PYLERA 140/125/12 Milligram Capsule

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE

Dostupno od:

Allergan Pharmaceuticals International Limited

ATC koda:

A02BD08

INN (International ime):

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE

Doziranje:

140/125/12 Milligram

Farmaceutski oblik:

Capsule

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Combinations for eradication of Helicobacter pylori

Status autorizacije:

Authorised

Datum autorizacije:

2016-05-06

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PYLERA 140 MG/125 MG/125 MG CAPSULES
BISMUTH SUBCITRATE POTASSIUM
METRONIDAZOLE
TETRACYCLINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PYLERA
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please 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 Pylera is and what it is used for
2.
What you need to know before you take Pylera
3.
How to take Pylera
4.
Possible side effects
5.
How to store Pylera
6.
Contents of the pack and other information
1.
WHAT PYLERA IS AND WHAT IT IS USED FOR
Pylera contains 3 different active ingredients: bismuth subcitrate
potassium, metronidazole and
tetracycline hydrochloride. Tetracycline and metronidazole belong to a
group of medicines called
antibiotics. Bismuth subcitrate potassium helps the antibiotics treat
the infection.
Pylera contains a group of medicines used to treat adult patients
infected with _Helicobacter pylori _
_(H. pylori) _who have or have had an ulcer. _H. pylori_ is a bacteria
found in the stomach lining.
PYLERA SHOULD BE TAKEN TOGETHER WITH A MEDICINE CALLED OMEPRAZOLE.
Omeprazole is a medicine
that works by reducing the amount of acid that your stomach produces.
Pylera, taken with omeprazole
works together to treat the infection and reduce the inflammation of
the stomach lining.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYLERA
DO NOT TAKE PYLERA

if you are PREGNANT OR BREAST-FEEDING

if you are less than 12 YEARS of age

if you suffer from KIDNEY PROBLEMS

if you suffer from LIVER PROBLEMS

if you are ALLERGIC (_hypersensitive_) to bismuth subcitrate
potassium, metronidazole or

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pylera 140 mg/125 mg/125 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 140 mg of bismuth subcitrate potassium
(equivalent to 40 mg bismuth oxide), 125 mg of
metronidazole and 125 mg of tetracycline hydrochloride.
Excipients with known effect: Each capsule contains 61 mg of lactose
monohydrate and 32mg of potassium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (Capsule)
Elongated, white, opaque capsule with Aptalis Pharma logo printed on
the body and ‘BMT’ printed on the cap in red
ink. It contains a white powder plus a smaller white opaque capsule
containing a yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In combination with omeprazole, Pylera is indicated for the
eradication of_ Helicobacter pylori_ and prevention of
relapse of peptic ulcers in patients with active or a history of_ H.
pylori_ associated ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Each dose of Pylera includes 3 identical hard capsules. Each dose
should be taken 4 times a day, 3 capsules after
breakfast, 3 capsules after lunch, 3 capsules after the evening meal
and 3 capsules at bedtime (preferably after a snack)
for a total of 12 capsules per day over a period of 10 days. One
omeprazole 20 mg capsule/tablet should be taken twice
a day, at the same time as the morning meal and evening meal doses of
Pylera for the full 10 days of therapy.
Table 1
Daily dosing schedule for Pylera
Missed doses can be made up by extending the normal dosing schedule
beyond 10 days until all the medicinal product
has been consumed. Patients should not take two doses at one time. If
more than 4 consecutive doses (1 day) are
missed, the prescribing physician should be contacted.
_Patients with hepatic or renal impairment_
TIME OF DOSE
NUMBER OF CAPSULES OF
PYLERA
NUMBER OF CAPSULES/TABLETS OF
OMEPRAZOLE
After breakfast
3
1
After lunch
3
0
After evening meal
3
1
At bedtime (preferably after a
snack)