Roaccutane 20mg Soft Capsules

  • Name:

    Roaccutane 20mg Soft Capsules

  • Company:
    info
  • Active Ingredients:

    Isotretinoin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/10/20

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Summary of Product Characteristics last updated on medicines.ie: 19/3/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Roche Products (Ireland) Ltd

Roche Products (Ireland) Ltd

Company Products

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Medicine Name Madopar 50mg/12.5mg, 100mg/25mg Dispersible Tablets Active Ingredients Benserazide Hydrochloride, Levodopa
Medicine Name Pulmozyme 2500 U/2.5ml Nebuliser Solution Active Ingredients Dornase Alfa
Medicine Name Rivotril 0.5mg Tablets Active Ingredients Clonazepam
Medicine Name Roaccutane 10mg Soft Capsules Active Ingredients Isotretinoin
Medicine Name Roaccutane 20mg Soft Capsules Active Ingredients Isotretinoin
Medicine Name Rocephin 1g Powder and Solvent for IM Injection Only Active Ingredients Ceftriaxone sodium
Medicine Name Rocephin 1g Powder for Solution for Injection or Infusion Active Ingredients Ceftriaxone sodium
Medicine Name Valcyte 450 mg Film-coated Tablets Active Ingredients valganciclovir hydrochloride
Medicine Name Valcyte 50mg/ml Powder for Oral Solution Active Ingredients valganciclovir hydrochloride
1 - 0 of 10 items.Total: Infinity pages

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 25 November 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 25 November 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 November 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 27 October 2020 PIL

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 19 March 2020

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Implementation of changes to the product information following the outcome of PSUSA/00010488/201905 - for Roaccutane 10 mg and 20 mg soft capsules - EE/H/0271/001-002/IA/075

Updated on 19 March 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 April 2019

Reasons for updating

  • 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

1. Addition of gynaecomastia as ADR in SmPC and PIL resulting from PSUSA/10488/201805

2. Correction of inconsistency between SmPC and PL based on MHRA request

Updated on 28 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 28 August 2018

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

MAH Transfer from RPL to Roche Products (Ireland) Limited issue of new PA licence number(s)

Updated on 8 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Addition of Black Inverted Triangle

Updated on 3 August 2018

Reasons for updating

  • 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 10 - Date of revision of the text
  • Addition of Black Inverted Triangle
  • File format updated to PDF

Updated on 31 October 2017 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Underlined text has been added:

4.8       Undesirable effects

[…]

System Organ Class

Very Common

Common

Rare

Very Rare

Not known*

Reproductive system and breast disorders

 

 

 

 

Sexual dysfunction including erectile dysfunction and decreased libido

 

[…]

Reporting of suspected 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.

10.       DATE OF REVISION OF THE TEXT

30 October 2017

 

Updated on 31 October 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 30 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 October 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 28 July 2015 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

$0Underlined text has been added, text with strike-through deleted:$0$02.         QUALITATIVE AND QUANTITATIVE COMPOSITION$0$0 $0$0Each soft capsule contains 20 mg of isotretinoin.$0$0 $0$0Excipients with known effect:  $0$0Contains soya bean oil (refined, hydrogenated and partially hydrogenated) and  sorbitol (E420).$0$0 $0$0For a full list of excipients, see section 6.1.$0$0 $0$04.2       Posology and method of administration$0$0 $0$0Posology$0$0 $0$0Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.$0$0 $0$0The capsules should be taken with food once or twice daily.$0$0 $0$0Paediatric Population$0$0Roaccutane should not be used for the treatment of prepubertal acne and is not recommended in children less than 12 years of age due to a lack of data on efficacy and safety.$0$0 $0$0Method of administration $0$0[…]$0$0Patients with severe renal insufficiencyrenal impairment $0$0In patients with severe renal insufficiency treatment should be started at a lower dose (e.g. 10 mg/day). The dose should then be increased up to 1 mg/kg/day or until the patient is receiving the maximum tolerated dose (see section 4.4).$0$0 $0$0Children$0$0Roaccutane is not indicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age due to a lack of data on efficacy and safety.$0$0[…]$0$04.3       Contraindications$0$0 $0$0Isotretinoin is contraindicated in women who are pregnant or breastfeeding (see section 4.6).$0$0 $0$0Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see section 4.4).$0$0 $0$0Isotretinoin is also contraindicated in patients with hypersensitivity to isotretinoin or to any of the excipients listed in section 6.1. Roaccutane 10  mg contains soya oil, partially hydrogenated soya oil, and hydrogenated soya oil. Therefore, Roaccutane 10  mg is contraindicated in patients allergic to peanut or soya.$0$0[…]$0$04.4       Special warnings and precautions for use$0$0[…]$0$0Musculo-skeletal and connective tissue disorders$0$0Myalgia, arthralgia and increased serum creatine phosphokinase values have been reported in patients receiving isotretinoin, particularly in those undertaking vigorous physical activity (see section 4.8). In some cases, this may progress to potentially life threatening rhabdomyolysis.$0$0[…]$0$04.6       Fertility, Ppregnancy and lactation$0$0 $0$0Pregnancy$0$0$0Pregnancy is an absolute contraindication to treatment with isotretinoin (see section 4.3). Women of childbearing potential have to use effective contraception during and up to one month after treatment. If pregnancy does occur in spite of these precautions during treatment with Roaccutane or in the month following, there is a great risk of very severe and serious malformation of the foetus. $0$0$0 $0$0$0Pregnancy is an absolute contraindication to treatment with isotretinoin (see section 4.3). If pregnancy does occur in spite of these precautions during treatment with isotretinoin or in the month following, there is a great risk of very severe and serious malformation of the foetus.$0$0$0[…]$0$0LactationBreastfeeding:$0$0Isotretinoin is highly lipophilic, therefore the passage of isotretinoin into human milk is very likely. Due to the potential for adverse effects in the child exposed via mothers’ milk, the use of Roaccutane isotretinoin is contraindicated during breast-feeding (see section 4.3)in nursing mothers.$0$0 $0$0 $0$0Fertility$0$0Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of the men taking isotretinoin.$0$0 $0$04.7          Effects on ability to drive and use machines$0$0 $0$0Roaccutane could potentially have an influence on the ability to drive and use machines. $0$0[…]$0$04.8       Undesirable effects$0$0 $0$0Summary of sSafety pProfile$0$0Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.  The following symptoms are the most commonly reported undesirable effects with isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis). $0$0 $0$0Tabulated list of adverse reactions$0$0The incidence of the adverse reactions calculated from pooled clinical trial data involving 824 patients and from post-marketing data are presented in the table below. The adverse reactions are listed below by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as Very common (³1/10), Common (³1/100 to <1/10), Uncommon (³1/1,000 to <1/100), Rare (³1/10,000 to <1/1,000), Very rare (³1/10,000 to <1/1,000) and not known (cannot be estimated from the available data). Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness. $0$0 $0$0Table 1                 Tabulated list of adverse reactions in patients treated with isotretinoin$0$0 $0$0$0$0$0$0Infections:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Gram positive (mucocutaneous) bacterial infection$0$0$0$0$0$0Blood and lymphatic system disorders:$0$0Very common (≥ 1/10)$0$0 $0$0Common (≥ 1/100, < 1/10)$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0 $0$0Anaemia, red blood cell sedimentation rate increased, $0$0thrombocytopenia, thrombocytosis$0$0Neutropenia$0$0Lymphadenopathy$0$0$0$0$0$0Immune system disorders:$0$0Rare (≥ 1/10 000,< 1/1000)$0$0$0$0 $0$0Allergic skin reaction, anaphylactic reactions, hypersensitivity$0$0$0$0$0$0Metabolism and nutrition disorders:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Diabetes mellitus, hyperuricaemia$0$0$0$0$0$0Psychiatric disorders:$0$0Rare (≥ 1/10 000,< 1/1000)$0$0 $0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.