EFMODY Modified-release hard capsule (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Efmody 5 mg modified-release hard capsules. Efmody 10 mg modified-release hard capsules. Efmody 20 mg modified-release hard capsules.

2. Qualitative and quantitative composition

Efmody 5 mg modified-release hard capsules: Each modified-release hard capsule contains 5 mg hydrocortisone. Efmody 10 mg modified-release hard capsules: Each modified-release hard capsule ...

3. Pharmaceutical form

Modified-release hard capsules. Efmody 5 mg modified-release hard capsules: A capsule (approx.19 mm long) with an opaque blue cap and opaque white body printed with CHC 5 mg containing white to ...

4.1. Therapeutic indications

Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.

4.2. Posology and method of administration

Posology Treatment should be initiated by physicians experienced in the management of CAH. As maintenance therapy the dose must be individualised according to the response of the individual patient. The ...

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

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

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

Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4). Concomitant administration of medicinal products that are inhibitors or inducers of CYP3A4 may therefore lead to unwanted alterations in serum ...

4.6. Fertility, pregnancy and lactation

Pregnancy Hydrocortisone crosses the placenta. Hydrocortisone is preferentially metabolised by placental 11βHSD2 to inactive cortisone reducing the fetal exposure. There are no indications that replacement ...

4.7. Effects on ability to drive and use machines

Efmody has minor influence on the ability to drive and use machines. Fatigue and dizziness have been reported. Untreated and poorly replaced adrenal insufficiency may affect the ability to drive and use ...

4.8. Undesirable effects

Summary of safety profile In the clinical trial programme the overall most common serious adverse events were acute adrenal insufficiency (4.2% of patients treated with Efmody), another common reaction, ...

4.9. Overdose

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for systemic use; glucocorticoids ATC code: H02AB09 Mechanism of action Hydrocortisone is a glucocorticoid. Glucocorticoids have multiple effects ...

5.2. Pharmacokinetic properties

Absorption Following a single oral administration in fasted dexamethasone-suppressed healthy adults, the rate of absorption of hydrocortisone from Efmody 20 mg was delayed and reduced compared to immediate ...

5.3. Preclinical safety data

Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intrauterine growth retardation and effects on brain growth and development. ...

6.1. List of excipients

Granules: Microcrystalline cellulose Povidone Methacrylic acid-methyl methacrylate copolymer (1:2) Methacrylic acid-methyl methacrylate copolymer (1:1) Talc Dibutyl sebacate Capsule: Gelatin ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original package. Keep the bottle tightly closed in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.

6.5. Nature and contents of container

The capsules are provided in high-density polyethylene bottles with child resistant, tamper-evident polypropylene screw cap with integrated desiccant. Pack size: 1 bottle containing 50 modified-release ...

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

Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072

8. Marketing authorization number(s)

Efmody 5 mg modified-release hard capsules EU/1/21/1549/001 (50 capsules) Efmody 10 mg modified-release hard capsules EU/1/21/1549/002 (50 capsules) Efmody 20 mg modified-release hard capsules EU/1/21/1549/003 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 27 May 2021

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