Unizet

Main information

  • Trade name:
  • Unizet Expectorant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Unizet Expectorant
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL06051293
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

UNIZET EXPECTORANT

Diphenhydramine Hydrochloride/Bromhexine Hydrochloride/Guaiphenesin/Ammonium Chloride/Levomenthol (8mg/4mg/50mg/

100mg/1mg per 5ml)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What UNIZET is used for

How UNIZET works

Before you use UNIZET

How to use UNIZET

While you are using it

Side effects

Storage and disposal of UNIZET

Product description

Manufacturer and Product

Registration Holder

Date of revision

What UNIZET is used for

It is recommended for productive cough

and alleviation of nasal stuffiness,

sneezing, lachrymation (flow of tears),

mucolytic congestion and bronchial

congestion.

How UNIZET works

Bromhexine is a mucolytic agent which

works by thinning the mucus in the

airways, thus making the mucus less

sticky and it facilitates the removal of the

mucus.

Guaiphenesin is reported to reduce

viscosity of tenacious sputum and is used

as expectorant

(to remove mucus).

Diphenhydramine is an antihistamine

which works by blocking a certain

natural substance (histamine) that your

body makes during an allergic reaction.

Levomenthol and flavoured syrupy base

give soothing effects.

Before you use UNIZET

When you must not use it

Do not use it when you have:

Impaired liver or kidney functions.

history of peptic ulceration.

Do not give to premature infants and

neonates,this group of patients has an

increased susceptibility to antimuscarinic

effect.

Pregnancy and lactation

Do not take UNIZET if you are pregnant,

trying to get pregnant or think you may

be pregnant.

Do not take UNIZET if you are breast-

feeding. Ask your doctor or pharmacist

for advice before taking any medicine.

Before you start to use it

UNIZET is not to be used in children

less than 2 years of age. To be used

with caution and doctor's advice in

children 2 to 6 years of age.

UNIZET should be used with caution

in conditions with closed angle

glaucoma

(increased pressure inside

the eyes), urinary retention, prostatic

hyperplasia

(enlargement of prostat)

and pyloroduodental obstruction

(gastric outflow obstruction).

Taking other medicines

Tell your doctor if you are taking any

other medicines, including any that

you buy without a prescription from a

pharmacy, supermarket or health food

shop.

Some medicines may interact with

UNIZET. They include:

central nervous system (CNS)

depressants

monoamine oxidase inhibitors

(MAOIs) for depression

How to use UNIZET

How much to use

Follow all directions given to you by

your doctor and pharmacist carefully.

They may differ from the information

contained in this leaflet. If you do not

understand the instructions on the

label, ask your doctor or pharmacist

for help.

Adults

10ml (2 teaspoonfuls) every 3 or 4

hours, not to exceed 12 teaspoons in

24 hours.

Children aged 6 to 12 years

One 5 ml dose of syrup 4 times a day.

Maximum daily dose 20 ml syrup.

When to use it

Use as directed by your doctor or

pharmacist.

How long to use it

Continue taking UNIZET for as long

as your doctor recommends.

If you forget to use it

Consult your doctor or pharmacist on

what you should do if you forget to use

Take the missed dose as soon as you

remember. If it is almost time for your

next dose, wait until then to take the

medicine and skip the missed dose. Do

not take a double dose to make up for

the missed dose.

If you use too much (overdose)

Contact your doctor immediately or go

to the Emergency Department of your

nearest hospital, if you think you or

anyone else may have taken too much

of this medicine. Do this even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention.

While you are using it

Things you must do

Take your medicine exactly as your

doctor has told you.

Tell all the doctors, dentists and

pharmacists treating you that you are

taking UNIZET.

Tell your doctor immediately if you

become pregnant while taking this

medication.

2

Consumer Medication Information Leaflet (RiMUP)

Things you must not do

Do not stop taking the medicine unless

advised by your doctor.

Do not take any new medicines

without consulting your doctor.

Do not give UNIZET to anyone else,

even if they have the same symptoms

or condition as you.

Things to be careful of

Driving and using machines

This medicine may affect your ability

to drive or use machines. Do not use

machines until you know how

UNIZET affects you.

Side effects

Like all medicines, UNIZET can cause

side effects, although not everybody gets

them.

Visit your doctor or pharmacist

immediately if you experience any side

effects after taking this medicine.

This medicine may cause:

Nausea

Vomiting

Profound acidosis

(an increased

acidity in the blood)

Hypokalaernia

(low potassium

level)

Sedation varying from slight

drowsiness to deep sleep and

including lassitude, dizziness and

incoordination

Dry mouth

Thick respiratory tract secretion

Blurred vision

Urinary difficulty and retention,

Reduced tone and motility of

gastrointestinal tract resulting in

constipation increased gastric

reflux.

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel: 03-

78835550, or visiting the website

portal.bpfk.gov.my (Consumers

Reporting).

Storage and disposal of UNIZET

Storage

Keep the bottle tightly closed and

protected from light.

Store below 30°C.

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

Clear red coloured liquid free from

foreign matter, with characteristic

flavor and odour.

Ingredients

Active ingredients

Diphenhydramine Hydrochloride,

Bromhexine Hydrochloride,

Guaiphenesin, Ammonium Chloride,

Levomenthol.

Inactive ingredients

Sucrose, Sodium Benzoate,

Saccharin Sodium, Glycerol,

Tartaric Acid, Propylene Glycol,

Citric Acid Monohydrate, Sodium

Citrate, Ponceau 4R, Sweet orange

Essence S 618, Purified Water.

MAL number:

MAL06051293A

Manufacturer

Alembic Pharmaceuticals Limited

Plot No. 21/22, EPIP, Phase I, Jharmajri,

Baddi, Dist. Solan, HP – 173 205, India.

Product Registration Holder

Unimed Sdn Bhd

No.53, Jalan Tembaga SD 5/2B,

Bandar Sri Damansara,

52200 Kuala Lumpur.

Date of revision

25/08/2015

Serial number

BPFK (R4/1)140815/00246