EFRACEA Modified-release hard capsule (2021)
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Περιεχόμενα
1. Name of the medicinal product
Efracea 40 mg modified-release hard capsules.
2. Qualitative and quantitative composition
Each capsule contains 40 mg doxycycline (as monohydrate). <u>Excipients with known effect:</u> 102-150 mg of sucrose and 26.6-29.4 μg of Allura red AC aluminium lake (E129). For the full list of excipients, ...
3. Pharmaceutical form
Modified-release hard capsule. Beige capsule, No. 2 size, bear the marking GLD 40.
4.1. Therapeutic indications
Efracea is indicated to reduce papulopustular lesions in adult patients with facial rosacea.
4.2. Posology and method of administration
Posology Adults, including older people Oral use. The daily dose is 40 mg (1 capsule). It can be taken as monotherapy or as part of combination treatment (see section 5.1). Patients with renal impairment ...
4.3. Contraindications
Hypersensitivity to the active substance, to other tetracyclines or to any of the excipients listed in section 6.1. Infants and children up to 12 years of age. Second and third trimesters of pregnancy ...
4.4. Special warnings and precautions for use
<b>Efracea contains doxycycline in a formulation designed to yield anti-inflammatory plasma levels below the antimicrobial threshold. Efracea must not be used to treat infections caused by organisms susceptible ...
4.5. Interaction with other medicinal products and other forms of interaction
The recommendations below regarding the potential interactions between doxycycline and other medicinal products are based upon experience with the larger doses generally used in antimicrobial formulations ...
4.6. Fertility, pregnancy and lactation
Pregnancy Studies in animals have not demonstrated a teratogenic effect. In humans, the use of tetracyclines during a limited number of pregnancies has not revealed any specific malformation to date. ...
4.7. Effects on ability to drive and use machines
Efracea has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile In the pivotal placebo-controlled studies with Efracea in rosacea, 269 patients were treated with Efracea 40 mg once daily and 268 patients were treated with placebo for 16 ...
4.9. Overdose
Symptoms To date no significant acute toxicity has been described in the case of a single oral intake of a multiple of therapeutic doses of doxycycline. In case of overdose there is, however, a risk of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use, Tetracyclines <b>ATC code:</b> J01AA02 Mechanism of Action The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation ...
5.2. Pharmacokinetic properties
Absorption Doxycycline is almost completely absorbed after oral administration. Following oral administration of Efracea, mean peak plasma concentrations were 510 ng/mL after a single dose and 600 ng/mL ...
5.3. Preclinical safety data
Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney. These effects were seen at exposure levels of 1.5 to 2 times those ...
6.1. List of excipients
<u>Capsule shell:</u> Gelatin Black iron oxide Red iron oxide Yellow iron oxide Titanium dioxide Printing inks Shellac Propylene glycol Black iron oxide Indigo Carmine aluminium lake Allura Red AC aluminium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store in the original package in order to protect from light.
6.5. Nature and contents of container
Aluminium/PVC/Aclar blister. <u>Pack size:</u> 56 capsules in 4 strips of 14 each 28 capsules in 2 strips of 14 each 14 capsules in 1 strip of 14 Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
8. Marketing authorization number(s)
PL 10590/0056
9. Date of first authorization / renewal of the authorization
2nd April 2009
10. Date of revision of the text
10 May 2021
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