Consumer medicine information

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.

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
• kidney disease

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.

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 or rifampicin, 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.

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.

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.

If you get a severe skin rash tell your doctor immediately. Do this even if the rash occurs after Clindamycin BNM has been stopped. A severe skin rash may mean you are having an allergic reaction to Clindamycin BNM. 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.

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.
• enlarged lymph glands and/or fever
• swelling of the legs, ankles, and feet, decreased urine output, irregular heartbeat, and confusion
• chest pain, and/or shortness of breath.

These are very serious side effects; you may need urgent medical attention or 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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some of these side effects (for example, abnormal blood test results and certain kidney and liver conditions) can only be found when your doctor does tests from time to time to check on your progress.

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 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 02 March 2022.

Published by MIMS April 2022

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

Clindamycin BNM capsules contain clindamycin hydrochloride, equivalent to 150 mg of clindamycin.

Excipients with known effect.

3 Pharmaceutical Form

Capsules.
The capsules have a powder blue opaque cap and a purple transparent body.

4 Clinical Particulars

4.1 Therapeutic 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.

Streptococci.

Staphylococci.

Pneumococci.

Adjunctive therapy.

4.2 Dose and Method of Administration

Adults.

Children.

4.3 Contraindications

Clindamycin BNM capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed under List of Excipients.

4.4 Special Warnings and Precautions for Use

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), have been reported in patients receiving clindamycin therapy (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)). If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued, and appropriate therapy should be initiated. The usual agents (adrenaline, corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions.
The use of clindamycin can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with C. difficile. Therefore, the drug should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the Therapeutic Indications. It should not be used in patients with non-bacterial infections such as most upper respiratory tract infections.
It is important to consider the diagnosis of antibiotic-associated colitis in patients who develop diarrhoea or colitis associated with antibiotic use. Antibiotic-associated colitis appears to result from a toxin produced by Clostridium difficile in the alimentary tract. The severity of the colitis may range from mild watery diarrhoea to severe, persistent, life-threatening bloody diarrhoea. The diagnosis is usually made by recognition of the clinical symptoms. The symptoms may occur during therapy or up to several weeks after cessation of therapy. Additional confirmatory signs of antibiotic-associated colitis include pseudomembrane formation seen with colonoscopy, C. difficile culture from the stool, or assay of the stool for C. difficile toxin.
Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate hydrochloride with atropine sulfate, may prolong and/or worsen the condition and should not be used.
Antibiotic-associated colitis and diarrhoea (due to C. difficile) occur more frequently and may be more severe in debilitated and/or elderly patients (> 60 years). When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
Clindamycin should not be used in patients with non-bacterial infections.
Clindamycin should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.
Clindamycin is potentially nephrotoxic. Acute kidney injury including acute renal failure has been reported. Therefore, monitoring of renal function should be considered during therapy of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs and monitoring of renal function should be performed if therapy is prolonged.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy. The use of clindamycin occasionally results in overgrowth of non-susceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Use in hepatic and renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin should be used with caution in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
In vitro studies of human liver and intestinal microsomes showed that clindamycin is metabolised predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects listed in Table 1 are presented by system organ class. Within each frequency category, the adverse effects are presented in the order of frequency and then by decreasing medical seriousness.

Post-marketing experience.

Infections and infestations.

Immune system disorders.

Skin and subcutaneous tissue disorders.

Renal and urinary disorders.

Reporting suspected adverse effects.

4.9 Overdose

Signs and symptoms.

Recommended treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacodynamic effects.

Resistance.

Antimicrobial activity.

Gram-positive bacteria.

Gram-negative bacteria.

Gram-negative bacteria.

Gram-positive bacteria.

Breakpoints.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Clindamycin BNM contains lactose monohydrate, magnesium stearate, maize starch, purified talc, gelatin, titanium dioxide, carmoisine, indigo carmine and patent blue V.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Clindamycin BNM is supplied in blister packs of 100 capsules and 24 capsules in cardboard cartons.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Clindamycin is methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4- propylpyrrolidine-2-carboxamido]-1-thio-α-L-threo-D-galacto-octapyranoside (CAS 18323-44-9). It is a semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes