Components:
Dihydrocodeine
Method of action:
Analgesic
Available in countries
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor Last updated on 2019.07.21

Name of the medicinal product

Paracodin

Qualitative and quantitative composition

Dihydrocodeine

Therapeutic indications

The information provided in Therapeutic indications of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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For the relief of severe pain in cancer and other chronic conditions.

Paracodin tablets are indicated for use in adults and children over 12 years of age.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Posology

60 mg:

Adults and children over 12 years: One or two tablets 12-hourly.

90 mg and 120 mg:

Adults: The usual dose is one tablet 12-hourly.

Elderly: Dosage should be reduced.

Paediatric population

Children 12 years or under: Not recommended.

Method of administration

Oral.

Contraindications

The information provided in Contraindications of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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<; severe respiratory depression with hypoxia; severe chronic obstructive lung disease; severe cor pulmonale; severe bronchial asthma; paralytic ileus; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Dihydrocodeine should be administered with caution to the elderly or patients with:

- a history of opioid abuse or dependence

- raised intracranial pressure or head injury

- biliary tract disorders

- prostatic hypertrophy

- pancreatitis

- impairment of hepatic function

- severe renal dysfunction

- constipation

- an obstructive bowel disorder

- respiratory depression with hypoxia

- chronic obstructive lung disease

- cor pulmonale

- bronchial asthma

- hypothyroidism

Dihydrocodeine must be administered with caution in patients taking:

- Monoamine oxidase inhibitors

Risk from concomitant use of benzodiazepines (and other CNS depressants):

Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death.). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with dihydrocodeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Dihydrocodeine has a recognised abuse and addiction profile similar to other agonist opioids. Dihydrocodeine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opiod analgesics, including dihydrocodeine. The product should be used with particular care in patients with a history of alcohol and drug abuse.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.

Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.

Paracodin tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potentially fatal dose of dihydrocodeine and may result in overdose effects.

Opioids, such as dihydrocodeine, may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decrease in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Dihydrocodeine may cause drowsiness and, 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 you have this medicine in your body over a specified limit unless you have a defence (called the 'statutory defence').

- This defence applies when:

- The medicine has been prescribed to treat a medical or dental problem; and

- You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

- Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).”

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

Undesirable effects

The information provided in Undesirable effects of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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The adverse experiences listed below are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of > 1% and uncommon adverse drug experiences have an incidence of < 1%.

Undesirable Effects

Common

(> 1%)

Uncommon

(< 1%)

Not Known (frequency cannot be estimated from the available data)

Immune system disorders

Angioedema

Psychiatric disorders

Confusional state

Drug dependence

Hallucination

Mood altered

Dysphoria

Nervous system disorders

Somnolence

Convulsions

Dizziness

Headache

Paraesthesia

Sedation

Eye disorders

Blurred vision

Ear and labyrinth disorders

Vertigo

Vascular disorders

Hypotension

Flushing

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Respiratory depression

Gastrointestinal disorders

Abdominal pain

Constipation

Dry mouth

Nausea

Vomiting

Diarrhoea

Paralytic ileus

Hepato-biliary disorders

Biliary colic

Hepatic enzymes increased

Skin and subcutaneous tissue disorders

Hyperhidrosis

Pruritus

Rash

Urticaria

Renal and urinary disorders

Urinary retention

Ureteric spasm

Reproductive system and breast disorders

Decreased libido

General disorders and administration site conditions

Asthenia

Fatigue

Malaise

Withdrawal syndrome

Drug tolerance

Drug withdrawal syndrome neonatal

Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

Paediatric population

Neonatal respiratory depression and withdrawal symptoms may occur in the newborn of mothers undergoing treatment with dihydrocodeine.

Reporting of adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose

The information provided in Overdose of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea , which may in severe cases result in a fatal outcome.

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.

As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

- Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.

- Paracodin tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Natural opium alkaloids

ATC code: N02A A08

Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.

Central Nervous System

The principal actions of therapeutic value of dihydrocodeine are analgesia and an antitussive effect (depression of the cough reflex by direct effect on the cough centre in the medulla). Antitussive effects may occur with doses lower than those usually required for analgesia.

Dihydrocodeine may produce respiratory depression by direct action on brain stem respiratory centres.

Gastrointestinal Tract and Other Smooth Muscle

Dihydrocodeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of Paracodin tablets and plasma levels are maintained throughout the twelve hour dosing interval.

Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine.

Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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Natural opium alkaloids

Preclinical safety data

The information provided in Preclinical safety data of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Incompatibilities

The information provided in Incompatibilities of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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None Known

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Paracodin is based on data of another medicine with exactly the same composition as the Paracodin of the medicine (Dihydrocodeine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Paracodin directly from the package or from the pharmacist at the pharmacy.
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No special requirements.