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Alliance Pharmaceuticals
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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: 29/07/2009
SPC Deltacortril Gastro-resistant Tablets

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 29/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10. Now reads

16th July 2009
Updated on 22/06/2009 and displayed until 29/07/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   11-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1: Now includes the following text

 

Deltacortril®2.5mg Gastro-resistant Tablets
Deltacortril® 5mg Gastro-resistant Tablets

Section 3: Now includes the following red text

 

Gastro-resistant Tablets 2.5 mg, uniformly brown in colour.
Gastro-resistant Tablets 5mg, uniformly maroon in colour.

Section 4.2: Now includes the following red text

 

The initial dosage of Deltacortril Gastro-resistant Tablets may vary from 5mg to 
60mg daily depending on the disorder being treated. 

If there is lack of a satisfactory clinical response to Gastro-resistant Tablets, the drug should 
be gradually discontinued and the patient transferred to alternative therapy.

 

A single dose of Gastro-resistant Tablets in the morning on alternate days or at longer intervals is acceptable therapy for some patients.

 

Section 4.4: Now includes the following red text

Caution is necessary when oral corticosteroids, including Deltacortril Gastro-resistant Tablets, are prescribed in patients with the following conditions, and frequent patient monitoring is 
necessary.

Section 4.5: Now includes the following red text

Lack of expected response may be observed and dosage of Deltacortril Gastro-resistant 
Tablets may need to be increased.

Section 4.7: Now includes the following red text

The effect of Deltacortril Gastro-resistant Tablets on the ability to drive or use machinery has not been evaluated.

Section 5.2: Now includes the following red text

 

Although peak plasma prednisolone levels are somewhat lower after administration of 
Deltacortril Gastro-resistant Tablets and absorption is delayed, total absorption and 
bioavailability are the same as after plain prednisolone.

Section 8: Now includes the following red text

 

Deltacortril 2.5 mg Gastro-resistant Tablets, Prednisolone 2.5mg Gastro-resistant Tablets - 
PL16853/0092

Deltacortril 5mg Gastro-resistant Tablets, Prednisolone 5mg Gastro-resistant Tablets - 
PL16853/0093

 
Updated on 12/05/2009 and displayed until 22/06/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   24-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5  the followng red text has been added


2.5mg

100 tablets in white HDPE bottles with a white polypropylene child resistant, tamper evident screw cap.

28, 30, 56, 60,100 or 500 tablets in HDPE containers with HDPE/polypropylene child resistant cap with PVDC faced pulp board wad.

30 tablets in aluminium /PVC blister strips with an aluminium foil (2 blisters per carton).

Not all pack sizes may be marketed.

 

5mg

28, 30, 56, 60 or 100 tablets in HDPE containers with HDPE/polypropylene child resistant cap with PVDC faced pulp board wad.

30 tablets in aluminium/PVC blister strips with an aluminium foil (2 blisters per carton).

500 tablets in polypropylene containers


Not all pack sizes may be marketed.


Section 7 the following text has been added
For Prednisolone 2.5mg and 5mg Gastro-resistant Tablets trading as: Alliance Generics, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom.
Updated on 14/04/2009 and displayed until 12/05/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   26-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - The following text has been added
Duchenne’s muscular dystrophy: transient rhabdomyolysis and myoglobinuria may occur following strenuous physical activity. It is not known whether this is due to prednisolone itself or the increased physical activity.
Updated on 19/02/2009 and displayed until 14/04/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1.The following text has been added

Prednisolone 2.5mg Gastro-resistant Tablets

Prednisolone 5mg Gastro-resistant Tablets.



Section 6.5. The following text has been added

2.5mg

Polypropylene container with HDPE Child-Resistant screw cap containing 30 or 100 tablets. Supplied with a patient information leaflet.

100 tablets in white HDPE bottles with a white polypropylene child resistant, tamper evident screw cap.

5mg

 
Updated on 13/06/2008 and displayed until 19/02/2009
Reasons for adding or updating:
  • 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
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   03-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: The following text was added
    Excipients: also includes lactose
    For a full list of excipients see section 6.1

Section 3: The following text was deleted
    and coded 'Pfizer'

Section 4.4: The following text was added

    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not
    take this medicine.


Section 6.1: The following text was deleted
    Printing Ink: Titanium dioxide (E171), shellac, propylene glycol, indigo carmine aluminium lake (E132)
Updated on 21/02/2008 and displayed until 13/06/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4- The following text has been added

Patients/ and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/ systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/ withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

 Section 4.8 - the Following text has been added

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, 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.

 
Updated on 14/06/2007 and displayed until 21/02/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 3- "and coded 'Pfizer' " removed
 
Section 6.1- Printing ink: titanium dixide (E171), shellac, propylene glycol, indigo carmine aluminium lake (E132) removed
 
Section 10- Date revised
Updated on 16/01/2007 and displayed until 14/06/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  prednisolone