$0$0Abnormal behaviour, psychotic disorder, suicidal ideation suicide attempt, suicide$0$0$0$0$0$0Nervous system disorders:$0$0Common (≥ 1/100, < 1/10)$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Headache$0$0Benign intracranial hypertension, convulsions, drowsiness, dizziness$0$0$0$0$0$0Eye disorders:$0$0Very common (≥ 1/10)$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Blepharitis, conjunctivitis, dry eye, eye irritation$0$0Blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as sign of benign intracranial hypertension), photophobia, visual disturbances.$0$0$0$0$0$0Ear and labyrinth disorders:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Hearing impaired$0$0$0$0$0$0Vascular disorders:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Vasculitis (for example Wegener’s granulomatosis, allergic vasculitis)$0$0$0$0$0$0Respiratory, thoracic and mediastinal disorders:$0$0Common (≥ 1/100, < 1/10)$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0 $0$0Epistaxis, nasal dryness, nasopharyngitis$0$0Bronchospasm (particularly in patients with asthma), hoarseness$0$0$0$0$0$0Gastrointestinal disorders:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis (see section 4.4)$0$0$0$0$0$0Hepatobiliary disorders:$0$0Very common (≥ 1/10)$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Transaminase increased (see section 4.4)$0$0Hepatitis$0$0$0$0$0$0Skin and subcutaneous tissues disorders:$0$0Very common (≥ 1/10)$0$0 $0$0Rare (≥ 1/10 000,< 1/1000)$0$0Very Rare (≤ 1/10 000)$0$0 $0$0 $0$0 $0$0 $0$0Frequency unknown*                             $0$0$0$0 $0$0 $0$0Cheilitis, dermatitis, dry skin, localised exfoliation, pruritus, rash erythematous, skin fragility (risk of frictional trauma)$0$0Alopecia$0$0Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased$0$0 $0$0Erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis.$0$0$0$0$0$0Musculo-skeletal and connective tissue disorders:$0$0Very common (≥ 1/10)$0$0Very Rare (≤ 1/10 000)$0$0 $0$0 $0$0 $0$0Frequency unknown*                                                     Arthralgia, Myalgia$0$0$0$0 $0$0Arthralgia, myalgia, back pain (particularly in children and adolescent patients)$0$0Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis$0$0 $0$0Rhabdomyolysis$0$0$0$0$0$0Renal and urinary disorders:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Glomerulonephritis$0$0$0$0$0$0General disorders and administration site conditions:$0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0 $0$0Granulation tissue (increased formation of), malaise$0$0$0$0$0$0Investigations:$0$0Very common (≥ 1/10)$0$0 $0$0Common (≥ 1/100, < 1/10)$0$0 $0$0Very Rare (≤ 1/10 000)$0$0$0$0 $0$0Blood triglycerides increased, high density lipoprotein decreased$0$0Blood cholesterol increased, blood glucose increased, haematuria, proteinuria$0$0Blood creatine phosphokinase increased $0$0$0$0$0$0* cannot be estimated from the available data$0$0The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data.$0$0$0$0$0$0System Organ Class$0$0$0$0Very Common$0$0$0$0Common$0$0$0$0Rare$0$0$0$0Very Rare$0$0$0$0Not known*$0$0$0$0$0$0$0$0Infections$0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Gram positive (mucocutaneous) bacterial infection$0$0$0$0 $0$0$0$0$0$0Blood and lymphatic system disorders$0$0 $0$0$0$0Thrombocytopenia, anaemia, thrombocytosis,$0$0red blood cell sedimentation rate increased, $0$0 $0$0$0$0Neutropenia$0$0 $0$0$0$0 $0$0$0$0Lymphadenopathy$0$0$0$0 $0$0$0$0$0$0Immune system disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Anaphylactic reactions, hypersensitivity, allergic skin reaction hypersensitivity$0$0$0$0 $0$0$0$0 $0$0$0$0$0$0Metabolism and nutrition disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Diabetes mellitus, hyperuricaemia$0$0$0$0 $0$0$0$0$0$0Psychiatric disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.$0$0 $0$0$0$0Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour$0$0$0$0 $0$0$0$0$0$0Nervous system disorders$0$0 $0$0$0$0 $0$0$0$0Headache$0$0 $0$0$0$0 $0$0$0$0Benign intracranial hypertension, convulsions, drowsiness, dizziness$0$0$0$0 $0$0$0$0$0$0Eye disorders$0$0 $0$0$0$0Blepharitis, conjunctivitis, dry eye, eye irritation$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Papilloedema (as sign of benign intracranial hypertension), cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, photophobia, visual disturbances, blurred vision.$0$0$0$0 $0$0$0$0$0$0Ear and labyrinth disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Hearing impaired$0$0$0$0 $0$0$0$0$0$0Vascular disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Vasculitis (for example Wegener’s granulomatosis, allergic vasculitis)$0$0$0$0 $0$0$0$0$0$0Respiratory, thoracic and mediastinal disorders$0$0 $0$0$0$0 $0$0$0$0Nasopharyngitis,, $0$0epistaxis, nasal dryness $0$0 $0$0$0$0 $0$0$0$0Bronchospasm (particularly in patients with asthma), hoarseness$0$0$0$0 $0$0$0$0$0$0Gastrointestinal disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Inflammatory bowel disease, colitis, ileitis, pancreatitis, gastrointestinal haemorrhage, haemorrhagic diarrhoea, nausea dry throat, (see section 4.4)$0$0$0$0 $0$0$0$0$0$0Hepatobiliary disorders$0$0 $0$0$0$0Transaminase increased (see section 4.4)$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Hepatitis$0$0$0$0 $0$0$0$0$0$0Skin and subcutaneous tissues disorders$0$0 $0$0$0$0Pruritus, rash erythematous, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility (risk of frictional trauma)$0$0 $0$0$0$0 $0$0$0$0Alopecia$0$0 $0$0$0$0Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased$0$0 $0$0$0$0Erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis.$0$0$0$0$0$0Musculo-skeletal and connective tissue disorders$0$0 $0$0$0$0Arthralgia, myalgia, back pain (particularly in children and adolescent patients)$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis$0$0 $0$0$0$0Rhabdomyolysis ** $0$0$0$0$0$0Renal and urinary disorders$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Glomerulonephritis$0$0$0$0 $0$0$0$0$0$0General disorders and administration site conditions$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0 $0$0$0$0Granulation tissue (increased formation of), malaise$0$0$0$0 $0$0$0$0$0$0Investigations$0$0 $0$0$0$0Blood triglycerides increased, high density lipoprotein decreased$0$0 $0$0$0$0Blood cholesterol increased, blood glucose increased, haematuria, proteinuria$0$0 $0$0$0$0 $0$0$0$0Blood creatine phosphokinase increased$0$0$0$0 $0$0$0$0$0$0* cannot be estimated from the available data$0$0 $0$0** Serious cases of rhabdomyolysis, often leading to hospitalisation and some with fatal outcome, have been reported, particularly in those undertaking vigorous physical activity. $0$0 $0$0Reporting of suspected adverse reactions$0$0Reporting 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 the national reporting system listed in Appendix V.$0$0 $0$05.1       Pharmacodynamic properties$0$0[…]$0$0Clinical Eefficacy and safety$0$0Hypercornification of the epithelial lining of the pilosebaceous unit leads to shedding of corneocytes into the duct and blockage by keratin and excess sebum. This is followed by formation of a comedone and, eventually, inflammatory lesions. Isotretinoin inhibits proliferation of sebocytes and appears to act in acne by re-setting the orderly program of differentiation. Sebum is a major substrate for the growth of Propionibacterium acnes so that reduced sebum production inhibits bacterial colonisation of the duct.$0$0[…]$0$05.2       Pharmacokinetic properties$0$0[…]$0$0MetabolismBiotransformation$0$0After oral administration of isotretinoin, three major metabolites have been identified in plasma: 4-oxo-isotretinoin, tretinoin, (all-trans retinoic acid), and 4-oxo-tretinoin. These metabolites have shown biological activity in several in vitro tests. 4-oxo-isotretinoin has been shown in a clinical study to be a significant contributor to the activity of isotretinoin (reduction in sebum excretion rate despite no effect on plasma levels of isotretinoin and tretinoin).  Other minor metabolites includes glucuronide conjugates. The major metabolite is 4-oxo-isotretinoin with plasma concentrations at steady state, that are 2.5 times higher than those of the parent compound.  $0$0[…]$0$0Pharmacokinetics in special populationsHepatic impairment$0$0Since isotretinoin is contraindicated in patients with hepatic impairment, limited information on the kinetics of isotretinoin is available in this patient population. $0$0 $0$0Renal impairment$0$0Renal failure does not significantly reduce the plasma clearance of isotretinoin or 4-oxo-isotretinoin.$0$05.3       Preclinical safety data$0$0[…]$0$0Fertility$0$0Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of the men taking isotretinoin.$0$0 $0$0[…]$0$06.4       Special precautions for storage$0$0 $0$0Duplex (PVC/PVDC)-aluminium blisters:$0$0Do not store above 25 °C.$0$0Store in the original package and keep blister in the outer carton in order to protect from moisture and light.$0$0 $0$0 $0$06.5       Nature and contents of container$0$0 $0$0Duplex (PVC/PVDC)  -aluminium blister packs containing 20, 30, 50 or 100 capsules$0$0 $0$0Not all pack sizes may be marketed.$0$09.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION$0$0 $0$0 $0$0Date of first Authorisation $0$019 April 1983$0$0 $0$0Date of last common renewal$0$0210 July 2009$0$0 $0$010.     DATE OF REVISION OF THE TEXT$0$0 $0$01 July 2015$0$0 $0

Updated on 27 July 2015 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 30 May 2012 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

 

Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.  The following symptoms are the most commonly reported undesirable effects with isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).

 

Infections:

Very Rare (≤ 1/10 000)

 

Gram positive (mucocutaneous) bacterial infection

Blood and lymphatic system disorders:

Very common (≥ 1/10)

 

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

 

Anaemia, red blood cell sedimentation rate increased,

thrombocytopenia, thrombocytosis

Neutropenia

Lymphadenopathy

Immune system disorders:

Rare (≥ 1/10 000,< 1/1000)

 

Allergic skin reaction, anaphylactic reactions, hypersensitivity

Metabolism and nutrition disorders:

Very Rare (≤ 1/10 000)

 

Diabetes mellitus, hyperuricaemia

Psychiatric disorders:

Rare (≥ 1/10 000,< 1/1000)

 

Very Rare (≤ 1/10 000)

 

Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.

Abnormal behaviour, psychotic disorder, suicidal ideation suicide attempt, suicide

Nervous system disorders:

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

Headache

Benign intracranial hypertension, convulsions, drowsiness, dizziness

Eye disorders:

Very common (≥ 1/10)

Very Rare (≤ 1/10 000)

 

Blepharitis, conjunctivitis, dry eye, eye irritation

Blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as sign of benign intracranial hypertension), photophobia, visual disturbances.

Ear and labyrinth disorders:

Very Rare (≤ 1/10 000)

 

Hearing impaired

Vascular disorders:

Very Rare (≤ 1/10 000)

 

Vasculitis (for example Wegener’s granulomatosis, allergic vasculitis)

Respiratory, thoracic and mediastinal disorders:

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

 

Epistaxis, nasal dryness, nasopharyngitis

Bronchospasm (particularly in patients with asthma), hoarseness

Gastrointestinal disorders:

Very Rare (≤ 1/10 000)

 

Colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis (see section 4.4)

Hepatobiliary disorders:

Very common (≥ 1/10)

Very Rare (≤ 1/10 000)

 

Transaminase increased (see section 4.4)

Hepatitis

Skin and subcutaneous tissues disorders:

Very common (≥ 1/10)

 

Rare (≥ 1/10 000,< 1/1000)

Very Rare (≤ 1/10 000)

 

 

 

Frequency unknown*                     

 

 

Cheilitis, dermatitis, dry skin, localised exfoliation, pruritus, rash erythematous, skin fragility (risk of frictional trauma)

Alopecia

Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Musculo-skeletal and connective tissue disorders:

Very common (≥ 1/10)

 

Very Rare (≤ 1/10 000)

 

 

 

Frequency unknown*                                                      

 

 

Arthralgia, myalgia, back pain (particularly in children and adolescent patients)

Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis

 

rhabdomyolysis

Renal and urinary disorders:

Very Rare (≤ 1/10 000)

 

Glomerulonephritis

General disorders and administration site conditions:

Very Rare (≤ 1/10 000)

 

 

Granulation tissue (increased formation of), malaise

Investigations:

Very common (≥ 1/10)

Common (≥ 1/100, < 1/10)

 

Very Rare (≤ 1/10 000)

 

Blood triglycerides increased, high density lipoprotein decreased

Blood cholesterol increased, blood glucose increased, haematuria, proteinuria

Blood creatine phosphokinase increased

* cannot be estimated from the available data

The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data.

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 19 April 1983

Date of last renewal: 10 July 2009

 

Updated on 3 May 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 3 April 2012 SPC

Reasons for updating

  • 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

All underlined text to be added.

4.8      Undesirable effects

Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.  The following symptoms are the most commonly reported undesirable effects with isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).

Infections:

Very Rare (≤ 1/10 000)

 

Gram positive (mucocutaneous) bacterial infection

Blood and lymphatic system disorders:

Very common (≥ 1/10)

 

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

 
Anaemia, red blood cell sedimentation rate increased,

thrombocytopenia, thrombocytosis


Neutropenia

Lymphadenopathy

Immune system disorders:

Rare (≥ 1/10 000,< 1/1000)

 

Allergic skin reaction, anaphylactic reactions, hypersensitivity

Metabolism and nutrition disorders:

Very Rare (≤ 1/10 000)

 

Diabetes mellitus, hyperuricaemia

Psychiatric disorders:

Rare (≥ 1/10 000,< 1/1000)

 

Very Rare (≤ 1/10 000)

 

Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.

Abnormal behaviour, psychotic disorder, suicidal ideation suicide attempt, suicide

Nervous system disorders:

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

Headache

Benign intracranial hypertension, convulsions, drowsiness, dizziness

Eye disorders:

Very common (≥ 1/10)

Very Rare (≤ 1/10 000)

 

Blepharitis, conjunctivitis, dry eye, eye irritation

Blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as sign of benign intracranial hypertension), photophobia, visual disturbances.

Ear and labyrinth disorders:

Very Rare (≤ 1/10 000)

 

Hearing impaired

Vascular disorders:

Very Rare (≤ 1/10 000)

 

Vasculitis (for example Wegener’s granulomatosis, allergic vasculitis)

Respiratory, thoracic and mediastinal disorders:

Common (≥ 1/100, < 1/10)

Very Rare (≤ 1/10 000)

 

 

Epistaxis, nasal dryness, nasopharyngitis

Bronchospasm (particularly in patients with asthma), hoarseness

Gastrointestinal disorders:

Very Rare (≤ 1/10 000)

 

Colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis (see section 4.4)

Hepatobiliary disorders:

Very common (≥ 1/10)

Very Rare (≤ 1/10 000)

 

Transaminase increased (see section 4.4)

Hepatitis

Skin and subcutaneous tissues disorders:

Very common (≥ 1/10)

 

Rare (≥ 1/10 000,< 1/1000)

Very Rare (≤ 1/10 000)

 

 

 

Frequency unknown*                             

 

 
Cheilitis, dermatitis, dry skin, localised exfoliation, pruritus, rash erythematous, skin fragility (risk of frictional trauma)

Alopecia

Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Musculo-skeletal and connective tissue disorders:

Very common (≥ 1/10)

 

Very Rare (≤ 1/10 000)

 

 

 Frequency unknown*                                                                         

 

 
Arthralgia, myalgia, back pain (particularly in children and adolescent patients)


Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis

 
rhabdomyolysis

Renal and urinary disorders:

Very Rare (≤ 1/10 000)

 

Glomerulonephritis

General disorders and administration site conditions:

Very Rare (≤ 1/10 000)

 

 

Granulation tissue (increased formation of), malaise

Investigations:

Very common (≥ 1/10)

Common (≥ 1/100, < 1/10)


Very Rare (≤ 1/10 000)

 

Blood triglycerides increased, high density lipoprotein decreased

Blood cholesterol increased, blood glucose increased, haematuria, proteinuria

Blood creatine phosphokinase increased

* cannot be estimated from the available data

The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data.

 

10.      DATE OF REVISION OF THE TEXT

 

 October 2010 11th January 2012

 

 

 

Updated on 9 February 2012 PIL

Reasons for updating

  • Change to further information section

Updated on 29 July 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 April 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 25 October 2010 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

 

The following text has been added:

There have been post-marketing reports of severe skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) associated with isotretinoin use. As these events may be difficult to distinguish from other skin reactions that may occur (see section 4.8), patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. If a severe skin reaction is suspected, isotretinoin treatment should be discontinued.

 

Paragraph below has been relocated

Allergic reactions

Anaphylactic reactions have been rarely reported, in some cases after previous topical exposure to retinoids. Allergic cutaneous reactions are reported infrequently. Serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement have been reported. Severe allergic reactions necessitate interruption of therapy and careful monitoring.

 

 

4.8     Undesirable effects

 

(underlined text added)

Skin and subcutaneous tissues disorders:

 

Frequency unknown*

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

 

* cannot be estimated from the available data

 

6.4     Special precautions for storage

 

(underlined text added, text with strike through deleted)

Triplex Duplex (PVC/PE/PVDC)-aluminium blisters:

Do not store above 25 °C.

Store in the original package and keep blister in the outer carton in order to protect from moisture and light.

 

Aluminium-aluminium blisters:

Do not store above 30 °C.

Store in the original package in order to protect from moisture and light.

 

 

 

6.5     Nature and contents of container

 

TriplexDuplex-aluminium blister packs containing 20, 30, 50 or 100 capsules

 

Aluminium-aluminium blister packs containing 20, 30, 50 or 100 capsules

 

Not all pack sizes or pack types may be marketed.

 

Updated on 21 October 2010 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects

Updated on 24 November 2009 PIL

Reasons for updating

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

Updated on 24 November 2009 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 12 - Instructions for preparation of radiopharmaceuticals

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

Free text change information supplied by the pharmaceutical company

Underlined text = new text
Struck through text = deleted text


2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Excipients:  Contains soya bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol (E420).

 

 

3.       PHARMACEUTICAL FORM

 

20 mg capsules: Oval, opaque, brown-red and white capsules imprinted with ROA 20 in black ink.

 

 

4.3     Contraindications

 

Isotretinoin is also contraindicated in patients with hypersensitivity to isotretinoin or to any of the excipients. Roaccutane 20 mg contains soya oil, partially hydrogenated soya oil, and hydrogenated soya oil. Therefore, Roaccutane 20 mg is contraindicated in patients allergic to peanut or soya.

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

19th April 1983/31st December 2004

Date of first Authorisation: 19 April 1983

 

Date of last common renewal: 10 July 2009

 

 

10.     DATE OF REVISION OF THE TEXT

 

November 2008. NovemberOctober 2009

 

 

11.DOSIMETRY

 

Not applicable.

 

 

12.10.INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

 

Not applicable.

 

Updated on 2 July 2009 SPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 June 2009 PIL

Reasons for updating

  • Change to further information section

Updated on 17 September 2007 PIL

Reasons for updating

  • Change to information about driving or using machinery

Updated on 14 February 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 September 2005 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision

Updated on 1 March 2005 PIL

Reasons for updating

  • New PIL for medicines.ie
  • Physician Checklist/Acknowledgement Form for Prescribing Roaccutane® (isotretinoin) to Female PatientsRisk Minimisation Materials

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  • Pharmacist Checklist – Guidance for dispensing Roaccutane® (isotretinoin)Risk Minimisation Materials

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  • Roaccutane® (isotretinoin) Contraception and Pregnancy Prevention Patient Reminder CardRisk Minimisation Materials

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