Consumer medicine information

Painstop Day-Time Pain Reliever

Codeine phosphate hemihydrate; Paracetamol

BRAND INFORMATION

Brand name

Painstop For Children Day-Time Pain Reliever Syrup

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Painstop Day-Time Pain Reliever.

What is in this leaflet

This leaflet answers some common questions about Painstop Day-Time Pain Reliever®.

It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Painstop DayTime Pain Reliever® against the benefits they expect it will have for you.

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

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

What Painstop DayTime Pain Reliever® is used for

Painstop Day-Time Pain Reliever® is an analgesic (pain reliever). It works to temporarily relieve acute moderate pain when paracetamol alone is not sufficient in adults and children 12 years and older.

It contains paracetamol and codeine phosphate.

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.

Ask your pharmacist or doctor if you have any questions about this medicine.

This medicine may be addictive if taken for more than a few days at a time.

It is only available from your pharmacist.

Before you take/give Painstop Day-Time Pain Reliever®

When you must not take it

Do not take Painstop Day-Time Pain Reliever® if you:

  • are under 12 years of age
  • are breastfeeding
  • are aged 18 years or younger and have had recent surgery on your tonsils or adenoids
  • are known to be an ultra-rapid metaboliser of codeine.

Do not take Painstop Day-Time Pain Reliever® if you have an allergy to:

  • any medicine containing paracetamol
  • any medicine containing codeine
  • any of the ingredients listed at the end of this leaflet.

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

Do not take this medicine if you have any of the following conditions:

  • acute breathing difficulties such as bronchitis, unstable asthma or emphysema
  • chronic constipation
  • diarrhoea caused by antibiotics or poisoning

Do not take this medicine if you regularly drink large quantities of alcohol.

Do not take codeine during labour, especially if the baby is premature.

The medicine may produce withdrawal effects in the newborn baby.

Do not take this medicine/it after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your pharmacist or doctor if you have or have had any of the following medical conditions:

  • liver or kidney disease
  • difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing conditions
  • a history of drug or alcohol dependence
  • recent surgery on the throat, stomach or intestines
  • head injury
  • enlarged prostate
  • low blood pressure
  • underactive thyroid.

Tell your pharmacist or doctor if you are pregnant or plan to become pregnant.

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

If you have not told your pharmacist or doctor about any of the above, tell them before you start taking Painstop Day-Time Pain Reliever®.

Taking other medicines

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.

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

Painstop Day-Time Pain Reliever® and some other medicines may interfere with each other. These include:

  • 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

These medicines may be affected by Painstop Day-Time Pain Reliever® or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist will have more information on these and other medicines to be careful with or avoid while taking this medicine.

How to take Painstop Day-Time Pain Reliever®

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.

How much to take

Adults and children 12 years and over: 20 mL to 35 mL by mouth every 6 hours as needed.

Always use a metric medicine measure to ensure you give the correct dose

Do not take more than the recommended dose

How long to take it

Adults: Only take Painstop DayTime Pain Reliever® for a few days at a time unless your doctor tells you to take it for longer.

Children and adolescents aged 1217: Only take the medicine for 48 hours unless your doctor tells you to take it for longer.

If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Painstop Day-Time Pain Reliever®. Do this even if there are no signs of discomfort or poisoning.

Taking too much paracetamol can lead to delayed, serious liver damage. You may need urgent medical attention.

While you are using Painstop Day-Time Pain Reliever®

Things you must 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.

Things you must not do

Do not take with other medicines containing paracetamol unless your doctor or pharmacist tells you to.

Adults: Do not take for more than a few days at a time unless your doctor tells you to.

Adolescents 12 to 18 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.

Things to be careful of

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.

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.

Be careful driving or operating machinery until you know how Painstop Day-Time Pain Reliever® affects you.

This medicine may cause dizziness in some people. If this happens, do not drive or operate machinery.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Painstop Day-Time Pain Reliever®.

This medicine helps most people who need a pain reliever, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

  • nausea or dyspepsia
  • vomiting
  • drowsiness
  • dizziness
  • constipation

The above list includes the more common side effects of your medicine. They are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

  • unusual or extreme mood swings
  • flushing of the face
  • fast heartbeat.

The above list includes serious side effects that may require medical attention. Serious side effects are rare for low doses of this medicine and when used for a short period of time.

If any of the following happen, tell your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital:

  • 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

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Painstop Day-Time Pain Reliever®

Storage

Keep your medicine in the original pack until it is time to take.

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store Painstop Day-Time Pain Reliever® or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

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

Disposal

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

Product description

What it looks like

Painstop Day-Time Pain Reliever® is a clear colourless solution with a tutti-fruity flavour. It comes in 100mL and 200mL amber PET bottles with a child-resistant cap.

Ingredients

Painstop Day-Time Pain Reliever® contains 24 mg of paracetamol and 1 mg of codeine phosphate per mL.

It also contains: macrogol, glycerol, sodium chloride, citric acid monohydrate, sodium citrate, methyl hydroxybenzoate, propyl hydroxybenzoate, saccharin sodium, xanthan gum, menthol, tutti frutti flavour and purified water. This medicine does not contain sugar, alcohol, lactose, gluten or colourants.

Manufacturer/Distributor/ Supplier

Painstop Day-Time Pain Reliever® is distributed and supplied in Australia by:

Care Pharmaceuticals Pty Ltd
Suite 302, Level 3, 75 Grafton Street
Bondi Junction NSW 2022
Australia
Phone: 1800 788 870
Fax: (02) 9387 6654
E-mail: [email protected]
Website: www.carepharmaceuticals.com.au

® = Registered Trademark or

­­

™ = Trademark (if appropriate)

This leaflet was prepared in March 2018

The AUST R number of Painstop Day-Time Pain Reliever® is 131721

BRAND INFORMATION

Brand name

Painstop For Children Day-Time Pain Reliever Syrup

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

1 Name of Medicine

Paracetamol and codeine phosphate hemihydrate.

6.7 Physicochemical Properties

Paracetamol.

Chemical structure.


CAS number.

103-90-2.

Codeine phosphate.

Chemical structure.


CAS number.

52-28-8.

2 Qualitative and Quantitative Composition

Painstop Day-Time Pain Reliever contains the following active ingredients: Paracetamol 24 mg in 1 mL and codeine phosphate hemihydrate 1 mg in 1 mL; and the following inactive ingredients (excipients) with known effect: methyl hydroxybenzoate, propyl hydroxybenzoate and saccharin sodium. For the full list of excipients see Section 6.1. 'List of Excipients'.

3 Pharmaceutical Form

Painstop Day-Time Pain Reliever is a clear colourless solution with a tutti fruity flavour for oral use (dosage form: 'oral liquid'). It is presented in 100 mL and 200 mL amber PET bottles with a child resistant cap.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.
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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. The elimination half-life varies from about 1 to 3 hours.

Distribution.

Codeine crosses the placenta and is distributed into breast milk.
Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses.

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. The plasma half-life of codeine has been reported to be between 3 and 4 hours after oral administration.
About 8% of patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. 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.

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.
Paracetamol is excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol.

5.3 Preclinical Safety Data

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of acute moderate pain when paracetamol alone is not sufficient in patients over the age of 12 years (see also Section 4.3 Contraindications and Paediatric use).

4.3 Contraindications

Painstop Day-Time Pain Reliever Is contraindicated for use in patients who are:
CYP2D6 ultra-rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use).
Younger than 12 years (see Section 4.4 Special Warnings and Precautions for Use - Paediatric use).
Aged between 12 and 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 and life-threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use - Paediatric use).
Breastfeeding (see Section 4.6 Fertility, Pregnancy and Lactation - Use in lactation).
With known hypersensitivity or idiosyncratic reaction to paracetamol, codeine or any of the other ingredients in the product.
With acute 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).
Refer to Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

CYP2D6 metabolism.

Painstop Day-Time Pain Reliever is 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 to infants of rapid metaboliser mothers who take codeine.
The prevalence of codeine ultra-rapid metabolism by CYP2D6 in children is not known, but 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.
(Refer to Section 4.6 Fertility, Pregnancy and Lactation - Use in lactation and Section 4.4 Special Warnings and Precautions for Use - Paediatric use.)

Paediatric use.

Painstop Day-Time Pain Reliever is contraindicated for use in children:
Younger than 12 years.
Aged between 12 and 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 a CYP2D6 polymorphism.
(See also Section 4.4 Special Warnings and Precautions for Use - CYP2D6 metabolism.)

Additional precautions.

Codeine should be used with caution in patients:
With decreased respiratory reserve e.g. asthma or COPD. Painstop Day-Time Pain Reliever is contraindicated for use in patients with acute respiratory depression (see Section 4.3 Contraindications).
With pre-existing respiratory depression.
Who have a history of drug abuse.
Who are taking other respiratory depressants or sedatives, including alcohol.
Who have had recent gastrointestinal tract surgery.
With raised intracranial pressure or head injury.
With prostatic hypertrophy.
With hepatic or renal impairment.
With hypertension.
With hypothyroidism.
Codeine may obscure the diagnosis or the course of gastrointestinal diseases. Prolonged use of codeine may produce physical and psychological dependence.

Use in hepatic impairment.

Painstop Day-Time Pain Reliever should be used with caution in patients with impaired hepatic function.

Use in renal impairment.

Painstop Day-Time Pain Reliever should be used with caution in 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.

Effect on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with codeine have been noted:
CNS depressants. Concomitant use with central nervous system depressants (e.g. barbiturates, chloral hydrate, sedatives, alcohol and centrally acting muscle relaxants) can cause additive CNS depression.
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.
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.
Tranquillisers, sedatives and hypnotics. Codeine may potentiate the effects of these preparations.
The following interactions with paracetamol have been noted:
Anticoagulant drugs (warfarin). Dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that 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 and anticonvulsant agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within one hour of paracetamol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Codeine and paracetamol have been taken by a large number of pregnant women and women of child bearing 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. Painstop Day-Time Pain Reliever is contraindicated for use during labour when delivery of a premature infant is anticipated as it may produce codeine withdrawal symptoms in the neonate (see Section 4.3 Contraindications).
Painstop Day-Time Pain Reliever is contraindicated during breastfeeding (see also Section 4.4 Special Warnings and Precautions for Use - CYP2D6 metabolism) due to risk of respiratory depression in the infant.
Analgesic doses excreted in breast milk are generally low. However, infants of breastfeeding mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultrarapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolised by cytochrome P4502D6 (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 also Section 4.4 Special Warnings and Precautions for Use - CYP2D6 metabolism).
Therefore, Painstop Day-Time Pain Reliever is 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. Breastfeeding mothers should be told how to recognise 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.

4.8 Adverse Effects (Undesirable Effects)

Adverse 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 effects include cough suppression, respiratory depression, euphoria, dysphoria, skin rashes, histamine release (hypotension, flushing of the face, tachycardia, breathlessness) and other allergic reactions. Prolonged use of codeine may produce physical and psychological dependence.
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 http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

20 mL to 35 mL orally every 6 hours as needed.

4.7 Effects on Ability to Drive and Use Machines

Codeine may cause drowsiness. Those affected should not drive or operate machinery.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Macrogol, glycerol, sodium chloride, citric acid monohydrate, sodium citrate, methyl hydroxybenzoate, propyl hydroxybenzoate, saccharin sodium, xanthan gum, menthol, tutti frutti flavour and water purified.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The duration of shelf life of Painstop Day-Time Pain Reliever is 24 months.

6.4 Special Precautions for Storage

Painstop Day-Time Pain Reliever should be stored below 25 degrees Celsius, do not refrigerate.

6.5 Nature and Contents of Container

Painstop Day-Time Pain Reliever is presented in 100 mL and 200 mL amber PET bottles with a child resistant cap.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes