Consumer medicine information

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

Paracetamol + Codeine phosphate hemihydrate

BRAND INFORMATION

Brand name

Cipla Pain Relief Paracetamol and Codeine 8

Active ingredient

Paracetamol + Codeine phosphate hemihydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets.

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

 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 and Codeine Phosphate Hemihydrate 8 tablets?

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets contains the active ingredient Paracetamol and Codeine Phosphate. Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets is used to temporarily relieve acute moderate pain fever when other analgesics have proven not to be effective.. For more information, see Section 1. Why am I using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets? in the full CMI.

 2. What should I know before I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

Do not use if you have ever had an allergic reaction to paracetamol and codeine phosphate 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 Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets 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 and Codeine Phosphate Hemihydrate 8 tablets?
  • For adults and adolescents over 12 years take one to two tablets to be taken every four to six hours, when required, up to four times daily. DO NOT exceed 8 tablets in 24 hours. Do not give to children under 12 years of age.

More instructions can be found in Section 4. How do I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets? in the full CMI.

 5. What should I know while using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets.
Things you should not do
  • Do not take with other medicines containing paracetamol unless your doctor or pharmacist tells you to
Driving or using machines
  • This medicine may cause dizziness in some people. If this happens do not drive or use operate machinery.
Drinking alcohol
  • Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects
Looking after your medicine
  • Keep your medicine in a cool dry place where the temperature stays below 30°C
  • Do not store in the bathroom or near a sink. Do not leave it on a window sill or in the car

For more information, see Section 5. What should I know while using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets? in the full CMI.

 6. Are there any side effects?

Tell your pharmacist or doctor if you notice any of the following and they worry you such as nausea, vomiting, drowsiness, dizziness, constipation. These are common side effects of your medicine. They are usually mild.

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.

WARNING:

Limitations of use

Because of the risks associated with the use of opioids Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets 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.

Hazardous and harmful use

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets 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.

Life threatening respiratory depression

Serious, life-threatening or fatal respiratory depression may occur with the use of Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets. 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.

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 and Codeine Phosphate Hemihydrate 8 tablets

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

Active ingredient(s): Paracetamol and codeine phosphate hemihydrate

 Consumer Medicine Information (CMI)

This leaflet provides important information about using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets. 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 Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets.

Where to find information in this leaflet:

1. Why am I using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?
2. What should I know before I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?
3. What if I am taking other medicines?
4. How do I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?
5. What should I know while using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?
6. Are there any side effects?
7. Product details

 1. Why am I using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets contains the active ingredient Paracetamol and Codeine Phosphate Hemihydrate. Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets is analgesic (pain reliever).

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets is used to temporarily relieve acute moderate pain. fever when other analgesics have proven not to be effective.

Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

Codeine phosphate is an opioid pain reliever.

 2. What should I know before I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

Warnings

Do not use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets if:

  • you are allergic to paracetamol and codeine phosphate, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • a history of drug or alcohol dependence

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

Check with your doctor if you:

  • have acute breathing difficulties such as bronchitis, unstable asthma or emphysema
  • have chronic constipation
  • have diarrhoea caused by antibiotics or poisoning
  • liver or kidney disease
  • difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing conditions
  • you drink large quantities of alcohol.
  • recent surgery on the stomach or intestines
  • head injury
  • enlarged prostate
  • low blood pressure
  • underactive thyroid.

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

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.

Codeine may affect your developing baby. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

This medicine passes into breastmilk and may affect the baby. It may cause breathing problems in newborn infants.

 3. What if I am taking other medicines?

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

Do not take with other medicines containing paracetamol.

It is important to check the labels of all other medicines you are taking to make sure they do not contain paracetamol. Taking too much paracetamol may cause serious liver damage.

Some medicines may interfere with Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets and affect how it works.

  • Tranquilisers (medicines for anxiety and nerves)
  • warfarin, a medicine used to prevent blood clots
  • metoclopramide, a medicine used to control nausea and vomiting
  • medicines used to treat epilepsy or fits
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • medicines used to help you relax, sleep or relieve anxiety, such as barbiturates and sedatives
  • medicines used to relieve stomach cramps or spasms
  • medicines used to prevent travel sickness
  • medicines used to treat Parkinson's disease
  • medicines used to treat high blood pressure
  • medicines for diarrhoea, such as kaolin, pectin and loperamide
  • monoamine oxidase inhibitors, medicines used to treat depression, if taken within the last 14 days
  • quinidine, a medicine used to treat abnormal or irregular heart beat
  • phenothiazines and antipsychotic agents, medicines used to treat mental disorders
  • other opioids, used to treat pain or suppress coughs
  • alcohol
  • if you are an ultra-rapid metaboliser of CYP2D6
  • if you are aged 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets.

 4. How do I use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

How much to take

  • Adults and adolescents over 12 years: One to two tablets to be taken every four to six hours, when required, up to four times daily. DO NOT exceed 8 tablets in 24 hours.
  • Do not give Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets to children under 12 years of age.
  • Adults (18 years and over): Keep to the recommended dose. Only take Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets for a few days at a time unless your doctor tells you to take it for longer.
  • Children aged over 12 years: Keep to the recommended dose. Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.
  • Do not take with other products containing paracetamol unless advised to do so by a doctor or pharmacist.
  • If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist.

Follow all directions for use written on the medicine's label.

Do not take more than the recommended dose on the label or for a longer period of time.

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

When to take

  • Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets should be used when required, up to four times daily. DO NOT exceed 8 tablets in 24 hours.

How to take Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

  • Swallow tablets whole with a glass of water.

If you forget to use Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

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

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

If you use too much Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

If you think that you have used too much Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets, you may need urgent medical attention.

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.

 5. What should I know while using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets?

Things you should do

Only take the medicine as recommended on the label.

Talk to your pharmacist or doctor if your symptoms do not improve.

Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Remind any doctor, dentist or pharmacist] you visit that you are using Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets.

Things you should not do

  • Do not take with other medicines containing paracetamol unless your doctor or pharmacist tells you to.
  • Adults (18 years and over): Do not take for more than a few days at a time unless your doctor tells you to.
  • Children over 12 years: Do not take for longer than 48 hours unless your doctor tells you to.
  • Do not take more than the recommended dose unless your doctor tells you to.
  • Do not take high doses of the medicine for long periods of time unless your doctor tells you to. Codeine may be habit forming.

Too much paracetamol may cause delayed, serious liver damage.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets affects you.

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets may cause dizziness in some people. If this happens do not drive or use operate machinery.

Drinking alcohol

Tell your doctor if you drink alcohol.

Only drink small quantities of alcohol (beer, wine or spirits) while taking paracetamol.

Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take.
  • Store below 30°C.
  • Heat and dampness can destroy some medicines.
  • A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

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

Less serious side effectsWhat to do
  • nausea or dyspepsia
  • vomiting
  • drowsiness
  • dizziness
  • constipation
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • cough suppression
  • unusual or extreme mood swings
  • flushing of the face
  • fast heart beat
  • 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
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets contains

Active ingredient
(main ingredient)
  • Paracetamol
  • Codeine phosphate hemihydrate
Other ingredients
(inactive ingredients)
  • Potato starch
  • Lactose monohydrate
  • Povidone
  • Docusate Sodium
  • Colloidal anhydrous silica
  • Magnesium stearate
  • Erythrosine aluminium lake

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

What Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets look like

Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets are pink, circular, flat beveled tablets with central break line on one side and plain on other side. The products are presented in blister packs of 10, 12, 20, 24, 30, 36 or 40 tablets. AUST R 322474

Who distributes Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8 tablets

Medreich Australia Pty Ltd
Unit 8, Homebush Business Village
11-21 Underwood Road, Homebush, NSW 2140

This leaflet was prepared in November 2020.

