ROWATANAL CREAM

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Zinc oxide; Menthol; Bismuth Subgallate; Calcium Carbonate.

זמין מ:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (שם בינלאומי):

Zinc oxide; Menthol; Bismuth Subgallate; Calcium Carbonate.

יחידות באריזה:

10gm mcg/mL; 26gm mcg/mL

תוצרת:

ROWA PHARM LTD

עלון מידע

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ROWATANAL
_® _
CREAM
Bismuth subgallate/ menthol/ calcium carbonate/ zinc oxide (2% w/w /
1% w/w / 5% w/w / 8% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Rowatanal
®
is used for
2.
How Rowatanal
®
works
3.
Before you use Rowatanal
®
4.
How to use Rowatanal
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Rowatanal
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ROWATANAL® IS USED FOR
For
the
treatment
of
piles
(hemorrhoids)
and
irritation
at
the
back passage (rectum).
HOW ROWATANAL
® WORKS
Rowatanal
®
Cream has antiseptic and
astringent
(cleansing)
properties.
It
relieves
the
intense
itching
and
burning
sensation
associated
with
haemorrhoids.
BEFORE YOU USE ROWATANAL
®
_- When you must not use it _
Do not use Rowatanal® if you:
are
allergic
to
menthol,
bismuth
subgallate,
calcium
carbonate,
zinc
oxide or any of the other ingredients of
this
medicine
(see
section
Product
Description).
_ _
_- Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before using Rowatanal
®
if your piles
are bleeding or have been present for
some time.
_ _
If the condition persists or worsens
you should also consult your doctor.
Rowatanal
®
contains
glycerine,
lanolin
and
nipastat
(parahydroxybenzoates).
This
medicine
contains
glycerine,
which
may have a mild laxative effect. It
contains
lanolin,
which
may
cause
local
skin
reactions
(e.g.
contact
dermatitis). It also contains nipastat
which
may
cause
allergic
reactions
(possibly delayed).
PREGNANCY AND BREASTFEEDING
This product should not be used during
pregnancy
and
breastfeeding
unless
considered
essential
by
your
physician.
Ask
your
doctor
or
pharmacist
for
advice before taking any medicine.
_- Taking other medicines _
Tell your doctor or pharmacist if you
are
taking,
have
recently
taken
or
might
take
any
other
medicines,
including medicines obtained without
a prescription.
HOW TO USE ROWATANAL
®
_- How much to use _
For internal haemorrh

מאפייני מוצר

Package Leaflet: Information for the user
Rowatanal Cream
Name and Strength of Active Substances
The active substances are menthol, bismuth subgallate, calcium carbonate and zinc oxide. Each 100g of cream contains 1g menthol, 2g bismuth subgallate, 5g calcium carbonate and 8g zinc oxide.
Other Ingredients
The other ingredients are: hard paraffin, glycerol, wool fat, glycerol mono-dioleate, polyoxyethylene-12-cetyl stearyl alcohol, purified water and as preservatives: butyl parahydroxybenzoate, ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218).
Product Description
Rowatanal® Cream is smooth in texture and light yellow in colour.
Pharmacodynamics/Pharmacokinetics Rowatanal® Cream has antiseptic and astringent (cleansing) properties. It relieves the intense itching and burning sensation associated with haemorrhoids.
Indication
For the treatment of haemorrhoids and proctitis (anal irritation).
Recommended DosageApply 2-3 times daily and after defecation. For internal haemorrhoids, use the cannula nozzle provided.
Route of Administration
For rectal use only.
Contraindications
Do not use Rowatanal® if you:• are allergic to menthol, bismuth subgallate, calcium carbonate, zinc oxide or any of the other ingredients of this medicine.
Warnings and Precautions
Talk to your doctor or pharmacist before using Rowatanal® if your piles are bleeding or have been present for some time.If the condition persists or worsens you should also consult your doctor.Rowatanal® contains glycerol, wool fat and parahydroxybenzoates. This medicine contains glycerol, which may have a mild laxative effect. It contains wool fat, which may cause local skin reactions (e.g. contact dermatitis). It also contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Rowatanal PIL Malaysia (11-18).indd 1 28/11/2018 15:43