CLINDAMYCIN

Main information

  • Trade name:
  • CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219946
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219946

CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Boucher & Muir Pty Ltd

Postal Address

PO Box 333,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

20/03/2015

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. CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack

Product Type

Single Medicine Product

Effective date

14/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Clindamycin BNM (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic

bacteria.,Clindamycin BNM 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/PE/PCTFE

(Aclar)/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PVC/PE/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100 Capsules

(S4) Prescription Only Medicine

24 Capsules

(S4) Prescription Only Medicine

Components

1. CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule with purple transparent body and powder blue opaque

cap containing a white/off white powder

Active Ingredients

clindamycin hydrochloride

162.87 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:09:33 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

© 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 03:09:33 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

Clindamycin BNM

19072017

Consumer Medicine Information

Clindamycin BNM

clindamycin (as hydrochloride)

Capsules 150 mg

What is in this leaflet

Please read this leaflet carefully before you start taking Clindamycin BNM.

This leaflet answers some common questions about Clindamycin BNM. It does not contain

all the available information. The most up-to-date Consumer Medicine Information can be

downloaded from www.ebs.tga.gov.au.

Reading this leaflet 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

Clindamycin BNM against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What Clindamycin BNM is used for

Clindamycin BNM contains clindamycin, an antibiotic. Clindamycin is used to treat

bacterial infections in different parts of the body.

It works by killing or stopping the growth of the bacteria causing your infection.

Clindamycin BNM will not work against viral infections such as colds or flu.

Clindamycin BNM is recommended for patients who are allergic to penicillin or patients for

whom penicillin is not suitable.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for

you.

Clindamycin BNM is available only with a doctor's prescription.

Clindamycin BNM is not addictive.

Clindamycin BNM

19072017

Before you take Clindamycin BNM

Clindamycin BNM is not suitable for everyone.

When you must not take it

Do not take Clindamycin BNM if you are allergic to any medicine containing

clindamycin, lincomycin (a very similar antibiotic), or any of the ingredients listed

at the end of this leaflet.

Do not take it after the expiry date (‘EXP’) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking this medicine, talk to your doctor

or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods,

preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any medical conditions,

especially the following:

diarrhoea, especially severe diarrhoea associated with fever, stomach pain or

cramps, or passage of blood and mucous

a history of gastrointestinal (stomach or gut) problems, particularly colitis

(inflammation of the large bowel)

severe liver or kidney problems

a history of allergies (e.g. asthma, hay fever or eczema)

lactose intolerance.

Tell your doctor if you are over 60 years old.

Diarrhoea and inflammation of the large bowel occur more frequently and may be more

severe if you are over 60 years old.

Tell your doctor if you are pregnant or intend to become pregnant.

Since the active ingredient in Clindamycin BNM crosses the placenta, it should be used in

pregnancy only if clearly needed. Your doctor will discuss the risks and benefits of using it

if you are pregnant.

Do not breast-feed if you are taking this medicine.

The active ingredient in Clindamycin BNM passes into breast milk and there is a possibility

that your baby may be affected.

Do not give Clindamycin BNM to children.

Clindamycin BNM is not recommended in children for formulation reasons.

If you have not told your doctor or pharmacist about any of the above, tell them

before you start taking Clindamycin BNM.

Clindamycin BNM

19072017

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any

that you get without a prescription from your pharmacy, supermarket or health food

shop.

Tell any healthcare professional who is prescribing a new medicine for you that you

are taking Clindamycin BNM.

Some medicines and Clindamycin BNM may interfere with each other. These include:

medicines used to relax muscles

erythromycin, an antibiotic (medicine used to treat infections).

If you have bowel problems, do not take opioid pain medicines or medicines for

diarrhoea without first checking with your doctor.

These medicines may make your bowel problems worse.

The above medicines may be affected by Clindamycin BNM, or may affect how well it

works. You may need different amounts of Clindamycin BNM, or you may need to take

different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or

avoid while taking Clindamycin BNM.

How to take Clindamycin BNM

Read the label carefully and follow all directions given to you by your doctor and

pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist

for help.

How much to take

The standard adult dose is one capsule every six hours (i.e. 4 times a day). Your doctor

may increase this dosage for more serious infections.

Clindamycin BNM is not recommended in children for formulation reasons.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take. This depends on your condition and the type

of infection.

If you take the wrong dose, Clindamycin BNM may not work as well and your problem may

not improve.

Clindamycin BNM

19072017

Swallow the capsules whole with a full glass of water and in an upright position.

The content of Clindamycin BNM capsules may irritate your food pipe, therefore it is

important they are swallowed without getting stuck.

When to take it

Take Clindamycin BNM with or without food (it does not matter), every six hours or

as advised by your doctor.

