Pentasa 1g suppositories

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Mesalazine

Prieinama:

CST Pharma Ltd

ATC kodas:

A07EC02

INN (Tarptautinis Pavadinimas):

Mesalazine

Dozė:

1gram

Vaisto forma:

Suppository

Vartojimo būdas:

Rectal

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01050100; GTIN: 5055946801834

Pakuotės lapelis

PENTASA
® 1G SUPPOSITORIES
(mesalazine)
Your medicine is known by the above name, but will be referred to as
Pentasa throughout this:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1) What Pentasa is and what it is used for
2) Before you take Pentasa
3) How to take Pentasa
4) Possible side effects
5) How to store Pentasa
6) Further Information
1) WHAT PENTASA IS AND WHAT IT IS USED FOR
The name of this medicine is Pentasa Suppositories. Each suppository
contains mesalazine 1g as the active ingredient. Mesalazine belongs to
a
group of medicines called salicylates.
Pentasa is used to treat inflammation in the gut caused by conditions
such
as ulcerative colitis. Sometimes ulcerative colitis only affects the
back
passage (rectum), this is known as ulcerative proctitis. Pentasa
suppositories are used to treat ulcerative proctitis and are intended
for
rectal use only.
The suppositories release the active ingredient slowly which then acts
locally to reduce the inflammation and help relieve or stop the pain.
2) BEFORE YOU TAKE PENTASA
DO NOT USE PENTASA IF YOU:
•
are ALLERGIC to mesalazine or any of the other ingredients in Pentasa
(see section 6)
•
are ALLERGIC to any other salicylates e.g. aspirin
•
have severe liver or kidney problems
TAKE SPECIAL CARE WITH PENTASA
You should consult your doctor before using these suppositories if:
•
you currently have, or have previously had liver or kidney disease
•
you are on any medication that may affect kidney function e.g.
azathioprine
•
you have ever had an allergy to a medication called sulphasalazine
•
you suddenly develop abdominal cramps, abdominal pain, fever, severe
headache and rash, STOP USING this medicine and seek medical advice
immediately.
•
you have lung problems, in particular asthma
You should make sure that you don’t become dehydrated, while you are
using this medicine. This can occur after severe or prolonged attacks
of
vomiting and/or diarrhoea, high fever or heavy sweating.
If this does occur, you should speak to a doctor or pharmacist for
a

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pentasa® Suppositories 1g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Mesalazine (BAN) 1g
3.
PHARMACEUTICAL FORM
Suppositories
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Pentasa Suppositories are indicated for the treatment of ulcerative
proctitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Ulcerative Proctitis:
_Usual adult dose: _Acute treatment: 1 suppository daily for 2 to 4
weeks.
_Maintenance treatment: _1 suppository daily.
_Children: _Not recommended.
_Elderly Patients: _ The usual adult dose applies.
4.3
CONTRAINDICATIONS
Pentasa is contraindicated in:
-
patients with known hypersensitivity to salicylates or any of the
excipients.
-
patients with severe liver and/or renal impairment
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such
as ALT or
AST; serum creatinine) and urinary status (dip sticks) should be
determined
prior to and during treatment, at the discretion of the treating
physician. As a
guideline, follow-up tests are recommended 14 days after commencement
of
treatment, then a further two to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out
every three
months. If additional symptoms occur, these tests should be performed
immediately.
Caution is recommended in patients with impaired hepatic function.
PENTASA should not be used in patients with impaired renal function.
Mesalazine-induced renal toxicity should be considered, if renal
function
deteriorates during treatment.
Patients with pulmonary disease, in particular asthma, should be very
carefully
monitored during a course of treatment with PENTASA.
Patients with a history of adverse drug reactions to preparations
containing
sulphasalazine (risk of allergy to salicylates), should be kept under
close
medical surveillance on commencement of a course of treatment with
PENTASA. Should PENTASA cause acute intolerance reactions such