Controloc Control
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
25-05-2023
Produktets egenskaber
(SPC)
25-05-2023
Offentlige vurderingsrapport
(PAR)
02-05-2013
Aktiv bestanddel:
pantoprazole
Tilgængelig fra:
Takeda GmbH
ATC-kode:
A02BC02
INN (International Name):
pantoprazole
Terapeutisk gruppe:
Proton pump inhibitors
Terapeutisk område:
Gastroesophageal Reflux
Terapeutiske indikationer:
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Produkt oversigt:
Revision: 15
Autorisation status:
Authorised
Autorisation dato:
2009-06-11
Indlægsseddel
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CONTROLOC 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 CONTROLOC Control tablets for more than 4 weeks
without consulting a
doctor.
WHAT IS IN THIS LEAFLET
1.
What CONTROLOC Control is and what it is used for
2.
What you need to know before you take CONTROLOC Control
3.
How to take CONTROLOC Control
4.
Possible side effects
5.
How to store CONTROLOC Control
6.
Contents of the pack and other information
1.
WHAT CONTROLOC CONTROL IS AND WHAT IT IS USED FOR
CONTROLOC Control contains the active substance pantoprazole, which
blocks the ‘pump’ that
produces stomach acid. Hence it reduces the amount of acid in your
stomach.
CONTROLOC 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 CONTROLOC 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 talk to a doctor if you do no
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CONTROLOC 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
CONTROLOC 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 _
_ _
CONTROLOC 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
CONTROLOC Control 20 mg gastro-resistant tablets should not be chewed
or crushed, and should be
swallowed whole with liquid before a meal.
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Co-administration of pantoprazole is not recommended with HIV protease
inhibitors for which
absorption is dependent on acidic intragastric pH such as atazanavir,
nelfinavir; due to significant
reduction in their bioavailability (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be instructed to consult a doctor if:
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