Pantecta Control
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
15-11-2016
Valmisteyhteenveto
(SPC)
15-11-2016
Julkisesta arviointikertomuksesta
(PAR)
15-11-2016
Aktiivinen ainesosa:
pantoprazole
Saatavilla:
Takeda GmbH
ATC-koodi:
A02BC02
INN (Kansainvälinen yleisnimi):
pantoprazole
Terapeuttinen ryhmä:
Proton pump inhibitors
Terapeuttinen alue:
Gastroesophageal Reflux
Käyttöaiheet:
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2009-06-12
Pakkausseloste
20
B. PACKAGE LEAFLET
Medicinal product no longer authorised
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTECTA CONTROL 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 PANTECTA Control tablets for more than 4 weeks
without consulting a
doctor.
WHAT IS IN THIS LEAFLET
1.
What PANTECTA Control is and what it is used for
2.
What you need to know before you take PANTECTA Control
3.
How to take PANTECTA Control
4.
Possible side effects
5.
How to store PANTECTA Control
6.
Contents of the pack and other information
1.
WHAT PANTECTA CONTROL IS AND WHAT IT IS USED FOR
PANTECTA Control contains the active substance pantoprazole, which
blocks the ‘pump’ that
produces stomach acid. Hence it reduces the amount of acid in your
stomach.
PANTECTA Control 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 PANTECTA Control, 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
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
PANTECTA Control 20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, oval biconvex film-coated tablets imprinted with “P20” in
brown ink on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PANTECTA Control 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 _
PANTECTA Control 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
PANTECTA Control 20 mg gastro-resistant tablets should not be chewed
or crushed, and should be
swallowed whole with liquid before a meal.
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
Medicinal product no longer authorised
3
Patients should be instructed to consult a doctor if:
They have unintentional weight loss, anaemia, gastrointestinal
bleeding, dysphagia, persistent
vomiting or vomiting with
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