Published by MIMS May 2021

BRAND INFORMATION

Brand name

Cipla Pain Relief Paracetamol and Codeine 8

Active ingredient

Paracetamol + Codeine phosphate hemihydrate

Schedule

S4

 

1 Name of Medicine

Paracetamol and codeine phosphate hemihydrate.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg and codeine phosphate hemihydrate 8 mg.

Excipients with known effect.

Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cipla Pain Relief Paracetamol and Codeine 8 are pink, circular, flat beveled tablets with central break line on one side and plain on other side.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of acute moderate pain in patients over the age of 12 years.

4.2 Dose and Method of Administration

Adults and children over 12 years.

One to two tablets repeated every four to six hours up to a maximum of four times daily. The daily intake should not exceed 8 tablets in 24 hours.
Cipla Pain Relief Paracetamol and Codeine 8 tablets are contraindicated for use in patients who are:
younger than 12 years;
aged between 12 - 18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea (also see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

4.3 Contraindications

Cipla Pain Relief Paracetamol and Codeine 8 are contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol, codeine or other opiates (or any of the other ingredients in the product).
They are also contraindicated for use in patients:
with severe respiratory disease, acute respiratory disease and respiratory depression;
with chronic constipation;
during labour when delivery of a premature infant is anticipated as it may produce codeine withdrawal symptoms in the neonate;
with active alcoholism;
with diarrhoea caused by pseudomembranous colitis or poisoning (until the causative organism or toxin has been eliminated from the gastrointestinal tract, since codeine may slow down the elimination, thereby prolonging the diarrhoea);
who are CYP2D6 ultra rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6);
younger than 12 years of age (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
aged between 12 - 18 years in whom respiratory function might be compromised, including post tonsillectomy, and/or adenoidectomy for obstructive sleep apnoea due to an increased risk of developing serious life threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
who are breastfeeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Hazardous and harmful use.

Cipla Pain Relief Paracetamol and Codeine 8 tablets contain the opioid (codeine phosphate hemihydrate) and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Cipla Pain Relief Paracetamol and Codeine 8 tablets at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Cipla Pain Relief Paracetamol and Codeine 8 tablets.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal). Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal.
Patients should be advised not to share Cipla Pain Relief Paracetamol and Codeine 8 tablets with anyone else.

Respiratory depression.

Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Cipla Pain Relief Paracetamol and Codeine 8 tablets but the risk is greatest during initiation of therapy or following an increase in dose. Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients, in patients with renal and hepatic impairment, and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma). Opioids should be used with caution and with close monitoring in these patients (see Section 4.2 Dose and Method of Administration). The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).
The risk of respiratory depression is greater with the use of high doses of opioids, especially high potency and modified release formulations, and in opioid naïve patients. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate release to modified release formulations, (see Section 4.2 Dose and Method of Administration), together with consideration of pharmacological differences between opioids. Consider starting the new opioid at a reduced dose to account for individual variation in response.

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Cipla Pain Relief Paracetamol and Codeine 8 tablets with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Cipla Pain Relief Paracetamol and Codeine 8 tablets concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Cipla Pain Relief Paracetamol and Codeine 8 tablets.

Use of opioids in chronic (long-term) non-cancer pain (CNCP).

Opioid analgesics have an established role in the treatment of acute pain, cancer pain and palliative and end-of-life care. Current evidence does not generally support opioid analgesics in improving pain and function for most patients with chronic non-cancer pain. The development of tolerance and physical dependence and risks of adverse effects, including hazardous and harmful use, increase with the length of time a patient takes an opioid. The use of opioids for long-term treatment of CNCP is not recommended.
The use of an opioid to treat CNCP should only be considered after maximised non-pharmacological and non-opioid treatments have been tried and found ineffective, not tolerated or otherwise inadequate to provide sufficient management of pain. Opioids should only be prescribed as a component of comprehensive multidisciplinary and multimodal pain management.
Opioid therapy for CNCP should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient (see Hazardous and harmful use, above). The expected outcome of therapy (pain reduction rather than complete abolition of pain, improved function and quality of life) should be discussed with the patient before commencing opioid treatment, with agreement to discontinue treatment if these objectives are not met.
Owing to the varied response to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose and titrated to achieve an adequate level of analgesia and functional improvement with minimum adverse reactions. Immediate-release products should not be used to treat chronic pain, but may be used for a short period in opioid-naïve patients to develop a level of tolerance before switching to a modified-release formulation. Careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment. Discontinue opioid therapy if there is no improvement of pain and/or function during the trial period or if there is any evidence of misuse or abuse. Treatment should only continue if the trial has demonstrated that the pain is opioid responsive and there has been functional improvement. The patient's condition should be reviewed regularly and the dose tapered off slowly if opioid treatment is no longer appropriate (see Ceasing opioids).

