Tritofen

Main information

  • Trade name:
  • Tritofen Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tritofen Syrup
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19972098
  • Last update:
  • 28-05-2018

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

TRITOFEN SYRUP

Ketotifen Fumarate (1mg/5ml)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What TRITOFEN is used for

How TRITOFEN works

Before you use TRITOFEN

How to use TRITOFEN

While you are using it

Side effects

Storage and Disposal of TRITOF

Product Description

Manufacturer

Product

Registration Holder

Date of revision

What TRITOFEN is used for

TRITOFEN is used for the prevention of

asthma, allergic bronchitis (inflammation

airways

lungs)

asthmatic symptoms associated with hay

fever. It is also used for the symptomatic

treatment

multi

system

allergy,

allergic

rhinitis

(inflammation

lining inside the nose) and allergic skin

reactions.

How TRITOFEN works

The active ingredient of this medicine is

ketotifen.

Ketotifen

type

antihistamine

that

alleviates

allergic

problems by blocking the reactions due

to the release of chemicals in the body

when exposed to allergens.

Before you use TRITOFEN

When you must not use it

TRITOFEN

allergic or hypersensitive to the ketotifen

or other ingredients of this product.

Do not take TRITOFEN if you are taking

Central nervous system depressants and

medicines for high blood pressure.

take

TRITOFEN

abortive

acute attacks of asthma.

Before you start to use it

Tell your do

ctor if:

taking

oral

antidiabetic

medicines to control your diabetes

You are allergic to any medicines, food

and dyes

pregnant,

trying

pregnant, think you may be pregnant or

breastfeeding.

Taking other medicines

Please tell your docto

r or pharmacist if

you are taking or have recently taken any

other

medicines,

including

those

obtained

without

prescription

herbal medicines.

Tell your doctor or pharmacist if you are

taking:

Central

nervous

system

depressants

(Medicines

used

treat

anxiety

sleep disorders).

-Antihypertensives

lower

blood

pressure)

- Antidiabetic agents (medicines used to

control the level of blood glucose) and

antihistamine

How to use TRITOFEN

How much to use

You should

take TRITOFEN exactly as

advised by your doctor or pharmacist.

amount

take

each

will

depend on your condition. Do not take

more

less

than

what

your

doctor

prescribes.

Adults: 1 mg twice daily, increased to a

maximum

twice

daily

necessary.

Children older than 3 years: 1 mg, twice

daily.

Children aged 6 months-3years: 0.5 mg

twice a day.

When to use it

TRITOFEN

is to be used as directed by

your doctor or pharmacist.

How long to use it

Continue

taking TRITOFEN for as long

as your doctor recommends.

should

withdrawn

suddenly

when long term treatment is begun

If you forget to use it

If you forget to

take TRITOFEN, take it

as soon as you remember. However, if it

is nearly time for your next dose, skip the

missed dose. Do not take a double dose

to make up for a forgotten dose.

If you use too much (overdose)

Contact y

our doctor immediately or go to

Emergency

Department

your

nearest

hospital,

think

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 you

r medicine exactly as your

doctor has told you.

Tell

doctors,

dentists

pharmacists

treating

that

taking TRITOFEN.

- Tell your doctor immediately if you

become

pregnant

while

taking

this

medication.

- Avoid alcohol consumption.

-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 or pharmacist.

- Do not give TRITOFEN to anyone else,

even if they have the same symptoms or

condition as you.

-Things to be careful of

During

the first few days of treatment

with

ketotifen,

your

reactions

impaired.

Care

must

taken

while

driving a vehicle or operating a machine.

If intercurrent infection occurs, ketotifen

treatment

must

supplemented

specific antiinfectious therapy.

2

Consumer Medication Information Leaflet (RiMUP)

Side effects

Like

medicines,

TRITOFEN

cause

side

effects,

although

everybody

gets

them.

experience

drowsiness,

impaired

reaction, dizziness and / or dry mouth.

You may also have weight gain.

report

side

effects

adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

npra.moh.gov.my (Public

Reporting

Medicinal Problems Side Effects / AEFI

/ Vaccine Safety).

Storage and Disposal of TRITOFEN

Storage

Stored i

n a cool place protected from

light.

Disposal

Do not use after the expiry

date stated on

the label.

Medicines should not be disposed of via

wastewater

household

waste.

your

pharmacist

dispose

medicines

longer

required.

These

measures

will

help

protect

environment.

Product Description

What it looks like

Cleared,

coloured

pleasantly

flavoured viscous liquid.

Ingredients

Active ingredient

Ketotifen Fumarate

Inactive ingredients

Propylene

glycol,

supra

Fast

red),

Glyserin,

Sodium

propyl

hydroxybenzoate,

Sorbitol

solution),

Anhydrous

Citric

Acid,

Sodium

methyl

hydroxybenzoate,

Purified water, Soluble essense of

pepper

mint,

American

cream

soda.

MAL number:

MAL19972098AZ

Manufacturer

FDC Limited

B-8, M.I.D.C Waluj

Dist. Aurangabad

431136

Product Registration Holder

Unimed sdn bhd

No.53 Jalan Tembaga SD 5/2B,

Bandar Sri Damansara,

52200 Kuala Lumpur

Date of revision

07/10/ 2017

Serial number:

NPRA(R4/1)190917/00251

TRITOFEN SYRUP

Ketotifen Fumarate (1mg/5ml)

29-5-2018

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