Colazide 750mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Balsalazide disodium

Dostupné z:

Almirall Ltd

ATC kód:

A07EC04

INN (Medzinárodný Name):

Balsalazide disodium

Dávkovanie:

750mg

Forma lieku:

Oral capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 01050100; GTIN: 5014162008953

Príbalový leták

ARTWORK INFORMATION PANEL
DESCRIPTION:
PRINTING COLOURS
NON PRINTING COLOURS
INLINE CONTROL CODE
COLOUR REFERENCE IN PMS BRIDGE
EQUATE WITH CMYK
PROOF:
REGULATORY TEXT:
ITEM NUMBER:
MATERIAL SIZE:
DESIGNER:
FONTS:
DATE:
MANUFACTURER’S TECHNICAL CHECK:
Manufacturer confirms the printability and
technical compliance of this packaging material
for correct use during packaging process.
Date and Signature
PIL Colazide 750mg tab GB Mock up
uk-pl-proposed 06.2018 mhtASP
_FRUTIGER LT COM BOLD ITALIC, _GRAPHIK SEMIBOLD / _SEMIBOLD ITALIC_ /
Medium / Regular
Mock up
210 x 297 mm
14.09.2018
5
Die cut
Black
WHAT IS IN THIS LEAFLET
1. What Colazide is and what it is used for
2. What you need to know before you take Colazide
3. How to take Colazide
4. Possible side effects
5. How to store Colazide
6. Contents of the pack and other information
1. WHAT COLAZIDE IS AND WHAT IT IS USED FOR
Colazide is used for the treatment of ulcerative colitis
(ulceration of the large intestine). It may also be used to
keep the disease under control by preventing further
episodes. It works as an anti-inflammatory agent.
This medicine contains balsalazide disodium as the
active ingredient.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLAZIDE
DO NOT TAKE COLAZIDE:
- if you are allergic to balsalazide or any of the other
ingredients of this medicine (listed in section 6)
- if you are allergic to mesalazine, aspirin or other salicylates
- if you have a severe liver disease
- if you have a moderate to severe kidney disease
- if you are pregnant or breast feeding
WARNINGS AND PRECAUTIONS
- asthma
- any blood disorders
- a mild kidney disorder
- a confirmed liver disease
- an active ulcer
If any of these apply to you, talk to your doctor or
pharmacist before taking Colazide.
TESTS ON YOUR LIVER, KIDNEY AND BLOOD
Before you start treatment with Colazide you will have a
blood and urine test to check how well your kidneys are
working and what your blood is doing.
During treatment your doctor will check how well your
liver, kidney and blood is working by ta

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Colazide
750 mg hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 750 mg of balsalazide disodium corresponding to
balsalazide 612.8 mg and to mesalazine 262.5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Size 00 beige gelatin capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Colazide is indicated for the treatment of mild-to-moderate active
ulcerative colitis
and maintenance of remission.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
TREATMENT OF ACTIVE DISEASE:_ _
_ _
_ _
2.25g Balsalazide disodium (3 capsules) three times daily (6.75g
daily) until remission or for 12 weeks maximum.
Rectal or oral steroids can be given concomitantly if necessary.
MAINTENANCE TREATMENT:
The recommended starting dose is 1.5g Balsalazide disodium (2
capsules) twice daily (3g daily). The dose can be adjusted based
on each patient’s response; there may be an additional benefit
with a dose up to 6g daily.
_Elderly:_
No dose adjustment is anticipated.
_Paediatric Population:_
Colazide is not recommended in children.
Method of administration
To be swallowed whole with or after food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to its metabolites,
including
mesalazine, or to any of the excipients listed in section 6.1.
History of hypersensitivity to salicylates.
Severe hepatic impairment, moderate-severe renal impairment.
Pregnant and breast feeding women.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Colazide should be used with caution in patients with asthma, bleeding
disorders,
active
ulcer
disease,
mild
renal
impairment
or
those
with
established hepatic disease.
Renal function should be monitored before starting an oral
aminosalicylate,
at
3
months
of
treatment,
and
then
annually
during
treatment
(more
frequently
in
renal
impairment).
Blood
disorders
can
occur
with
aminosalicylates (see recommendation below).
BLOOD DISORDERS
During treatment with