Pantoprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Takeda 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: 5060065110217

Patient Information leaflet

1
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, 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.
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 contains the active substance pantoprazole. 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 to treat adults and adolescents 12 years of age
and above for
•
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.
Pantoprazole is used to treat adults for
_ _
•
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 to any of the other ingredients
of this medicine (listed in
section 6).
-
If

Summary of Product characteristics

OBJECT 1
PANTOPRAZOLE 20 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 01-May-2020 | Takeda 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 of pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet (tablet).
Yellow, oval biconvex film-coated tablet imprinted with “P20” in
brown ink on one side.
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 patien