Pantoprazole 40mg gastro-resistant tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Pantoprazole sodium sesquihydrate

Dostupné s:

Accord-UK Ltd

ATC kód:

A02BC02

INN (Mezinárodní Name):

Pantoprazole sodium sesquihydrate

Dávkování:

40mg

Léková forma:

Gastro-resistant tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 01030500; GTIN: 5012617017697

Informace pro uživatele

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.
•
The full name of this medicine is
Pantoprazole 40mg Gastro-resistant Tablets
but within the leaflet it will be referred to as
Pantoprazole tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT PANTOPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PANTOPRAZOLE TABLETS
3 HOW TO TAKE PANTOPRAZOLE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE PANTOPRAZOLE TABLETS
6
CONTENTS OF THE PACK AND OTHER
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 TABLETS ARE 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 _Heliobacter _
_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 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
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU
• are ALLERGIC TO PANTOPRAZOLE or an

Charakteristika produktu

OBJECT 1
PANTOPRAZOLE 40MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 15-Mar-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 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 pantoprazole
(as pantoprazole sodium sesquihydrate 45.16 mg)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
Elliptical, biconvex, dark yellow gastro-resistant tablet
4. Clinical particulars
4.1 Therapeutic indications
_Adults and adolescents 12 years of age and above_
• Reflux oesophagitis.
_Adults_
• Eradication of _Helicobacter pylori _(_H. pylori_) in combination
with appropriate antibiotic therapy in
patients with _H. pylori _associated ulcers.
• Gastric and duodenal ulcer.
• Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions.
4.2 Posology and method of administration
Posology
_Adults and adolescent