PENTASA SUPPOSITORIES 1G

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Disponibil de la:

Ferring Sdn. Bhd.

INN (nume internaţional):

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Unități în pachet:

28 Units

Produs de:

Ferring International Center SA

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PENTASA
®
SUPPOSITORIES
Mesalazine (1g)
1
WHAT IS IN THIS LEAFLET
1. What PENTASA
®
is used for
2. How PENTASA
®
works
3. Before you use PENTASA
®
4. How to use PENTASA
®
5. While you are using it
6. Side effects
7. Storage and Disposal of
PENTASA
®
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
1. WHAT PENTASA
® IS USED FOR
PENTASA Suppositories 1g is used to
treat ulcerative proctitis (inflammation
of the anus and rectum (back passage)).
2. HOW PENTASA
® WORKS
The active ingredient in PENTASA
®
is
mesalazine, which belongs to a group
of medicines known as salicylates. It
has
a
healing
effect
upon
the
inflammation
(swelling,
redness
and
pain)
caused
in
the
intestine
by
conditions such as ulcerative colitis.
Each suppository contains mesalazine
1g as the active ingredient.
3. BEFORE YOU USE PENTASA
®
_When you must not use it_
DO NOT take PENTASA
®
•
If you are allergic to mesalazine,
other salicylic acid or its derivatives
or to any of the other ingredients of
PENTASA
®
.
•
If
you
have
severe
liver
and/or
kidney impairment.
If
this
applies
to
you,
do
not
take
PENTASA
®
and
tell
your
doctor
immediately.
_Before you start to use it _
WARNING AND PRECAUTIONS
•
Tell your doctor or pharmacist if
you have or have had any of the
following conditions:
-
Intolerant
or
hypersensitive
to
sulphasalazine
- With impaired liver function
- With kidney impairment
- With lung disease, in particular
asthma.
- Suddenly develop abdominal
cramps, abdominal pain, fever, severe
headache and rash.
- Kidney stones may develop with use
of mesalazine. Symptoms may include
pain in sides of abdomen and blood in
urine.
Take
care
to
drink
sufficient
amount of liquid during treatment with
mesalazine.
- If you have ever developed a severe
skin rash or skin peeling, blistering
and/or
mouth
sores
after
using
mesalazine.
Mesalazine
may
produce
red-brown
urine discoloration after contact with
sodium
hypochlorite
bleach
in
the
toilet
wat

Caracteristicilor produsului

PROPOSED PACKAGING MATERIAL
Code
PENSUP-I-MY-04-01
Size
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: #220753 _ _
Code of previous version
PENSUP-I-MY-03.01
Changes
CCDS 18: Updates following PRAC recommendation - warning added on
urine discolouration,&
DRESS
⊠
CCDS version: 18
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
JIWO, 11-Sep-2023
PENTASA
®
SUPPOSITORIES 1 G
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1 g mesalazine.
Excipients: magnesium stearate, talc, povidone, macrogol 6000.
PHARMACEUTICAL FORM
Suppositories 1g, White to tan, spotted, oblong suppositories
THERAPEUTIC INDICATIONS
Treatment of ulcerative proctitis.
POSOLOGY AND METHOD OF ADMINISTRATION
1 suppository 1-2 times daily.
Paediatric population: There is little experience and only limited
documentation for an effect in children.
PENTASA Suppositories are for rectal administration.
INSTRUCTION FOR USE
1. A visit to the toilet is recommended before inserting a
suppository.
2. Open the foil bag at the tear mark.
3. The suppository is inserted in the rectum until resistance is felt
and disappeared again.
4. In order to facilitate the administration, the suppository can be
moistured with water or moisture cream.
5. If the suppository is discharged within the first 10 minutes,
another can be inserted.
CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulphasalazine
are able to take PENTASA
®
without
risk
of
similar
reactions.
However,
caution
is
recommended
when
treating
patients
allergic
to
sulphasalazine (risk of allergy to salicylates). Severe cutaneous
adverse reactions (SCARs), including Drug
reaction with eosinophilia and systemic symptoms (DRESS),
Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN), have been reported in association with
mesalazine treatment. In case of acute
intoleran