SUMMARY CMI

Clindamycin LU

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 taking CLINDAMYCIN LU?

CLINDAMYCIN LU contains the active ingredient clindamycin hydrochloride. CLINDAMYCIN LU is used to treat infections in different parts of the body caused by bacteria.

For more information, see Section 1. Why am I taking CLINDAMYCIN LU? in the full CMI.

2. What should I know before I take CLINDAMYCIN LU?

Do not use if you have ever had an allergic reaction to clindamycin, lincomycin, lactose 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 take CLINDAMYCIN LU? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CLINDAMYCIN LU 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 take CLINDAMYCIN LU?

• CLINDAMYCIN LU capsules should be taken by mouth, with a full glass of water, with or without food, at least 30 minutes before lying down.
• The usual adult dose is one (1) capsule every six hours, but may increase for more serious infections. Your doctor will tell you how long to take your capsules. Space the doses of CLINDAMYCIN LU capsules evenly apart and take them at about the same time each day.
• CLINDAMYCIN LU capsules are not recommended for use in children.
• Continue taking CLINDAMYCIN LU capsules until you finish the box or until your doctor recommends.

More instructions can be found in Section 4. How do I take CLINDAMYCIN LU? in the full CMI.

5. What should I know while taking CLINDAMYCIN LU?

For more information, see Section 5. What should I know while taking CLINDAMYCIN LU? in the full CMI.

6. Are there any side effects?

Common side effects include: white, furry, sore tongue; sore or itchy vagina and/or discharge; stomach cramping/discomfort; inflammation/discomfort/ pain of the food pipe; loss or distorted sense of taste; nausea and/or vomiting; heartburn; diarrhoea; loss of appetite; skin rash or irritation; yellowing of the skin; and joint pain and swelling.

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

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

Clindamycin LU

Active ingredient(s): clindamycin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using CLINDAMYCIN LU. 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 CLINDAMYCIN LU.

Where to find information in this leaflet:

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

1. Why am I taking CLINDAMYCIN LU?

CLINDAMYCIN LU contains the active ingredient clindamycin hydrochloride.

CLINDAMYCIN LU capsule is an antibiotic. It is used to treat infections in different parts of the body caused by bacteria.

CLINDAMYCIN LU capsules works by killing or stopping the growth of the bacteria causing your infection.

CLINDAMYCIN LU capsules will not work against viral infections such as colds or flu.

CLINDAMYCIN LU capsules are recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable.

Your doctor may have prescribed CLINDAMYCIN LU capsules for another reason. Ask your doctor if you have any questions about why CLINDAMYCIN LU capsules have been prescribed for you.

This medicine is available only with a doctor's prescription. CLINDAMYCIN LU capsule is not addictive.

2. What should I know before I take CLINDAMYCIN LU?

Warnings

Do not take CLINDAMYCIN LU if:

• you are allergic to clindamycin, lincomycin, lactose or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  Symptoms of an allergic reaction may include swelling of the face, lips, tongue or other parts of the body, skin rash, itching or wheezing or difficulty in breathing.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• have or have ever had: severe diarrhoea associated with the use of antibiotics; severe liver disease; severe kidney disease; bowel disease; or any gastrointestinal (stomach or gut) problems
• have any other medical conditions
• if you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
• take any medicines for any other condition
• if you are taking erythromycin, a medicine used to treat bacterial infections

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.

Clindamycin crosses the placenta therefore CLINDAMYCIN LU capsules should only be used in pregnancy if clearly needed. Your doctor will discuss the risks and benefits of taking CLINDAMYCIN LU LU capsules during pregnancy.

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

CLINDAMYCIN LU capsules are not recommended during breastfeeding.

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 interfere with CLINDAMYCIN LU and may affect how it works, including:

• the antibiotic, erythromycin
• rifampicin, a medicine used to treat bacterial infections
• medicines used for muscle relaxation in anaesthesia

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

4. How do I take CLINDAMYCIN LU?

How much to take

• CLINDAMYCIN LU capsules should be taken by mouth, with a full glass of water.
• Your doctor or pharmacist will tell you how to take your CLINDAMYCIN LU capsules. Follow all directions given to you by your doctor and pharmacist carefully.
• CLINDAMYCIN LU capsules can be taken with or without food, it does not matter.
• To avoid the possibility of oesophageal irritation, CLINDAMYCIN LU capsules must be taken at least 30 minutes before lying down.
• Adults: One (1) capsule 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: CLINDAMYCIN LU capsules are not recommended in children for formulation reasons.
• Continue taking CLINDAMYCIN LU capsules 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.
  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 CLINDAMYCIN LU

• Space the doses of CLINDAMYCIN LU 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.

