Somac Control

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

pantoprazole

Beschikbaar vanaf:

Takeda GmbH

ATC-code:

A02BC02

INN (Algemene Internationale Benaming):

pantoprazole

Therapeutische categorie:

Proton pump inhibitors

Therapeutisch gebied:

Gastroesophageal Reflux

therapeutische indicaties:

Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

Product samenvatting:

Revision: 16

Autorisatie-status:

Authorised

Autorisatie datum:

2009-06-12

Bijsluiter

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOMAC 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 SOMAC Control tablets for more than 4 weeks
without consulting a
doctor.
WHAT IS IN THIS LEAFLET
1.
What SOMAC Control is and what it is used for
2.
What you need to know before you take SOMAC Control
3.
How to take SOMAC Control
4.
Possible side effects
5.
How to store SOMAC Control
6.
Contents of the pack and other information
1.
WHAT SOMAC CONTROL IS AND WHAT IT IS USED FOR
SOMAC Control contains the active substance pantoprazole, which blocks
the ‘pump’ that produces
stomach acid. Hence it reduces the amount of acid in your stomach.
SOMAC 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 SOMAC 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 not feel better or if you feel
worse after

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
SOMAC 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
SOMAC 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 _
_ _
SOMAC 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
SOMAC 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:
•
They have unin