SUMMARY CMI

CALINDAMIN Capsules

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CALINDAMIN?

CALINDAMIN contains the active ingredient clindamycin hydrochloride. CALINDAMIN is used to treat infections in different parts of the body caused by bacteria. It works by killing or stopping the growth of the bacteria causing your infection.

For more information, see Section 1. Why am I using CALINDAMIN? in the full CMI.

2. What should I know before I use CALINDAMIN?

Do not use if you have ever had an allergic reaction to clindamycin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CALINDAMIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CALINDAMIN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CALINDAMIN?

• Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
• One capsule (150mg) every six hours is the usual dose. The number of capsules may increase with more serious infections.

More instructions can be found in Section 4. How do I use CALINDAMIN? in the full CMI.

5. What should I know while using CALINDAMIN?

For more information, see Section 5. What should I know while using CALINDAMIN? in the full CMI.

6. Are there any side effects?

The common side effects include oral thrush - white, furry, sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, stomach cramping, stomach discomfort, diarrhoea, heart burn, loss of appetite, skin rash, joint pain and swelling.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CALINDAMIN Capsules

Active ingredient(s): clindamycin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using CALINDAMIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CALINDAMIN.

Where to find information in this leaflet:

1. Why am I using CALINDAMIN?
2. What should I know before I use CALINDAMIN?
3. What if I am taking other medicines?
4. How do I use CALINDAMIN?
5. What should I know while using CALINDAMIN?
6. Are there any side effects?
7. Product details

1. Why am I using CALINDAMIN?

CALINDAMIN contains the active ingredient clindamycin hydrochloride. CALINDAMIN is an antibiotic.

CALINDAMIN is used to treat infections in different parts of the body caused by bacteria.

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

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

Clindamycin 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 Clindamycin has been prescribed for you.

Your doctor may have prescribed Clindamycin for another reason.

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

Clindamycin capsules are not recommended in children for formulation reasons.

Clindamycin is not addictive.

2. What should I know before I use CALINDAMIN?

Warnings

Do not use CALINDAMIN if:

• you are allergic to clindamycin hydrochloride, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• Any medicine containing lincomycin.
• lactose or any of the 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 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.

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Clindamycin crosses the placenta and therefore should only be used in pregnancy if clearly needed.

Clindamycin capsules are not recommended during breast feeding.

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

If your have not told your doctor about any of the above, tell them before you start taking this medicine.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interact with clindamycin. These include:

Erythromycin, used to treat bacterial infections.

Rifampicin, used to treat bacterial infections.

Medicines used for muscle relaxation in anesthesia.

These medicines may be affected by clindamycin or may affect how well it works. You may need different amounts of your medicines or your may need to take different medicines.

Other medicines not listed above may also interact with clindamycin.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CALINDAMIN.

4. How do I use CALINDAMIN?

How much to take / use

Follow all directions given to you by your doctor or pharmacist carefully.

They may be different from the information contained in this leaflet.

If you do not understand the directions, ask your doctor or pharmacist for help.

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Adults

One capsule (150mg) every six hours is the usual dose. The number of capsules may increase with more serious infections.

Continue taking clindamycin 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 clindamycin 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.

When to take CALINDAMIN

Space the doses of this medicine evenly apart throughout the day and take them at about the same time each day.

• CALINDAMIN should be used taken at the same time each day will have the best effect and will also help your remember when to take it.
• It does not matter if you take it before, with or after food.

How to take CALINDAMIN

Clindamycin capsules should be taken by mouth, with a full glass of water.

Do not take CALINDAMIN immediately before lying down. You must wait at least half an hour.

If you forget to use CALINDAMIN

CALINDAMIN should be used regularly at the same time each day.

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 and then go back to taking your medicines as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you experiencing side effects.

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

If you use too much CALINDAMIN

If you think that you have used too much CALINDAMIN, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CALINDAMIN?

Things you should do

Call your doctor straight away if you:

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 diarrhea, tell your doctor, pharmacist or nurse immediately.

Do this even if it occurs several weeks after you have stopped taking CALINDAMIN.

Diarrhea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medicine for diarrhea 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 clindamycin has been stopped.

A severe skin rash may mean you are having an allergic reaction to clindamycin. You may need urgent medical care.

If you get a sore, white mouth or tongue while taking or soon after stopping clindamycin, 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 clindamycin allows fungi/yeast to grow and the above symptoms to occur.

Clindamycin does not work against fungi/yeast.

If you are going to have surgery, tell the surgeon or anesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

If you feel that clindamycin is not helping your condition, tell your doctor.

Tell your doctor if, for any reason, you have not used clindamycin exactly as prescribed.

Remind any doctor, dentist or pharmacist you visit that you are using CALINDAMIN.

Things you should not do

• Do not take this medicine to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have same condition as you.
• Do not stop taking your medicine or lower the dosage without checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CALINDAMIN affects you.

Speak to your doctor or pharmacist to know if CALINDAMIN affects your driving.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your medicine in its original packaging until it is time to take it.
• If you take your medicine out of its original packaging it may not keep well.
• Keep your medicine in a cool dry place where the temperature will stay below 25°C.
• Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it one a windowsill or in the car.
• Heat and dampness can destroy some medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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

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

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What CALINDAMIN contains

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

May contain traces of sulfites.

Contains sugars as lactose.

Do not take this medicine if you are allergic to any of these ingredients.

What CALINDAMIN looks like

CALINDAMIN capsules consist of a white cap and white body imprinted with ‘Clin 150’ in black printing ink.

AUST R 214410

Who distributes CALINDAMIN

Arrotex Pharmaceuticals
15-17 Chapel Street
Cremorne, VIC 3121

This leaflet was prepared in January 2025.

Published by MIMS February 2025

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.

Use in renal impairment.

Use in hepatic 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-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