Nitrofurantoine Adalvo 100 mg harde capsules met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NITROFURANTOINE 0-WATER 25 mg/stuk ; NITROFURANTOINE 1-WATER 80,7 mg/stuk SAMENSTELLING overeenkomend met ; NITROFURANTOINE 0-WATER 75 mg/stuk

INN (Algemene Internationale Benaming):

NITROFURANTOINE 0-WATER 25 mg/stuk ; NITROFURANTOINE 1-WATER 80,7 mg/stuk SAMENSTELLING overeenkomend met ; NITROFURANTOINE 0-WATER 75 mg/stuk

farmaceutische vorm:

Capsule met gereguleerde afgifte, hard

Samenstelling:

AMMONIA (E 527) ; CARBOMEER 971P ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WITTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

BIJSLUITER: INFORMATIE VOOR DE PATIËNT
NITROFURANTOINE ADALVO 100 MG HARDE CAPSULES MET GEREGULEERDE AFGIFTE
nitrofurantoine
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 Nitrofurantoin Adalvo is and what is it used for
2.
What do you need to know before you take Nitrofurantoin Adalvo
3.
How to take Nitrofurantoin Adalvo
4.
Possible side effects
5.
How to store Nitrofurantoin Adalvo
6.
Contents of the pack and other information
1.
WHAT NITROFURANTOIN ADALVO IS AND WHAT IS IT USED FOR
This medicine belongs to the group of nitrofurans. The active
ingredient in Nitrofurantoin Adalvo
works by killing most of the bacteria that cause urinary tract
infections.
This medication is used to treat acute (sudden onset) urinary tract
infections. Urinary tract infection is
an inflammation of the urinary tract and particularly common is the
infection of the bladder (cystitis).
These infections may cause discomfort such as pain and burning when
urinating, often the evacuation
of small amounts of urine and pain in the lower abdomen.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN ADALVO
DO NOT TAKE NITROFURANTOIN ADALVO:
-
if you are allergic to nitrofurantoin or any of the other ingredients
of this medicine (listed in
section 6)
-
if you have a disease of the kidneys which is severely affecting the
way they work (ask your
doctor if you are not sure).
-
if you have porphyria (reduced formation of red pigment in the blood).
-
if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency
(deficiency

Productkenmerken

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Nitrofurantoine Adalvo 100 mg harde capsules met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release capsule contains 25 mg of nitrofurantoin in the
macrocrystalline form and
80.7 mg in the monohydrate form, corresponding to 75 mg of anhydrous
nitrofurantoin.
Excipients with known effect:
Each capsule contains 73.50 mg lactose and 34.56 mg confectioner’s
sugar (containing 32.84 mg
sucrose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release hard capsule
Each capsule is 19.4 mm long and 6.91 mm wide and has a blue opaque
cap with imprinted “NTRF”
in white ink and a yellow opaque body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrofurantoin Adalvo is indicated for use in adults and children over
12 years old for treatment of
acute uncomplicated lower urinary tract infections caused by
nitrofurantoin sensitive microorganisms
(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
Dosage
_Adults and children above 12 years old _
Adults and children above 12 years old should take 2 capsules per day:
1 in the morning and 1 in the
evening (1 capsule every 12 hours).
The general use is for 7 days or at least 3 days after no more
infection is detectable in the urine.
_Children under 12 years old _
Nitrofurantoin Adalvo is a fixed dosage and is not suitable for young
children. For small children, the
use of other medicinal products containing nitrofurantoin available on
the market should be
considered.
Nitrofurantoin is contraindicated in neonates.
Method of administration
For oral use
Nitrofurantoin Adalvo is best taken during or right after a meal or
with milk or yogurt. This is to
ensure the greatest possible bioavailability and to aim for an optimal
gastrointestinal tolerance.
4.3
CONTRAINDICATIONS
Nitrofurantoin Adalvo is contraindicated in:
-
patients with know