APX-Paracetamol/Codeine Drug / Drugs Data

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Client Drugs Data (CMI) abstract

The complete CMI on the subsequent web page has extra particulars. If you’re fearful about utilizing this drugs,
converse to your physician or pharmacist.

 

WARNING: Essential security info is supplied in a boxed warning within the full CMI. Learn earlier than utilizing this drugs.

Why am I taking APX-Paracetamol/Codeine?

APX-Paracetamol/Codeine comprises the lively components paracetamol and codeine phosphate
hemihydrate. APX-Paracetamol/Codeine is used to alleviate extreme ache. For extra info,
see Part 1. Why am I utilizing APX-Paracetamol/Codeine? within the full CMI.

What ought to I do know earlier than I take APX-Paracetamol/Codeine?

Don’t use you probably have ever had an allergic response to APX-Paracetamol/Codeine or
any of the components listed on the finish of the CMI. Discuss to your physician you probably have some other medical circumstances, take some other medicines,
or are pregnant or plan to develop into pregnant or are breastfeeding.
You could develop habit, dependence and tolerance. For extra info, see Part
2. What ought to I do know earlier than I take advantage of APX-Paracetamol/Codeine? within the full CMI.

What if I’m taking different medicines?

How do I take APX-Paracetamol/Codeine?

The usual dose for adults is 1 or 2 tablets for extreme ache, taken each 4 to six
hours if needed. Extra directions may be present in Part 4. How do I take advantage of APX-Paracetamol/Codeine? within the full CMI.

What ought to I do know whereas taking APX-Paracetamol/Codeine?

Are there any negative effects?

Inform your physician or pharmacist instantly for those who discover any of the next aspect
results shortness of breath, wheezing or problem respiratory, swelling of the face,
lips, tongue, or different components of the physique, rash, itching or hives on the pores and skin. They
could be the indicators of an allergic response.

Inform your physician or pharmacist for those who discover any of the next they usually fear you:
nausea or vomiting; constipation; drowsiness or dizziness. These are extra frequent aspect
results of your drugs. They’re normally gentle.
For extra info, together with what to do you probably have any negative effects, see Part
6. Are there any negative effects? within the full CMI.

WARNING:

Limitations of use

APX-Paracetamol/Codeine ought to solely be used when your physician decides that different remedy
choices should not in a position to successfully handle your ache otherwise you can not tolerate them.

Hazardous and dangerous use

APX-Paracetamol/Codeine poses dangers of abuse, misuse and habit which might lead
to overdose and demise. Your physician will monitor you commonly throughout remedy.

Life threatening respiratory despair

APX-Paracetamol/Codeine could cause life-threatening or deadly respiratory issues (sluggish,
shallow, uncommon or no respiratory) even when used as really helpful. These issues can
happen at any time throughout use, however the threat is greater when first beginning APX-Paracetamol/Codeine
and after a dose improve, if you’re older, or have an present drawback along with your
lungs. Your physician will monitor you and alter the dose as applicable

Use of different medicines whereas utilizing APX-Paracetamol/Codeine

Utilizing APX-Paracetamol/Codeine with different medicines that may make you’re feeling drowsy such
as sleeping tablets (e.g. benzodiazepines), different ache relievers, antihistamines,
antidepressants, antipsychotics, gabapentanoids (e.g. gabapentin and pregabalin),
hashish and alcohol could end in extreme drowsiness, decreased consciousness, respiratory
issues, coma and demise.
Your physician will minimise the dose and period of use; and monitor you for indicators
and signs of respiratory difficulties and sedation. You have to not drink alcohol whereas
utilizing APX-Paracetamol/Codeine.

Lively ingredient(s):
paracetamol and codeine phosphate hemihydrate

Client Drugs Data (CMI)

This leaflet offers essential details about utilizing APX-Paracetamol/Codeine. You must also converse to your physician or pharmacist if you need additional info
or you probably have any issues or questions on utilizing APX-Paracetamol/Codeine.

The place to search out info on this leaflet:

Why am I utilizing APX-Paracetamol/Codeine?

APX-Paracetamol/Codeine comprises the lively components paracetamol and codeine phosphate
hemihydrate.

Paracetamol and codeine work collectively to cease the ache messages from getting via
to the mind. Your physician could have prescribed this drugs for an additional use.

APX-Paracetamol/Codeine is used to alleviate extreme ache for which different remedy choices
have failed, are contraindicated, not tolerated or are in any other case inappropriate to
present adequate administration of ache.

What ought to I do know earlier than I take advantage of APX-Paracetamol/Codeine?

Warnings

Don’t use APX-Paracetamol/Codeine if:

you’re allergic to paracetamol or codeine phosphate hemihydrate, or any of the components
listed on the finish of this leaflet.

At all times verify the components to ensure you should utilize this drugs.

you may have acute respiratory difficulties resembling bronchitis, unstable bronchial asthma or emphysema

you may have Glucose-6-phosphatedehydrogenase deficiency (an enzyme deficiency)

you’re a CYP 2D6 ultra-rapid metaboliser (a quick metaboliser of codeine by the CYP
2D6 enzyme)

you may have diarrhoea brought on by antibiotics or poisoning

you may have liver failure.

Don’t take APX-Paracetamol/Codeine you probably have a historical past of drug dependence, together with
alcohol dependence.

Don’t take APX-Paracetamol/Codeine you probably have skilled systemic allergy (generalised
rash or shortness of breath) to morphine or oxycodone.

Don’t take APX-Paracetamol/Codeine is you may have a historical past of intolerance to paracetamol
and/or codeine.

Don’t take APX-Paracetamol/Codeine if you’re underneath 18 years of age and have had
your tonsils or adenoids eliminated to deal with sleep apnoea.

Don’t take APX-Paracetamol/Codeine in the course of the third trimester of being pregnant.

Don’t take APX-Paracetamol/Codeine throughout labour particularly if the child is untimely.

Don’t use APX-Paracetamol/Codeine if you’re breastfeeding or planning to breastfeed.

Don’t take this drugs after the expiry date (EXP) printed on the pack. For those who take it after the expiry date it could don’t have any impact in any respect, or worse, have
a completely surprising impact.

Don’t take this drugs if the packaging is torn or reveals indicators of tampering.

Don’t use this drugs to deal with some other grievance except your physician says it’s
protected.

APX-Paracetamol/Codeine shouldn’t be really helpful for kids underneath 12 years.

Verify along with your physician you probably have or have had any of the next medical circumstances:

lung, coronary heart, liver or kidney issues

low blood stress

problem respiratory, wheezing, continual cough, bronchial asthma, or different continual respiratory
circumstances

a historical past of drug dependence, together with alcohol dependence

you drink massive portions of alcohol

current cessation of alcohol consumption

low glutathione reserves

Gilbert’s syndrome

gall bladder issues or your gall bladder has been eliminated

a number of sclerosis

current abdomen, gut or urinary tract surgical procedure

irritable bowel syndrome or different bowel issues

prostate issues

underneath lively thyroid gland or issues along with your adrenal glands

suits or seizures

head damage

mind tumours.

Throughout remedy, you could be liable to creating sure negative effects. It is necessary
you perceive these dangers and how one can monitor for them. See extra info
underneath Part 6. Are there any negative effects?

Being pregnant and breastfeeding

Verify along with your physician if you’re pregnant or intend to develop into pregnant.

Don’t take APX-Paracetamol/Codeine in the course of the third trimester of being pregnant.

Don’t take APX-Paracetamol/Codeine throughout labour, particularly if the child is untimely.

This drugs could cause respiratory issues and will produce withdrawal results within the
new child child.

Don’t take APX-Paracetamol/Codeine if you’re breastfeeding planning to breastfeed.

The medication passes into breast milk and will have an effect on the child.

Habit

You possibly can develop into hooked on APX-Paracetamol/Codeine even for those who take it precisely as
prescribed. APX-Paracetamol/Codeine could develop into behavior forming inflicting psychological and bodily
dependence. If abused it could develop into much less in a position to cut back ache.

Dependence

As with all different opioid containing merchandise, your physique could develop into used to you taking
APX-Paracetamol/Codeine. Taking it could end in bodily dependence. Bodily dependence
means that you could be expertise withdrawal signs for those who cease taking APX-Paracetamol/Codeine
instantly, so it is very important take it precisely as directed by your physician.

Tolerance

Tolerance to APX-Paracetamol/Codeine could develop, which implies that the impact of the
drugs could lower. If this occurs, extra could also be wanted to take care of the identical impact.

What if I’m taking different medicines?

Inform your physician or pharmacist if you’re taking some other medicines, together with any
medicines, nutritional vitamins or dietary supplements that you simply purchase with out a prescription out of your pharmacy,
grocery store or well being meals store.

Some medicines could intervene with APX-Paracetamol/Codeine and have an effect on the way it works.

These embrace:

any drugs inflicting sleepiness or drowsiness

tranquillisers (medicines for anxiousness and nerves)

benzodiazepines (medicines used as sedatives or to deal with anxiousness)

medicines used to deal with alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine
or methadone)

medicines containing alcohol (ethanol), e.g. some cough syrups

cough suppressants or antitussives

antihistamines (medicines used to deal with allergy symptoms)

medicines used to deal with despair

medicines used to deal with psychological sickness

monoamine oxidase inhibitors (medicines used to deal with despair) taken inside the
final 10 days

salicylates or non-steroidal antiinflammatory medication (NSAIDS), resembling aspirin or ibuprofen

medicines which skinny the blood

medicines to deal with epilepsy

different ache reduction medicine

medicines used to deal with hypertension

medicines used to loosen up muscle mass

medicines used to deal with diarrhoea, nausea or vomiting

propantheline, a drug used to deal with abdomen ulcers

cholestyramine (drugs used to deal with bile issues and/or excessive ldl cholesterol

chelating resin

chloramphenicol (antibiotic used to deal with ear and eye infections)

flucloxacillin, zidovudine or rifampicin (medicines used to deal with infections)

medicines used to regulate electrolytes ranges in kidney illness

Verify along with your physician or pharmacist if you’re unsure about what medicines, nutritional vitamins
or dietary supplements you take and if these have an effect on APX-Paracetamol/Codeine.

How do I take APX-Paracetamol/Codeine?

How a lot to take

The really helpful dose of APX-Paracetamol/Codeine is:

Adults: 1 or 2 tablets for extreme ache. This dosage could also be repeated in 4-6 hours if
needed.

Observe the directions supplied.

Don’t take greater than 8 tablets in 24 hours.

Don’t take greater than the really helpful dose.

Taking greater than the really helpful dose could trigger liver harm.

The instructions given to you by your physician or pharmacist could also be totally different from the
info on this leaflet. If you’re uncertain what dose to take ask your pharmacist
or physician.

Discuss to your physician about ache management if the drugs shouldn’t be serving to.

Relying in your physique’s particular person capability to interrupt down codeine, you could be getting
diminished profit or expertise indicators of overdose even if you take APX-Paracetamol/Codeine
as really helpful by your physician. If overdose signs happen, search instant medical
recommendation.

Learn how to take APX-Paracetamol/Codeine

Swallow the tablets with water.

How lengthy to take it for

Ask your physician or pharmacist if you’re unsure how lengthy to take the drugs for.

For those who neglect to take APX-Paracetamol/Codeine

Whether it is nearly time in your subsequent dose, skip the dose you missed and take your subsequent
dose if you find yourself meant to.

Don’t take a double dose to make up for the dose you missed.

This may occasionally improve the possibility of you getting an undesirable aspect impact.

If you’re unsure what to do, ask your pharmacist or physician.

In case you have bother remembering to take your drugs, ask your pharmacist for some
hints.

For those who take an excessive amount of APX-Paracetamol/Codeine

For those who or another person obtain an excessive amount of (overdose), and expertise a number of of
the signs beneath, instantly name triple zero (000) for an ambulance. Maintain the
individual awake by speaking to them or gently shaking them once in a while. It is best to
observe the above steps even when somebody apart from you may have unintentionally used APX-Paracetamol/Codeine
that was prescribed for you. If somebody takes an overdose they might expertise one
or extra of the next signs:

Gradual, uncommon or tough respiratory

Drowsiness, dizziness or unconsciousness

Gradual or weak heartbeat

Nausea or vomiting

Convulsions or suits

For those who suppose that you’ve used an excessive amount of APX-Paracetamol/Codeine, you could want pressing
medical consideration.

It is best to instantly:

cellphone the Poisons Data Centre

(by calling 13 11 26), or

contact your physician, or

go to the Emergency Division at your nearest hospital.

It is best to do that even when there are not any indicators of discomfort or poisoning.

When looking for medical consideration, take this leaflet and remaining drugs with you
to indicate the physician. Additionally inform them about some other medicines or alcohol which have
been taken.

What ought to I do know whereas taking APX-Paracetamol/Codeine?

Issues it is best to do

Take APX-Paracetamol/Codeine precisely as your physician has prescribed.

Inform your physician for those who develop into pregnant whereas taking APX-Paracetamol/Codeine.

Remind any physician, dentist or pharmacist you go to that you’re utilizing APX-Paracetamol/Codeine.

Issues you shouldn’t do

Don’t take greater than the really helpful dose except your physician tells you to.

Adults mustn’t take greater than 8 tablets a day.

Don’t take excessive doses of the drugs for lengthy durations of time except you physician
tells you to.

Taking greater than the really helpful dose could cause liver harm.

APX-Paracetamol/Codeine could also be behavior forming if taken in excessive doses for prolonged durations
of time.

Don’t give this drugs to anybody else.

Driving or utilizing machines

Watch out earlier than you drive or use any machines or instruments till you know the way APX-Paracetamol/Codeine
impacts you.

APX-Paracetamol/Codeine could trigger dizziness, light-headedness, drowsiness and issues
with imaginative and prescient in some individuals, particularly after the primary dose.

Kids mustn’t trip bikes if affected and needs to be supervised to keep away from potential
hurt.

Consuming alcohol

Don’t drink alcohol whereas taking APX-Paracetamol/Codeine.

Consuming alcohol will increase the chance of turning into drowsy.

Withdrawal

Proceed taking your drugs for so long as your physician tells you. For those who cease having
this drugs instantly, your ache could worsen and you could expertise some or all of
the next withdrawal signs:

Nervousness, restlessness, agitations, bother sleeping or anxiousness

Physique aches, weak spot or abdomen cramps

Lack of urge for food, nausea, vomiting or diarrhoea

Elevated coronary heart fee, respiratory fee or pupil dimension

Watery eyes, runny nostril, chills or yawning

Elevated sweating

Taking care of your drugs

Retailer beneath 25°C.

Observe the directions within the carton on how one can care for your drugs correctly.

Retailer it in a cool dry place away from moisture, warmth or daylight; for instance, do
not retailer it:

within the rest room or close to a sink, or

within the automobile or on window sills.

Maintain it the place younger kids can not attain it.

Eliminating any undesirable drugs

For those who not want to make use of this drugs or it’s outdated, take it to any pharmacy
for protected disposal.

Don’t use this drugs after the expiry date.

Are there any negative effects?

All medicines can have negative effects. For those who do expertise any negative effects, most of
them are minor and short-term. Nevertheless, some negative effects may have medical consideration.

See the knowledge beneath and, if it’s good to, ask your physician or pharmacist for those who
have any additional questions on negative effects.

Much less critical negative effects

Much less critical negative effects

What to do

Gastrointestinal associated:

nausea or vomiting

indigestion

constipation

abdomen ache

Head and neurology associated:

dry mouth

drowsiness or sleepiness

headache

ringing within the ears

Pores and skin associated:

sweating

Communicate to your physician you probably have any of those much less critical negative effects they usually fear
you.

Critical negative effects

Critical negative effects

What to do

Allergy associated:

shortness of breath, wheezing or problem respiratory

swelling of the face, lips, tongue or different components of the physique

pores and skin rash, itching or hives on the pores and skin

flushing of the face

Coronary heart associated:

quick heartbeat

Pores and skin associated:

extreme blisters and bleeding within the lips, eyes, mouth, nostril and genitals

painful crimson areas with blisters and peeling layers of pores and skin which can be accompanied
by fever and/or chills

yellowing of the pores and skin and eyes (jaundice)

An infection associated:

mouth ulcers, fever and sore throat

Bleeding associated:

bleeding, bruising extra simply

Head and neurology associated:

dizziness, light-headedness

uncommon or excessive temper swings

confusion

seizures

Liver associated:

hepatitis (signs embrace lack of urge for food, itching, yellowing of the pores and skin and eyes,
mild colored bowel motions, darkish colored urine)

Urinary associated:

issues passing urine

darkish colored urine

Eyes associated:

blurred imaginative and prescient.

Metabolism associated:

Signs of speedy respiratory, speedy coronary heart fee and adjustments in consciousness prompted
by pyroglutamic acidosis (an accumulation of pyroglutamic acid as a result of low ranges of
a protein referred to as glutathione).

Name your physician immediately, or go straight to the Emergency Division at your
nearest hospital for those who discover any of those critical negative effects.

 

Inform your physician or pharmacist for those who discover the rest that could be making you
really feel unwell.

Different negative effects not listed right here could happen in some individuals.

Reporting negative effects

After you may have acquired medical recommendation for any negative effects you expertise, you possibly can
report negative effects to the Therapeutic Items Administration on-line at www.tga.gov.au/reporting-problems . By reporting negative effects, you possibly can assist present extra info on the protection of
this drugs.

At all times ensure you converse to your physician or pharmacist earlier than you resolve to cease taking any of your medicines.

Product particulars

This drugs is barely out there with a health care provider’s prescription.

What APX-Paracetamol/Codeine comprises

Don’t take this drugs if you’re allergic to any of those components.

What APX-Paracetamol/Codeine seems like

APX-Paracetamol/Codeine is a white to off-white capsule-shaped pill, marked “P”
and “F” both aspect of a rating line on one aspect and plain on the opposite (AUST R 338093).

It is available in containers of 10 or 20 tablets.

*Not all pack sizes could also be marketed

Who distributes APX-Paracetamol/Codeine

Arrotex Prescription drugs Pty Ltd

15-17 Chapel Avenue

Cremorne, VIC, 3121

Australia

Toll Free Quantity (medical info): 1800 195 055

This leaflet was ready in December 2021.

apx-para-cod-ccdsv5-cmiv3-03dec21

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