Pharmaniaga

Main information

  • Trade name:
  • Pharmaniaga Diphenoxylate A Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmaniaga Diphenoxylate A Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19880347
  • Last update:
  • 28-05-2018

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

PHARMANIAGA DIPHENOXYLATE A

TABLET

Diphenoxylate Hydrochloride/Atropine Sulphate (2.5mg/0.025mg)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What Pharmaniaga

Diphenoxylate A Tablet is

used for

How Pharmaniaga

Diphenoxylate A Tablet

works

Before you use Pharmaniaga

Diphenoxylate A Tablet

How to use Pharmaniaga

Diphenoxylate A Tablet

While you are using it

Side effects

Storage and Disposal of

Pharmaniaga Diphenoxylate

A Tablet

Product Description

Manufacturer and Product

Registration Holder

Date of Revision

What Pharmaniaga

Diphenoxylate A Tablet is used

for

Pharmaniaga

Diphenoxylate

Tablet is used in the treatment of

diarrhoea.

When

have

diarrhoea,

your

body

loses

water

important

salts. Therefore, your doctor may

also give you other medicines to

help replace the water and salts that

you have lost which you may need

to take before using Pharmaniaga

Diphenoxylate A Tablet.

Your doctor may also give you

Pharmaniaga

Diphenoxylate

Tablet to reduce the

number of

stools and make them less watery

if you have had a colostomy (part

your

bowel

removed

causing

external

bag)

ileostomy.

How Pharmaniaga

Diphenoxylate A Tablet works

Pharmaniaga

Diphenoxylate

Tablet

contains

ingredients

diphenoxylate

atropine

sulphate.

Diphenoxylate

hydrochloride

works

slowing

down

activity

intestines

therefore reduces the diarrhoea.

When

given by

mouth, atropine

sulphate

reduces

smooth-muscle

contraction and diminishes gastric

and intestinal motility.

Before you use Pharmaniaga

Diphenoxylate A Tablet

-When you must not use it

You should not use Pharmaniaga

Diphenoxylate A Tablet if you are

allergic

diphenoxylate

hydrochloride

atropine

sulphate

other

ingredients

Pharmaniaga

Diphenoxylate A tablet as listed at

the end of this leaflet.

You should not use Pharmaniaga

Diphenoxylate A Tablet if you are

treated

diarrhea

caused

antibiotics such as clindamycin or

lincomycin.

-Before you start to use it

Check

with

your

doctor

pharmacist

before

taking

Pharmaniaga

Diphenoxylate

Tablet

have

ulcer

inflammation in the large intestine

or obstructive bowel disorder.

-Taking other medicines

Please

tell

your

doctor

pharmacist

taking

have

recently

taken

other

medicines.

This

includes

medicines

that

bought

without a prescription and herbal

medicines.

This

because

Pharmaniaga

Diphenoxylate A Tablet can affect

some

other

medicines

work

those

medicines

affect

Pharmaniaga

Diphenoxylate A tablet works.

How to use Pharmaniaga

Diphenoxylate A Tablet

-How much to use

Follow all directions given to you

by doctor and pharmacist carefully.

They

differ

from

information

contained

this

leaflet. If you do not understand the

instructions on the label, ask your

doctor or pharmacist to help.

The standard dose for Pharmaniaga

Diphenoxylate

Tablet

follows:

Adult:

Initial

dose

tablets

four

times a daily, later reduced when

the diarrhoea is controlled.

Children:

6-8 years: one tablet three times

daily.

9-11 years: one tablet four times

daily.

Over 12

years: two tablet three

times daily.

Pharmaniaga

Diphenoxylate

Tablet

should

used

children under 6 years of age.

When to use it

Use as directed by your doctor or

pharmacist.

If your diarrhoea contains blood or

still does not stop, you should go

back to see the doctor.

-How long to use it

Continue

taking

Pharmaniaga

Diphenoxylate A Tablet for as long

as your doctor recommends.

Your doctor may advise

you to

stop

taking

Pharmaniaga

Diphenoxylate A Tablet when your

diarrhoea stops or has improved.

-If you forget to use it

Take the missed dose as soon as

you remember. If it is almost time

PHARMANIAGA DIPHENOXYLATE A

TABLET

Diphenoxylate Hydrochloride (2.5mg) & Atropine Sulphate (0.025mg)

2

Consumer Medication Information Leaflet (RiMUP)

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)

Symptoms of overdosage include

dryness

skin,

flushing,

feeling unusually warm with a high

temperature

fast

heartbeat,

pinpoint

pupils,

poor

reflexes,

tiredness,

coma

severe

breathing difficulty.

