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Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 328 1629
Medical Information e-mail: medinfo.uk@roche.com
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1707 384555

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 05/03/2012
SPC Roaccutane 20mg Soft Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Underlined text has been added

Underlined text has been added

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

 
Updated on 25/10/2010 and displayed until 05/03/2012
Reasons for adding or 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
Date of revision of text on the SPC:   14-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

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 20/10/2010 and displayed until 25/10/2010
Reasons for adding or 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
Date of revision of text on the SPC:   14-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Underlined text has been added, text with strike through deleted:

 

4.4     Special warnings and precautions for use

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.

 

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.

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

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

* cannot be estimated from the available data

 

6.4     Special precautions for storage

 

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

 

DuplexTriplex-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 15/10/2009 and displayed until 20/10/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   08-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Underlined text has been added, text with strike through deleted:

4.3     Contraindications

 

Isotretinoin is contraindicated in women who are pregnant or breastfeeding (see section 4.6).

 

Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see section 4.4).

 

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.

 

Isotretinoin is also contraindicated in patients

·        With hepatic insufficiency

·        With excessively elevated blood lipid values

·        With hypervitaminosis A

·        Receiving concomitant treatment with tetracyclines (see section 4.5).

Updated on 28/09/2009 and displayed until 15/10/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Underlined text has been added, text with strike through deleted

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each soft capsule contains 20 mg of isotretinoin.

 

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

 

For a full list of excipients, see section 6.1.

 

 

3.       PHARMACEUTICAL FORM

 

Capsules, soft

 

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

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

June 1983/July 1997/December 2004

Date of first Authorisation:  19 April 1983

 

Date of last common renewal:  July 2009

 

 

10.     DATE OF REVISION OF THE TEXT

 

November 2008.

 

 

11.DOSIMETRY

 

Not applicable.

 

 

12.10.INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

 

Not applicable.

 

July 2009

 
Updated on 13/03/2009 and displayed until 28/09/2009
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  isotretinoin