Pantoprazole 40mg gastro-resistant tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Pantoprazole sodium sesquihydrate

Доступна с:

Mawdsley-Brooks & Company Ltd

код АТС:

A02BC02

ИНН (Международная Имя):

Pantoprazole sodium sesquihydrate

дозировка:

40mg

Фармацевтическая форма:

Gastro-resistant tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 01030500

тонкая брошюра

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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
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 38.12 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow to ochre elongated coated_ _tablet.
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
_Recommended dose _
_Adults and adolescents 12 years of age and above _
Reflux oesophagitis
One tablet of Pantoprazole per day. In individual cases the dose may
be doubled (increase to 2
tablets Pantoprazole daily) especially when there has been no response
to other treatment. A
4-week period is usually required for the treatment of reflux
oesophagitis. If this is not
sufficient, healing will usually be achieved within a further 4 weeks.
_Adults_
Eradication of _H. pylori_ in combination with two appropriate
antibiotics
In _H. pylori _positive patients with gastric and duodenal ulcers,
eradication of the germ by a
combination therapy should be achieved. Considerations should be given
to official local
guidance (e.g. national recommendations) regarding bacterial
resistance and the appropriate
use and prescription of antibacterial agents. Depending upon the
resistance pattern, the
following combinations can be recommended for the eradication of _H.
pylori_:
a)
twice daily one tablet pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b)
twice daily one tablet pantoprazole
+ twice daily 400 – 500 m