Roaccutane 10mg Soft Capsules
- Name:
Roaccutane 10mg Soft Capsules
- Company:
Roche Products (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/11/20
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Roche Products (Ireland) Ltd
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Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Madopar 200mg/50mg Hard Capsules | Active Ingredients Benserazide Hydrochloride, Levodopa |
| 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 |
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 27 November 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
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 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
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 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 2 August 2018 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 31 October 2017 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
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
Updated on 31 October 2017 SPC
Reasons for updating
- New SPC 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 4.2 - 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
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 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
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: 20 November 2006
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
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 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) |
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)
Very Rare (≤ 1/10 000)
|
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)
|
Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis |
|
Renal and urinary disorders: Very Rare (≤ 1/10 000) |
Glomerulonephritis |
|
General disorders and administration site conditions: Very Rare (≤ 1/10 000) |
|
|
Investigations: Very common (≥ 1/10)
|
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 11 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
10 mg capsules: Oval, opaque, brown-red capsules imprinted with ROA 10 in black ink.
4.3 Contraindications
Isotretinoin is also contraindicated in patients with hypersensitivity to isotretinoin or to any of the excipients. 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.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first Authorisation: 20 November 2006
Date of last common renewal: 10 July 2009
10. DATE OF REVISION OF THE TEXT
OctoberNovember 2008. 2009
11. DOSIMETRY
Not applicable.
11. 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
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
(Click to Download)Pharmacist Checklist – Guidance for dispensing Roaccutane® (isotretinoin)Risk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines
Roaccutane® (isotretinoin) Contraception and Pregnancy Prevention Patient Reminder CardRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines