Losiwuto 2 mg/125 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LOPERAMIDEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; LOPERAMIDE ; SIMETICON SAMENSTELLING overeenkomend met ; ; DIMETICON (E 900)

Beschikbaar vanaf:

Actavis Group PTC ehf

ATC-code:

A07DA53

INN (Algemene Internationale Benaming):

LOPERAMIDEHYDROCHLORIDE COMPOSITION corresponding to ; LOPERAMIDE ; SIMETICON COMPOSITION corresponding to ; ; DIMETICON (E 900)

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TRICALCIUMFOSFAAT, CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TRICALCIUMFOSFAAT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Loperamide, Combinations

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TRICALCIUMFOSFAAT;

Autorisatie datum:

2014-01-27

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
LOSIWUTO 2 MG/125 MG, TABLETTEN
loperamide hydrochloride, simeticone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after two days.
WHAT IS IN THIS LEAFLET
1.
What /.../ is and what it is used for
2.
What you need to know before you take /.../
3.
How to take /.../
4.
Possible side effects
5.
How to store /.../
6.
Contents of the pack and other information
1.
WHAT /.../ IS AND WHAT IT IS USED FOR
The tablets are used to treat a short-lived attack of diarrhoea when
it occurs with stomach cramps,
bloating and wind.
The tablets contain loperamide hydrochloride, which helps reduce
diarrhoea by slowing down an
overactive bowel. It also helps the body to absorb more water and
salts from the bowel. The tablets
also contain simeticone, which breaks up the trapped wind in the bowel
that causes cramps and
bloating.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE /.../
DO NOT TAKE /.../
-
In children less than 12 years old.
-
If you are allergic to loperamide hydrochloride, simeticone or any of
the other ingredients of
this medicine (listed in section 6).
-
If you have a high temperature (e.g. above 38° C) or blood in your
stools.
-
If you are having a flare up of an inflammatory bowel condition like
ulcerative colitis.
-
If you have severe diarrhoea after taking antibiotics.
-
If you are constipated or your stomach appears swollen.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking /.../:
-
/.../ only treat the symptoms of diarrhoea. In some cases, th

Productkenmerken

Loperamide/simeticone, NL/H/2662/001, 26.02.19
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losiwuto 2 mg/125 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains loperamide hydrochloride 2 mg and simeticone
equivalent to 125 mg dimeticone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off white capsule shaped tablet (approximately 16.6 x 6.8 mm)
with “LO-SI” debossed on
one side and ‘2’ & ‘125’ debossed on the opposite side at
either side of a score line
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ tablets are indicated for the symptomatic treatment of acute
diarrhoea in adults and adolescents
over 12 years when acute diarrhoea is associated with gas-related
abdominal discomfort including
bloating, cramping or flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults over 18 years _
Take two tablets initially, followed by one tablet after every loose
stool. Not more than 4 tablets
should be taken in a day, limited to no more than 2 days.
_Adolescents between 12 and 18 years _
Take one tablet initially, followed by one tablet after every loose
stool. Not more than 4 tablets should
be taken in a day, limited to no more than 2 days.
_Paediatric population _
Losiwuto tablets must not be used in children under 12 years.
_Use in the elderly: _
No dosage adjustments are required for the elderly.
_Renal impairment _
No dosage adjustment is necessary in renal impairment.
_Hepatic impairment _
Although no pharmacokinetic data are available in patients with
hepatic insufficiency, /.../ tablets
Loperamide/simeticone, NL/H/2662/001, 26.02.19
2
should be used with caution in such patients because of reduced first
pass metabolism (see section
4.4).
Method of administration
The tablets should be taken with liquid.
4.3
CONTRAINDICATIONS
/.../ tablets must not be used in:
•
Children less than 12