CALINDAMIN

Main information

  • Trade name:
  • CALINDAMIN Clindamycin (as hydrochloride) 150 mg capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALINDAMIN Clindamycin (as hydrochloride) 150 mg capsules blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214410
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214410

CALINDAMIN Clindamycin (as hydrochloride) 150 mg capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

22/08/2014

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. CALINDAMIN Clindamycin (as hydrochloride) 150 mg capsules blister pack

Product Type

Single Medicine Product

Effective date

26/04/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci.

Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.

Anaerobes

Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia;

intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal

gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and

post-surgical vaginal cuff infection.

Streptococci

Serious respiratory tract infections; serious skin and skin structure infections, septicaemia.

Staphylococci

Serious respiratory tract infections; serious skin and skin structure infections; septicaemia;

acute haematogenous osteomyelitis.

Pneumococci

Serious respiratory tract infections.

Adjunctive Therapy

In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in

conjunction with antibiotic therapy.

Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

48 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

24 capsules

(S4) Prescription Only Medicine

100 capsules

(S4) Prescription Only Medicine

Components

1. CALINDAMIN Clindamycin (as hydrochloride) 150 mg capsules blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

A hard gelatin capsule, size 1 white/white containing white crystalline

powder, with marking "CLIN 150"

Active Ingredients

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:53:47 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

clindamycin hydrochloride

162.87 mg

© 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 2 of

Produced at 26.11.2017 at 09:53:47 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

CALINDAMIN

Clindamycin

hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about CALINDAMIN

capsules. 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 taking CALINDAMIN against the

benefits this medicine is expected to

have for you.

If you have any concerns about

using this medicine, ask your doctor

or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What CALINDAMIN

capsules are used for

CALINDAMIN is an antibiotic. It is

used to treat infections in different

parts of the body caused by bacteria.

CALINDAMIN works by killing or

stopping the growth of the bacteria

causing your infection.

CALINDAMIN will not work against

viral infections such as colds or flu.

CALINDAMIN is recommended for

patients who are allergic to penicillin

or patients for whom penicillin is not

suitable.

Your doctor may have prescribed

CALINDAMIN for another reason. Ask

your doctor if you have any

questions about why CALINDAMIN

has been prescribed for you.

This medicine is available only with a

doctor’s prescription.

CALINDAMIN is not addictive.

Before taking

CALINDAMIN capsules

When you must not take

CALINDAMIN capsules

Do not take CALINDAMIN capsules:

1. if you have an allergy to:

clindamycin or lincomycin

lactose or any of the other

ingredients listed at the end of

this leaflet (see ‘Product

Description’)

Symptoms of an allergic reaction may

include skin rash, itching or difficulty

in breathing.

2. if the packaging is torn or shows

signs of tampering

3. after the expiry date (EXP) printed

on the label.

If you take it after the expiry date, it

may have no effect at all, or worse,

an entirely unexpected effect.

If you are not sure whether you

should start taking CALINDAMIN

capsules, talk to your doctor.

Before you start to take

CALINDAMIN capsules

You must tell your doctor about all

of the following before you start to

take CALINDAMIN:

1. if you have any allergies to any

other medicines or any other

substances such as foods,

preservatives or dyes.

2. if you are pregnant or intend to

become pregnant

Clindamycin crosses the placenta

therefore CALINDAMIN capsules

should only be used in pregnancy if

clearly needed. Your doctor will

discuss the risks and benefits of

taking CALINDAMIN during

pregnancy.

3. if you are breast-feeding or plan

to breast-feed.

CALINDAMIN capsules are not

recommended during breastfeeding.

4. if you have or have ever had:

severe diarrhoea associated with

the use of antibiotics

severe liver disease

severe kidney disease

any gastrointestinal (stomach or

gut) problems

5. if you have had any other health

problems or medical conditions

If you have not told your doctor or

pharmacist about any of the above,

do so before you start taking

CALINDAMIN capsules.

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.

There may be interference between

CALINDAMIN and some other

medicines including:

the antibiotic, erythromycin

medicines used for muscle

relaxation in anaesthesia

These medicines may be affected by

CALINDAMIN or may affect how well

CALINDAMIN works. You may need

different amounts of your medicine

or you may need to take different

medicines. Your doctor or pharmacist

may have more information on

medicines to be careful with or avoid

while taking CALINDAMIN.

How to take

CALINDAMIN capsules

Your doctor or pharmacist will tell

you how to take your CALINDAMIN

capsules.

Follow all directions given to you by

your doctor and pharmacist

carefully.

Their directions may differ from the

information contained in this leaflet.

You may be given a different dosage

depending on your condition and

how you react to the medicine.

The directions your doctor or

pharmacist gives you should be

strictly followed.

If you do not understand the

instructions in this leaflet, ask your

doctor or pharmacist for help.

How much to take and how long to

take it

Adults

One (1) capsule (150 mg) every six

hours is the usual dose. The number

of capsules may increase with more

serious infections. Your doctor will

tell you how long to take your

capsules.

Children

CALINDAMIN capsules are not

recommended in children for

formulation reasons.

Continue taking CALINDAMIN until

you finish the box or until your

doctor recommends. Check with

your doctor if you are not sure how

long you should be taking it.

Do not stop taking CALINDAMIN

capsules because you are feeling

better.

If you do not complete the full

course prescribed by your doctor, all

of the bacteria causing your infection

may not be killed. These bacteria

may continue to grow and multiply

so that your infection may not clear

completely or may return.

How to take it and when to take it

CALINDAMIN capsules should be

taken by mouth, with a full glass of

water. CALINDAMIN can be taken

with or without food, it does not

matter.

If you forget to take it

If it is almost time for your next dose,

skip the dose you missed and take

your next dose when you are meant

to. Otherwise, take it as soon as you

remember, then go back to taking

your capsules as you would normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

Do not double a dose to make up for

the dose you have missed.

If you take too much (overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency

(Casualty) at your nearest hospital if

you think that you or anyone else

may have taken too much

CALINDAMIN. Do this even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention.

Keep telephone numbers for these

places/services handy. Have the

CALINDAMIN box or this leaflet

available to give details if needed.

While you are taking

CALINDAMIN capsules

Things you must do

If the symptoms of your infection do

not improve within a few days, or if

they become worse, tell your doctor.

If you get severe diarrhoea, tell your

doctor, pharmacist or nurse

immediately. Do this even if it occurs

several weeks after you have

stopped taking CALINDAMIN.

Diarrhoea may mean that you have a

serious condition affecting your

bowel. You may need urgent medical

care. Do not take any medicines for

diarrhoea without first checking with

your doctor.

If you get a sore, white mouth or

tongue while taking or soon after

stopping CALINDAMIN, tell your

doctor. Also tell your doctor if you

get vaginal itching or discharge.

This may mean you have a

fungal/yeast infection called thrush.

Sometimes the use of CALINDAMIN

allows fungi/yeast to grow and the

above symptoms to occur.

CALINDAMIN does not work against

fungi/yeast.

If you become pregnant while taking

CALINDAMIN, tell your doctor

immediately.

If you are about to start taking any

new medicines, tell your doctor and

pharmacist that you are taking

CALINDAMIN.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking CALINDAMIN.

If you feel that CALINDAMIN is not

helping your condition, tell your

doctor.

Tell your doctor if, for any reason,

you have not used CALINDAMIN

exactly as prescribed.

Things you must not do

Do not give CALINDAMIN to anyone

else, even if they have the same

condition as you.

Do not use CALINDAMIN to treat any

other medical complaints unless your

doctor tells you to.

Side effects

Check with your doctor or

pharmacist as soon as possible if

you have any problems while taking

CALINDAMIN, even if you do not

think the problems are connected

with the medicine or are not listed

in this leaflet.

Like other medicines, CALINDAMIN

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.

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:

oral thrush – white, furry, sore

tongue and mouth

vaginal thrush – sore and itchy

vagina and/or discharge

stomach cramping

stomach discomfort

inflammation of the food pipe;

discomfort or/and pain of the

food pipe

loss or distorted sense of taste

nausea and/or vomiting

heartburn

diarrhoea

loss of appetite

skin rash; severe irritation of the

skin

jaundice (yellowing of the skin)

joint pain and swelling

Tell your doctor immediately if you

notice any of the following side

effects while you are taking

CALINDAMIN capsules or several

weeks after stopping treatment:

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. You may need urgent

medical attention.

Do not take any medicine for

diarrhoea without first checking with

your doctor.

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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After using

CALINDAMIN capsules

Storage

Keep your CALINDAMIN capsules in

their original container in a cool, dry

place where the temperature stays

below 25°C. If you take the capsules

out of their original container, they

may not keep as well.

Do not store your CALINDAMIN

capsules, or any other medicine, in a

bathroom or near a sink. Do not

leave them in the car or on window

sills. Heat and dampness can destroy

some medicines.

Keep your CALINDAMIN capsules

where children cannot reach them.

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

CALINDAMIN or the capsules have

passed their expiry date, ask your

pharmacist what to do with any

capsules left over.

Product description

What it looks like

CALINDAMIN capsules consist of a

white cap and white body imprinted

with ‘Clin 150’ in black printing ink.

Ingredients

CALINDAMIN capsules contain 150

mg of clindamycin (as hydrochloride).

Also contains the following inactive

ingredients:

lactose

magnesium stearate

maize starch

purified talc

titanium dioxide

gelatin

black printing ink (shellac, iron

oxide black)

Supplier

Aspen Australia

34-36 Chandos Street

St Leonards NSW 2065

Australia

AUST R 214410

Date of preparation:

February 2016

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24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety