Pharmaniaga

Main information

  • Trade name:
  • Pharmaniaga Hiderm Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmaniaga Hiderm Ointment
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL06030818
  • Last update:
  • 28-05-2018

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

PHARMANIAGA HIDERM OINTMENT

Hydrocortisone (1% w/w)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What PHARMANIAGA

HIDERM OINTMENT is used

How PHARMANIAGA

HIDERM OINTMENT works

Before you use

PHARMANIAGA HIDERM

OINTMENT

How to use PHARMANIAGA

HIDERM OINTMENT

While you are using it

Side effects

Storage and disposal of

PHARMANIAGA HIDERM

OINTMENT

Product description

Manufacturer and Product

Registration Holder

10.Date of revision

What PHARMANIAGA

HIDERM OINTMENT is used

for

It is used for the relief of

inflammatory manifestations of

corticosteroid responsive skin

condition, including the anus and

genital area.

How PHARMANIAGA

HIDERM OINTMENT works

PHARMANIAGA HIDERM

OINTMENT contains

hydrocortisone which belongs to a

group of medicines called topical

corticosteroids.

PHARMANIAGA HIDERM

OINTMENT works by reducing

inflammation of the skin thus

relieving the symptoms of redness,

swelling and itchiness in certain

skin conditions.

Before you use PHARMANIAGA

HIDERM OINTMENT

-When you must not use it

Do not use PHARMANIAGA

HIDERM OINTMENT if you have

Known allergy to hydrocortisone

or any other ingredients

contained in this medicine as

listed at the end of this leaflet.

Skin lesions caused by infection

with viruses (e.g. herpes simplex,

chickenpox).

Skin conditions caused by fungal

infection (e.g. candidiasis, tinea)

or bacteria (e.g. impetigo).

If you are not sure whether you

should start using this medicine, talk

to your doctor or pharmacist.

-Before you start to use it

In infants and children, long-term

continuous topical therapy should

avoided

where

possible,

adrenal suppression can occur

Appropriate

antimicrobial

therapy

should be used whenever treating

inflammatory

lesions

which

have

become

infected.

spread

infection

requires

withdrawal

topical corticosteroid therapy, and

systemic

antimicrobial

agents.

with

corticosteroids,

prolonged application to the face is

undesirable.

Pregnancy and Lactation

You must tell your doctor if you are

pregnant

breast-feeding.

Your

doctor or pharmacist will advice you

if you can use PHARMANIAGA

HIDERM

OINTMENT

during

pregnancy or while you are breast-

feeding.

-Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines,

including any that you buy without

prescription

from

pharmacy,

supermarket or health food shop

How to use PHARMANIAGA

HIDERM OINTMENT

Always use the medicine exactly as

your doctor or pharmacist has told

you.

Read

directions

labels carefully. If you have any

concerns

about

this

medicine,

talk

your

doctor

pharmacist.

-How much to use

Your

doctor

pharmacist

will

advise you how much to use each

day and for how long you will need

to use.

Apply a thin layer to the affected

area.

-When to use it

Apply 2 – 3 times daily. Follow the

directions on the label carefully and

instructed

your

doctor

pharmacist.

-How long to use it

Follow

instructions

given

your doctor or pharmacist.

-If you forget to use it

If you forget to apply the ointment,

use it as soon as you remember. If

almost

time

your

next

application, wait until then to use

the ointment and skip the missed

dose. Do not apply extra to make up

for the missed application.

-If you use to much (overdose)

If you have accidentally applied too

much PHARMANIAGA HIDERM

OINTMENT, wipe off any excess.

In the case of long term overdosage

misuse,

features

hypercorticism (increased hormone

levels) may appear.

While you are using it

-Things you must do

Use the medication exactly as your

doctor prescribed.

This medicine is for external use

only.

Tell your doctor or pharmacist

what other prescription and non-

prescription medicines that you

are taking.

Wash your hands before and after

using this ointment.

-Things you must not do

give

PHARMANIAGA

HIDERM OINTMENT to anyone

else, even if they have the same

PHARMANIAGA HIDERM OINTMENT

Hydrocortisone (1% w/w)

2

Consumer Medication Information Leaflet (RiMUP)

symptoms or condition as you. Do

not use your medicine to treat any

other complaints unless your doctor

or pharmacist tells you to. Avoid

this medicine from getting into your

eyes.

Do not use under a nappy or airtight

dressing for more than seven days

unless instructed by your doctor or

pharmacist.

-Things to be careful of

If irritation occurs, stop using it and

inform your doctor or pharmacist.

Side effects

Like all medicines,

PHARMANIAGA HIDERM

OINTMENT can cause side effects,

although not everybody gets them.

Inform your doctor or pharmacist

immediately if you experience any

side effects after using this

medicine.

Side

effects

reported

include

itching, burning, dryness and acne-

form eruptions. Local skin changes

occur

where

skin

folds

involved or in areas such as the

nappy area in small children where

constant moist conditions increase

the absorption of PHARMANIAGA

HIDERM OINTMENT.

This effect is more likely to occur in

infants and children

Systemic absorption has produced

reversible

manifestations

Cushing’s

Syndrome,

high

blood

sugar and presence of sugar in the

urine.

Other side effects not listed above

may occur in some people. Ask your

doctor or pharmacist to answer any

questions you may have.

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 Problems /

Side Effects / AEFI / Vaccine

Safety).

Storage and Disposal of

PHARMANIAGA HIDERM

OINTMENT

-Storage

Keep all medicines out of the sight

and reach of children.

Do not use this medicine after the

expiry date stamped on the pack.

Store below 30°C. Keep tube tightly

closed. Protect from light.

Disposal

Medicines should not be disposed of

via wastewater or 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

A white, translucent ointment free

from foreign matter.

-Ingredients

-Active ingredient(s):-

Each gram contains Hydrocortisone

base micronised 1% w/w.

-Inactive ingredients:-

White Soft Paraffin, Light Mineral

Oil.

-MAL number(s):-

MAL06030818AZ

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

21/08/2017

Serial Number

NPRA(R4/1)160817/00211