Reasons for adding or updating:

• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 06-Mar-2017

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PRAC Recommendation DDI with CYP3A inhibitors including cobicistat-containing products

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 10 - Date of revision of the text

Date of revision of text on the SPC: 17-May-2015

Legal Category:POM

Black Triangle (CHM): NO

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Section 4.4 updated to include new paragraph:

Systemic glucocorticoid treatment can cause chorioretinopathy which can lead to visual disorders including visual loss. Prolonged use of systemic glucocorticoid treatment even at low dose can cause chorioretinopathy (see section 4.8).

Section 4.8: to include 'chorioretinophathy' under 'Eye Disorders.

Reasons for adding or updating:

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

Date of revision of text on the SPC: 04-Jul-2014

Legal Category:POM

Black Triangle (CHM): NO

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Section 4.8 updated to reflect the new PV legislation wording on adverse effect reporting.

Reasons for adding or 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

Date of revision of text on the SPC: 15-Aug-2013

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Black Triangle (CHM): NO

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Section 4.4 updated as follows:-

Paragraph title 'Adrenal suppression' updated:
Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency which could be fatal, being tapered off over weeks or months according to the dose and duration of treatment. 

New paragraph added to 'Anti-inflammatory/immunosuppressive effects and infection:-

Tendonitis and tendon rupture are known class effect of glucocorticoids. The risk of such reactions may be increased by coadministration of quinolones (see section 4.8 undesirable effects).

New paragraph added to 'Special precautions':-

Glucocorticoids are known to cause irregular menstruation and leucocytosis, care should be taken with deflazacort.  

Paragraph title 'Use in Children' changed to 'Paediatric population'

Section 4.5 updated:-

The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, beta 2-agonists, xanthines and carbenoxolone are enhanced.

Section 4.8 updated as detailed below:

4.8       Undesirable effects

 

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see Warnings and Precautions).

 

The following CIOMS frequency rating is used, when applicable: Very common (≥10%); common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); not known (cannot be estimated from available data).

 

Endocrine disorders/metabolic

Uncommon: Suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea, Cushingoid facies.

Not known: Ggrowth suppression in infancy, childhood and adolescence., menstrual irregularity and amenorrhoeaand.  Cushingoid facies., hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy.  Negative protein and calcium balance.  Increased appetite.

 

Metabolism and nutrition disorders

Common: Weight gain.

Uncommon: impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, sodium and water retention with hypertension, potassium loss and hypokalaemic alkalosis when coadministered with beta 2-agonist and xanthines.

Not known: Negative protein and calcium balance, increased appetite.

 

Anti-inflammatory and immunosuppressive effectsInfections and Infestations

Uncommon: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see Warnings and Precautions).

 Not known: candidiasis.

 

Musculoskeletal and connective tissue disorders

Uncommon: Osteoporosis, vertebral and long bone fractures.

Rare: , Muscle wasting

Not known: avascular osteonecrosis, tendonitis and tendon rupture when coadministered with quinolones (see warnings and precautions),.  Muscle wasting or myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants – see section 4.5), negative nitrogen balance.

 

Reproductive system and breast disorders

Not known: Menstrual irregularity

 

Fluid and electrolyte disturbance

Sodium and water retention with hypertension, oedema and heart failure, potassium loss, hypokalaemic alkalosis.

Cardiac disorders

Not known: Heart failure

 

NeuropsychiatricNervous system disorders

Uncommon: Headache, vertigo., psychological dependence, hypomania or depression, Not known: , restlessness, .  Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal,.  aAggravation of epilepsy.

 

Psychiatric disorders

A wide range of psychiatric reactions including affective disorders such as:

Uncommon:  (such as irritable, euphoric, depressed and labile mood.

Not known: irritable, euphoric,,, and suicidal thoughts.),

psychotic reactions (including:

Not known:  mania, delusions, hallucinations, and aggravation of schizophrenia

Other recations including:

Uncommon: ), behavioural disturbances, irritability,

Not known: anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported.

Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.

 

OphthalmicEye disorders

Not known: Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts especially in children, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.

 

Gastrointestinal disorders

Uncommon: Dyspepsia, peptic ulceration, haemorrhage, nausea. with

Not known: perforation of peptic ulcer, acute pancreatitis (especially in children),  and haemorrhage, acute pancreatitis (especially in children), candidiasis.,. Nausea.

 

DermatologicalSkin and subcutaneous tissue disorders

Impaired healing, Uncommon: hirsutism, striae, acne,

Rare: bruising

Not known: Sskin atrophy, ,telangiectasia.

bruising, telangiectasia, striae, acne.

 

General disorders and administration site conditions

Uncommon: Oedema.

Not known: impaired healing.Hypersensitivity including anaphylaxis has been reported.  Leucocytosis.  Thromboembolism.  Rare incidence of benign intracranial hypertension.

 

Immune system disorders

Uncommon: Hypersensitivity including anaphylaxis has been reported.

 

Blood and lymphatic system disorders

Not known: Leucocytosis

 

Vascular disorders

Not known: Thromboembolism in particular in patients with underlying conditions associated with increased thrombotic tendency, rare incidence of benign intracranial hypertension

 

Withdrawal symptoms and signs

Not known: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see Warnings and Precautions).

 

A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.  This may occur in patients even without evidence of adrenal insufficiency.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life

Date of revision of text on the SPC: 28-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

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Type IAIN No. B.II.f.1.a.1 variation to reduce the shelf life of the finished product as packaged for sale.

Shelf life reduced from 5 years to 36 months.

Reasons for adding or updating:

• Change to section 6.1 - List of Excipients

Date of revision of text on the SPC: 22-Jul-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of sucrose

Reasons for adding or updating:

• Change of Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Feb-2008

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Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 marketing authorisation holder now sanofi-aventis

Reasons for adding or updating:

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

Legal Category:POM

Black Triangle (CHM): NO