Go to the Emergency Department

your

nearest

hospital

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

your doctor or pharmacist has told

you.

When

seeking

other

medical

treatment,

tell

doctors,

dentists and pharmacists treating

that

taking

Pharmaniaga

Diphenoxylate

Tablet.

-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 drink alcohol while you are

taking

Pharmaniaga

Diphenoxylate A Tablet.

give

Pharmaniaga

Diphenoxylate A Tablet to anyone

else, even if they have the same

symptoms or conditions as you.

-Things to be careful of

Pregnancy and breast feeding

Pharmaniaga

Diphenoxylate

Tablet should not be used during

pregnancy or breast feeding. Ask

your

doctor

pharmacist

advice before taking any medicine.

Driving and using machines

Pharmaniaga

Diphenoxylate

Tablet may make you feel drowsy

dizzy

affect

your

concentration.

should

drive or use machines when you

first start to take this medicine until

you are certain that you are not

getting these side effects. If in any

doubt,

speak

your

doctor

pharmacist before you drive or use

machines.

This medicine may result in fluid

retention in the intestines, which

aggravate

mask

dehydration

depletion

electrolytes,

especially

young

children. If severe dehydration or

electrolyte

imbalance

present,

diphenoxylate should be withheld

until appropriate corrective therapy

has been initiated by doctor.

Side effects

Like all medicines, Pharmaniaga

Diphenoxylate

Tablet

sometimes

cause

side

effects,

although not everybody gets them.

experience

sudden

wheeziness, difficulty in breathing,

swelling of the eyelids, face, gum

or lips, rash or itching (especially

affecting

your

whole

body)

should see a doctor immediately.

The following side effects may

occur:

Nausea and vomiting.

Sleeping difficulty.

Drowsiness and headaches.

Reduced appetite and

constipation.

Flushing and dryness of your

skin and mouth.

Chest pain.

Transient slow heartbeat

followed by fast heartbeat,

with strong and irregular

heartbeat.

Difficulty passing urine.

Increased pressure in the eye

causing changes to vision.

Sensitivity towards light.

If any of the side effects get 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

calling

Tel:

03-78835550,

visiting

website

npra.moh.gov.my

(Public

Reporting

Medicinal

Problems

Side

Effects

AEFI

Vaccine

Safety).

Storage and Disposal of

Pharmaniaga Diphenoxylate A

Tablet

-Storage

Keep the medicines in a cool dry

place where the temperature stays

below 25°C. Protect from light.

store

other

medicine in the bathroom, or near

a sink, or on a window sill.

Do not leave it in the car on hot

days.

Heat

dampness

destroy some medicines.

Do not use this medication after the

expiry date which is printed on the

product packaging. The expiry date

refers to the last day of that month.

Keep

where

children

cannot

reach it.

PHARMANIAGA DIPHENOXYLATE A

TABLET

Diphenoxylate Hydrochloride (2.5mg) & Atropine Sulphate (0.025mg)

3

Consumer Medication Information Leaflet (RiMUP)

-Disposal

Medicines should not be disposed

wastewater

household

waste. Ask your pharmacist how to

dispose

medicines

longer

required. These measures will help

to protect the environment.

Product Description

-What it looks like

White, round, biconvex tablet with

Pharmaniaga icon on one side and

scoreline on the other.

-Ingredients:

-Active ingredient(s):

Diphenoxylate Hydrochloride

2.5mg & Atropine Sulphate

0.025mg

-Inactive ingredient(s):

Talcum, Povidone, Lactose

Monohydrate, Starch,

Croscarmellose Sodium, Purified

Water and Stearic Acid

-MAL number(s):

MAL19880347AZ

Manufacturer

Pharmaniaga Manufacturing

Berhad (60016-D),

11A, Jalan P/1, Kawasan

Perusahaan Bangi, 43650 Bandar

Baru Bangi, Selangor Darul

Ehsan, Malaysia.

Product Registration Holder

Pharmaniaga Manufacturing

Berhad (60016-D),

11A, Jalan P/1, Kawasan

Perusahaan Bangi, 43650 Bandar

Baru Bangi, Selangor Darul

Ehsan, Malaysia.

Date of Revision

01/11/2017

Serial Number

NPRA(R4/1)241017/00280