How long to take it

Continue taking the capsules until you finish the pack or until your doctor tells you

to stop. Check with your doctor if you are not sure how long you should be taking

it.

Do not stop taking Clindamycin BNM because you are feeling better.

If you do not complete the full course prescribed by your doctor, some of the bacteria

causing your infection may not be killed. These bacteria may continue to grow and multiply,

so your infection may not clear up completely or it may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next

dose when you are meant to.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you

remember, and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for

hints.

While you are taking Clindamycin BNM

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist

that you are taking Clindamycin BNM. Likewise, tell any other doctors, dentists and

pharmacists who are treating you that you are taking this medicine.

Tell your doctor if the symptoms of your infection do not improve within a few days,

or if they become worse.

If you become pregnant while taking this medicine, tell your doctor immediately.

Clindamycin BNM

19072017

If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this

even if it occurs several weeks after you have stopped taking Clindamycin BNM. Do

not take any medicines for diarrhoea without first checking with your doctor.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may

need urgent medical care.

Tell your doctor if you get a sore, white mouth or tongue while taking or soon after

stopping Clindamycin BNM. 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

antibiotics allows fungi/yeast to grow and the above symptoms to occur. Clindamycin BNM

does not work against fungi/yeast.

Your doctor may want to carry out liver and kidney function tests or blood counts during

long-term treatment.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as

you.

This medicine is only intended for the use of the person it has been prescribed for.

Do not take Clindamycin BNM to treat any other complaints unless your doctor tells

you to.

Things to be careful of

Be careful driving or operating machinery until you know how Clindamycin BNM

affects you.

Make sure you know how you react to it before you drive a car, operate machinery, or do

anything else that could be dangerous.

In case of overdose

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone

13 11 26), or go to Accident and Emergency at your nearest hospital, if you think

that you or anyone else may have taken too much Clindamycin BNM.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too many capsules, you may notice some of the following signs and symptoms

of overdose:

severe diarrhoea, usually with blood and mucous, stomach pain, fever (symptoms of

pseudomembranous colitis, an inflammation of the large bowel)

skin rash.

Clindamycin BNM

19072017

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you

are taking Clindamycin BNM.

Like all medicines, Clindamycin BNM may occasionally cause side effects in some people.

Sometimes they are serious, most of the time they are not. You may need medical

attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

nausea and/or vomiting

itching of the skin

taste disturbance or loss of taste.

These side effects are usually mild.

Tell your doctor or pharmacist if you notice any of the following:

stomach pain or cramping

diarrhoea

inflammation of the food pipe, or ulcers and/or pain in the food pipe

heartburn

skin rash, hives, irritation of the skin

jaundice (yellowing of the skin)

oral thrush (white, furry, sore tongue and/or mouth)

vaginal thrush (discharge and itching in the vagina)

painful or swollen joints.

These may be serious side effects. You may need urgent medical attention.

Tell your doctor immediately if you develop the following symptoms while you are

taking Clindamycin BNM, or several weeks after you have finished taking it:

severe stomach cramps

severe diarrhoea (sometimes with blood and mucous)

fever, in combination with one or both of the above.

These are symptoms of pseudomembranous colitis, an inflammation of the large bowel,

which may require urgent medical care.

Tell your doctor immediately, or go to Accident and Emergency at your nearest

hospital if you notice any of the following:

serious allergic reaction (swelling of the face, lips, mouth or throat which may cause

difficulty in swallowing or breathing)

severe skin reactions accompanied by fever and chills, aching muscles and generally

feeling unwell.

These

very

serious

side

effects;

need

urgent

medical

attention

hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel

unwell.

Other side effects not listed above may also occur in some patients.

Clindamycin BNM

19072017

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking Clindamycin BNM

Storage

Keep your capsules in the pack until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Keep Clindamycin BNM in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window

sill. Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it and any other medicine 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.

Do not keep Clindamycin BNM past its expiry date.

Disposal

Return any unused medicine and any medicine past its expiry date (as shown on

the labelling) to your pharmacy.

Product description

What it looks like

Clindamycin BNM is available in blister packs of 24 or 100 capsules. The capsules have a

powder blue opaque cap and a purple transparent body.

Ingredients

Active ingredient:

Clindamycin hydrochloride, equivalent to 150 mg of clindamycin per capsule

Inactive ingredients:

Lactose monohydrate

magnesium stearate

maize starch

purified talc

gelatin

titanium dioxide

carmoisine

indigo carmine

patent blue V.

Clindamycin BNM

19072017

Clindamycin BNM contains lactose.

Clindamycin BNM does not contain sucrose, tartrazine or any other azo dyes.

Sponsor details

Boucher & Muir Pty Ltd

Level 9, 76 Berry Street

North Sydney NSW 2060

AUST R 219946

Date of preparation

This leaflet was prepared on 19 July 2017.

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Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 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

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 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

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

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety