Doproct

Main information

  • Trade name:
  • Doproct Suppository
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doproct Suppository
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL06071061
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

DOPROCT SUPPOSITORY

Hydrocortisone acetate / Benzocaine / Zinc oxide (7.5mg/40mg/250mg)

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

Always use Doproct exactly according to the

instruction given to you by your doctor or

pharmacists. If you are unsure, check with

you doctor or pharmacist.

How much to use

Insert 1 suppository twice daily in the anal

canal.

When to use it

Insert 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

Insert your dose as soon as you remember

and continue to take it as you would

normally. Do not take double dose to make

up for the dose you missed

If you use too much (overdose)

If you or anyone else takes too many

suppository, you should refer this to your

doctor or pharmacists.

When using Doproct Supppository 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 Suppository

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 strips.

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.

Consumer Medication Information Leaflet (RiMUP)

2

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 suppository is a white, oblong-shape

suppository

Ingredients

Active ingredient

Each Doproct contains hydrocortisone

acetate 7.5mg, benzocaine 40mg, and zinc

oxide 250mg.

Inactive ingredients

Witepsol W35

Packing

Each strips containing 5 suppositories and

each box contains 2 strips.

MAL Number

MAL06071061AZ

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)070917/00245