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 shortness of breath, wheezing, swelling of the face, lips, tongue or other parts of the body, skin rash, itching or hives on the skin and 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 breast-feeding.

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:

• erythromycin, a medicine used to treat bacterial infections
• rifampicin, a medicine used to treat bacterial infections
• 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 or go to Accident and 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

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

After finishing it

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.

Clindamycin 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.

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

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.

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 monohydrate
• magnesium stearate
• maize starch
• purified talc
• titanium dioxide
• gelatin
• black printing ink (shellac, iron oxide black)

May contain traces of sulfites. Contains sugars as lactose. Gluten free.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

AUST R 214410

Date of preparation:

May 2023

Published by MIMS July 2023

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

Calindamin capsules contain clindamycin hydrochloride, equivalent to 150 mg of clindamycin.
It is a semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Excipients with known effect.

3 Pharmaceutical Form

Capsules.
The capsules consist of a white cap and white body imprinted with 'Clin 150' in black printing ink.

4 Clinical Particulars

4.1 Therapeutic 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.

Streptococci.

Staphylococci.

Pneumococci.

Adjunctive therapy.

4.2 Dose and Method of Administration

Adults.

Children.

4.3 Contraindications

Clindamycin capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed (see 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 clindamycin capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with Clostridium difficile. Therefore, the drug should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described (see Section 4.1 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 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.
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 nonbacterial 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 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, 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-desmethyl clindamycin. 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

Clinical trials.

Mechanism of action.

Pharmacodynamic effects.

Resistance.

Antimicrobial activity.

Aerobic bacteria.

Anaerobic bacteria.

Fungi.

Protozoans.

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

The inactive ingredients are lactose monohydrate, magnesium stearate, maize starch, purified talc, titanium dioxide and gelatin with black printing ink (shellac, iron oxide black, propylene glycol, strong ammonia solution).

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. Protect from light.

6.5 Nature and Contents of Container

Available in PVC/Al 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

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.
Clindamycin hydrochloride is white or almost white, crystalline powder, very soluble in water, slightly soluble in ethanol (96 per cent).

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4: Prescription-only Medicine.

Summary Table of Changes