Pivmecillinam LEO 400 mg film-coated tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

PIVMECILLINAM HYDROCHLORIDE

Fáanlegur frá:

LEO Pharma A/S

ATC númer:

J01CA; J01CA08

INN (Alþjóðlegt nafn):

PIVMECILLINAM HYDROCHLORIDE

Skammtar:

400 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Penicillins with extended spectrum; pivmecillinam

Leyfisstaða:

Not marketed

Leyfisdagur:

2016-12-02

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIVMECILLINAM LEO 400 MG FILM-COATED TABLETS
Pivmecillinam hydrochloride
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pivmecillinam LEO is and what it is used for
2.
What you need to know before you take Pivmecillinam LEO
3.
How to take Pivmecillinam LEO
4.
Possible side effects
5.
How to store Pivmecillinam LEO
6.
Contents of the pack and other information
1.
WHAT PIVMECILLINAM LEO IS AND WHAT IT IS USED FOR
Pivmecillinam LEO belongs to a group of medicines called penicillins.
It is a type of antibiotic.
Pivmecillinam LEO works by killing germs (bacteria) that cause
infections.
Pivmecillinam LEO is used to treat Infections of the bladder
(cystitis) in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIVMECILLINAM LEO
Your doctor may have prescribed a different use or dosage than stated
in this information. Always follow
your doctors instructions.
DO NOT TAKE PIVMECILLINAM LEO:
-
If you are allergic (hypersensitive) to pivmecillinam or any of the
the other ingredients of this
medicine (listed in section 6).
-
If you are allergic (hypersensitive) to other antibiotics. Such
antibiotics include penicillin or
cephalosporins.
-
If you have narrowing of the food pipe.
-
If you suffer from a condition which may reduce the amount of a
substance called carnitine in in
your body. Such conditions include carnitine transporter defect,
methylmalonic aciduria and
propionic acidaemia.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pivmecillinam LEO 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg Pivmecillinam hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
A white capsule-shaped, film-coated tablet, size 8 x 17 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pivmecillinam LEO is indicated for adults in the treatment of acute
uncomplicated cystitis caused by bacteria sensitive
to mecillinam (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 400 mg, 3 times daily.
Duration of treatment
Recommended treatment duration is 3 days.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_Paediatric population_
Pivmecillinam LEO should not
be used in children and adolescents below 18 years because the
efficacy and safety
have not yet been established.
_Elderly population_
Renal excretion of mecillinam is delayed in the elderly, but
significant accumulation of the drug is not likely at the
recommended adult dosage of Pivmecillinam LEO. Dosage adjustment is
not necessary.
_Renal impairment_
Renal excretion of mecillinam is delayed in patients with reduced
kidney function, but significant accumulation of the
drug is not likely at the recommended adult dosage of Pivmecillinam
LEO. Dosage adjustment is not necessary (see
section 5.2).
_Hepatic impairment_
Dosage adjustment is not necessary.
Method of administration
Pivmecillinam LEO must be taken with at least half a glass of liquid.
Pivmecillinam LEO may be taken with food.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_