New Zealand Consumer Medicine Information

CODEINE PHOSPHATE TABLETS (PSM)

Codeine Phosphate Hemihydrate 15 mg, 30 mg & 60 mg

What is in this leaflet

Please read this leaflet carefully before you start using Codeine Phosphate Tablets
(PSM).

This leaflet answers some common questions about Codeine Phosphate Tablets
(PSM).

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 you using
Codeine Phosphate Tablets (PSM) against the benefits they expect it will have for
you.

If you have any concerns about using this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is Codeine Phosphate Tablets (PSM)

The name of your medicine is CODEINE PHOSPHATE TABLETS (PSM).

The active ingredient is called codeine phosphate hemihydrate.

Codeine phosphate hemihydrate belongs to a group of medicines called analgesics,

which are used to block pain.
It is an opioid analgesic, and it acts by blocking pain and your emotional response to
pain.

What Codeine Phosphate Tablets (PSM) are used for

Codeine phosphate is indicated for:

• the relief of mild to moderate pain (including pain associated with terminal
illness, post-operative pain, headache and cough),

• the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning).

1
Your doctor may have prescribed Codeine Phosphate Tablets (PSM) for another
reason.

Ask your doctor if you have any questions about why Codeine Phosphate Tablets
(PSM) has been prescribed for you.

Codeine Phosphate Tablets (PSM) are available only with a doctor's prescription.

Codeine is an addictive substance.

Before you use Codeine Phosphate Tablets (PSM)

When you must not use it

Do not use Codeine Phosphate Tablets (PSM) if you have a known

hypersensitivity/are allergic to:

• Codeine phosphate, other opioids (such as morphine or oxycodone), or any of

the ingredients listed at the end of this leaflet;

Some of the symptoms of an allergic reaction to codeine phosphate may

include red, itchy skin rashes; difficulty breathing; faintness; hay fever and
swelling of the face or throat;

Do not use Codeine Phosphate Tablets (PSM) if you:

• are aged less than 12 years.

• are an adolescents aged less than 18 years for pain following surgery to
remove tonsils or adenoids;
• are an adolescents aged less than 18 years in whom respiratory function
might be compromised;
• are breastfeeding;
• are experiencing breathing difficulties such as asthma, bronchitis, emphysema,
obstructive airways disease;
• suffer acute alcoholism, or have recently ingested a large amount of alcoholic
beverages;
• have recently had a head injury or a condition that raise the pressure within your
head;
• are at risk of paralysis of the intestine;
• have liver failure;
• have heart failure secondary to chronic lung disease;
• are suffering from diarrhoea caused by poisoning or antibiotics;

2
 • are taking monoamine oxidase inhibitors (medicines for treating depression or
mood swings) or it is within fourteen days of stopping such treatment.

Do not give Codeine Phosphate Tablets (PSM) to:

• Children aged less than 12 years.

• Adolescents aged less than 18 years for pain following surgery to remove
tonsils or adenoids;
• Adolescents aged less than 18 years in whom respiratory function might be
compromised; Women who are breastfeeding

Do not use Codeine Phosphate Tablets (PSM) after the expiry date (EXP) printed on
the pack has been reached.

If you take it after the expiry date has passed, it may have no effect at all, or worse,
there may be an entirely unexpected effect.
If you are not sure whether you should start using Codeine Phosphate Tablets (PSM),
talk to your doctor.

Codeine Phosphate Tablets (PSM) should not be used during pregnancy without
consulting your doctor.

Codeine phosphate hemihydrate is distributed to the breast milk so should not be

usedfor breastfeeding mothers.

Elderly patients are more likely to have less effective kidney function due to age.
This may increase the risk of side effects.

Before you start to use it

• Tell your doctor if you are allergic to any other medicines.

• have any other medical conditions/health problems including:
• have recent removal of tonsils, adenoids or have had other throat surgery;
• have an underactive thyroid gland;
• have addison’s disease (low activity of the adrenal glands);
• have impaired kidney or liver function;
• a prostate disorder;
• shock/hypotension (sudden low blood pressure);
• myasthenia gravis (an autoimmune neuromuscular disease);
• convulsions / convulsive disorders;
• gall bladder disease or gall stones;
• recent gastro-intestinal surgery;
• urinary tract surgery;
• a breathing disorder; lung disease or history of asthma;
• obstructive bowel disorders;

3
• CYP2D6 genetic polymorphism.
• are taking monoamine oxidase inhibitors or it is within 14 days of stopping
such treatment;
• are suffering from opioid dependence;
• are suffering from opioid withdrawal symptoms;
• are pregnant or intend to become pregnant;
• are breast feeding or intend to breastfeed;
• are a child aged less than 12 years;
• are an adolescents aged less than 18 years for pain following surgery to
remove tonsils or adenoids
• are an adolescents aged less than 18 years in whom respiratory function
might be compromised
• are elderly.

If you have not told your doctor about any of the above, tell them before you
start using Codeine Phosphate Tablets (PSM).

Taking other medicines

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

You should also tell any health professional who is prescribing a new medication for
you that you are taking Codeine Phosphate Tablets (PSM).

Some medicines may interfere with Codeine Phosphate Tablets (PSM).

These include:
• Monoamine oxidase inhibitors (medicines for treating depression);
• Alcohol;
• Hypnotics and anxiolytics (Medicines to help you sleep or relieve anxiety);
• Anticholinergics (medicines used to treat muscle spasms);
• Metoclopramide and Domperidone (medicines used to relieve nausea and
vomiting);
• Medicines used to treat diarrhoea;
• Anaesthetics;
• Tricyclic antidepressants (medicines used to treat depression);
• Antipsychotics (including phenothiazines);
• Other opioid analgesics used to block pain;
• Quinidine (a medicine used to treat abnormal or irregular heart beat);
• Antihypertensive drugs (medicines used to treat high blood pressure);
• Ciprofloxacin (an antibiotic);

4
 • Ritonavir (an antiviral);
• Mexiletine (a medicine used to treat arrhythmias within the heart, or serious
irregular heart beats);
• Cimetidine (a medicine used to treat reflux or stomach ulcer).

The above medicines may reduce the effectiveness of Codeine Phosphate tablets
(PSM), and/ or react with Codeine Phosphate tablets (PSM) resulting in untoward or
sometimes dangerous side effects.

This list is not exhaustive.

Your doctor or pharmacist has more information on medicines to be careful with or

avoid while taking Codeine Phosphate Tablets (PSM).

How to use Codeine Phosphate Tablets (PSM)

How much to take

The recommended dose of Codeine phosphate tablets (PSM) is:

Adults:
Given orally in divided doses of 15 mg to 60 mg, as prescribed by your doctor.
The maximum recommended daily dose should not exceed 300 mg.

Adolescents and paediatrics:

As prescribed by your Doctor.

When to take it

Adults:
Every 4 to 6 hours, as prescribed by your doctor, up to a maximum recommended
daily dose is 300 mg.

Adolescents and paediatrics:

As prescribed by your Doctor.

How long to take it

Continue taking Codeine Phosphate Tablets (PSM) for as long as your doctor tells
you.

If symptoms persist, see your doctor.

For long term users, seek advice from the prescriber before stopping the medicine.
Stopping the medicine may lead to withdrawal symptoms.

5
If you forget to take it

Take your dose as soon as you remember and then go back to taking it as you would
normally.

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

If you are unsure about whether to take your next dose, speak to your doctor or
pharmacist.

Do not try to make up for a missed dose by taking more than one dose at a time.
This may increase the chance of you getting an unwanted effect.

The medicine is only intended for the use of the person it has been prescribed for.

If you have trouble remembering when to take your medicine, ask your pharmacist
for some hints.

While you are using Codeine Phosphate Tablets

(PSM)

Things you must do

Use Codeine Phosphate Tablets (PSM) exactly as directed or as prescribed by your

doctor.

Contact a doctor immediately if you become pregnant while you are taking the
medicine.

If you are about to be started on any new medicine tell your doctor and pharmacist
that you are taking Codeine Phosphate Tablets (PSM).

Tell your doctor if you feel Codeine Phosphate tablets is not helping your condition.

Visit your doctor regularly, as your doctor needs to check your progress and see
whether you need to keep taking Codeine Phosphate tablets (PSM).

Always discuss with your doctor any problems or difficulties during or after taking
Codeine Phosphate tablets (PSM).

You should tell any other doctors or dentists treating you that you are taking Codeine
Phosphate tablets (PSM).

6
Things you must not do

Do not take any other medicines while you are taking Codeine Phosphate tablets
(PSM) without first telling your doctor.

Do not drive or operate machinery until you know how Codeine Phosphate tablets
(PSM) affects you.

Codeine Phosphate may cause dizziness in some people and therefore may affect
alertness.

Make sure you know how you react to Codeine Phosphate before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy or
have blurred vision.

Do not give this medicine to anyone else, even if his or her symptoms seem similar to
yours.

Things to be careful of

Be careful drinking alcohol while taking Codeine Phosphate tablets (PSM).

If you drink alcohol, it could make some of the unwanted side effects of
Codeine Phosphate worse.

Your doctor may suggest that you avoid alcohol completely or reduce the amount of
alcohol you drink while you are taking Codeine Phosphate tablets.

Some people may experience side effects such as nausea, vomiting, constipation,
drowsiness, dizziness, which may further affect the risk when driving or using
dangerous machinery.

Codeine Phosphate tablets (PSM) may be habit forming if used for extended periods
of time.

In case of overdose

If you take too much (overdose)

Immediately telephone your doctor or the National Poisons Centre (telephone 0800
POISON or 0800 764 766), or go to accident and emergency at your nearest
hospital, if you think that you or anyone else may have taken too many Codeine
Phosphate Tablets (PSM).

Do this even if there are no signs of discomfort or poisoning.

7
The signs and systems of overdose may include weakness, dizziness, lethargy,
nausea, vomiting, sweating, mental confusion and hypotension.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while
you are using Codeine Phosphate Tablets (PSM).

Codeine Phosphate tablets (PSM) helps most people in the treatment of mild to
moderate pain. However, it may have unwanted side effects in some people,
especially in elderly patients or those with underlying disorders.

All medicines have side effects. Sometimes they are serious, most of the time they
are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Common Side Effects:

Tell your doctor if you notice any of the following and they worry you:
• stomach cramps
• dry mouth
• loss of appetite
• constipation
• nausea (feeling sick)
• vomiting
• dizziness
• drowsiness
• feeling faint
• excitability
• skin rashes
• unable to sleep
• unusual dreams

Some side effects are potentially serious. Contact your doctor immediately if
you notice any of the following less common side effects:
• itchy, raised or red skin rash
• swelling of face
• muscle stiffness
• breathing difficulties

8
 • heartbeat irregularities
• blurred or double vision
• difficulty in urinating (passing water)

Other adverse effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible adverse effects. You may not experience
any of them.

Check with your doctor as soon as possible if you have any problems while
taking Codeine Phosphate tablets (PSM) even if you do not think the problems
are connected with the medicine or are not listed in this leaflet.

After using Codeine Phosphate Tablets (PSM)

Storage

Keep out of reach of children

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Keep Codeine Phosphate tablets (PSM) in a cool dry place where the temperature
stays below 25°C and protect from light.

Do not store it, or any other medicines, in a bathroom or near a sink.

Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines.

The tablets should not be taken if they show visible signs of deterioration.

Do not take Codeine Phosphate if the tablets do not look quite right.

Keep your tablets in the pack they were provided in until it is time to take them.

Disposal

If your doctor tells you to stop taking this medication OR it has passed their expiry
date, ask your pharmacist what to do with any left over.

Product description

What it looks like

9
Codeine Phosphate Tablets (PSM) are white, biconvex circular tablets.

Ingredients

Codeine Phosphate Tablets (PSM) 15 mg:

Each tablet contains: 15mg of codeine phosphate hemihydrate, plus

Lactose, Maize Starch (cornflour) and Magnesium stearate.

Codeine Phosphate Tablets (PSM) 30 mg:

Each tablet contains: 30mg of codeine phosphate hemihydrate, plus

Lactose, Maize Starch (cornflour), Acacia Gum, Purified Talc and Magnesium
stearate.

Codeine Phosphate Tablets (PSM) 60 mg:

Each tablet contains: 60mg of codeine phosphate hemihydrate, plus

Lactose, Maize Starch (cornflour) and Magnesium Stearate.

Sponsor Details

Codeine Phosphate Tablets (PSM) are supplied in New Zealand by:

PSM Healthcare Ltd, t/a API Consumer Brands

PO Box 76 401
Manukau City
Auckland 2241
NEW ZEALAND
Phone 0508 776746

Date of Preparation
This leaflet was prepared in May 2018
(based on the data sheet dated May 2018

10