Last Updated on eMC 20-11-2017 View medicine  | Aspen Contact details

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.

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text

Text strikethrough = deleted text

 

 

 

3.         PHARMACEUTICAL FORM

 

Oral tablet.

 

White, Round, biconvex, white tablets, scored on one side and engraved on the other side with “FT01 SQUIBB and 429”. The tablet can be divided into equal doses.

 

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

28/03/2011 16 November 1988 / 27 January 2004

 

10.       DATE OF REVISION OF THE TEXT

 

14/11/2017 12/10/2017

Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:12-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text

Text strikethrough = deleted text

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains fludrocortisone acetate Ph.Eur 0.1 mg

 

Excipient(s) with known effect

 

This product Also contains lactose, 59.59mg per tablet

 

For the full list of excipients, see section 6.1.For excipients, see 6.1

 

 

 

 

3.         PHARMACEUTICAL FORM

 

Oral tablet.

 

Round, biconvex, white tablets, scored on one side and engraved on the other side with “SQUIBB and 429”. The tablet can be divided into equal doses. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

 

 

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 Google Play or Apple App Store.

 

 

4.2       Posology and method of administration

Posology

 

Adults:

A daily dosage range of 0.05-0.3mg Fludrocortisone acetate tablets orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid effect is desirable, cortisone or hydrocortisone by mouth should be given concomitantly with Fludrocortisone acetate tablets.

 

Elderly:

No specific dosage recommendations (See Section 4.4Precautions).

 

Children Paediatric population:

One half tablet (0.05 mg) to one tablet (0.1 mg) daily. May be used adjusted to the age and weight of the child according to the severity of the condition Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases (See Section 4.3Contraindications).

 

4.3       Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity to any of the ingredients.

Systemic infections unless specific anti-infective therapy is employed.

 

Because of its marked effect on sodium retention, the use of Fludrocortisone acetate in the treatment of conditions other than those indicated, is not advised.

 

Since Fludrocortisone acetate is a potent mineralocorticoid both the dosage and salt intake should be carefully monitored to avoid the development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy.

 

Precautions:

Fludrocortisone acetate is a potent mineralocorticoid and is used predominantly for replacement therapy. Although glucocorticoid side effects may occur, these can be reduced by reducing the dosage.

Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (See dosage section).

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. Patients on long-term systemic therapy with Fludrocortisone acetate may require supportive corticosteroid therapy in times of stress (such as trauma, surgery or severe illness) both during the treatment period and up to a year afterwards. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage and the duration of treatment.

Anti-inflammatory/immunosuppressive effects:

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

Chickenpox, shingles and measles are of particular concern since these illnesses may be fatal in immunosuppressed patients. Patients should be advised to avoid exposure to these diseases, and to seek medical advice without delay if exposure occurs.

Chickenpox: Unless they have had chickenpox, patients receiving oral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should preferably be given within 3 days of exposure, and not later than 10 days after exposure to chickenpox. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Measles: Prophylaxis with normal immunoglobulin may be needed.

During corticosteroid therapy antibody response will be reduced and therefore affect the patient's response to vaccines. Live vaccines should not be administered.

 

4.4       Special warnings and precautions for use

 

Fludrocortisone acetate is a potent mineralocorticoid and is used predominantly for replacement therapy. Although glucocorticoid side effects may occur, these can be reduced by reducing the dosage.

 

Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (See dosage section Section 4.2).

 

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. Patients on long-term systemic therapy with Fludrocortisone acetate may require supportive corticosteroid therapy in times of stress (such as trauma, surgery or severe illness) both during the treatment period and up to a year afterwards. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

 

Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage and the duration of treatment.

 

Anti-inflammatory/immunosuppressive effects:

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

 

Chickenpox, shingles and measles are of particular concern since these illnesses may be fatal in immunosuppressed patients. Patients should be advised to avoid exposure to these diseases, and to seek medical advice without delay if exposure occurs.

 

Chickenpox: Unless they have had chickenpox, patients receiving oral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should preferably be given within 3 days of exposure, and not later than 10 days after exposure to chickenpox. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

 

Measles: Prophylaxis with normal immunoglobulin may be needed.

During corticosteroid therapy antibody response will be reduced and therefore affect the patient's response to vaccines. Live vaccines should not be administered.

 

Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection, producing false negative results.

 

 

Tuberculosis: Those with a previous history of, or X-ray changes characteristic of, tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of anti-tuberculosis therapy.

 A restrictive treatment of patients with active tuberculosis is recommended to cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. Chemoprophylaxis should be used in patients with latent tuberculosis or tuberculin reactivity who are taking corticosteroids.

 

Corticosteroids should be used with caution in patients with the following conditions: nonspecific ulcerative colitis (if there is a probability of perforation, abscess, or other pyogenic infection);

Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary. Rrecent intestinal anastomoses;, diverticulitis;, thrombophlebitis;, existing or previous history of severe affective disorders (especially previous steroid psychosis);, exanthematous disease;, chronic nephritis or renal insufficiency;, metastatic carcinoma;, osteoporosis (post-menopausal females are particularly at risk);, in patients with an active or latent peptic ulcer (or a history of peptic ulcer);, Myasthenia myasthenia gravis;. Latent latent or healed tuberculosis, in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics;, iIn acute psychoses, in acute glomerulonephritis.; Hypertension hypertension, congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver failure.

 

 

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

An adequate protein intake is advised for patients on long-term corticosteroids to counteract any tendency to weight-loss or muscle wasting/weakness associated with negative nitrogen balance.

 

 

Prolonged use of corticosteroids may produce posterior subcapsular cataracts or glaucoma, with possible damage to the optic nerve. Prolonged use may also enhance the likelihood of secondary ocular infections.

 

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

Dietary salt restriction and potassium supplementation may be necessary.   All corticosteroids increase calcium excretion, which may predispose to osteoporosis or aggravate pre-existing osteoporosis.

 

 

Pre-existing emotional instability or psychosis may also be aggravated by corticosteroids. Fludrocortisone should be used with caution in patients with, or with a previous history of, severe affective disorders. Fludrocortisone should also be used with caution in patients who have a first degree relative(s) with any existing, or previous history of, severe affective disorders. Specifically, these include depressive or maniac-depressive illness and previous steroid psychosis. The use of antidepressant drugs does not relieve and may exacerbate adrenocorticoid-induced mental disturbances.

 

 

Children: Paediatric population:

Because corticosteroids can suppress growth, the growth and development of infants, children and adolescents on prolonged corticosteroid therapy should be carefully observed monitored. Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible.

 

Corticosteroids may also affect endogenous steroid production

 

4.5       Interaction with other medicinal products and other forms of interaction

 

CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

 

Digitalis glycosides: Enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Potassium levels should be monitored and potassium supplements used if necessary.

 

Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.  A reduction in corticosteroid dosage may be required when oestrogen therapy is initiated, and an increase required when oestrogen is stopped.

 

Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated (See Section 4.4 Special Warnings and Special Precautions for Use).

 

 

4.8       Undesirable effects

 

Summary of the safety profile

 

Tabulated list of adverse reactions

 

The list below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories:

Very common (≥1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to < 1/100)

Rare (≥ 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

not known (cannot be estimated from the available data)

 

General disorders and administration site conditions

Investigations

System Organ Class

Frequency

MedDRA Terms

Metabolism and nutrition

disorders

Very common

Hypokalaemia

Uncommon

Hypokalaemic alkolosis ; Decreased appetite

Psychiatric disorders

Uncommon

Delusional perception, illusion

Uncommon

hallucination

Nervous System disorders

Common

Headache

Uncommon

seizure, epilepsy, syncope, loss of consciousness, dysgeusia

Cardiac disorders

Very common

cardiac failure congestive

Uncommon

Cardiomegaly

Vascular disorders

Very common

Hypertension

Gastrointestinal disorders

Uncommon

Diarrhoea

Musculoskeletal and connective tissue disorders

Common

Muscular weakness

Uncommon

Muscle atrophy

Common

Oedema, swelling

Uncommon

blood potassium decreased

 

Description of selected adverse reactions

 

When fludrocortisone is used at the recommended dosages, the glucocorticoid side effects are not usually present; however, the following adverse events have been spontaneously reported in two or more patients taking Fludrocortisone acetate overdose.

 

Withdrawal Symptoms and Signs:

On withdrawal, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss may occur. Too rapid a reduction in dose following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (See Section 4.4).

 

 

 

4.9       Overdose

Chronic Symptoms

Development of hypertension, oedema, hypokalaemia, significant increase in weight, and increase in heart size may be signs of excessive dosage of fludrocortisone acetate. When these are noted, administration of the drug should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate, if necessary, should be resumed at a reduced dose. Muscle weakness due to excessive potassium loss may develop and can be treated with potassium supplements.

Acute

Management

When symptoms of excessive dosage of fludrocortisone acetate (listed above) are noted, administration of the drug should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate, if necessary, should be resumed at a reduced dose.

 

 

5.3 Preclinical safety data

There are not sufficient data to determine whether fludrocortisone acetate is carcinogenic, mutagenic, or impairs fertility in males or females.No studies have been conducted.

 

 

10.       DATE OF REVISION OF THE TEXT

 

12/10/2017 July 2016

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
  • Improved presentation of SPC

Date of revision of text on the SPC:28-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 

 

4.4       Special warnings and precautions for use

 

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

 

 

4.8       Undesirable effects

 

 

Eye disorders: Vision, blurred (see also section 4.4)

 

 

10        DATE OF REVISION OF THE TEXT

 

28/07/2017

 

 

21 Feb 20117

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:21-02-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text



4.5 Interaction with other medicinal products and other forms of interaction

CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.


10 DATE OF REVISION OF THE TEXT
21 February 2017 26 Nov 2015

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
  • Submitted in error

Date of revision of text on the SPC:28-02-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

4.5       Interaction with other medicinal products and other forms of interaction

 

CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Reasons for adding or 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

Date of revision of text on the SPC:30-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 

 

 

7          MARKETING AUTHORISATION HOLDER

 

Tiofarma B.V.,

Benjamin Franklinstraat  5-10

3261 LW Oud-Beijerland,

The Netherlands

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

 

 

 

 

8          MARKETING AUTHORISATION NUMBER(S)

 

 

PL 17299/000139699/0089

 

 

 

10        DATE OF REVISION OF THE TEXT

 

24/10/2016December 2016

 

 

Reasons for adding or 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

Date of revision of text on the SPC:30-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



7        MARKETING AUTHORISATION HOLDER

 

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tiofarma B.V.,

Benjamin Franklinstraat  5-10

3261 LW Oud-Beijerland,

The NetherlandsAspen

8        MARKETING AUTHORISATION NUMBER(S)

 

PL 39699/0090 17299/0002

 

 

 

10       DATE OF REVISION OF THE TEXT

 

December 2016 20/09/2016

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text


1                 NAME OF THE MEDICINAL PRODUCT

Fludrocortisone  FLORINEF acetate 0.1 mg tablets

4.2            Posology and method of administration

Adults:

A daily dosage range of 0.05-0.3mg Florinef Fludrocortisone acetate  tablets orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid effect is desirable, cortisone or hydrocortisone by mouth should be given concomitantly with Florinef  Fludrocortisone acetate tablets.

Elderly:

No specific dosage recommendations. (See Precautions).

Children:

May be used adjusted to the age and weight of the child according to the severity of the condition. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases. (See 4.3 Contraindications).

4.3            Contraindications

Hypersensitivity to any of the ingredients.

Systemic infections unless specific anti-infective therapy is employed.

Because of its marked effect on sodium retention, the use of Florinef Fludrocortisone acetate in the treatment of conditions other than those indicated, is not advised.

Since Florinef Fludrocortisone acetate is a potent mineralocorticoid both the dosage and salt intake should be carefully monitored to avoid the development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy.

Precautions:

Florinef Fludrocortisone acetate is a potent mineralocorticoid and is used predominantly for replacement therapy. Although glucocorticoid side effects may occur, these can be reduced by reducing the dosage.

Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (See dosage section).

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. Patients on long-term systemic therapy with Florinef Fludrocortisone acetate may require supportive corticosteroid therapy in times of stress (such as trauma, surgery or severe illness) both during the treatment period and up to a year afterwards. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

4.5           Interaction with other medicinal products and other forms of interaction5

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalemia.

Anticholinesterases: Effects of anticholinesterase agents may be antogonised.

Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.

Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.

Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.

Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, include oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic Enzyme Inducers (e.g. aminoglutethemide, barbiturates, carbamazepine, phenytoin, primidone, rifabutin, rifampicin): There may be increased metabolic clearance of FlorinefFludrocortisone acetate. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.

Human growth hormone: The growth-promoting effect may be inhibited.

Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.

10        DATE OF REVISION OF THE TEXT

10 May 201530 November 2015

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO