CIPLA PAIN RELIEF PARACETAMOL + CODEINE with CALMATIVE tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxylamine succinate, Quantity: 5.1 mg; codeine phosphate hemihydrate, Quantity: 10 mg; paracetamol, Quantity: 500 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,doxylamine succinate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; povidone; purified talc; magnesium stearate; pregelatinised maize starch; sodium lauryl sulfate; colloidal anhydrous silica; hyprolose; stearic acid

Administration route:

Oral

Units in package:

20 tablets, 40 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain

Product summary:

Visual Identification: White, capsule shaped, biconvex tablets with a central break line on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-06-20

Patient Information leaflet

Cipla Pain Relief Paracetamol + Codeine with Calmative
1
CIPLA PAIN RELIEF PARACETAMOL + CODEINE WITH
CALMATIVE
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING CIPLA PAIN RELIEF PARACETAMOL + CODEINE WITH CALMATIVE?
Cipla Pain Relief Paracetamol + Codeine with Calmative contains the
active ingredient paracetamol, codeine phosphate
hemihydrate and doxylamine succinate. Cipla Pain Relief Paracetamol +
Codeine with Calmative is used for temporary relief of
acute moderate pain. For more information, see Section 1. Why am I
using Cipla Pain Relief Paracetamol + Codeine with
Calmative? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA PAIN RELIEF PARACETAMOL +
CODEINE WITH CALMATIVE?
Do not use if you have ever had an allergic reaction to Cipla Pain
Relief Paracetamol + Codeine with Calmative 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. You may develop addiction, dependence, and
tolerance.For more information, see Section 2. What should I know
before I use Cipla Pain Relief Paracetamol + Codeine with
Calmative? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Pain Relief Paracetamol +
Codeine with Calmative 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 CIPLA PAIN RELIEF PARACETAMOL + CODEINE WITH CALMATIVE?
The standard dose for adults is 1 or 2 tablets for severe pain, taken
every 4 to 6 hours if necessary. More instructions can be
found in Section 4. How do I use Cipla Pain Relief Paracetamol +
Codeine with Calmative? in the full CMI.
5.
WHAT SHOULD I K

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - CIPLA PAIN RELIEF PARACETAMOL +
CODEINE WITH CALMATIVE (PARACETAMOL, CODEINE PHOSPHATE
HEMIHYDRATE AND DOXYLAMINE SUCCINATE) TABLETS
WARNINGS
_Limitations of use _
Because of the risks associated with the use of opioids, Cipla Pain
Relief Paracetamol + Codeine with
Calmative should only be used in patients for whom other treatment
options, including non-opioid
analgesics, are ineffective, not tolerated or otherwise inadequate to
provide appropriate management
of pain (see section 4.4 Special Warnings and Precautions for Use).
_Hazardous and harmful use _
Cipla Pain Relief Paracetamol + Codeine with Calmative poses risks of
hazardous and harmful use
which can lead to overdose and death. Assess the patient’s risk of
hazardous and harmful use before
prescribing and monitor the patient regularly during treatment (see
section 4.4. Special Warnings and
Precautions for Use).
_Life threatening respiratory depression _
Serious, life-threatening or fatal respiratory depression may occur
with the use of Cipla Pain Relief
Paracetamol + Codeine with Calmative. Be aware of situations which
increase the risk of respiratory
depression, modify dosing in patients at risk and monitor patients
closely, especially on initiation or
following a dose increase (see section 4.4 Special Warnings and
Precautions for Use).
_Concomitant use of benzodiazepines and other central nervous system
(CNS) depressants, including _
_alcohol _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death. Limit dosages and
durations to the minimum required; and monitor patients for signs and
symptoms of respiratory
depression and sedation. Caution patients not to drink alcohol while
taking Cipla Pain Relief
Paracetamol + Codeine with Calmative.
1
NAME OF THE MEDICINE
Paracetamol, Codeine phosphate hemihydrate