If you forget to take CLINDAMYCIN LU

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 take a double dose to make up for the dose you missed.

If you take too much CLINDAMYCIN LU

If you think that you have used too much CLINDAMYCIN LU, 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 taking CLINDAMYCIN LU?

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 CLINDAMYCIN LU capsules. 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 CLINDAMYCIN LU capsules, 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 LU allows fungi/yeast to grow, and the above symptoms to occur. CLINDAMYCIN LU does not work against fungi/yeast.
• If you get a severe skin rash tell your doctor immediately. Do this even if the rash occurs after CLINDAMYCIN LU has been stopped. A severe skin rash may mean you are having an allergic reaction to CLINDAMYCIN LU. You may need urgent medical care.
• If you become pregnant while taking CLINDAMYCIN LU, tell your doctor immediately.
• If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking CLINDAMYCIN LU.
• If you feel that CLINDAMYCIN LU is not helping your condition, tell your doctor.
• Tell your doctor if, for any reason, you have not used CLINDAMYCIN LU exactly as prescribed.
• 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.

Remind any doctor, dentist or pharmacist you visit that you are taking CLINDAMYCIN LU.

Things you should not do

• Do not stop taking CLINDAMYCIN LU capsules or change the dose because you are feeling better. If you stop taking CLINDAMYCIN LU suddenly, the infection may not clear completely or your symptoms may return.
• Do not give CLINDAMYCIN LU to anyone else, even if they have the same condition as you.
• Do not use CLINDAMYCIN LU to treat any other medical complaints unless your doctor tells you to.

Looking after your medicine

• Keep your CLINDAMYCIN LU capsules in their original container where the temperature stays below 30°C. If you take the capsules out of their original container, they may not keep as well.
  Keep your CLINDAMYCIN LU 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.

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 window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

Do not take 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

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.

Keep all of your doctor's appointments so that your progress can be checked.

Serious side effects

After finishing it CLINDAMYCIN LU

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

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

CLINDAMYCIN LU 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.

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

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.

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.

CLINDAMYCIN LU capsules each contain 150 mg of clindamycin hydrochloride.

What CLINDAMYCIN LU contains

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

What CLINDAMYCIN LU looks like

CLINDAMYCIN LU hard capsules are apple green marked with "CLD 150" in white ink, available in packs of 24, 50 or 100 capsules.

(AUST R 214526)

Not all pack sizes may be marketed.

Who distributes CLINDAMYCIN LU

Luminarie Pty Ltd
Baulkham Hills
NSW 2153
Australia
www.luminarie.com.au

This leaflet was prepared in July 2024

Published by MIMS August 2024

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

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

Excipient(s) with known effect.

3 Pharmaceutical Form

Capsule, hard. The capsules are No. 2 apple green in color and imprinted with CLD 150.

4 Clinical Particulars

4.1 Therapeutic Indications

Clindamycin Lu (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin Lu 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 hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as 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 clindamycin hydrochloride 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 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, 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 hydrochloride should not be used in patients with nonbacterial infections.
Clindamycin hydrochloride should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver function tests and blood counts should be performed.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy. The use of clindamycin occasionally results in over growth of nonsusceptible organisms, particularly yeasts. Should superinfection occur, appropriate measures should be taken as indicated by the clinical situation.

Use in hepatic impairment.

Use in 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 hydrochloride 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.
Clindamycin may be less effective in the presence of strong CYP3A4 inducers such as rifampicin.

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 of clinical importance.

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

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur (see Section 4.8 Adverse Effects (Undesirable Effects)).
The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis that may result in death. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently. Rapid administration of large doses intravenously has resulted in ventricular dysrhythmias, hypotension and cardiac arrest.

Recommended treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Disc susceptibility tests.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, lactose, povidone, sodium starch glycolate, purified talc and magnesium stearate. Hard gelatin capsule size 2 P Lt Green Op/ Plt Green Op (proprietary ingredient number: 109543), TekPrint SB-0007P White Ink (proprietary ingredient number: 2216).

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 30°C. Protect from light, heat and moisture.

6.5 Nature and Contents of Container

Clindamycin capsules are available in PVC/Al blister packs of 24 capsules, 50 capsules, and 100 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 (or) any unused medicine or waste material should be disposed of in accordance with local requirements.

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 semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Molecular formula is C₁₈H₃₃ClN₂O₅S,HCl and Molecular weight is 461.5 for clindamycin hydrochloride.
Clindamycin hydrochloride is a white or almost white crystalline powder that is very soluble in water and slightly soluble in ethanol (96%).

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes