Alliance Pharmaceuticals

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

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.

Prednisolone 2.5mg Gastro-resistant Tablets

Prednisolone 5mg Gastro-resistant Tablets.

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

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

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.