Consumer medicine information

SANDOZ ANALGESIC CALMATIVE

Paracetamol; Codeine phosphate hemihydrate; Doxylamine succinate

BRAND INFORMATION

Brand name

Sandoz Analgesic/Calmative

Active ingredient

Paracetamol; Codeine phosphate hemihydrate; Doxylamine succinate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using SANDOZ ANALGESIC CALMATIVE.

What is in this CMI

This leaflet answers some common questions about Sandoz Analgesic/Calmative Tablets.

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 taking this medicine against the benefits they expect it will have for you.

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

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

What are Sandoz Analgesic/Calmative Tablets used for

The name of your medicine is Sandoz Analgesic/Calmative Tablets.

It contains the active ingredients paracetamol, codeine phosphate & doxylamine succinate.

Paracetamol, an analgesic with antipyretic action 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 these components.

Sandoz Analgesic/Calmative Tablets are 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.

It also reduces fever.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Before you take Sandoz Analgesic/Calmative Tablets

When you must not take it

Do not take this medicine if you have an allergy to:

  • any medicine containing paracetamol, codeine, doxylamine or other antihistamines or
  • any of the inactive ingredients listed at the end of this leaflet.

Signs of an allergic reaction may include:

  • rash
  • itching of the skin
  • shortness of breath and
  • swelling of the tongue and face.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

Do not take this medicine if the packaging is torn or shows signs of tampering.

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

  • 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

Do not take this medicine if you have alcohol dependence.

Do not take this medicine during labour, especially if the baby is premature. The medicine may produce withdrawal effects in the newborn baby.

Do not take this medicine if you are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression.

Do not take this medicine if you are breastfeeding or plan to breastfeed. It passes into the breast milk and there is a possibility that the baby may be affected.

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

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines,
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant, intend to become pregnant, or are breastfeeding or intend to breastfeed. Your doctor or pharmacist will discuss the possible risks and benefits of using this medicine during pregnancy and breastfeeding.

Tell your doctor or pharmacist if you suffer from 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.

Tell your pharmacist or doctor if you take sedatives (medicines used to help you relax or sleep).

Tell your doctor if you plan to have surgery. If you have not told your doctor about any of the above, tell them before you use this medicine.

Taking other medicines

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

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

Some medicines may interact with this medicine. 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

These medicines may be affected by Sandoz Analgesic/Calmative Tablets or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist will advise you. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take Sandoz Analgesic/Calmative Tablets

Follow all directions given to you by your doctor or pharmacist carefully and keep to the recommended dose. They may differ from the information contained 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 this medicine before or after food.

How long to take it

This medicine is for short term use only.

Adults and children over 12 years:
The usual dose is one to two tablets to be taken every four to six hours, as needed for relief, up to four times daily. Do not exceed 8 tablets in a 24 hour period. Keep to the recommended dose.

Adults:
Don't 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.

This medicine is not recommended for children under 12 years of age. 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 double a dose to make up for the dose you have missed.

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

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

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.

If you have taken too much of this medicine, you may feel drowsy, sick in the stomach, or restless and you may need urgent medical attention.

While you are taking Sandoz Analgesic/Calmative Tablets

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking this medicine.

If you are about to be started on a new medicine tell you doctor or pharmacist that you are taking this medicine.

If you plan to have surgery that needs a general anesthetic, tell your doctor or dentist that you are taking this medicine.

Tell your doctor 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.

Do not give this medicine to anyone else, even if they have the same symptoms as you.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine. This medicine helps most people with pain, but may have unwanted 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.

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

  • 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 if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Sandoz Analgesic/Calmative Tablets

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Keep your medicine in a cool, dry place where it stays below 30°C

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

Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep this medicine where young 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

Return any unused medicines to your pharmacist.

Product Description

What it looks like

Tablets are white, circular, flat bevel edged tablets plain on both sides.

It is available in packs of 20 and 40 tablets.

Active ingredients:
Each tablet contains:

  • Paracetamol 500mg
  • Codeine Phosphate 10mg
  • Doxylamine Succinate 5.1mg

Other ingredients:

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

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
Level 2, 19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500

This leaflet was prepared in June 2013.

Australian Register Number
AUST R 211514

Published by MIMS February 2014

BRAND INFORMATION

Brand name

Sandoz Analgesic/Calmative

Active ingredient

Paracetamol; Codeine phosphate hemihydrate; Doxylamine succinate

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.
Paracetamol:

Description

Paracetamol.

Molecular formula: C8H9NO2. MW: 151.2. CAS: 103-90-2. 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.H3PO4.½H2O. MW: 406.4. CAS: 1444-62-6. Codeine phosphate is a white or almost white, crystalline powder or small, colourless crsytals. 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. MW: 388.46. CAS: 562-10-7. Doxylamine succinate is a white or creamy white powder with a characterisitc 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 concetrations occurring about every 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 phosphate.

Codeine phosphate and its salts are well absorbed from the gastrointestinal tract: peak plasma codeine concentrations occur after about one hour after ingestion of codeine phosphate. Codeine phosphate is metabolized by O and N-demethylation and in the liver (via the cytochrome P450 system) to morphine (about 10 per cent of a codeine dose is demethylated to morphine), norcodeine and other metabolites including normorphine and hydrocodone. Codeine phosphate 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 phosphate due to reduced formation of the active metabolite, morphine. The plasma half-life of codeine phosphate 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

Sandoz Analgesic/Calmative Tablet is 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).
Sandoz Analgesic/Calmative Tablet is 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.
Sandoz Analgesic/Calmative Tablet is 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.
Sandoz Analgesic/Calmative Tablet 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.
Sandoz Analgesic/Calmative Tablet 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.

Sandoz Analgesic/CalmativeTablet 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 additives 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 Sandoz Analgesic/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 system (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 circular, flat, bevel edged, plain on both sides): 20's, 40's (blister pack).

Storage

Store below 30°C.

Poison Schedule

S3.