IPECACUANHA AND MORPHINE MIXTURE BP 1980

Active substance: MORPHINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ipecacuanha and Morphine Mixture BP 1980

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Hydrochloride
Ipecacuanha Tincture
Liquorice Liquid Extract

3

0.458mg per 5ml.
0.1ml per 5ml.
0.525ml per 5ml.

PHARMACEUTICAL FORM
Mixture

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of coughs.

4.2

Posology and method of administration
Oral.
Recommended doses and dosage schedule
Adults and children over 12 years: 10ml.
The elderly and Debilitated Patients, use with caution; a reduced dose can be
recommended by a doctor.
This dose can be repeated up to 4 times in any 24 hours.

4.3

Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Children under the age of 12 years.
Respiratory depression, and when there is a risk of paralytic ileus.
Acute alcoholism, head injuries and raised intracranial pressure, comatose
patients, delayed gastric emptying, acute abdomen and phaeochromocytoma and
obstructive or inflammatory bowel disorders.
It should not be given during an attack of asthma or to patients with heart failure
secondary to chronic lung disease.

4.4

Special warnings and precautions for use
Use with care in hypotension, shock, myasthenia gravis, prostatic hypertrophy,
diseases of the biliary tract, convulsive disorders, pancreatitis, and cardiac
arrhythmias. Caution is advised in patients with asthma or other respiratory
disorders, hepatic and renal disease, and a history of drug abuse.

Cough suppressants may cause sputum retention and this may be harmful in
patients with chronic bronchitis and bronchiectasis.
A reduced dose is recommended in elderly or debilitated patients, in hepatic and
renal impairment (but avoid if severe), in hypothyroidism, and in adrenocortical
insufficiency.
Administration of some opioid analgesics to patients taking a monoamine
oxidase inhibitor (MAOI) has been associated with very severe and sometimes
fatal reactions. If the use of Ipecacuanha and Morphine Mixture is considered
essential, then great care should be taken in patients taking MAOIs or within 14
days of stopping MAOIs (see section 4.5).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 3.1 vol% ethanol (alcohol) i.e. up to 245 mg per
10 ml dose, equivalent to 6 ml beer or 3 ml wine per dose. It is harmful for
those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver
disease, or epilepsy.
Labels state:

4.5

Do not exceed the stated dose.
If symptoms persist consult your doctor.
The elderly. Ask your doctor for advice; a lower dose might be
more suitable.
Do not give to children under 12 years old.
Keep out of the sight and reach of children.
Shake the bottle.

Interaction with other medicinal products and other forms of interaction
Morphine may potentiate the effects of baclofen, esmolol and gabapentin. The
efficacy of rifampicin may be reduced by morphine. The plasma concentration
of morphine may be reduced by ritonavir. Morphine may have an additive
sedative effect if taken with benzodiazepines.

As an opioid analgesic, morphine may also interact with a range of other drugs
if given concomitantly. Effects of the following drugs may be enhanced if
given with opioid analgesics: alcohol, general anaesthetics (intravenous and
volatile gases), tricyclic antidepressants, sedating antihistamines, antipsychotics,
sodium oxybate, anxiolytics and hypnotics.
The CNS effects of opioid analgesics may be enhanced by barbiturates and by
cisapride. The metabolism of opioid analgesics is inhibited by cimetidine.
The effects of other drugs may be reduced if given with opioid analgesics:
ciprofloxacin (when used for surgical prophylaxis), cisapride, mexiletine,
domperidone and metoclopramide.
Possible CNS excitation or depression (hypertension or hypotension) can occur
when opioid analgesics are given with antidepressants such as MAOIs, e.g.
moclobemide and selegiline (avoid concomitant use and for 2 weeks after
stopping MAOIs).

4.6

Pregnancy and Lactation
As with all medicines use should be avoided during pregnancy, especially in
the first trimester, and in lactation unless recommended by a doctor.

4.7

Effects on ability to drive and use machines
Although considered unlikely with this product, morphine may cause
drowsiness and other central nervous system disorders which may have an
effect on the ability to drive or operate machinery. If affected, patients should
not drive or operate machinery.

This medicine can impair cognitive function and can affect a patient’s ability to
drive safely. This class of medicine is in the list of drugs included in regulations
under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients
should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called “statutory
defence”) if:
o The medicine has been prescribed to treat a medical or dental problem
and
o You have taken it according to the instructions given by the prescriber
and in the information provided with the medicine and
o It was not affecting your ability to drive safely

4.8

Undesirable effects
Adverse effects would not be expected to occur when this preparation is taken at
the recommended dose.
The following undesirable effects have been reported for use of morphine or
opioid analgesics and may arise from use of Ipecacuanha and Morphine
Mixture. The frequency of adverse effects cannot be estimated from available
data.
Psychiatric disorders: hallucinations, dysphoria, euphoria, mood changes,
confusion, dependence, restlessness, agitation, delirium, disorientation,
excitation
Nervous system disorders: dizziness, drowsiness, sleep disturbances,
headache, vertigo, raised intracranial pressure, malaise, seizures, paraesthesia
Eye disorders: miosis, visual disturbances, nystagmus
Cardiac disorders: palpitations, bradychardia, tachycardia
Vascular disorders: postural hypotension, hypotension, hypothermia, facial
flushing, oedema, hypertension, syncope
Respiratory, thoracic and mediastinal disorders: respiratory depression (with
larger doses), bronchospasm
Gastrointestinal disorders: nausea, vomiting, constipation, abdominal pain,
anorexia, exacerbation of pancreatitis, dry mouth, paralytic ileus, dyspepsia,
taste disturbances
Hepatobiliary disorders: biliary spasm
Skin and subcutaneous tissue disorders: rashes, urticaria, pruritis, sweating
Musculoskeletal and connective tissue disorders: muscular rigidity (with
higher doses), muscle fasciculation, myoclonus
Renal and urinary disorders: difficulty with micturition, urinary retention,
ureteric spasm
Reproductive system and breast disorders: decreased libido or potency,
amenorrhoea.

4.9

Overdose
Overdose with this preparation is unlikely to occur due to the low concentrations
of the active ingredients present.
Large doses of ipecacuanha irritate the gastro-intestinal tract and may give rise
to bloody vomiting and diarrhoea. Absorption of emetine may have adverse
effects on the heart, such as conduction abnormalities or myocardial infarction.
Respiratory depression, nausea and vomiting may occur due to the morphine.
Large doses of opioids may also produce pin point pupils, hypotension,
circulatory failure and coma.
After acute overdosage of ipecacuanha, activated charcoal should be given to
delay absorption, followed by gastric lavage if necessary. Excessive vomiting
should be controlled by administration of an antiemetic, fluid and electrolyte
imbalance corrected if necessary and facilities should be available to correct any
cardiac effects and subsequent shock.
In acute opioid poisoning the stomach should be emptied by aspiration and
lavage, intensive supportive therapy may be required to correct respiratory
failure and shock. Activated charcoal may be given orally in conscious patients
if a substantial overdose has been ingested within 1 hour provided that the
airway can be protected.
Severe respiratory depression and coma produced by excessive doses of opioids
can be counteracted by the administration of naloxone given intravenously at a
dose of 0.4 to 2 mg, repeated at 2-3 minute intervals if necessary, up to 10 mg.
Excessive use of liquorice may cause sodium and water retention, hypertension
and hypokalaemia.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ipecacuanha is an expectorant, and in larger doses an emetic.
Morphine is an opioid analgesic acting mainly on the central nervous system
and smooth muscle. It is used for relief of moderate to severe pain and is also
effective as a cough suppressant.

5.2

Pharmacokinetic Properties
Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised
slowly, it has been detected in urine 40-60 days after discontinuation of
treatment.
Morphine salts are absorbed from the gastro-intestinal tract. Morphine is
distributed throughout the body. It crosses the placenta and traces have been
found in milk and sweat.
Conjugation to morphine 3- and 6- glucuronides occurs in the liver. About
10% of a dose is excreted through the bile into the faeces, the remainder being
excreted in the urine in the form of conjugates. About 90% of total morphine
is excreted in 24 hours with traces up to 48 hours.

5.3

Preclinical Safety Data
None.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Treacle Black Commercial, Peppermint Oil, Ethanol (96%), Diethyl Ether
(Peroxide Free), Chloroform, Syrup and Purified Water.

6.2

Incompatibilities
None known.

6.3

Shelf Life
18 months unopened, 8 weeks after first opening.

6.4

Special Precautions for Storage
Store below 25°C.

6.5

Nature and contents of container
200ml: Amber glass bottle with plastic screw cap and liner or white 28mm
Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6

Instructions for Use/Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaith Laboratories
Huddersfield
HD7 5QH

8.

MARKETING AUTHORISATION NUMBER
PL 00240/6491R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

05/03/2009

10

DATE OF REVISION OF THE TEXT
30/07/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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