Tolerance, dependence and withdrawal.

Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence. Tolerance is the need for increasing doses to maintain analgesia. Tolerance may occur to both the desired and undesired effects of the opioid.
Physical dependence, which can occur after several days to weeks of continued opioid usage, results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced. Withdrawal symptoms can also occur following the administration of an opioid antagonist (e.g. naloxone) or partial agonist (e.g. buprenorphine). Withdrawal can result in some or all of the following symptoms: dysphoria, restlessness/agitation, lacrimation, rhinorrhoea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, increasing pain, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, increased blood pressure, increased respiratory rate and increased heart rate.
When discontinuing Cipla Pain Relief Paracetamol and Codeine 8 tablets in a person who may be physically-dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually (see Ceasing opioids; see Section 4.2 Dose and Method of Administration).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Cipla Pain Relief Paracetamol and Codeine 8 tablets, especially by children, can result in a fatal overdose of opioid. Patients and their caregivers should be given information on safe storage and disposal of unused Cipla Pain Relief Paracetamol and Codeine 8 tablets (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Hyperalgesia.

Hyperalgesia may occur with the use of opioids, particularly at high doses. Hyperalgesia may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain. Hyperalgesia should not be confused with tolerance (see Tolerance, dependence and withdrawal). If opioid induced hyperalgesia is suspected, the dose should be reduced and tapered off if possible. A change to a different opioid may be required.

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms and uncontrolled pain (see Tolerance, dependence and withdrawal). Such symptoms may lead the patient to seek other sources of licit or illicit opioids. Opioids should not be ceased abruptly in a patient who is physically dependent but withdrawn by tapering the dose slowly. Factors to take into account when deciding how to discontinue or decrease therapy include the dose and duration of the opioid the patient has been taking, the type of pain being treated and the physical and psychological attributes of the patient. A multimodal approach to pain management should be in place before initiating an opioid analgesic taper. During tapering, patients require regular review and support to manage any increase in pain, psychological distress and withdrawal symptoms.
There are no standard tapering schedules suitable for all patients and an individualised plan is necessary. In general, tapering should involve a dose reduction of no more than 10 percent to 25 percent every 2 to 4 weeks (see Section 4.2 Dose and Method of Administration). If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to go back to the previous dose until stable before proceeding with a more gradual taper.
When ceasing opioids in a patient who has a suspected opioid use disorder, the need for medication assisted treatment and/or referral to a specialist should be considered.

Other precautions.

Cipla Pain Relief Paracetamol and Codeine 8 tablets should be administered with caution to patients with:
raised intracranial pressure or head injury, prostatic hypertrophy, hypotension, hypothyroidism, have had recent gastrointestinal tract surgery.
Codeine may obscure the diagnosis or the course of gastrointestinal diseases.

CYP2D6.

Cipla Pain Relief Paracetamol and Codeine 8 are contraindicated for use in patients who are CYP2D6 ultra-rapid metabolisers.
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Children are particularly susceptible due to their immature airway anatomy. Deaths have been reported in children with rapid metabolism who were given codeine for analgesia post adenotonsillectomy. Morphine can also be ingested by infants through breast milk, causing risk of respiratory depression in infants of rapid metaboliser mothers who take codeine.
The prevalence of codeine ultra-rapid metabolism by CYP2D6 in children is not known, but it is assumed to be similar to that reported in adults. The prevalence of ultra-rapid metabolisers is estimated to be 1% in those of Chinese, Japanese and Hispanic descent, 3% in African Americans and 1%-10% in Caucasians. The highest prevalence (16%-28%) occurs in North African, Ethiopian and Arab populations. See Paediatric use; see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

Use in hepatic impairment.

Cipla Pain Relief Paracetamol and Codeine 8 should be administered with caution to patients with impaired hepatic function.

Use in renal impairment.

Cipla Pain Relief Paracetamol and Codeine 8 tablets should be administered with caution to patients with impaired renal function.

Use in the elderly.

The elderly are more likely to have age related renal impairment and may be more susceptible to the respiratory depressant effects of codeine.

Paediatric use.

Cipla Pain Relief Paracetamol and Codeine 8 are contraindicated for use in children:
younger than 12 years;
aged between 12 - 18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Respiratory depression and death have occurred in some children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolisers of codeine due to CYP2D6 polymorphism. Also see Section 4.4 Special Warnings and Precautions for Use, CYP2D6.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticoagulant drugs (warfarin) - dosage may require reduction if this medication and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as alcohol or anticonvulsant agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
CNS depressants - concomitant use of codeine with central nervous system depressants (e.g. benzodiazepines, barbiturates, chloral hydrate, sedatives, hypnotics, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis, centrally acting muscle relaxants or other CNS depressants) including alcohol, can cause additive CNS depression and may result in profound sedation, respiratory depression, coma and death (see Section 4.4, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).
Anticholinergics - concurrent use of codeine with anticholinergic agents may increase the risk of severe constipation and/or urinary retention.
Antihypertensives - hypotensive effects may be potentiated when used concurrently with codeine and lead to orthostatic hypotension.
Antiperistaltic antidiarrhoeals (e.g. kaolin, pectin and loperamide) - concurrent use with codeine may increase the risk of severe constipation.
Metoclopramide - codeine may antagonise the effects of metoclopramide on gastrointestinal activity.
Monoamine oxidase inhibitors (MAOIs) - concurrent administration or use within 14 days of ceasing MAOIs may enhance the potential respiratory depressant effects of codeine.
Opioid analgesics - concurrent use of codeine and other opioid receptor antagonists is usually inappropriate as additive CNS depression, respiratory depression and hypotensive effects may occur (see Section 4.4, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).
Substances that inhibit CYP2D6 such as quinidine, phenothiazines and antipsychotic agents can interfere with the metabolism of codeine to morphine, reducing the analgesic effect of codeine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Category A: Both paracetamol and codeine have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Opioid analgesics may cause respiratory depression in the newborn infant. Prolonged high-dose use of codeine prior to delivery may produce codeine withdrawal symptoms in the neonate.
 Paracetamol and codeine both appear in breast milk in low concentrations. Maternal ingestion of paracetamol in recommended doses does not appear to present a risk to breastfed infants. However, codeine may cause respiratory depression in newborn infants.
Cipla Pain Relief Paracetamol and Codeine 8 tablets are contraindicated during breastfeeding (also see Section 4.4 Special Warnings and Precautions for Use, CYP2D6) due to risk of respiratory depression in the infant.
Analgesic doses excreted in breast milk are generally low. However, infants of breast feeding mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultra-rapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolised by cytochrome P450 2D6 (CYP2D6) into morphine, which is excreted into breast milk. If nursing mothers are CYP2D6 ultra-rapid metabolisers, higher levels of morphine may be present in their breast milk. This may result in symptoms of opioid toxicity in both mother and the breastfed infant. Life-threatening adverse events or neonatal death may occur even at therapeutic doses (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6).
Therefore Cipla Pain Relief Paracetamol and Codeine 8 are contraindicated for use during breastfeeding. However, in circumstances where a breastfeeding mother requires codeine therapy, breastfeeding should be suspended and alternative arrangements should be made for feeding the infant for any period during codeine treatment.
Breast feeding mothers should be told how to recognize signs of high morphine levels in themselves and their babies. For example, in a mother, symptoms include extreme sleepiness, and trouble caring for the baby. In the baby, symptoms include signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Medical advice should be sought immediately.

4.7 Effects on Ability to Drive and Use Machines

This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
The most common adverse effects associated with codeine are nausea, vomiting, drowsiness, dizziness and constipation.
Other side effects include: cough suppression, respiratory depression, euphoria, dysphoria, skin rashes, histamine release (hypotension, flushing of the face, tachycardia, breathlessness) and other allergic reactions.

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.

4.9 Overdose

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 131 126; in New Zealand call 0800 764 766) for advice or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage with paracetamol.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol.

Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.

Codeine.

Codeine acts centrally. It has an analgesic effect, which is thought to be due mainly to its partial metabolic conversion to morphine. Codeine has about one-sixth the analgesic activity of morphine.
Systematic reviews1,2,3 comparing paracetamol-codeine combinations versus paracetamol alone concluded that in single-dose studies addition of codeine to paracetamol produced a comparatively small but statistically significant increase in analgesic effect; however, there was an increased incidence of adverse effects with the combination.
1 de Craen AJM, et al. Analgesic efficacy and safety of paracetamol-codeine combinations versus paracetamol alone: a systematic review. BMJ 1996; 313: 321-5. PubMed.
2 Moore A, et al. Single dose paracetamol (acetaminophen), with and without codeine, for postoperative pain. Available in the Cochrane Database of Systematic Reviews; Issue 4. Chichester: John Wiley; 1998. PubMed.
3 Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. Art No.: CD001547. DOI:10.1002/14651858.CD001547.pub2.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Paracetamol.

Absorption.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration.

Distribution.

Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses.

Metabolism.

Paracetamol is metabolised extensively in the liver and the metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

Excretion.

The elimination half-life varies from about 1 to 3 hours. Metabolites are excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged.

Codeine.

Absorption.

Codeine and its salts are well absorbed from the gastrointestinal tract: peak plasma-codeine concentrations occur at about one hour after ingestion of codeine phosphate.

Distribution.

Codeine is rapidly distributed to skeletal muscle, kidneys, liver, gastrointestinal tract, lungs, spleen and brain. It crosses the placenta and is distributed in low levels in breast milk.

Metabolism.

Codeine is metabolised by O- and N-demethylation in the liver (via the cytochrome P450 system) to morphine (about ten per cent of a codeine dose is demethylated to morphine), norcodeine and other metabolites including normorphine and hydrocodone.
About 8% of people metabolise drugs poorly via CYD2D6, and are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite, morphine.

Excretion.

Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Approximately 3% to 16% of a dose is eliminated unchanged in the urine.
The plasma half-life of codeine has been reported to be between 3 and 4 hours after oral administration.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Potato starch, lactose monohydrate, povidone, docusate sodium, colloidal anhydrous silica, magnesium stearate, erythrosine aluminium lake.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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.

6.5 Nature and Contents of Container

Cipla Pain Relief Paracetamol and Codeine 8 are pink, circular, flat beveled tablets with central break line on one side and plain on other side. The products are presented in Alu-PVC/PVdC blister packs of 10, 12, 20, 24, 30, 36 or 40 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Paracetamol.

Chemical name: Paracetamol is N-(4-Hydroxyphenyl)acetamide.
Molecular formula: C8H9NO2.
Molecular weight: 151.2.

Chemical structure.


CAS number.

103-90.

Codeine phosphate.

Chemical name: 4,5α-Epoxy-3-methoxy-17-methyl-7,8-didehydromorphinan-6α-ol phosphate hemihydrate.
Molecular formula: C18H24NO7P, ½ H2O.
Molecular weight: 406.40.

Chemical structure.


CAS number.

41444-62-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes