SUMMARY CMI

ClindaTech^®

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 ClindaTech?

ClindaTech contains the active ingredient clindamycin hydrochloride. ClindaTech is used on the skin to treat certain forms of acne.

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

2. What should I know before I use ClindaTech?

Do not use if you have ever had an allergic reaction to ClindaTech or any of the ingredients listed at the end of the CMI or have a history of inflammatory diseases of the intestines or the large bowel.

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 ClindaTech? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ClindaTech 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 ClindaTech?

Carefully follow all directions given by your doctor or other healthcare professionals.

• Apply no more than twice daily, once in the morning and once at bedtime, to those parts of your skin affected by acne lesions as well as those likely to be affected by acne.

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

5. What should I know while using ClindaTech?

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

6. Are there any side effects?

Common side effects include dry or peeling skin, skin irritations or rashes, oily skin, reddening of the skin, burning or stinging feeling on the skin and a mild upset stomach.

Serious side effects include stomach problems such as severe pain, cramps, bloody or watery diarrhoea and vomiting and nausea.

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

ClindaTech^®

Active ingredient: Clindamycin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using ClindaTech. 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 ClindaTech.

Where to find information in this leaflet:

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

1. Why am I using ClindaTech?

ClindaTech contains the active ingredient clindamycin hydrochloride. Clindamycin belongs to a group of medicines called antibiotics.

ClindaTech is used on the skin to treat certain forms of acne. It works by decreasing acne lesions and/or stopping the growth of skin bacteria which cause acne.

It is usually used by itself, but your doctor may prescribe one or more other medicines that are also applied on the skin or taken orally. Your doctor may also prescribe ClindaTech for another purpose. Therefore, ask your doctor if you have any questions why ClindaTech has been prescribed for your condition.

2. What should I know before I use ClindaTech?

Warnings

Do not use ClindaTech if:

• you are allergic to medicines that contain clindamycin (either taken orally or given as an injection) or lincomycin.
• you are allergic to any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you have a history of inflammatory diseases of the intestines or the large bowel (colitis, including ulcerative colitis, colitis caused by antibiotics, pseudomembranous colitis, or enteritis).

Check with your doctor if you:

• have a history of stomach or intestinal diseases.
• have any medical conditions especially those affecting the liver or kidney.
• have very sensitive skin or any other skin conditions.
• are taking medication to treat diarrhoea
• take any medicines for any other conditions or are using specific skin products.

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:

Before using ClindaTech, 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. Nursing mothers should not use ClindaTech as it is not known if the active ingredient passes into breast milk, and if there is a possibility that your baby may be affected.

3. What if I am taking other medicines?

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

While using ClindaTech, avoid also using at the same time:

• skin products containing high concentrations of alcohol (e.g. astringents, after-shave lotion, medicated cosmetics) as these will dry your skin and may cause skin irritations.
• other topical acne products or products containing benzoyl peroxide, resorcinol, salicylic acid or tretinoin as concurrent use may cause skin irritations.

Some medicines may interfere with ClindaTech and affect how it works. Avoid using ClindaTech at the same time as other antibiotic medicines, including those which contain clindamycin, erythromycin or tetracycline.

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

4. How do I use ClindaTech?

How to use:

• Your doctor will decide the best treatment according to your skin condition. Follow your doctor's instructions and keep using ClindaTech for the entire course even if your pimples clear up after a few days.
• ClindaTech is for external use only and is applied directly to the skin.
• The usual treatment is to apply a thin film no more than twice daily, once in the morning and once at bedtime. Apply to those parts of your skin affected by acne lesions as well as those likely to be affected by acne, not just the pimples themselves.

How to apply ClindaTech:

1. Before applying ClindaTech remove any make-up or cosmetics and shave if needed.
2. Wash the affected areas thoroughly with warm water and a neutral or pH balanced mild soap, rinse well and pat dry.
3. After washing or shaving, allow the skin to dry for 15 to 30 minutes before applying ClindaTech. Since it contains alcohol, it may irritate your freshly washed or shaved skin.
4. ClindaTech comes in a bottle with an applicator, to apply the medicine directly to the skin.

a. Tilt the bottle and press the tip firmly against your skin. Using a dabbing motion instead of a rolling motion allow the solution to flow through the applicator tip onto the skin.

b. If the flow is too slow, increase the pressure slightly until the solution flows more freely. If the applicator tip becomes dry, turn the bottle upside down and press the tip several times to moisten it

5. Apply ClindaTech to the affected areas over the entire face. Avoid applying to open wounds, inflamed skin, eyes or any mucous membranes.
6. Be careful applying ClindaTech around the mouth as it has an unpleasant taste.

If you forget to apply ClindaTech:

It is important that you do not miss any doses of ClindaTech. Ask your pharmacist for some guidance if you have trouble remembering when to apply ClindaTech.

ClindaTech should be used regularly at the same time each day. If you miss your application at the usual time, apply ClindaTech as soon as you remember.

If it is almost time for your next application, skip the application you missed and apply your next treatment when you are meant to.

Do not apply a double amount to make up for the application you missed.

If you use too much ClindaTech:

Let your doctor know even if you do have not had any signs of skin discomfort.

5. What should I know while using ClindaTech?

Things you should do:

If your acne does not improve after a few weeks or becomes worse, see your doctor or pharmacist. The treatment may take up to 8 to 12 weeks before you see a clear improvement with your skin.

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

Things you should not do:

• ClindaTech is for external use only. Do not swallow this medicine. If you or someone else accidentally swallow ClindaTech, 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.
• Do not apply to open wounds.
• Do not apply to the eyes, around eyelid areas, mouth, lips, mucosa or angles of the nose.
  - If ClindaTech gets in your eyes, immediately wash them out with large amounts of cool, clean water. If your eyes still burn or become painful, contact your doctor immediately.
• Do not apply ClindaTech more often than or longer than what your doctor has prescribed for you because it may cause your skin to become too dry.

Things to be careful of:

• If your skin becomes unnaturally dry or irritated even under normal use, check with your doctor or pharmacist about adjusting the frequency of use or temporarily discontinue application.
• Do not use any skin preparations or medicated dressings on the same affected areas unless your doctor has advised you to do so. If your doctor has prescribed other medicines for applying to the skin, check with your doctor or pharmacist when and how you should apply these medicines.
• Avoid using any peeling agents (e.g. resorcinol, salicylic acid, benzoyl peroxide) or preparations that contain high concentrations of alcohol (astringents, medicated cosmetics).
• Check with your doctor or pharmacist which cosmetics and perfumed toiletries you can use. Use a mild bland soap, or any suitable soap-free cleansers as advised by your pharmacist. It is best not to use cosmetics too heavily or too often because this may make your acne worse. Wash off any cosmetics every time before you apply ClindaTech.

Looking after your medicine:

• Store below 30°C. Do not freeze or expose to excessive heat and direct light.

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.

When to discard your medicine:

Discard the product three months after opening.

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

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.

What ClindaTech contains:

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

What ClindaTech looks like:

ClindaTech is a clear colourless solution packed in a bottle with an outer carton. It is supplied in 50 mL or 100 mL pack sizes.

Australian registration number: AUST R 66687

Who distributes ClindaTech:

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

This leaflet was prepared in December 2023.

Published by MIMS February 2024

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

ClindaTech is a clear hydroalcoholic solution containing clindamycin hydrochloride 1%. Dioctyl malate, a noncomedogenic humectant, is incorporated to prevent skin dryness.
ClindaTech contains alcohol 69% v/v. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

ClindaTech clindamycin hydrochloride 10 mg/mL solution bottle. A clear, colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

ClindaTech is indicated for the topical treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

4.2 Dose and Method of Administration

ClindaTech is for external use only and is applied directly on the skin.
Wash the entire face with mild, non-alkaline soap and warm water prior to any application. Using the Dab-O-Matic applicator provided, apply a thin film directly to each acne lesion or to areas having potential of eruption.
ClindaTech is usually applied to affected areas twice daily, once every morning and once at bedtime. The frequency of treatment will depend on the severity of acne condition as well as skin tolerance, but should not be more than twice daily.
Treatment of acne vulgaris needs to be individualised according to the type of lesion predominating and the response of therapy. Application to the entire face of an average adult is equivalent to approximately 2 mL of solution or clindamycin 20 mg.
Generally, a decrease in the number of inflammatory lesions should be noticed after two or six weeks, but more than eight weeks of therapy may be required before any definite beneficial effects are observed. Therapy is usually continued until a satisfactory response is obtained. If condition does not seem to improve or worsens, modification of treatment or alternative therapy should be considered.

4.3 Contraindications

ClindaTech is contraindicated in patients with known history of hypersensitivity reactions to preparations containing clindamycin, lincomycin or other ingredients in the formulation.

4.4 Special Warnings and Precautions for Use

For external use only.
ClindaTech has an unpleasant taste. Caution should be exercised when applying the solution around the mouth to avoid any possible ingestion.
Avoid any contact with eyes, eyelids, abraded skin, nasal folds, lips or mucous membranes because of the irritating dryness caused by the alcoholic solvent. In the event of any accidental contact, bathe with copious amount of cool water.

Use with caution in the following circumstances.

Check the following before use.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent use of topical preparations containing alcohol (e.g. astringents, aftershave lotion, medicated cosmetics) should be avoided because they potentiate the drying action on the skin. The solvent vehicles in some abrasive cleansers, medicated soaps or cosmetics are alcoholic. They may cause a cumulative irritant effect in patients undergoing treatment.
Topical acne preparations containing desquamative or abrasive agents (e.g. benzoyl peroxide, salicylic acid, resorcinol or tretinoin) may sensitise the skin to various local reactions. Concurrent use of these agents and topical clindamycin should be treated with caution in combination therapy. Concomitant use of other anti-acne or comedogenic cosmetic products should be avoided.
Both clindamycin and erythromycin appear to compete for the same ribosomal binding site in exerting their antibacterial action. Antagonism between the two anti-infective agents has been demonstrated. Concomitant use of either antibiotic in the topical treatment of acne is not recommended.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the actions of other neuromuscular blocking agents.

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 most frequent adverse effect associated with the use of topical clindamycin solution is dryness of skin. Other local reactions including erythema, peeling, oiliness, contact dermatitis, irritation, itching and burning have been reported. While the exact proportion of patients reporting skin reactions was not available in controlled clinical studies, these effects were generally mild and most skin intolerance did not cause discontinuation of treatment.
Patients very frequently (> 10%) experience a sensation of warmth, irritating dryness and/ or burning experience following application of topical clindamycin, especially during the early phase of treatment. Many of these reactions can be attributed to the dehydrating effect of the hydroalcoholic vehicle.
Diarrhoea is commonly reported (> 1%, < 10%), and infrequently, abdominal pain, bloody diarrhoea (including pseudomembranous colitis) have also been reported following topical use of clindamycin hydrochloride. In one multicentre, double blind and placebo controlled study comparing two formulations of 1% topical clindamycin in acne patients, it was noted that 6 of the 120 patients (≈ 5%) in the clindamycin hydrochloride group, 6 of the 124 patients (≈ 5%) in the clindamycin phosphate group and 2 of the 113 patients (≈ 2%) in the placebo group reported diarrhoea during the 8 week study. The diarrhoea episode in one clindamycin treated patient was considered by the investigator to be related to treatment. Sigmoidoscopy was performed and there was no evidence of pseudomembranous colitis. The other patients with diarrhoea continued the study and diarrhoea settled. No cause and effect relationship was established.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
No information is available concerning overdosage of topical clindamycin in humans.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Pharmacokinetic studies have not been undertaken with ClindaTech. Published results of studies which involved other clindamycin formulations are described below.
In an in vitro model using human skin, approximately 10% of the dose was absorbed into the stratum corneum following topical application of a 1% hydroalcoholic solution of radiolabelled clindamycin as the hydrochloride.
Absorption of clindamycin into comedones was assessed in an in vivo study in which comedones were removed from acne patients who had applied 1% clindamycin hydrochloride twice daily for 2 weeks or longer. The whole comedonal concentration of clindamycin ranged from 0 to 5 microgram/mg of comedonal material with a mean concentration of 0.824 microgram/mg. It was stated that these antibiotic concentrations are above the minimum inhibitory concentration of clindamycin for most wild strains of P. acnes in vitro at 0.05 to 0.1 microgram/mL or below.
Systemic absorption of clindamycin was assessed by measurement of serum clindamycin in another open study of 18 acne patients. No clindamycin was detected in serum from any of the subjects obtained one to nine hours after application of a 1% clindamycin hydrochloride solution. The patients had been instructed to apply the solution with their fingertips to the affected areas 2 to 3 times daily. The duration of use ranged from 6 to 150 days with mean duration at 43.4 days, but the total volume of solution and surface area of application was not stated. The lower limit of quantification was 1 microgram/mL.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Dioctyl malate, ethanol, purified water.

6.2 Incompatibilities

Information on the physical or chemical compatibility of topical clindamycin with other topical preparations is not available. ClindaTech should only be constituted using the base solution provided.

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. Do not freeze or expose to excessive heat and direct light.

6.5 Nature and Contents of Container

ClindaTech is packaged in a ready to use pack.
The ready to use pack, in either 6 mL*, 10 mL*, 30 mL*, 50 mL or 100 mL, consists of a white HDPE bottle fitted with a screw neck top and a Dab-O-Matic applicator and a polypropylene closure.
* Not marketed.
A package insert is included with the product in the carton.

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 name: methyl 6-amino-7-chloro- 6,7,8-trideoxy- N-[(2S,4R)-1-methyl- 4-propylprolyl] -1-thio-L-threo-α-D-galacto-octopyranoside hydrochloride.
Molecular formula is C₁₈H₃₃ClN₂O₅S.HCl (molecular weight 461.5).

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes