Panrazol Tablets Gastro-Resistant 20mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PANTOPRAZOLE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE 20 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2008-10-06

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANRAZOL 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.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
-
You should not take Panrazol for more than 4 weeks without consulting
a doctor.
WHAT IS IN THIS LEAFLET
1.
What Panrazol is and what it is used for
2.
What you need to know before you take Panrazol
3.
How to take Panrazol
4.
Possible side effects
5.
How to store Panrazol
6.
Contents of the pack and other information
1.
WHAT PANRAZOL IS AND WHAT IT IS USED FOR
Panrazol contains the active substance pantoprazole, which blocks the
‘pump’ that produces
stomach acid. Hence it reduces the amount of acid in your stomach.
Panrazol is used for the short-term treatment of reflux symptoms (for
example heartburn, acid
regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the gullet
(“foodpipe”), which may become
inflamed and painful. This may cause you symptoms such as a painful
burning sensation in the
chest rising up to the throat (heartburn) and a sour taste in the
mouth (acid regurgitation).
You may experience relief from your acid reflux and heartburn symptoms
after just one day of
treatment with Panrazol, but this medicine is not meant to bring
immediate relief. It may be
necessary to take the tablets for 2-3 consecutive days to relieve the
symptoms.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU T

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Panrazol 20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as 22.58
mg pantoprazole sodium
sesquihydrate).
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
Panrazol is indicated for short-term treatment of reflux symptoms
(e.g. heartburn, acid
regurgitation) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms. Once complete relief of symptoms has occurred, treatment
should be discontinued.
The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous
treatment, the patient should be
instructed to consult a doctor.
Special populations
No dose adjustment is necessary in elderly patients or in those with
impaired renal or liver function.
_Paediatric population _
Panrazol is not recommended for use in children and adolescents below
18 years of age due to
insufficient data on safety and efficacy.
Method of administration
Tablets should not be chewed or crushed, and should be swallowed whole
1 hour before a meal with
some water.
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4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Co-administration with atazanavir (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be instructed to consult a doctor if:
-
They have unintentional weight loss, anaemia, gastrointestinal
bleeding, dysphagia, persistent
vomiting or vomiting with blood, since it may alleviate symptoms and
delay diagnosis of a
severe condition. In these cases, malignancy should be exc