Pantoprazol Heumann 20 mg, maagsapresistente tabletten

Nchi: Uholanzi

Lugha: Kiholanzi

Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Viambatanisho vya kazi:

PANTOPRAZOL NATRIUM 1,5-WATER SAMENSTELLING overeenkomend met ; PANTOPRAZOL

Inapatikana kutoka:

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 NÜRNBERG (DUITSLAND)

ATC kanuni:

A02BC02

INN (Jina la Kimataifa):

PANTOPRAZOL NATRIUM 1,5-WATER COMPOSITION corresponding to ; PANTOPRAZOL

Dawa fomu:

Maagsapresistente tablet

Tungo:

AMMONIA (E 527) ; BRUINE INKT ; CALCIUMSTEARAAT (E 470A) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MANNITOL (D-) (E 421) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Njia ya uendeshaji:

Oraal gebruik

Eneo la matibabu:

Pantoprazole

Bidhaa muhtasari:

Hulpstoffen: AMMONIA (E 527); BRUINE INKT; CALCIUMSTEARAAT (E 470A); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MANNITOL (D-) (E 421); NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Idhini ya tarehe:

2013-01-02

Taarifa za kipeperushi

Pantoprazol Heumann, 20 mg, maagsapresistente tabletten –
NL/H/1846/003/DC
Page 1
NLpl
NL/p/005/14/8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOL HEUMANN 20 MG, MAAGSAPRESISTENTE TABLETTEN
Pantoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1.
What [product name] 20 mg is and what it is used for
2.
What you need to know before you take [product name] 20 mg
3.
How to take [product name] 20 mg
4.
Possible side effects
5.
How to store [product name] 20 mg
6.
Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product name] contains the active substance pantoprazole. [product
name] 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.
[PRODUCT NAME] IS USED TO TREAT:
_ _
_Adults and adolescents 12 years of age and above for: _
−
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to
gastro-oesophageal reflux disease caused by reflux of acid from the
stomach.
−
Long-term management of reflux oesophagitis (inflammation of the
oesophagus accompanied
by the regurgitation of stomach acid) and preventing its return.
_[product name] is used to treat adults for: _
−
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs
(NSAIDs, for example, ibuprofen) in patients at risk who need to take
NSAIDs continuously.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Tabia za bidhaa

Pantoprazol Heumann, 20 mg, maagsapresistente tabletten –
NL/H/1846/003/DC
Page 1
NLSmPC
NL/s/002/14/6
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazol Heumann 20 mg, maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as
pantoprazole sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3_. _
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow coloured, oval shaped, biconvex, enteric-coated tablets, 8.9 x
4.6 mm, imprinted with “20” on
one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_[product name] 20 mg gastro-resistant tablets is indicated for use in
adults and adolescents 12 years _
_of age and above for:_
Symptomatic gastro-oesophageal reflux disease.
For long-term management and prevention of relapse in reflux
oesophagitis.
_[product name] 20 mg gastro-resistant tablets is indicated in adults
for:_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs
(NSAIDs) in patients at risk with a need for continuous NSAID
treatment (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dose _
_Adults and adolescents 12 years of age and above _
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one gastro-resistant tablet [product
name] 20 mg per day. Symptom
relief is generally accomplished within 2-4 weeks. If this is not
sufficient, symptom relief will
normally be achieved within a further 4 weeks. When symptom relief has
been achieved, reoccurring
symptoms can be controlled using an on-demand regimen of 20 mg once
daily, when required. A
switch to continuous therapy may be considered in case satisfactory
symptom control cannot be
maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one gastro-resistant
tablet [product name] 20 mg
per day is recomm