Doproct

Main information

  • Trade name:
  • Doproct Rectal Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doproct Rectal Ointment
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL07050013
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

DOPROCT RECTAL OINTMENT

®

Hydrocortisone acetate/Benzocaine/Zinc oxide (5mg/10mg/200mg)

1

What is in the leaflet

What Doproct is used for

How Doproct works

Before you use Doproct

How to use Doproct

While you are using it

Side effects

Storage and Disposal of Doproct

Product Description

Manufacturer and Product Registration

Holder

Date of Revision

What Doproct

is used for

Doproct is used to treat:

Pain, itchiness and inflammation due to the

irritation in the anal e.g. haemorrhoids,

fissures and postoperative haemorrhoid

removal.

How Doproct

works

Hydrocortisone is categorize under a group

of corticosteroids. It has the properties of

anti-inflammatory and anti-itching.

Benzocaine is a local anaesthetic that are

used to block the sensory nerve endings in

the skin.

Zinc oxide is used for soothing and protect

against haemorrhoids.

Doproct is a product combination of

hydrocortisone acetate, benzocaine and zinc

oxide. These agents help to ease itchiness

and thus allowing healing of the condition.

Before you use Doproct

When you must not use it

You have a history of hypersensitivity to

active ingredients, hydrocortisone acetate,

benzocaine or any other ingredients in

Doproct.

If you are not sure whether you should start

taking this medicine, consult your doctor.

Before you start to use it

Tell your doctor if you have allergies to any

other medicines, foods, preservatives or

dyes.

Tell your doctor if you:

Have traumatised mucosa or sepsis (life-

threatening blood poisoning from infection)

in anorectal region.

Have not undergone adequate examination

on colon, rectum, and anus.

Have infections

Your doctor will perform an adequate

examination and test to exclude probability

of cancer, infections, allergy and other causal

factors.

Taking other medicines

Tell your doctor if you are taking any other

medicine, including any that you buy without

a prescription. You may need to use different

amounts of these medicines, or you may

need to take different medicines. Your doctor

will advise you. In particular, tell your doctor

if you take any of the following:

Aminosalicyclic acid (used to treat

tuberculosis; bacterial infection that mainly

affects the lungs.)

Sulfonamides (antibiotic for ulcerative

colon inflammation)

Pregnancy and lactation

Doproct is unlikely to harm pregnant

women. Hydrocortisone acetate released into

breast milk are in small quantities and thus

no significant harm on nursing infants.

However, it is not recommended to be used

on extended areas, in large amounts or for

prolonged periods of time.

How to use Doproct

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.

How much to use

Apply a small amount of Doproct 2 times

daily to the anal canal.

When to use it

Apply it in the morning and evening after

bowel movement.

How long to use it

Continue to take your medicine as long as

your doctor tells you.

If you forget to use it

Consult your doctor or pharmacist on what

you should do if you forget to use it.

Apply the missed dose as soon as you

remember. If it is almost time for your next

dose, wait until then to apply the medicine

and skip the missed dose. Do not apply a

double dose to make up for the missed dose.

If you use too much (overdose)

Consult your doctor immediately or go to the

Emergency Department of your nearest

hospital, if you think you or anyone else may

have applied too much ointment. Do this

even if there are no signs of discomfort or

poisoning. You may need urgent medical

attention.

When using Doproct Rectal Ointment to the

rectum, care should be taken to avoid the

introduction of an excessive amount. It

should be borne in mind that the systemic

availability is relatively high with rectal

administration, and large doses can cause

effects on the central nervous system.

Prolonged use of large doses of

hydrocortisone can result in systemic effects

or local effects such as skin thinning.

Contact sensitivity such as dry skin, itching,

irritation, transient burning or stinging

sensations may occur if Doproct Ointment is

used excessively. Discontinue use if such

symptoms occur.

While you are using it

Things you must do

If you are about to be started on any new

medicine, remind your doctor and pharmacist

that you are applying Doproct.

If you are pregnant or plan to be pregnant,

get advice from your doctor.

Things you must not do

Do not stop taking your medicines without

consulting your doctor.

Do not use Doproct after the expiry date

which is stated on the carton and tube.

Consumer Medication Information Leaflet (RiMUP)

2

Do not give this medication to anyone else,

even if they have the same condition as you.

Things to be careful of

If irritation or rectal bleeding develops, the

product should be discontinued.

Side effects

All medicines can have side effects. Doproct

may cause unwanted side effects although

not everybody gets them.

Tell your doctor or pharmacist if you notice

the following side effects:

Dry skin

Itching

Irritation

Transient burning or stinging sensations

Tell your doctor or pharmacist immediately

if you notice the side effects gets serious or

anything else that make you feel unwell.

Other side effects not listed above may also

occur in some people.

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 Doproct

Storage

Keep medicines in original packaging.

Store in cool (below 25°C), dry place, away

from heat and light.

Do not leave your medicine in the car.

Keep all medicines out of the reach of

children.

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

Doproct is a white colored ointment.

Ingredients

Active ingredient

The ointment contains hydrocortisone acetate

5mg, benzocaine 10mg, and zinc oxide

200mg.

Inactive ingredients

Purified water, mineral oil, glycerin, lactic

acid, isopropyl myristate, methyl paraben,

propyl paraben, and emulgade 1000 Ni T.

Packing

Box of (1x10g) tube and box of (10x10g)

tubes

MAL Number

MAL07050013AZ

Manufacturer

Continental-Pharma Co. Ltd.

85/5 Soi Prachoomporn, Chaengwattana

Road, Laksi, Bangkok 10210, Thailand.

Product Registration Holder

IMEKS Pharma Sdn. Bhd.

No. 5 & 9, Jalan Udang Harimau 2,

Medan Niaga Kepong,

51200 Kuala Lumpur, Malaysia.

Date of revision

11/09/2017

Serial number

NPRA(R4/1)070917/00244