Mesavancol 1200 mg maagsapresistent, tabletten met verlengde afgifte

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

MESALAZINE 1200 mg/stuk

Verfügbar ab:

Giuliani S.p.A. Via Palagi 2 20129 MILAAN (ITALIË)

ATC-Code:

A07EC02

INN (Internationale Bezeichnung):

MESALAZINE 1200 mg/stuk

Darreichungsform:

Tablet met verlengde afgifte

Zusammensetzung:

CARMELLOSE NATRIUM (E 466) ; CARNAUBAWAS (E 903) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2)(E 1207) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CARMELLOSE NATRIUM (E 466) ; CARNAUBAWAS (E 903) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CARMELLOSE NATRIUM (E 466) ; CARNAUBAWAS (E 903) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Mesalazine

Produktbesonderheiten:

Hulpstoffen: CARMELLOSE NATRIUM (E 466); CARNAUBAWAS (E 903); COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2); COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MESAVANCOL 1200MG MAAGSAPRESISTENT, TABLETTEN MET EEN VERLENGDE
AFGIFTE
(MESALAZINE)
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 pharmacists. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What MESAVANCOL is and what it is used for
2. What you need to know before you take MESAVANCOL
3. How to take MESAVANCOL
4. Possible side effects
5. How to store MESAVANCOL
6. Contents of the pack and other information
1. WHAT MESAVANCOL IS AND WHAT IT IS USED FOR
_Pharmacotherapeutic group: Aminosalicylic acid and similar agents. _
MESAVANCOL gastro-resistant, prolonged release tablets contain the
active substance mesalazine, which is
an anti-inflammatory drug for the treatment of ulcerative colitis.
Ulcerative colitis is a disease of the colon (large bowel) and rectum
(back passage), where the lining of the
gut becomes red and swollen (inflamed) resulting in symptoms of
frequent and bloody stools together with
stomach cramps.
When given for an acute episode of ulcerative colitis, MESAVANCOL acts
through the entire colon and rectum
to treat the inflammation and reduce symptoms. The tablets can also be
taken to help prevent
reccurrence of ulcerative colitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MESAVANCOL
DO NOT TAKE MESAVANCOL
− If you are allergic (hypersensitive) to a family of drugs known as
salicylates (which include aspirin)
− If you are allergic (hypersensitive) to mesalazine or any of the
other ingredients of this medicine (listed in
section 6 of this leaflet)
− If you have severe kidney or severe liver

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mesavancol 1200 mg maagsapresistent, tabletten met een verlengde
afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1200 mg mesalazine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
Red-brown, ellipsoidal, film-coated tablet (dimensions 20.5 × 9.5 ×
7.5 mm), debossed on one side with S476.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the induction and maintenance of clinical and endoscopic remission
in patients with mild to moderate,
active
ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Mesavancol is intended for once daily, oral administration. The
tablets must not be crushed or chewed and
should be taken with food.
_Adults, including the elderly (>65 years) _
For induction of remission: 2.4 g to 4.8 g (two to four tablets)
should be taken once daily. The highest dose
of 4.8 g/day is recommended for patients not responding to lower doses
of mesalazine. When using the
highest dose (4.8 g/day), the effect of the treatment should be
evaluated at 8 weeks.
For maintenance of remission: 2.4 g (two tablets) should be taken once
daily.
_Children and adolescents _
Mesavancol is not recommended for use in children below the age of 18
years due to a lack of data on
safety and efficacy.
_Hepatic and renal impairment _
Specific studies have not been performed to investigate Mesavancol in
patients with hepatic or renal
impairment (see sections 4.3 and 4.4).
4.3 CONTRAINDICATIONS
History of hypersensitivity to salicylates (including mesalazine) or
any of the excipients
listed in section 6.1.
Severe renal impairment (GFR <30 ml/min/1.73 m
2
) and/or severe hepatic impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs), including Drug reaction
with eosinophilia and systemic
symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN), have