Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pivmecillinam hydrochloride

Available from:

KARO PHARMA AB

ATC code:

J01CA; J01CA08

INN (International Name):

Pivmecillinam hydrochloride

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Penicillins with extended spectrum; pivmecillinam

Authorization status:

Not marketed

Authorization date:

2016-12-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIVMECILLINAM HYDROCHLORIDE KARO PHARMA 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 hydrochloride Karo Pharma is and what it is used
for
2.
What you need to know before you take Pivmecillinam hydrochloride Karo
Pharma
3.
How to take Pivmecillinam hydrochloride Karo Pharma
4.
Possible side effects
5.
How to store Pivmecillinam hydrochloride Karo Pharma
6.
Contents of the pack and other information
1.
WHAT PIVMECILLINAM HYDROCHLORIDE KARO PHARMA IS AND WHAT IT IS USED
FOR
Pivmecillinam hydrochloride Karo Pharma belongs to a group of
medicines called penicillins. It is a type of
antibiotic. Pivmecillinam hydrochloride Karo Pharma works by killing
germs (bacteria) that cause infections.
Pivmecillinam hydrochloride Karo Pharma is used to treat Infections of
the bladder (cystitis) in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIVMECILLINAM HYDROCHLORIDE KARO
PHARMA
Your doctor may have prescribed a different use or dosage than stated
in this information. Always follow
your doctors instructions.
DO NOT TAKE PIVMECILLINAM HYDROCHLORIDE KARO PHARMA:
-
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 whi

Summary of Product characteristics

Health Products Regulatory Authority
03 January 2024
CRN00CZ2Y
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pivmecillinam hydrochloride Karo Pharma 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 hydrochloride Karo Pharma 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 hydrochloride Karo Pharma 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 hydrochloride Karo Pharma.
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
hydrochloride Karo Pharma. Dosage adjustment is not necessary
(see section 5.2).
_Hepatic impairment_
Dosage adjustment is not necessary.
Method of administration
Pivmecillinam hydrochloride Karo Pharma must be taken with at least
half a glass of liquid. Pivmecillinam hydrochloride Karo
Pharma may be taken with food.
Health Products Regulatory Authority
03 Januar