PLENADREN Modified-release tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Plenadren 5 mg modified-release tablets. Plenadren 20 mg modified-release tablets.

2. Qualitative and quantitative composition

Plenadren 5 mg modified-release tablets: Each modified-release tablet contains hydrocortisone 5 mg. Plenadren 20 mg modified-release tablets: Each modified-release tablet contains hydrocortisone ...

3. Pharmaceutical form

Modified-release tablet. Plenadren 5 mg modified-release tablets: The tablets are round (diameter 8 mm), convex and pink. Plenadren 20 mg modified-release tablets: The tablets are round (diameter ...

4.1. Therapeutic indications

Treatment of adrenal insufficiency in adults.

4.2. Posology and method of administration

Posology Plenadren is given as maintenance therapy. Oral replacement doses must be individualised according to the clinical response. A common maintenance dose is 20-30 mg per day, given once daily in ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Acute adrenal insufficiency Acute adrenal insufficiency may develop in patients with known adrenal insufficiency who are on inadequate daily doses or in situations with increased cortisol need. Events ...

4.5. Interaction with other medicinal products and other forms of interaction

Hydrocortisone interactions listed below have been reported after therapeutic doses of glucocorticoids. Potent CYP 3A4 inducers such as phenytoin, rifabutin, carbamazepine, barbiturates, rifampicin, St ...

4.6. Fertility, pregnancy and lactation

Pregnancy Plenadren can be used during pregnancy. There is no indication that hydrocortisone replacement therapy in pregnant women with adrenal insufficiency is associated with adverse outcome of the mother ...

4.7. Effects on ability to drive and use machines

Plenadren has minor influence on the ability to drive and use machines. Fatigue and episodes of short-lasting vertigo have been reported. Untreated and poorly replaced adrenal insufficiency may affect ...

4.8. Undesirable effects

Summary of the safety profile Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels. The adverse reaction profile in the treatment of adrenal insufficiency is therefore ...

4.9. Overdose

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Symptoms may range from excitement/arousal to mania or psychosis. Signs include high blood ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids ATC code: H02AB09 Pharmacodynamic action Hydrocortisone is a glucocorticoid and the synthetic form of endogenously ...

5.2. Pharmacokinetic properties

Absorption Following oral administration, hydrocortisone is rapidly and well absorbed from the gastrointestinal tract and the absorption has been reported to be more than 95% for an oral 20 mg dose (tablets). ...

5.3. Preclinical safety data

Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations). Animal studies have also shown that prenatal ...

6.1. List of excipients

Tablet core: Hypromellose Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate Plenadren 5 mg modified-release tablets Tablet coating: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

HDPE bottles with PP screw cap containing 50 modified-release tablets. Carton containing 1 bottle of 50 modified-release tablets. Carton containing 2 bottles of 50 modified release tablets (100 tablets). ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Shire Services BVBA, Rue Montoyer 47, B 1000 Brussels, Belgium

8. Marketing authorization number(s)

Plenadren 5 mg modified-release tablets: EU/1/11/715/001 EU/1/11/715/003 Plenadren 20 mg modified-release tablets: EU/1/11/715/002 EU/1/11/715/006

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 3rd November 2011 Date of latest renewal: 8th August 2016

10. Date of revision of the text

05/2018

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