PAINAMOL PLUS Tablet Ref.[50534] Active ingredients: Codeine Paracetamol

Do not use continuously for more than 10 days without consulting your doctor.

Dosages in excess of those recommended may cause severe liver damage.

Codeine should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.

Painamol Plus tablets contain tartrazine which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, myasthenia gravis, impaired renal function, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.

The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, phenothiazines, tricyclic antidepressants.

The prolonged use of high doses of codeine has produced dependence of the morphine type. The administration of codeine during labour may cause respiratory depression in the new born infant.

PAINAMOL PLUS contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of Paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes. The plasma-paracetamol concentrations considered an indication for antidote treatment should be halved in patients receiving enzyme-inducing drugs such as carbamazepine, phenobarbital, phenytoin, primidone or rifampicin.

Excretion of paracetamol may be reduced and plasma concentrations increased when given with probenecid.

Hepatotoxicity at therapeutic doses of paracetamol has been reported in patients receiving isoniazid.

The depressant effects of Codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. The hypotensive actions of diuretics and antihypertensive agents may be potentiated when used concurrently with opioid analgesics. Concurrent use of hydroxyzine with Codeine may result in increased analgesia as well as increased CNS depressant and hypotensive effects.

Concurrent use of Codeine with antidiarrhoeal and antiperistaltic agents such as loperamide and kaolin may increase the risk of severe constipation.

Concomitant use of antimuscarinics or medications with antimuscarinic action may result in an increased risk of severe constipation which may lead to paralytic ileus and/or urinary retention.

The respiratory depressant effects caused by neuromuscular blocking agents may be additive to the central respiratory depressant effects of opioid analgesics. CNS depression or excitation may occur if Codeine is given to patients receiving monoamine oxidase inhibitors, or within two weeks of stopping treatment with them. Quinidine can inhibit the analgesic effect of Codeine.

Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic effect of the latter. Codeine may antagonise the gastrointestinal effects of metoclopramide, cisapride and domperidone.

Cimetidine inhibits the metabolism of opioid analgesics resulting in increased plasma concentrations.

Naloxone antagonises the analgesic, CNS and respiratory depressant effects of opioid analgesics. Naltrexone also blocks the therapeutic effect of opioids.

Interference with laboratory tests: Opioid analgesics interfere with a number of laboratory tests including plasma amylase, lipase, bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine aminotransferase and aspartate aminotransferase. Opioids may also interfere with gastric emptying studies as they delay gastric emptying, and with hepatobiliary imaging using technetium Tc99m disofenin as opioid treatment may cause constriction of the sphincter of Oddi and increases biliary tract pressure.

Pregnancy

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dose. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. Codeine crosses the placenta. There is no adequate evidence of safety in human pregnancy and a possible association with respiratory and cardiac malformations has been reported.

Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. Use during pregnancy should be avoided if possible. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

Breast-feeding

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Codeine is contraindicated in women during breastfeeding (see section 4.3).

Administration to nursing women is not recommended as codeine may be secreted in breast milk and may cause respiratory depression in the infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

Codeine may cause drowsiness, if affected patients should be advised not to drive or operate machinery.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/index/8.

None known.