Pantoprazole 40mg gastro-resistant tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Pantoprazole sodium sesquihydrate

Boleh didapati daripada:

Takeda UK Ltd

Kod ATC:

A02BC02

INN (Nama Antarabangsa):

Pantoprazole sodium sesquihydrate

Dos:

40mg

Borang farmaseutikal:

Gastro-resistant tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 01030500; GTIN: 5060065110224

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE 40 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
•
Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your throat
to your stomach) accompanied by the regurgitation of stomach acid.
Pantoprazole is used to treat adults for
•
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.
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 ingre

Ciri produk

OBJECT 1
PANTOPRAZOLE 40 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 28-Jul-2022 | 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 40 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 40 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 “P40” 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:
- 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 ulcers.
- Gastric and duodenal ulcer.
- Zollinger-Ellison Syndrome and other pathologic