ZORALIX 5 SF Elixir 5mg/5ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
PROMETHAZINE HYDROCHLORIDE
Available from:
HOE PHARMACEUTICALS SDN. BHD.
INN (International Name):
PROMETHAZINE HYDROCHLORIDE
Units in package:
90ml mL
Manufactured by:
HOE PHARMACEUTICALS SDN. BHD.
Authorization number:
MAL12035003AZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

12-04-2019

Consumer Medication Information Leaflet (RiMUP)

1

ZORALIX 5 SF ELIXIR

Promethazine Hydrochloride (5mg/5ml)

What is in this leaflet

1. What ZORALIX 5 SF ELIXIR

is used for

2. How ZORALIX 5 SF ELIXIR

works

3. Before you use ZORALIX 5

SF ELIXIR

4. How to use ZORALIX 5 SF

ELIXIR

5. While you are using

ZORALIX 5 SF ELIXIR

6. Side effects

7. Storage and Disposal of

ZORALIX 5 SF ELIXIR

8. Product description

9. Manufacturer and Product

Registration Holder

10. Date of revision

This leaflet answers some

common questions about

ZORALIX 5 SF ELIXIR. It does

not contain all the available

information. It does not take the

place of talking to your

pharmacist or doctor.

All medicines have risks and

benefits. Your pharmacist or

doctor has weighed the risks of

you taking ZORALIX 5 SF

ELIXIR against the benefits they

expect it will have for you.

Keep this leaflet with the

medicine.

You may need to read it again.

What ZORALIX 5 SF ELIXIR

is used for

ZORALIX 5 SF ELIXIR is an

antihistamine used to treat a

number of conditions:

Allergic conditions

Motion sickness

Nausea & vomiting

Hypnosis

How ZORALIX 5 SF ELIXIR

works

ZORALIX 5 SF ELIXIR is an

antihistamine which helps to

reduce allergic symptoms by

preventing the effects of a

substance called histamine.

Histamine is produced by the

body in response to foreign

substances that the body is

allergic.

Ask your pharmacist or doctor if

you have any questions about this

medicine.

Before you use ZORALIX 5 SF

ELIXIR

-When you must not take it

Do not take ZORALIX 5 SF

ELIXIR if you are hypersensitive

Any medicine containing

Promethazine Hydrochloride

Other similar anti-histamines

Any of the ingredients listed at

the end of this leaflet.

-Before you start to use it

Take special care with ZORALIX

5 SF ELIXIR:

Increased eye pressure, enlarged

prostate

People with liver disease

Should not be used in children

less than 2 years of age because

of the potential for fatal

breathing difficulty

To be used with caution and

doctor’s advice in children 2 to

6 years of age (when used for

treatment of cough and cold).

Pregnancy and breast feeding:

Do not use ZORALIX 5 SF

ELIXIR in pregnancy unless

recommended by your health

professionals. The use of this

product is not recommended in

the 2 weeks prior to delivery in

view of the risk of irritability and

excitement in the new born

babies. The amount excreted in

milk is insignificant. However,

there are risks of irritability and

excitement in new born babies.

-Taking other medicines

Please tell your doctor or

pharmacist if you are taking or

have recently taken any other

medicines, including medicines

obtained without a prescription.

Some medicines and ZORALIX 5

SF ELIXIR may interfere with

each other. These include:

anti-cholinergic agent, tricyclic

anti-depressant, sedative or

hypnotic

other antihistamines

alcohol

barbiturates, hypnotics, narcotic

analgesics, sedatives and

tranquilizers

How to use ZORALIX 5 SF

ELIXIR

-How much to use

Allergic Conditions

Children 6-12 years: 10 to 25ml

of the elixir as a single dose at

night, or 10ml of the elixir, two to

three times daily.

Children

2-5

years:

5-15ml

elixir as a single dose at night, or

5ml of elixir, two to three times

daily.

Hypnosis

For short term use on the advice

of a pharmacist or doctor.

Children 6-12 years: 10 to 25ml

of the elixir, as a single dose at

night.

Children

2-5

years:

5-15ml

elixir as a single dose at night.

Consumer Medicine Information Leaflet (RiMUP)

2

Motion Sickness

Children 6-12 years: 10ml of the

elixir.

Children 2-5 years: 5ml of elixir.

Nausea and Vomiting

Children 6-12 years: 10ml of the

elixir, every 4 to 6 hours

to a

maximum daily dose of 25ml of

the elixir.

Children 2-5 years: 5ml of elixir

every 4 to 6 hours to a maximum

daily dose of 15ml.

-When to use it

Take the medicine orally as per

directed by your doctor or

pharmacist.

-How long to use it

Do not exceed the recommended

dosage as directed by your doctor

or pharmacist.

-If you forget to use it

Take the missed dose as soon as

you remember.

If it is almost time for your next

dose, skip the missed dose and

take the medicine at your next

regularly scheduled time.

Do not take a double dose to

make up for the one you have

missed.

-If you use too much (overdose)

If you accidentally take too much

of ZORALIX 5 SF ELIXIR,

overdosage signs and symptoms

such as dry mouth, fixed dilated

pupils, flushing and

gastrointestinal symptoms may

also occur.

While you are using ZORALIX

5SF ELIXIR

-Things you must do

If you are about to start taking on

any other new medicine, tell your

pharmacist or doctor that you are

taking ZORALIX 5 SF ELIXIR.

-Things you must not do

Do not consume any food or

beverages or carry out any

activities which are restricted by

doctors while taking ZORALIX 5

SF ELIXIR.

-Things to be careful of

Antihistamines may cause

drowsiness with ZORALIX 5 SF

ELIXIR. Do not to take charge of

vehicles or machinery until the

effect of ZORALIX 5 SF ELIXIR

treatment on the individual is

known.

ZORALIX 5 SF ELIXIR may

interfere with urine pregnancy

tests to produce false results.

ZORALIX 5 SF ELIXIR should

be discontinued at least 72 hours

before the time start of skin tests.

Side effects

ZORALIX 5 SF ELIXIR may

cause side effects. Tell your

doctor if any of these symptoms

are severe or do not go away.

dry mouth

sedation

lassitude

low blood pressure

inability to concentrate

muscular weakness

loss of appetite

nausea or vomiting

diarrhea or constipation

epigastric pain

headache

dizziness

blurred vision

in-coordination

jaundice - yellow tinge

to skin or eyes

tinnitus - buzzing,

hissing, ringing or other

persistent noise in the

ears

irritability

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

You may report any side effects

or adverse drug reactions directly

to the National Centre for

Adverse Drug Reaction

Monitoring by calling Tel: 03-

78835490, or visiting the website

npra.moh.gov.my (Consumers →

Reporting →Reporting Side

Effects to Medicines (ConSERF)

or Vaccines (AEFI)).

Storage and Disposal of

ZORALIX 5 SF ELIXIR

-Storage

Store below 30

C. Keep out of the

reach of children. Protect from

strong light. Keep container well

closed.

-Disposal

Medicines should not be disposed

of via wastewater or household

waste. Ask your pharmacist how

to dispose of medicines no longer

required. These measures will

help to protect the environment.

Product description

-What it looks like

ZORALIX 5 SF ELIXIR is clear

orange syrup liquid with banana

and vanilla flavor in 90ml amber

plastic bottle with cap.

-Ingredients

-Active ingredients:

Promethazine Hydrochloride

-Inactive ingredients:

Sodium

Benzoate,

Citric

Acid

Anhydrous,

Banana

Flavour,

Glycerin,

Disodium

Edetate,

Sodium

Citrate,

Propylene

Glycol,

Sunset

Yellow

FCF,

Quinoline

Yellow,

Hydroxyethylcellulose

Purified

Water,

Propyl

Gallate,

Vanillin.

-MAL number:

MAL12035003AZ

Consumer Medicine Information Leaflet (RiMUP)

3

Manufacturer:

HOE Pharmaceuticals Sdn Bhd

Lot 10, Jalan Sultan Mohamed 6,

Bandar Baru Suleiman,

42000 Port Klang, Selangor,

Malaysia.

Product Registration Holder:

HOE Pharmaceuticals Sdn Bhd

Lot 10, Jalan Sultan Mohamed 6,

Bandar Baru Suleiman,

42000 Port Klang, Selangor,

Malaysia.

Date of Revision:

12/4/2019

Serial Number:

NPRA(R4/1)271118/00355

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