Selexid 200mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Pivmecillinam hydrochloride

Disponível em:

Karo Healthcare UK Ltd

Código ATC:

J01CA08

DCI (Denominação Comum Internacional):

Pivmecillinam hydrochloride

Dosagem:

200mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05010105; GTIN: 5702191004939 5702191013276

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SELEXID
® 200 MG FILM-COATED TABLETS
pivmecillinam hydrochloride
151233PIL01
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.
•
In this leaflet Selexid
®
200 mg Film-coated Tablets will be called Selexid.
WHAT IS IN THIS LEAFLET:
1.
What Selexid
®
is and what it is used for
2.
What you need to know before you take
Selexid
®
3.
How to take Selexid
®
4.
Possible side effects
5.
How to store Selexid
®
6.
Contents of the pack and other information
1. WHAT SELEXID
®
IS AND WHAT IT IS USED FOR
Selexid belongs to a group of medicines
called penicillins. It is a type of antibiotic.
Selexid works by killing germs (bacteria) that
cause infections.
If the infection is not treated, germs can
continue to grow in your body. The infection
will make you feel very unwell, and could
even be life-threatening.
Selexid is used to treat:
•
Infections of the bladder or tubes leading
from the kidneys (urinary tract infections).
•
Infections caused by a bacteria called
Salmonella (salmonellosis).
You must talk to a doctor if you do not feel
better or if you feel worse after completing
your prescribed course of Selexid.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SELEXID
®
DO NOT TAKE SELEXID:
•
If you are allergic (hypersensitive) to
pivmecillinam hydrochloride or any of the
other ingredients of this medicine (listed in
section 6).
•
If you are allergic (hypersensitive) to other
antibiotics such as penicillin or
cephalosporins.
•
If you know you have any condition that can
make your

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Selexid
200 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pivmecillinam hydrochloride 200 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
A white circular film-coated convex tablet embossed with an Assyrian
lion on
one side and 137 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Selexid is indicated for the treatment of infections due to mecillinam
sensitive
organisms (see section 5.1), including:
•
urinary tract infections
•
salmonellosis
Preliminary experience in a small number of patients suggests that
Selexid
tablets may be a useful alternative antibiotic in the treatment of
acute typhoid
fever and in some carriers of salmonellae when antibiotic treatment is
considered essential.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN WEIGHING MORE THAN 40 KG:
Urinary tract infections:
•
Acute uncomplicated cystitis: 72 hour course of 2 tablets immediately
followed by 1 tablet 3 times daily to a total of 10 tablets.
•
Chronic or recurrent bacteriuria: 2 tablets three to four times daily.
Salmonellosis:
•
Enteric fever: 1.2-2.4 g daily for 14 days.
•
Salmonella carriers: 1.2-2.4 g daily for 2-4 weeks.
CHILDREN WEIGHING LESS THAN 40 KG:
•
Urinary tract infections: 20-40 mg/kg body weight, daily, in 3 to 4
divided
doses.
•
Salmonellosis: 30-60 mg/kg body weight, daily, in 3 to 4 divided
doses.
DOSAGE IN THE ELDERLY:
Renal excretion of mecillinam is delayed in the elderly, but
significant
accumulation of the drug is not likely at the recommended adult dosage
of
Selexid tablets.
Method of administration
Route of administration is oral. The tablets must be taken with at
least half a
glass of fluid, and preferably taken with or immediately after a meal.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipient