DALACIN

Main information

  • Trade name:
  • DALACIN T 1% clindamycin 10mg/mL (as phosphate) lotion bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DALACIN T 1% clindamycin 10mg/mL (as phosphate) lotion bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 67060
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

67060

DALACIN T 1% clindamycin 10mg/mL (as phosphate) lotion bottle

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

22/02/1999

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. DALACIN T 1% clindamycin 10mg/mL (as phosphate) lotion bottle

Product Type

Single Medicine Product

Effective date

18/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Dalacin T topical lotion is indicated in the treatment of acne vulgaris, particularly forms in which comedomes, papules and pustules predominate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60ml

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Smooth, white to off-white emulsion.

Active Ingredients

Clindamycin

10 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:47:26 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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

DALACIN

®

T

Clindamycin phosphate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about DALACIN T. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using DALACIN T

against the benefits they expect it

will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What DALACIN T is

used for

DALACIN T is an antibiotic lotion

used on the skin to help treat acne.

DALACIN T works by decreasing

acne lesions and/or stopping the

growth of skin bacteria that cause

acne.

DALACIN T is not addictive.

This medicine is available only with

a doctor's prescription.

Before using

DALACIN T

When you must not use it

Do not use DALACIN T:

1.

if you have an allergy to:

clindamycin or lincomycin

any of the ingredients listed at

the end of this leaflet

Symptoms of an allergic reaction

may include skin rash and itching.

2.

if the packaging shows signs of

tampering.

3.

if the expiry date (EXP) printed

on the pack has passed.

If you are not sure whether you

should start using DALACIN T,

contact your doctor.

Before you start to use it

You must tell your doctor if:

1.

you have any allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes

2.

you are pregnant or intend to

become pregnant

3.

you are breast-feeding or plan

to breast-feed.

4.

you have or have had any other

medical conditions, including:

other allergies

If you have not told your doctor

about any of the above, tell them

before you use DALACIN T.

Taking other medicines

Tell your doctor if you are taking any

other medicines, including medicines

you buy without a prescription from

a pharmacy, supermarket or health

food shop.

Some medicines may interfere with

DALACIN T. These include:

the antibiotic erythromycin

neuromuscular blocking

medicines (certain agents used for

muscle relaxation in anaesthesia)

These medicines may be affected by

DALACIN T or may affect how well

it works. You may need different

amounts of your medicine or you

may need to take different medicines.

Your doctor will advise you.

Your doctor or pharmacist may have

more information on medicines to be

careful with or avoid while using

DALACIN T.

How to use DALACIN

T

How much to use and how

to use it

Shake the bottle immediately before

use. Apply a thin layer twice a day to

the affected areas of the skin.

Avoid contact with eyes, lips and

mucous membranes.

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 long to use it

Continue using DALACIN T for as

long as your doctor recommends.

If you are not sure how long you

should be using DALACIN T,

check with your doctor.

If your acne does not improve within

6 weeks, or if it becomes worse,

DALACIN

contact your doctor. However,

treatment of acne may take up to 8 to

12 weeks before full improvement is

seen.

If you forget to use it

Apply DALACIN T Lotion when

you remember, unless it is almost

time for your next application, in

which case wait and apply at the next

application time.

If you use too much

If you use too much DALACIN T,

you may experience some of the side

effects listed below under side

effects.

While you are using

DALACIN T

Things you must do

If you become pregnant while you

are using DALACIN T, tell your

doctor.

If you are about to start taking any

new medicines, tell your doctor and

pharmacist that you are using

DALACIN T.

Things you must not do

Do not give DALACIN T to anyone

else, even if they have the same

condition as you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using DALACIN

Check with your doctor as soon as

possible if you have any problems

while using DALACIN T, even if

you do not think they are

connected with the medicine or are

not listed in this leaflet.

Like other medicines, DALACIN T

can cause some side effects. If they

occur, most are likely to be minor

and temporary. However, some may

be serious and need medical

attention.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

skin irritation (burning, redness,

peeling)

itchy skin

dry skin

hives

skin oiliness

stomach upset (diarrhoea, nausea,

vomiting)

stomach pain

These side effects are usually mild.

Tell your doctor immediately if

you notice any of the following side

effects during use, or several weeks

after stopping treatment with

DALACIN T:

severe stomach cramps

watery and severe diarrhoea,

which may also be bloody

fever, in combination with one or

both of the above

These are rare but serious side

effects. DALACIN T can change

bacteria, which are normally present

in the bowel and harmless, to

multiply and therefore cause the

above symptoms. You may need

urgent medical attention. This side

effect is rare.

Do not take any diarrhoea medicine

without first checking with your

doctor.

Ask your doctor or pharmacist if you

don't understand anything in this list.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

After using DALACIN

T

Storage

Keep DALACIN T in a cool, dry

place where the temperature stays

below 25°C.

Do not store it, or any other

medicine, in a bathroom or near a

sink. Do not leave it in the car or on

window sills. Heat and dampness can

destroy some medicines.

Keep DALACIN T where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop using

DALACIN T, ask your pharmacist

what to do with any lotion left over.

Product description

What it looks like

DALACIN T is a white to off-white

lotion. It is available in a 60 mL

bottle.

Ingredients

DALACIN T Lotion contains

clindamycin phosphate equivalent to

clindamycin 10 mg/mL as the active

ingredient.

It also contains glycerol, sodium

lauroyl sarcosinate, stearic acid,

glyceryl monostearate, mono- and di-

glycerides, potassium hydroxide,

cetostearyl alcohol, isostearyl

alcohol, purified water and methyl

hydroxybenzoate.

Identification

DALACIN T can be identified by the

Australian Register Number, AUST

R 67060, which is found on the

carton label.

DALACIN

Supplier

DALACIN T is supplied in Australia

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free number: 1800 675 229

This leaflet was revised in May 2016

Registered trademark

© Pfizer Australia Pty Ltd

DALACIN