Levocetirizine

Main information

  • Trade name:
  • Levocetirizine Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Levocetirizine Tablets
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL10100016
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

LEVOCETIRIZINE TABLET

Levocetirizine Dihydrochloride (5mg)

What is in this leaflet

What

LEVOCETIRIZINE

is used for

LEVOCETIRIZINE

works

Before you use

LEVOCETIRIZINE

How to use

LEVOCETIRIZINE

While you are using it

Side effects

Storage and Disposal of

LEVOCETIRIZINE

Product Description

Manufacturer and Product

Registration Holder

Date of revision

What

LEVOCETIRIZINE

is used for

LEVOCETIRIZINE

anti-allergic

agent.

used

treat

symptoms

associated

with allergic conditions, such

allergic rhinitis

(inflammation of the lining

inside the nose)

How LEVOCETIRIZINE works

LEVOCETIRIZINE helps to relieve

allergic symptoms by blocking a certain

natural substance (histamine) that your

body makes during an allergic reaction.

Before you use LEVOCETIRIZINE

When you must not use it

Do not take

LEVOCETIRIZINE

You are allergic (hypersensitive) to

LEVOCETIRIZINE

, or any other related

substance, or any of the other ingredients

LEVOCETIRIZINE

contains.

You have severe kidney impairment

You have been told by your doctor that

you have intolerance to some sugars

Before you start to use it

Check with your doctor of pharmacist

before taking

LEVOCETIRIZINE

:

If you suffer from kidney

impairment, you may

require a lower dosage

and should discuss your

situation with your doctor.

Pregnancy and Breast-Feeding

No information is available on the safe

use of

LEVOCETIRIZINE

during

pregnancy or breast-feeding. When

you are pregnant or breast-feeding you

should only use

LEVOCETIRIZINE

there is a clear benefit outweighing the

possible risks. Your doctor will make

this decision for you.

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. Other medicines may be affected

LEVOCETIRIZINE.

They, in turn,

may affect how well

LEVOCETIRIZINE

works.

How to use LEVOCETIRIZINE

How much to use

Always use

LEVOCETIRIZINE

exactly as your doctor has told you.

You should check with your doctor

or pharmacist.

Adults and adolescents 12

years

and above:

The daily recommended dose of

LEVOCETIRIZINE

is 5mg daily.

Children aged 6 to 12 years:

The daily recommended dose of

LEVOCETIRIZINE

is 5mg

daily.

Elderly

Adjustments of the dose is

recommended in elderly with kidney

impairment.

Kidney impairment

Dosing will be adjusted according to

kidney function.

LEVOCETIRIZINE

is not recommended

in children less than 6 years since the

currently available film-coated tablets

do not allow dose adaptation.

When to use it

Use as directed by your doctor or

pharmacist. The film-coated tablet must

be taken orally, swallowed whole with

or without food. It is recommended to

take the daily dose in one single intake.

How long to use it

Continue taking

LEVOCETIRIZINE

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

it. 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.

Taking too many tablets may cause

drowsiness in adults and initially

agitation and restlessness, followed

by drowsiness in children.

While you are using it

Things you must do

Take your medicine exactly as

your doctor has told you.

Consume this medicine orally.

Tell all the doctors, dentists and

pharmacists treating you that you

are taking

LEVOCETIRIZINE

Tell your doctor immediately if you

become pregnant while taking this

medication

.

Things you must not do

Do not stop taking the medicine

unless advised by your doctor.

1

hronic unknown cause of hives.

Consumer Medication Information Leaflet (RiMUP)

Do not take any new medicines

without consulting your doctor or

pharmacist.

Do not give

LEVOCETIRIZINE

anyone else, even if they have the

same symptoms or condition as you.

- Things to be careful of

You should be cautious if you take

LEVOCETIRIZINE

at the same time as

alcohol In sensitive people, may cause

additional reductions in alertness and

impairment of performance.

Driving and using machines

Do not exceed the recommended dose

and you have to take into account of

how this medicine will affect you if you

intend to drive, engage in potentially

hazardous activities or operate

machinery.

Side effects

Like all medicines,

LEVOCETIRIZINE

can cause side effects, although not

everybody gets them. Adverse events

observed in association with the use of

LEVOCETIRIZINE

are listed below.

Common:

Sleepiness

Headache

Dry mouth

Tiredness

Less common:

Feeling of weakness

Visit your doctor or pharmacist

immediately if you experience any side

effects after taking this medicine.

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

npra.moh.gov.my (Public

Reporting Medicinal Problem/Side

Effect/ AEFI / Vaccine Safety).

Storage and Disposal of

LEVOCETRIZINE

Storage

Keep out of the reach and sight of

children.

Store in a dry place below 25 °C.

Protect from light

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

Yellow coloured circular, biconvex film

coated tablets plain on both sides

.

Ingredients

Active ingredient(s)

Levocetirizine Dihydrochloride

Inactive ingredients

Lactose, microcrystalline

cellulose, isopropyl alcohol,

croscarmellose sodium,

magnesium stearate,

hydroxypropyl

methylcellulose,

colloidal silicon

dioxide,

olyvinyl Pyrolidone (Povidone

K-30), Titanium Dioxide,

Polyethylene Glycol 400, Talc,

Quinoline yellow, Methylene

Chloride.

MAL number

MAL10100016AZ

Manufacturer

FDC Limited,

Phase III-A, Plot No. L-121/B, Salcette,

Verna Industrial Estate 403722 Goa

India

Product Registration Holder

Unimed Sdn Bhd

No. 53, Jalan Tembaga SD5/2B

Bandar Sri Damansara

52200 Kuala Lumpur

2

Date of revision

11/10/2017

Serial Number:

NPRA(R4/1)231017/00276