (HYPERSENSITIVE) to PANTOPRAZOLE, or to any of

Αρχείο Π.Χ.Π.

OBJECT 1
PANTOPRAZOLE 40MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 01-Jun-2022 | Sandoz
Limited
•
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 40 mg Gastro-resistant Tablets
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium
sesquihydrate).
Excipient with known effect:
Each gastro-resistant tablet contains 2 microgram of azo colouring
agent Ponceau 4R aluminium lake (E124).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
A yellow, oval coated tablet, approx.. 11.7 x 6.0 mm.
4. Clinical particulars
4.1 Therapeutic indications
Pantoprazole is indicated for use in adults and adolescents 12 years
of age and above for;
- Reflux oesophagitis
Pantoprazole is indicated in adults for:
- Eradication of _Helicobacter pylori _(_H. pylori_) in combination
with appropriate antibiotic therapy in patients
with _H. pylori _associated u