Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about DALACIN C 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 DALACIN C 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 need to read it again.

What DALACIN C capsules are used for

DALACIN C is an antibiotic. It is used to treat infections in different parts of the body caused by bacteria.

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

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

DALACIN C is recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable.

Ask your doctor if you have any questions about why DALACIN C has been prescribed for you. Your doctor may have prescribed DALACIN C for another reason.

This medicine is available only with a doctor's prescription.

DALACIN C is not addictive.

Before you take DALACIN C capsules

When you must not take it

Do not take DALACIN C capsules if you have an allergy to:

• clindamycin or lincomycin
• lactose monohydrate or any of the other ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• severe diarrhoea associated with the use of antibiotics
• severe liver disease
• kidney disease
• bowel disease
• any gastrointestinal (stomach or gut) problems.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Clindamycin crosses the placenta therefore DALACIN C capsules should only be used in pregnancy if clearly needed.

DALACIN C capsules are not recommended during breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking DALACIN C capsules.

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.

Some medicines and DALACIN C may interfere with each other. These include:

• erythromycin, a medicine used to treat bacterial infections
• rifampicin, a medicine used to treat bacterial infections
• some medicines that may be used during surgery.

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

• erythromycin, a medicine used to treat bacterial infections.

These medicines may be affected by DALACIN C or may affect how well it works. You may need different amounts of your medicines, 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 this medicine.

How to take DALACIN C capsules

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many capsules you need to take each day. This may depend on your condition and whether or not you are taking any other medicines.

The usual adult dose of DALACIN C is one capsule of 150 mg taken four times a day. The number of capsules may increase with more serious infections. Your doctor will tell you how long to take your capsules.

DALACIN C capsules are not recommended in children for formulation reasons.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Space the doses of DALACIN C capsules evenly apart and take them at about the same time each day. This will allow the medicine to have its best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

Continue taking your medicine until you finish the pack.

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 medicine as you would normally.

Do not take a double dose to make up for the dose that you have missed. This may increase the chance of you getting an unwanted side effect.

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 some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency at the nearest hospital, if you think that you or anyone else may have taken too much DALACIN C.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking DALACIN C capsules

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking DALACIN C capsules.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

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 DALACIN C. 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 severe skin rash tell your doctor immediately. Do this even if the rash occurs after DALACIN C has been stopped. A severe skin rash may mean you are having an allergic reaction to DALACIN C. You may need urgent medical care.

If you get a sore, white mouth or tongue while taking or soon after stopping DALACIN C, 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 DALACIN C allows fungi/yeast to grow and the above symptoms to occur. DALACIN C does not work against fungi/yeast.

If you become pregnant while taking DALACIN C, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take DALACIN C to treat any other complaints unless your doctor tells you to.

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

Do not stop taking your medicine or lower the dosage without checking with your doctor.

If you stop taking DALACIN C suddenly, the infection may not clear completely or your symptoms may return.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DALACIN C.

This medicine helps most people with bacterial infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

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:

• 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; irritation of the skin
• joint pain and swelling.

Tell your doctor immediately or go to Emergency at your nearest hospital, if you notice any of the following:

• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• moderate or severe skin rash or blisters often with flu-like symptoms
• enlarged lymph glands and/or fever
• diarrhoea, usually with blood and mucus, stomach pain and fever
• yellowing of the eyes or skin, also called jaundice
• swelling of the legs, ankles, or feet, passing less urine, irregular heartbeat, confusion, shortness of breath, weakness, fatigue and nausea
• chest pain, and/or shortness of breath.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

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

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

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with DALACIN C:

• severe stomach cramps;
• watery and severe diarrhoea which may also be bloody;
• fever, in combination with one or both of the above.

DALACIN C can cause some bacteria, which are normally present in the bowel and normally harmless to multiply and therefore cause the above symptoms. You may need urgent medical attention. However this side effect is rare.

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

Tell your doctor if you notice anything else that is making you feel unwell.

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

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 using DALACIN C capsules

Storage

Keep your DALACIN C 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 your capsules in a cool, dry place where the temperature stays below 25°C.

Do not store DALACIN C capsules or any other medicine in the bathroom or near a sink. Do not leave them on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep your DALACIN C 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 taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

DALACIN C capsules with a strength of 150 mg are available in blister packs of 100 capsules or 24 capsules. The opaque, white capsules are marked with "Clin 150" and "Pfizer" in black.

Ingredients

DALACIN C capsules contain 150 mg of clindamycin hydrochloride as the active ingredient.

It also contains:

• lactose monohydrate
• magnesium stearate
• maize starch
• purified talc
• gelatin
• titanium dioxide
• edible black ink.

Supplier

DALACIN C capsules are supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

® = Registered Trademark

© Pfizer Australia Pty Ltd

This leaflet was prepared in February 2022.

Australian registration numbers

150 mg capsule: AUST R 12275

Published by MIMS March 2022

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

Each Dalacin C capsule contains clindamycin hydrochloride, equivalent to 150 mg of clindamycin.
It is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Excipient(s) with known effect.

3 Pharmaceutical Form

Capsules.

4 Clinical Particulars

4.1 Therapeutic Indications

Dalacin C (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Dalacin C 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 judgment 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

Dalacin C capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients listed under Section 6.1 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. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)). The usual agents (adrenaline, corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions.
The use of Dalacin C capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with Clostridioides difficile. Therefore, the drug should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in Section 4.1 Therapeutic Indications. It should not be used in patients with nonbacterial 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 C. 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 (Lomotil), 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.
C. 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.
Dalacin C 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.
Dalacin C should not be used in patients with nonbacterial infections.
Dalacin C should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver 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 nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high dose therapy.

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, Dalacin C 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

Serum level studies with a 150 mg oral dose of clindamycin in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak serum level of 2.5 microgram/mL was reached in 45 minutes; serum levels averaged 1.51 microgram/mL at 3 hours and 0.70 microgram/mL at 6 hours. Absorption of an oral dose is virtually complete (90%).
Concomitant administration of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose. Serum level studies following multiple doses of clindamycin for up to 14 days show no evidence of accumulation or altered metabolism of drug. Multiple dose studies in newborns and infants up to 6 months of age show that the drug does not accumulate in the serum and is excreted rapidly.
Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
Concentrations of clindamycin in the serum increased linearly with increased dose. Serum levels exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Clindamycin is widely distributed in body fluids and tissues, including bones. In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly oxidised by CYP3A4, with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin. The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the faeces; the remainder is excreted as bio-inactive metabolites.
Doses of up to 2 g of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, magnesium stearate, maize starch, purified talc, titanium dioxide, gelatin with traces of edible black ink.

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

Available in blister packs of 100 capsules and 24 capsules.

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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes