Consumer medicine information

Dalacin C Capsules

Clindamycin

BRAND INFORMATION

Brand name

Dalacin C Capsules

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dalacin C Capsules.

What is in this leaflet

This leaflet answers some common questions about DALACIN C capsules. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking DALACIN C against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What DALACIN C capsules are used for

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

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

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

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

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

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

DALACIN C is not addictive.

Before you take DALACIN C capsules

When you must not take it

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

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

Some of the symptoms of an allergic reaction may include:

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

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

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

Before you start to take it

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

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

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

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

DALACIN C capsules are not recommended during breastfeeding.

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

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

Taking other medicines

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

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

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

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

  • erythromycin, a medicine used to treat bacterial infections.

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

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

How to take DALACIN C capsules

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

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

How much to take

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

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

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

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

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

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

How long to take it

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

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

Continue taking your medicine until you finish the pack.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, then go back to taking your medicine as you would normally.

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

If you are not sure what to do, ask your doctor or pharmacist.

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

If you take too much (overdose)

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

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

While you are taking DALACIN C capsules

Things you must do

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

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

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after you have stopped taking DALACIN C. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

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

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

If you get a sore, white mouth or tongue while taking or soon after stopping DALACIN C, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal/yeast infection called thrush. Sometimes the use of DALACIN C allows fungi/yeast to grow and the above symptoms to occur. DALACIN C does not work against fungi/yeast.

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

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

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

Things you must not do

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

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

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

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

Side effects

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

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

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

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • oral thrush – white, furry, sore tongue and mouth
  • vaginal thrush – sore and itchy vagina and/or discharge
  • stomach cramping
  • stomach discomfort
  • inflammation of the food pipe; discomfort or/and pain of the food pipe
  • loss or distorted sense of taste
  • nausea and/or vomiting
  • heartburn
  • diarrhoea
  • loss of appetite
  • skin rash; irritation of the skin
  • joint pain and swelling.

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

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

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

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

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

After finishing it

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

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

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

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

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

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

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

After using DALACIN C capsules

Storage

Keep your DALACIN C capsules in the pack until it is time to take them. If you take the capsules out of the pack, they may not keep well.

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

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

Keep your DALACIN C capsules where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

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

Ingredients

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

It also contains:

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

Supplier

DALACIN C capsules are supplied in Australia by:

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

® = Registered Trademark

© Pfizer Australia Pty Ltd

This leaflet was prepared in February 2022.

Australian registration numbers

150 mg capsule: AUST R 12275

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Dalacin C Capsules

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

Each Dalacin C capsule contains clindamycin hydrochloride, equivalent to 150 mg of clindamycin.
It is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Excipient(s) with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

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

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. 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. No specific antidote is known. Support respiratory and cardiac function. In cases of overdose, drug levels of clindamycin are not clinically useful. However, monitoring serum concentrations in patients with markedly reduced renal and hepatic function, may be indicated during high dose therapy. Monitor full blood count in patients with significant exposure as clindamycin may produce abnormalities of the haematopoietic system. Because clindamycin may cause hepatotoxicity, monitor liver function tests in patients with significant exposure.
Neither haemodialysis nor peritoneal dialysis appear to be effective in reducing clindamycin levels significantly.
Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen and intravenous corticosteroids should also be administered as indicated.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLINDH.gif C18H33ClN2O5S.HCl. MW: 461.5.
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).
CAS number. 21462-39-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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