Pantoprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Accord-UK Ltd

ATC code:

A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5012617017703

Patient Information leaflet

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
20mg 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 20mg tablets are 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 caused 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 TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU
• are ALLERGIC TO PANTOPRAZOLE, or any of the other
ingredients in this medicine (liste

Summary of Product characteristics

OBJECT 1
PANTOPRAZOLE 20MG 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 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