CILICAINE VK 500mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenoxymethylpenicillin potassium, Quantity: 554.37 mg (Equivalent: phenoxymethylpenicillin, Qty 500 mg)

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; Gelatin; titanium dioxide; iron oxide red; sodium lauryl sulfate; purified water

Administration route:

Oral

Units in package:

50 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic stretococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recent streptococcal infections including the prevention of recurrence following rhematic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/pr 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 childbirth.

Product summary:

Visual Identification: Size 0 hard capsule, opaque, maroon in colour; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-09-23

Patient Information leaflet

CILICAINE
® VK
C
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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 CILICAINE VK?
CILICAINE VK contains the active ingredient phenoxymethylpenicillin
(as potassium). CILICAINE VK is used to treat infections in
different parts of the body caused by bacteria.
For more information, see Section 1. Why am I using CILICAINE VK? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CILICAINE VK?
Do not use if you have ever had an allergic reaction to
phenoxymethylpenicillin (as potassium) 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
CILICAINE VK? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CILICAINE VK 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 CILICAINE VK?
•
Your doctor will decide your dose and how long you take CILICAINE VK
for.
•
This will depend on the type of infection you have.
•
Take CILICAINE VK 1 hour before food.
More instructions can be found in Section 4. How do I use CILICAINE
VK? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CILICAINE VK?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CILICAINE VK.
•
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.
•
If you are about to have any blood or urine tests, tell your doctor
that you are taking this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not take

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CILICAINE
® VK
_phenoxymethylpenicillin capsules _
1
NAME OF THE MEDICINE
Phenoxymethylpenicillin (as potassium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CILICAINE VK capsule contains 250 mg or 500 mg of
phenoxymethylpenicillin (as potassium) as the
active ingredient.
Excipients of known effect: sulfites
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CILICAINE VK 250 mg capsules: Size 2 hard gelatin capsule shell,
opaque, maroon.
CILICAINE VK 500 mg capsules: Size 0 hard capsule, opaque, maroon in
colour.
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.
4.2
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.
4.3
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:
CILICAINE
®
VK – PRODUCT INFORMATION
2
HISTORY OF SENSITIVITY (ALLERGY TO PENICILLINS/CEPHALOSPORINS)
S