FOLIO SYRUP

Country: Malaysia

Language: English

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

Active ingredient:

Hedera helix

Available from:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Hedera helix

Units in package:

90 ml; 90 ml

Manufactured by:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
FOLIO SYRUP
Ivy Leaf Extract Syrup 7mg/ml
WHAT IS IN THIS LEAFLET:
1.
What Folio Syrup is used for
2.
How Folio Syrup works
3.
Before you use Folio Syrup
4.
How to use Folio Syrup
5.
While you are using Folio Syrup
6.
Side Effects
7.
Storage and Disposal of Folio Syrup
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT FOLIO SYRUP IS USED FOR
Folio
Syrup
contains
the
active
ingredient
ivy
leaf
extract.
It
is
a
traditional herbal medicinal product used
to
relieve
throat
irritation,
cough,
and
reducing phlegm.
HOW FOLIO SYRUP WORKS
The mechanism of action of the dried
leaves
of
ivy,
_Hedera _
_Helix_
is
not
known.
BEFORE YOU USE FOLIO SYRUP
_- When you must not use it _
If you are allergic (hypersensitive) to the
ivy
leaf
and
other
ingredients
of
the
syrup.
_- Before you start to use it _
Contact your doctor or pharmacist if you
have any doubts.
_- Taking other medicines _
Studies investigating the effects of Folio
Syrup on other medicines have not been
performed.
Please
tell
your
doctor
or
pharmacist
if
you
are
taking/using
or
have
recently
taken/used
any
other
medicines, including medicines obtained
without a prescription.
_Pregnancy and Breast-feeding _
Ask you doctor or pharmacist for advice
before taking any medicine. The safety
of
this
product
during
pregnancy
and
breast-feeding has not been established,
therefore the use of this product during
pregnancy
and
breast-feeding
is
only
allow if the potential benefit justifies the
potential risk.
HOW TO USE FOLIO SYRUP
Folio Syrup is for oral use only. Always
use Folio Syrup exactly as directed by
your doctor or pharmacist only. Do not
exceed
the
stated
dose.
You
should
check with your doctor or pharmacist if
you are not sure. Shake the bottle well
each time before use.
_- How much to use it _
_Adolescents, Adults, Elderly: _
5 ml 3 times daily
_Children between 6-11 years: _
2.5 ml three times daily
_Children between 2-5 years: _
1.5 ml 3 times daily
The use in child

Summary of Product characteristics

7223-00
FOLIO SYRUP
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Each 1ml contains
Ivy Leaf Extract (Hedera
helix)………………………………………….7mg
PRESERVATIVE:
Methylparaben…………………………………………………………..1mg/ml
Propylparaben……………………………………………………...……0.2mg/ml
PRODUCT DESCRIPTION:
Brownish green colour syrup with peppermint flavour.
INDICATION:
Traditionally used for relief of throat irritation, cough and reducing
phlegm.
RECOMMENDED DOSAGE:
For Adolescent, Adults and Elderly: 5ml 3 times daily.
For Children between 6-11 years : 2.5ml 3 times daily
For Children between 2-5 years: 1.5ml 3 times daily.
The use in children under 2 years of age is contraindicated because of
the risk of aggravation of respiratory
symptoms.
Duration of Use: If symptoms persists longer than one week during the
use of the medicinal product, a doctor or a
pharmacist should be consulted.
This medicine should be taken after meal. Shake the bottle well each
time before use.
ROUTE OF ADMINISTRATION:
Oral
CONTRAINDICATIONS:
Unknown
WARNINGS AND PRECAUTIONS:
This is a traditional medicine. This medicine should generally be
taken after consulting by doctor.
Please consult your pharmacist/doctor if symptoms persist/worsen.
Persistent or recurrent cough in children between 2-4 years of age
requires medical diagnosis before treatment.
When dyspnoea, fever or purulent sputum occurs, a doctor or a
pharmacist should consulted.
Concomitant use with opiate antitussives such as codeine or
dextromethorphan is not recommended without
medical advice.
Caution is recommended in patients with gastritis or gastric ulcer.
Pregnancy and Lactation: Safety during pregnancy and lactation has not
been established. In the absence of
sufficient data, the use during pregnancy and lactation s not
recommended.
INTERACTIONS WITH OTHER MEDICAMENTS:
Unknown.
PREGNANCY AND LACTATION:
Use only after having consulted by doctor.
ADVERSE EFFECTS/ UNDESIRABLE EFFECTS:
Unknown
OVERDOSE AND