SEVREDOL Tablets *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 June 2021

File name

spc_1622549633.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3: Reformatting into a bulleted list, addition of severe bronchial asthma, hypoxia and hypercapnia.

Section 4.4: Reformatting into a bulleted list, addition of pre-existing conditions where caution should be exercised; intracranial lesions and reduced level of consciousness of uncertain origin; constipation. Addition of warning statements regarding risk of respiratory depression and sleep apnoea.

Section 4.5: Reworded to improve clarity

Section 4.8: Addition of sleep apnoea syndrome as a possible side effect, update of the term visual disturbance to visual impairment.

Updated on 01 June 2021

File name

pil_1622549482.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2: (Do not take …) addition of severe asthma

Section 2: (Warnings and precautions) addition of warning for sleep apnoea and constipation.

Section 2: (Other medicines …) reworded to improve clarity

Section 4: (Possible side effects …) addition of sleep apnoea

Updated on 01 October 2020

File name

spc_1601558495.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: Addition of PRAC mandated warnings regarding concomitant use with oral P2Y12 inhibitor antiplatelet therapy.

Section 4.5: Addition of PRAC mandated text describing interaction between morphine and P2Y12 inhibitors.

Updated on 18 June 2019

File name

Approved_SPC_clean_Tablets_English_SEVREDOL_PSUSA_medicines_ie_1560854338.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction to section 5.1 'Endocrine System'

Updated on 10 April 2019

File name

Approved_package_leaflet_clean_Tablets_English_SEVREDOL_PSUSA_RtQ__MDC_medicines_ie_1554893341.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 10 April 2019

File name

Approved_SPC_Clean_Tablets_English_SEVREDOL_PSUSA_medicines_ie_1554893144.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to SPC in line with the CMDh wording following Morphine PSUSA/00010549/201710 assessment outcome.

Updated on 08 August 2018

File name

Approved_package_leaflet_clean_English_Sevredol_All_1533720535.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 04 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 July 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Section 2:$0$0The spellingof ‘sulphate’ has been corrected to ‘sulfate’.$0$0MorphineSulfate has been capitalised.$0$0 $0$0Section 3:$0$0Informationabout scoreline has been added.$0$0 $0$0Section 4.2:$0$0Informationabout the route of administration has been moved to the end of this section.$0$0The subtitle‘Posology’ has been added.$0$0‘Children 3-12 years of age’ has beenreplaced by ‘Paediatric population’.$0$0 $0$0Section 4.3:$0$0Informationabout hypersensitivity to the active substance and excipients has beenreworded.$0$0 $0$0Section 4.4:$0$0The spellingof ‘sulphate’ has been corrected to ‘sulfate’.$0$0‘Very rarely’ has been removed as adescription of hyperalgesia.$0$0 $0$0Section 4.6:$0$0Informationabout neonatal opioid withdrawal syndrome has replaced the text on withdrawalsymptoms in newborns.$0$0 $0$0Section 4.8:$0$0‘Allergic reaction’ has been replaced by‘Hypersensitivity’.$0$0‘Asthenic conditions’ has been replacedby ‘Asthenia, Fatigue, Malaise’.$0$0Drugwithdrawal syndrome neonatal has been added under General disorders andadministration site conditions with a frequency of not known.$0$0 $0$0Section 4.9:$0$0‘Pneumonia aspiration’ has been added asa sign of morphine toxicity/overdose.$0$0 $0$0Section 10:$0$0The date ofrevision has been updated to 20 June 2017.$0

Updated on 05 August 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reporting of suspected adverse reactions - the following text has been added.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Updated on 08 June 2015

File name

PIL_8260_788.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 June 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 30 July 2014

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1

Film coat details for 20mg tablets has changed.

Updated on 11 December 2013

Reasons for updating

  • Change of inactive ingredient

Updated on 01 March 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4  The following has been added:

Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur, particularly in high doses. A morphine sulphate dose reduction or change in opioid may be required.

Section 4.8 Has been rewritten throughout


Section 4.9

Overdosage has been changed to overdose

Signs of morphine toxicity and overdosage are pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression and hypotension has been changed to read:

Signs of morphine toxicity and overdose are pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression, hypotension, somnolence and central nervous system depression which can progress to stupor or coma.

Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug - has been deleted

Updated on 28 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects

Updated on 27 February 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 January 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 Marketing Authorisation Holder

is now
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8 Marketing Authorisation Numbers

are now

PA 1688/9/1-3

Updated on 30 January 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 October 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 18 February 2009

Reasons for updating

  • Change to side-effects
  • Change of contraindications

Updated on 17 February 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 severe bronchial asthma added. there is a potential for development of psyychological dependence sentance added.
 
Section 4.5 Gabapentin added
 
Section 4.8 headache as common side effect added

Updated on 01 June 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4.      Special warnings and precautions for use

 

Has been replaced with:

 

The major risk of opioid excess is respiratory depression.

 

As with all narcotics, a reduction in dosage may be advisable in the elderly, in hypothyroidism, in renal and chronic hepatic disease. Use with caution in patients with impaired respiratory function, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, severe cor pulmonale, opioid dependent patients, patients with a history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy and adrenocortical insufficiency. Sevredol tablets should not be used where there is a possibility of paralytic ileus occurring.  Should paralytic ileus be suspected or occur during use, Sevredol tablets should be discontinued immediately.

 

Morphine may lower the seizure threshold in patients with a history of epilepsy.

 

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

 

Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive Sevredol tablets for 4 hours prior to the intervention. If further treatment with Sevredol tablets is indicated then the dosage should be adjusted to the new post-operative requirement. Sevredol tablets should be used with caution pre-operatively and within the first 24 hours post-operatively. Sevredol tablets should also be used with caution following abdominal surgery.

 

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 morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

 

Morphine has an abuse profile similar to other strong agonist opioids.  Morphine may be sought and abused by people with latent or manifest addiction disorders. 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.

 

4.5.      Interaction with other medicinal products and other forms of interaction

 

Has been replaced with :

 

                        Morphine should be used with caution in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anaesthetics, phenothiazines, other tranquilisers, muscle relaxants, antihypertensives and alcohol.  Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of morphine.

 

                        Mixed agonist/antagonist opioid analgesics (e.g. buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.

 

                        Cimetidine inhibits the metabolism of morphine.

 

                        Monoamine oxidase inhibitors are known to interact with narcotic analgesics producing CNS excitation or depression with hyper- or hypotensive crisis. Morphine should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy.

 

                        Plasma concentrations of morphine may be reduced by rifampicin.

 

                        Although there are no pharmacokinetic data available for concomitant use of ritonavir with morphine, ritonavir induces the hepatic enzymes responsible for the glucuronidation of morphine, and may possibly decrease plasma concentrations of morphine.      

 

4.6.      Pregnancy and lactation

 

Has been replaced with:

 

            Sevredol tablets are not recommended during pregnancy and labour due to the risk of neonatal respiratory depression. Administration to nursing mothers is not recommended as morphine is excreted in breast milk. Withdrawal symptoms may be observed in the new born of mothers undergoing chronic treatment.

 

4.8.      Undesirable effects

 

Has been replaced with:

 

In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness.  With chronic therapy, nausea and vomiting are unusual with Sevredol tablets but should they occur the tablets can be readily combined with an anti-emetic if required.  Constipation may be treated with appropriate laxatives.  

 

Common (incidence of ¡Ý 1%) and Uncommon (incidence of <1%) adverse drug reactions are listed in the table below:

           

Body System

Common (¡Ý 1%)

 

Uncommon (< 1%)

Immune system disorders

 

Allergic reaction

Anaphylactic reaction

Anaphylactoid reaction

Psychiatric disorders

Confusion

Insomnia

Thinking disturbances

Agitation

Drug dependence

Dysphoria

Euphoria

Hallucinations

Mood altered

Nervous system disorders

Headache

Involuntary muscle contractions

Myoclonus

Somnolence

Convulsions

Hypertonia

Paraesthesia

Syncope

Vertigo

Eye disorders

 

Miosis

Visual disturbance

Cardiac disorders

 

Bradycardia

Palpitations

Tachycardia

Vascular disorders

 

Facial flushing

Hypertension

Hypotension

Respiratory, thoracic and mediastinal disorders

Bronchospasm

Cough decreased

Pulmonary oedema

Respiratory depression

 

Gastrointestinal disorders

Abdominal pain

Anorexia

Constipation

Dry mouth

Dyspepsia

Nausea

Vomiting

Gastrointestinal disorders

Ileus

Taste perversion

 

Hepatobiliary disorders

Exacerbation of pancreatitis

Biliary pain

Increased hepatic enzymes

Skin and subcutaneous tissue disorders

Hyperhidrosis

Rash

 

Urticaria

Renal and urinary disorders

 

Ureteric spasm

Urinary retention

Reproductive system and breast disorders

 

Amenorrhoea

Decreased libido

Erectile dysfunction

General disorders and administration site conditions

Asthenia

Pruritus

Drug tolerance

Drug withdrawal syndrome

Malaise

Peripheral oedema

                                                                                         

 

The effects of morphine have led to its abuse and dependence may develop with regular, inappropriate use.  This is not a major concern in the treatment of patients with severe pain.

 

 

4.9.      Overdose

 

Has been replaced with:

 

Signs of morphine toxicity and overdosage are pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases. Overdosage can result in death.  Rhabdomyolosis progressing to renal failure has been reported in opioid overdosage.

 

Treatment of morphine overdosage:

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

 

The pure opioid antagonists are specific antidotes against the effects of opioid overdose.  Other supportive measures should be employed as needed.

 

In the case of massive overdosage, administer naloxone 0.8 mg intravenously.  Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).

 

The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient's response.  However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established.

 

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 morphine overdosage.  Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on morphine.  In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

 

Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.

 

5.1.      Pharmacodynamic properties

 

Has been replaced with:

            Pharmacotherapeutic group: Natural opium alkaloid

            ATC code: N02A A01

 

Morphine acts as an agonist at opiate receptors in the CNS particularly mu and to a lesser extent kappa receptors.  Mu receptors are thought to mediate supraspinal analgesia, respiratory depression, and euphoria, and kappa receptors, spinal analgesia, miosis and sedation. 

 

Central Nervous System

The principal actions of therapeutic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis). Morphine produces respiratory depression by direct action on brain stem respiratory centres. 

 

Morphine depresses 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. Morphine causes miosis, even in total darkness.  Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g., pontine lesions of haemorrhagic or ischaemic origin may produce similar findings).  Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose.

 

Gastrointestinal Tract and Other Smooth Muscle

Morphine 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.

 

Cardiovascular System

Morphine may produce release of histamine with or without associated peripheral vasodilation.  Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

 

Endocrine System

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

 

Other Pharmacological Effects

In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.

 

Updated on 21 May 2007

Reasons for updating

  • Correction of spelling/typing errors
  • Change to drug interactions
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects

Updated on 16 January 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1         Name updated to SEVREDOL 10 mg Tablets
Section 2        Removed PhEur and added Each tablet contains
Section 5.1     Pharmaceutical group and atc code added
Section 6.1    Changed purified talc to Talc
Section 6.2    Updated to Not applicable
Section 6.6    Updated to No special requirements
Section 10    Updated to December 2006

Updated on 11 January 2007

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 16 May 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)