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Efracea 40 mg Modified Release Hard Capsules (14 capsules)

Efracea 40 mg Modified Release Hard Capsules (14 capsules)

Efracea

Prescription-only oral medicine for rosacea
  • MHRA Licensed medicinal product in the United Kingdom (PL 10590/0056)
  • Manufactured and marketed in accordance with EU/UK Good Manufacturing Practice (GMP) and pharmacovigilance standards
Low-dose doxycycline modified-release capsules

Description

Efracea 40 mg Modified-Release Hard Capsules are a prescription-only oral treatment containing a low, anti-inflammatory dose of doxycycline monohydrate. They are indicated in adults to reduce papulopustular (red bumps and pimples) lesions of facial rosacea. Each pack contains 14 modified-release hard capsules for once-daily dosing.

Bnefits

  • Reduces papulopustular lesions (red bumps and pustules) in adult facial rosacea
  • Helps reduce facial redness, swelling and inflammatory spots
  • Low, sub-antimicrobial dose of doxycycline focused on anti-inflammatory action
  • Modified-release formulation provides steady exposure with once-daily dosing
  • