Consumer medicine information

APOHealth Paracetamol Plus Codeine & Calmative Tablets

Codeine phosphate hemihydrate; Doxylamine succinate; Paracetamol

BRAND INFORMATION

Brand name

APOHealth Paracetamol Plus Codeine & Calmative Tablets

Active ingredient

Codeine phosphate hemihydrate; Doxylamine succinate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Paracetamol Plus Codeine & Calmative Tablets.

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up-to-date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets. It contains the active ingredient paracetamol, codeine phosphate & doxylamine succinate.

This medicine is used to provide effective temporary relief from the pain and discomfort associated with:

  • neck and back pain
  • headache
  • tension headache
  • toothache
  • backache
  • migraine headache
  • muscle pain
  • nerve pain
  • arthritis
  • rheumatics
  • osteoarthritis
  • period pain
  • symptoms of
    - cold
    - sore throat
    - flu
  • trauma
  • surgery
  • dental procedures
  • and other pain where a combined calmative and analgesic action is required.

This medicine also reduces fever.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Your doctor or pharmacist may have recommended this medicine for another reason.

How it works

Paracetamol is an analgesic with antipyretic action, meaning it also reduces fever.

Doxylamine succinate is an antihistamine with pronounced sedative effects.

Codeine phosphate is an analgesic, and in combination with paracetamol and doxylamine produces greater analgesia than any of these drugs alone and avoids the side effects associated with large doses of codeine.

Use in children

This medicine should not be used in children under 17 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You have or have had any of the following:
    - glaucoma (high pressure in the eyes)
    - stomach or duodenal ulcer, or other stomach problems
    - prostate problems
    - bladder problems
    - acute breathing difficulties such as bronchitis, unstable asthma or emphysema
    - chronic constipation
    - diarrhoea caused by antibiotics or poisoning
  • You have alcohol dependence.
  • You are in labour, especially if the baby is premature.
    The medicine may produce withdrawal effects in the newborn baby.
  • You are breastfeeding.
    It passes into the breast milk and there is a possibility that the baby may be affected.
  • You are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression.
  • You are hypersensitive to, or have had an allergic reaction to, paracetamol, codeine, doxylamine or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

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

Before you start to take it

Before you start taking this medicine, tell your doctor or pharmacist if:

  1. You have allergies to:
    - any other medicines
    - any other substances, such as foods, preservatives or dyes.
  2. You have or have had any medical conditions, especially the following:
    - kidney or liver problems
    - epilepsy
    - difficulty breathing
    - wheezing
    - chronic cough
    - asthma
    - other chronic breathing conditions
    - glaucoma
    - urinary retention
    - chronic alcohol consumption
    - a history of drug dependence, alcohol dependence
    - recent surgery on the stomach or intestines
    - head injury
    - prostate problems
    - low blood pressure
    - underactive thyroid
  3. You are currently pregnant or you plan to become pregnant.
    Do not take this medicine whilst pregnant until you and your doctor or pharmacist have discussed the risks and benefits involved.
  4. You are currently breastfeeding or you plan to breastfeed.
    Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  5. You are planning to have surgery.
  6. You are taking or are planning to take any other medicines.
    This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Taking other medicines

Do not take with other medicines containing paracetamol, unless your doctor or pharmacist says you can.

Some medicines may interact with paracetamol, codeine and doxylamine.

These include:

  • sleeping tablets or sedatives
  • medicines to control fits or anti-epileptic drugs e.g. Dilantin or Tegretol
  • anti-depressant tablets
  • anti-coagulant tablets

If you are taking any of these you may need a different dose or you may need to take different medicines. Your doctor or pharmacist will advise you.

Other medicines not listed above may also interact with paracetamol, codeine and doxylamine.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist and keep to the recommended dose. Their instructions may be different to the information in this leaflet.

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

How much to take

The usual dose for adults and children over 12 years of age is one to two tablets every 4 to 6 hours, as needed for pain relief.

Do not take more than 8 tablets in a 24 hour period.

Do not give this medicine to a child under 12 years.

How to take it

Swallow the tablets with a full glass of water.

When to take it

It does not matter if you take it before, with or after food.

How long to take it for

This medicine is for short term use only.

Adults:
Do not take this medicine for longer than a few days at a time unless advised by a doctor.

Adolescents:
Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.

If pain persists for more than three days, please see your doctor

If you forget to take it

There is no need to take extra doses if the pain has gone away.

If the pain is still present, take your next dose if required.

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

This may increase the chance of you experiencing side effects.

If you are not sure what to do, ask your doctor or pharmacist.

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

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor or pharmacist that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are breastfeeding or are planning to breastfeed
  • you are going to have surgery or an anaesthetic or are going into hospital.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Tell your doctor or pharmacist if:

  • you develop a skin rash or hives while taking this medicine
  • you become pregnant while taking this medicine

Things you must not do

Do not:

  • Drink alcohol.
  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor or pharmacist.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.

This medicine may cause drowsiness or lightheadedness in some people and affect mental alertness.

Make sure you know how you react to this medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you get dizzy

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.

This medicine helps most people with pain, but may have unwanted side effects in a few people.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

  • drowsiness
  • depression
  • dizziness
  • feeling sick or stomach pains
  • diarrhoea
  • loss of appetite, weight loss
  • constipation
  • skin rashes

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Allergic reactions

If you think you are having an allergic reaction to this medicine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

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

Do not store your medicine, 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 this medicine 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

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets looks like

Paracetamol 500mg, Codeine Phosphate 10mg and Doxylamine 5.1mg tablets:
White, capsule shaped, biconvex, bevel edged, uncoated tablets with break line on one side and plain on other side.
It is available in packs of 20 and 40 tablets.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 500mg of paracetamol, 10mg codeine phosphate, 5.1mg doxylamine succinate as the active ingredients.

It also contains the following inactive ingredients:

  • Lactose
  • Starch-Maize
  • Povidone
  • Ethanol
  • Crospovidone
  • Cellulose-microcrystalline, Stearic Acid
  • Magnesium Stearate.

Australian Registration Numbers

APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets (blister pack): AUST R 230135

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

APOHEALTH is a trademark used under license.

This leaflet was last updated in January 2015.

BRAND INFORMATION

Brand name

APOHealth Paracetamol Plus Codeine & Calmative Tablets

Active ingredient

Codeine phosphate hemihydrate; Doxylamine succinate; Paracetamol

Schedule

S4

 

Name of the medicine

Paracetamol 500 mg, codeine phosphate 10 mg and doxylamine succinate 5.1 mg.

Excipients.

Lactose, maize starch, povidone, ethanol, crospovidone, microcrystalline cellulose, stearic acid, magnesium stearate.

Description

Paracetamol.

Molecular formula: C8H9NO2. MW: 151.2. CAS: 130-90-2. Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is an analgesic and antipyretic.

Codeine phosphate.

Molecular formula: C18H21NO3, HPO4.½H2O. MW: 406.4. CAS: 1444-62-6. Codeine phosphate is a white or almost white, crystalline powder or small, colourless crystals. It is freely soluble in water, slightly soluble or very slightly soluble in ethanol (96%). Codeine phosphate is a cough suppressant and an analgesic.

Doxylamine succinate.

Molecular formula: C17H22N2O.C4H6O4. Relative molecular mass: 388.46. CAS: 562-10-7. Doxylamine succinate is a white or creamy white powder with a characteristic odour.

Pharmacology

Paracetamol is an effective and fast acting analgesic that relieves mild to moderate pain. It is rapidly absorbed from the gastrointestinal tract with peak plasma levels usually reached 30 to 60 minutes after oral administration. It also reduces fever by a direct effect on the heat regulating centres to increase dissipation of body heat.
Codeine phosphate is an effective oral analgesic that provides relief from mild to moderate pain. It is also well absorbed from the gastrointestinal tract after oral administration.
Doxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties.

Pharmacokinetics.

Paracetamol.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
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 conjunction 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 metabolized differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

Codeine.

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. Codeine is metabolized by O and N-demethylation and in the liver (via the cytochrome P450 system) to morphine (about 10 percent of a codeine dose is demethylated to morphine), norcodeine and other metabolites including normorphine and hydrocodone. 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.
About 8% of people metabolise drugs poorly via CYP2D6, and are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite, morphine. The plasma half-life of codeine has been reported to be between 3 and 4 hours after oral administration.

Doxylamine succinate.

Doxylamine succinate is readily absorbed from the gastrointestinal tract. Following oral administration, the mean peak plasma concentration occurs after 2-3 hours. It has an elimination half-life of about 10 hours in healthy adults. It is excreted in the urine as unchanged doxylamine (60%) and metabolites (nordoxylamine and dinordoxylamine).
The major metabolic site is the liver and major metabolic pathways are N-demethylation, N-oxidation, hydroxylation, N-acetylation, N-desalkylation and ether cleavage.

Indications

For the effective temporary relief of pain and discomfort associated with neck and back pain, headache, tension headache, migraine headache, toothache, muscle pain, neuralgia, arthritis, rheumatics, osteoarthritis, period pain, symptoms of cold and flu, sore throat, trauma, surgery, dental procedures, other pain where a combined calmative and analgesic action is required. Reduces fever.

Contraindications

APOHealth Paracetamol Plus Codeine & Calmative tablets are contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol, codeine, doxylamine succinate or substances of similar chemical structure or other opiates or other antihistamines of the ethanolamine class (or any of the other ingredients in the product).
APOHealth Paracetamol Plus Codeine & Calmative tablets are also contraindicated for use in patients:
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);
narrow angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction.
APOHealth Paracetamol Plus Codeine & Calmative tablets are contraindicated for use in:
newborns or premature infants;
lactating women;
patients taking monoamine oxidase inhibitors (MAOIs).

Precautions

Products containing codeine should not be given for prolonged periods as codeine may be habit forming. This medication may be dangerous when used in large amounts or for long periods.
Hepatotoxicity may develop following a dose of paracetamol 10 g and hepatic failure is known to occur occasionally with the long-term use of paracetamol.
Patients should be cautioned against the concomitant ingestion of alcohol and antihistamines.
APOHealth Paracetamol Plus Codeine & Calmative tablets should be used with caution in patients with:
impaired hepatic function;
impaired renal function;
epilepsy;
decreased respiratory reserve e.g. asthma or chronic obstructive pulmonary disease (COPD);
pre-existing respiratory depression;
raised intracranial pressure or head injury;
prostatic hypertrophy;
hypotension;
hypothyroidism;
This medicine should also be used with caution in patients who:
have a history of drug abuse;
are taking other respiratory depressants or sedatives, including alcohol;
have had recent gastrointestinal tract surgery;
Codeine present in this medicine may obscure the diagnosis or the course of gastrointestinal diseases.
Codeine present in this medicine may produce physical and psychological dependence, if used for a prolonged period.
APOHealth Paracetamol Plus Codeine & Calmative tablets may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

Impaired renal function.

Paracetamol should be given with care to patients with impaired kidney function.

Impaired hepatic function.

Paracetamol should be given with care to patients with impaired liver function.

Use in pregnancy.

(Category A)
Paracetamol, codeine phosphate and doxylamine succinate 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.

Use in lactation.

APOHealth Paracetamol Plus Codeine & Calmative tablet is not recommended for use by breastfeeding mothers as doxylamine, codeine and paracetamol are excreted in breast milk in small amounts.

Effect on ability to drive or operate machinery.

Both doxylamine succinate and codeine phosphate may cause drowsiness in some patients; therefore patients should be cautioned about operating vehicle or machinery, or engaging in activities that require them to be fully alert.

Interactions

The following interactions have been noted.

Interactions with paracetamol.

Coumarins.

Repeated high doses of paracetamol increase the risk of bleeding in patients taking warfarin and other coumarin derivatives. Dosage reduction of anticoagulants, monitoring of coagulation and bleeding complications is required.

Chloramphenicol.

Paracetamol may slow down the excretion of chloramphenicol, causing the risk of increased toxicity.

Cholestyramine.

Cholestyramine reduces the absorption of paracetamol if given within one hour of paracetamol administration.

Barbiturates and antiepileptic medications.

The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol, barbiturates or antiepileptic drugs.

Probenecid.

Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Concomitant use of paracetamol and isoniazid, phenytoin, zidovudine or sulfinpyrazone has been reported to result in hepatotoxicity. Therefore, patients receiving isoniazid, phenytoin, zidovudine or sulfinpyrazone therapy should avoid large and/or chronic doses of paracetamol.
Narcotic analgesics and drugs, which decrease gastric emptying, may decrease the absorption of paracetamol and vice versa.
Drugs, which increase gastric emptying, may increase the absorption of paracetamol.

Interactions with codeine.

Anticholinergics.

Concomitant use of codeine and anticholinergic agents may increase the risk of severe constipation and/or urinary retention.

Neuromuscular blocking agents.

Codeine may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.

Antihypertensives.

Hypotensive effects may be potentiated when used concurrently with codeine and lead to orthostatic hypotension.

Antiperistaltic antidiarrhoeals (e.g. kaolin, pectin and loperamide).

Their concurrent use with codeine may increase the risk of severe constipation).

Alcohol.

Codeine may potentiate the effects of alcohol.

Metoclopramide.

Codeine may antagonise the effects of metoclopramide on gastrointestinal motility.

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.
Codeine may potentiate the effects of tranquillisers, sedatives, hypnotics, general anaesthetics and CNS depressants.

Interactions with doxylamine succinate.

Monoamine oxidase inhibitors (MAOIs).

Concurrent administration or use within 14 days of ceasing MAOIs may enhance or prolong the anticholinergic and CNS depressive effects of doxylamine succinate.

Adverse Effects

Side effects with APOHealth Paracetamol Plus Codeine & Calmative tablets are infrequent. However, among those reported are anorexia, drowsiness, depression, dizziness, gastrointestinal discomfort (e.g. nausea and diarrhoea), dry mouth and, on rare occasions, rash.
Paracetamol may occasionally cause skin reactions, and isolated cases of agranulocytosis and thrombocytopenic purpura have been reported. Doxylamine succinate may cause drowsiness in some individuals. Constipation may occur in association with codeine.
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.

Central Nervous Systems (CNS) effects.

CNS depressive effects of doxylamine succinate include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night time dose.
CNS stimulatory effects of doxylamine succinate may include anxiety, hallucinations, appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.
High doses of doxylamine succinate may cause nervousness, tremor, insomnia, agitation, and irritability.

Anticholinergic effects.

Side effects of doxylamine succinate associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.

Dosage and Administration

Adults and children over 12 years.

One or two tablets every four to six hours as needed for relief. Do not exceed eight tablets in a 24 hour period. For short-term use only. This product is not recommended for use over long periods.

Children under 12 years.

Not recommended for use in children under 12 years.

Overdosage

In case of overdose, immediately contact the Poisons Information Centre (in Australia, call 131 126), or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage with paracetamol.

Paracetamol.

It has been reported that paracetamol may produce symptoms of acute toxicity in adults following the ingestion of more than 15 g. Hepatotoxicity may develop after the ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) and a dose of more than 25 g is potentially fatal. Patients may be asymptomatic for several days following ingestion of large doses of paracetamol and laboratory evidence of hepatotoxicity may be delayed for up to one week. Nonfatal hepatic damage is usually reversible. The antidote, N-acetylcysteine, should be administered as early as possible.

Codeine.

In an evaluation of codeine intoxication in children, symptoms ranked by decreasing order of frequency included sedation, rash, miosis, vomiting, itching, ataxia and swelling of the skin. Respiratory failure may occur. Blood concentrations of codeine ranged from 1.4 to 5.6 microgram/mL in eight adults whose deaths were attributed primarily to codeine overdosage.

Doxylamine.

Reactions associated with doxylamine overdosage may vary from CNS depression to stimulation. Stimulation is particularly likely in children. Insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions can occur. Atropine-like signs and symptoms (e.g. dry mouth, fixed and dilated pupils, flushing and gastrointestinal symptoms) may also occur.

Presentation

Tablets (white, capsule shaped, biconvex, bevel edged, uncoated, break line on one side and plain on reverse): 20's, 40's (blister pack).

Storage

Store below 30°C.

Poison Schedule

S3.