Consumer medicine information

Cilicaine VK

Phenoxymethylpenicillin

BRAND INFORMATION

Brand name

Cilicaine VK

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cilicaine VK.

What is in this leaflet

This leaflet answers some common questions about CILICAINE VK. 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 using CILICAINE VK against the benefits they expect it will 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 CILICAINE VK is used for

This medicine contains the active ingredient phenoxymethylpenicillin. It is a type of antibiotic that belongs to the group of medicines called penicillins.

CILICAINE VK is used to treat infections in different parts of the body caused by bacteria. It works by killing the bacteria that are causing the infection.

CILICAINE VK will not work against infections caused by viruses such as colds or the flu.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed CILICAINE VK for another purpose.

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

Before you take CILICAINE VK

When you must not take it

Do not take CILICAINE VK if you have an allergy to:

  • any medicine containing phenoxymethylpenicillin
  • any other penicillin medicines or cephalosporins
  • any of the ingredients listed at the end of this leaflet

If you have an allergic reaction to cephalosporin you may have an increased chance of being allergic to CILICAINE VK.

Some 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 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:

  • diarrhoea after taking antibiotics previously
  • bleeding disorders
  • kidney problems
  • liver problems
  • any other health problem

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

The active ingredient in CILICAINE VK passes into breast milk and there is a possibility that your baby may be affected.

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

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 CILICAINE VK may interfere with each other. These include:

  • probenecid, a medicine used to treat gout
  • antacids, medicines used to reduce heartburn or indigestion
  • oral contraceptive pills, medicines used for contraception

You may need to use other birth control methods while you are taking CILICAINE VK.

  • aminoglycosides, medicines used treat some bacterial infections
  • methotrexate, a medicine used treat rheumatoid arthritis, some cancers and inflammatory conditions

These medicines may be affected by CILICAINE VK 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 CILICAINE VK

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, ask your doctor or pharmacist for help.

How much to take

The usual dose is:

Adults
250 mg to 500 mg every four to six hours.

To prevent recurrence of rheumatic fever
250 mg twice a day for as long as your doctor tells you to.

The dose you take will depend on the type of treatment you are to receive. Your doctor will decide your dose and how long you take CILICAINE VK for.

How to take it

Swallow the capsules whole with a glass of water.

When to take it

Take your medicine 1 hour before food.

How long to take it

Continue taking your medicine until you finish the pack or for as long as your doctor tells you.

It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is less than 4 hours before 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 medicine as you would normally.

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

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 Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CILICAINE VK. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using CILICAINE VK

Things you must do

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

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

If you become pregnant while taking this medicine, tell your doctor immediately.

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

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

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

Things you must not do

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

Do not take CILICAINE VK 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 CILICAINE VK without checking with your doctor. Your infection and symptoms may not clear completely.

Things to be careful of

Tell your doctor if you get a sore mouth or tongue while taking or after you have stopped taking CILICAINE VK. This could be due to a fungal infection called thrush. This may also result in fever and irritation in your stomach.

Be careful driving or operating machinery until you know how CILICAINE VK affects you.

Side effects

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

This medicine helps most people but it may have some 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:

  • skin rash
  • nausea or vomiting
  • black hairy tongue
  • diarrhoea
  • upset stomach
  • difficulty in breathing

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 using CILICAINE VK

Storage

Keep your 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 CILICAINE VK or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-anda-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

CILICAINE VK 250 mg and 500 mg capsules are maroon in colour.

Ingredients

CILICAINE VK contains 250 mg or 500 mg of phenoxymethylpenicillin as the active ingredient.

The capsules also contain the following inactive ingredients:

  • gelatin
  • titanium dioxide
  • iron oxide red
  • magnesium stearate

Distributor

CILICAINE VK is distributed in Australia by:

Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

This leaflet was prepared in May 2020.

250 mg capsules: AUST R 55676

500 mg capsules: AUST R 55675

cilicaine-vk_cmi\May20/00

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Cilicaine VK

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

1 Name of Medicine

Phenoxymethylpenicillin (as potassium).

6.7 Physicochemical Properties

Chemical structure.


Phenoxymethylpenicillin (or penicillin V) potassium is the potassium salt of the phenoxymethyl analog of penicillin G. It is a white crystalline powder and is soluble in water and polar organic solvents but practically insoluble in vegetable oils and liquid paraffins.
Chemical name: potassium (6R)-6-(2-phenoxyacetamido) penicillanate.
Molecular formula: C16H17KN2O5S.
Molecular weight: 388.5.

CAS number.

132-98-9.

2 Qualitative and Quantitative Composition

Each Cilicaine VK capsule contains 250 mg or 500 mg of phenoxymethylpenicillin (as potassium) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cilicaine VK 250 mg capsules are size 2 hard gelatin capsules, opaque, maroon.
Cilicaine VK 500 mg capsules are size 0 hard capsules, opaque, maroon.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Phenoxymethylpenicillin produces a bactericidal effect on penicillin sensitive organisms during the stage of active multiplication through inhibition of biosynthesis of cell wall mucopeptides. The antibacterial spectrum of phenoxymethylpenicillin is similar to that of benzylpenicillin, however it has the advantage of being acid stable and hence better absorbed from the gastrointestinal tract than benzylpenicillin. It is resistant to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when given on an empty stomach. Average blood levels are two to five times higher than the levels following the same dose of oral penicillin G and show much less individual variation.

Microbiology.

Penicillin V exerts a bactericidal action against penicillin sensitive microorganisms during the stage of active multiplication. It is not active against the penicillinase producing bacteria, which include many strains of staphylococci.
Sensitive organisms include the following:
Gram-positive cocci, e.g. Streptococci (groups A, C, G, H, L and M), and non-penicillinase producing Staphylococcus pyogenes.
Gram-positive bacilli, e.g. Clostridium tetani, Cl. perfrigens, Corynebacterium diphtheriae and Bacillus anthracis.
Gram-negative bacteria: some isolates of both Neisseria meningitidis and N. gonorrhoeae remain sensitive to penicillins while most strains of Haemophilus influenzae and Moraxella catarrhalis are now resistant. Other aerobic Gram-negative bacilli are highly resistant.
Treponema pallidum is sensitive, but treatment of syphilis with oral penicillins is not recommended.

Susceptibility test.

Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable.
A report of "intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinical feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small-uncontrolled technical factors from causing major discrepancies in interpretation.
A report of "resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

the prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Usually, up to 60% of the drug is absorbed into the bloodstream after oral administration. Absorption is usually rapid and may produce peak serum concentrations within 30 minutes and demonstrable levels are maintained for 4 hours.

Distribution.

Penicillin levels are highest in the kidney tissues with lesser amounts in the liver, skin and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid.

Metabolism.

Approximately 80% of phenoxymethylpenicillin is serum protein bound. About 56% of a 500 mg oral dose of the drug is metabolised into inactive metabolite. The oral plasma half-life is about 30 minutes in healthy adults and about 1 to 3 hours in neonates. The half-life is greatly extended in patients with renal or hepatic impairment.

Excretion.

About 23 to 36% of the drug is rapidly excreted in the unchanged form in the urine. Bile excretion depends on renal function, being low in normal renal function and high in renal impairment.
The drug is excreted as rapidly as it is absorbed in individuals with normal kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants and individuals with impaired kidney function, excretion is considerably delayed.

5.3 Preclinical Safety Data

Genotoxicity.

The genotoxic potential of phenoxymethylpenicillin has not been examined.

Carcinogenicity.

Long term studies have not been performed in animals.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response.
For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.

Note.

Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

4.3 Contraindications

Hypersensitivity to penicillins and/or cephalosporin.

4.4 Special Warnings and Precautions for Use

Risk/ benefit should be considered when the following medical problems exist.

History of sensitivity (allergy to penicillins/ cephalosporins).

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or history of sensitivity to multiple allergens.
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.

Gastrointestinal disease (pseudomembranous colitis).

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including phenoxymethylpenicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered.
Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Phenoxymethylpenicillin is not recommended for chronic, severe or deep seated infections as therapeutic concentrations may not be achieved in the relevant tissues.
Oral administration should not be relied upon to achieve therapeutic levels in some patients with severe illness or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility. Occasionally patients will not absorb therapeutic amounts of oral penicillin. Parenteral administration of suitable antibiotics is recommended in these patients.
In a streptococcal infection, therapy should continue for a minimum of ten days. Cultures should be taken following completion of treatment to determine whether Streptococci have been eradicated.
Use of an alternative or additional method of contraception is strongly recommended if an estrogen containing contraceptive is taken concurrently (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

History of bleeding disorders.

Some penicillins may cause platelet dysfunction and haemorrhage.

Prolonged use.

Prolonged use of penicillins may lead to the development of oral candidiasis.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, phenoxymethylpenicillin should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

The half-life is greatly extended in these patients.

Use in renal impairment.

Because most penicillins are excreted through the kidneys, a reduction in dosage, or increase in dosing interval, is recommended in patients with renal function impairment; and the potassium content of high doses of phenoxymethylpenicillin potassium, should be considered in patients with severe renal function impairment.
The half-life is greatly extended in these patients.

Use in the elderly.

There are no age specific problems documented with the use of phenoxymethylpenicillin, however, the elderly are more likely to have age-related renal function impairment, which may require dosage adjustment.

Paediatric use.

The half-life of phenoxymethylpenicillin is prolonged in premature infants and neonates up to 3 months of age. Consequently, only three doses a day may be adequate to maintain plasma levels in these infants.

Effects on laboratory tests.

With diagnostic test results.

Glucose, urine: high urinary concentrations of penicillin may produce false positive or elevated test results with copper sulfate tests (Benedict's, Clinitest or Fehling's).

Direct antiglobulin (Coombs') tests.

False positive results may occur during therapy with any penicillin.

White blood cell count.

Leukopenia or neutropenia is associated with the use of all penicillins; the effect is more likely to occur with prolonged therapy and severe hepatic function impairment.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Bacteriostatic drugs may antagonise the effect of penicillin.
Probenecid reduces the tubular excretion of penicillin, thereby increasing concentrations in the bloodstream of concomitantly administered penicillin.
Food has a variable effect, generally delaying absorption.
Antacids may reduce absorption of the drug.
When used concurrently with an estrogen containing oral contraceptive, the effectiveness of the oral contraceptive may be decreased because of stimulation of estrogen metabolism or reduction of enterohepatic circulation of estrogens, resulting in menstrual irregularities, intermenstrual bleeding and unplanned pregnancies. This interaction may be of greater clinical significance with long-term use of this penicillin; patients should be advised to use an alternative or additional method of contraception while taking this penicillin.

Aminoglycosides.

Mixing penicillins with aminoglycosides in vitro has resulted in substantial mutual inactivation.

Methotrexate.

Concurrent use with penicillins has resulted in decreased clearance of methotrexate toxicity; probably due to competition for renal tubular secretion; patients should be closely monitored.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproductive studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility due to phenoxymethylpenicillin.
(Category A)
Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed.
The drug is excreted in breast milk in concentrations lower than plasma levels. As safety to newborn infants has not been established, it is not recommended for breast feeding mothers unless the benefits outweigh any potential risk.

4.8 Adverse Effects (Undesirable Effects)

The most common reactions are nausea, vomiting, epigastric distress, diarrhoea, pruritus ani, black hairy tongue, allergic skin reactions, urticaria and other serum sickness reactions.
The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum sickness-like reactions, laryngeal oedema and anaphylaxis. Fever and eosinophilia may frequently be the only reaction observed.
Haemolytic anaemia, leucopenia, thrombocytopenia, neuropathy and nephropathy are uncommon reactions usually associated with high doses of parenteral penicillin.
Anaphylaxis is a less common reaction.

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Adults.

250 mg to 500 mg every four to six hours, preferably one hour before food. The dosage should be determined according to sensitivity of the organisms and severity of the infection.

Prevention of recurrence following rheumatic fever.

250 mg twice a day continuously.

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.

4.9 Overdose

Phenoxymethylpenicillin has low toxicity. However, if there is gross renal impairment, the drug may accumulate in the blood, and the dose should be reduced accordingly.

Treatment.

Management of overdose should include monitoring of electrolyte balance, cardiovascular status and renal function. Penicillins are generally not readily removed by dialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

The capsules also contain gelatin, iron oxide red, magnesium stearate and titanium dioxide.

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. Store in a dry place.

6.5 Nature and Contents of Container

Container type: blister pack (PVC/PVDC/Al).
Pack size: 50.
Some strengths, pack sizes and/or pack types may not be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

Summary Table of Changes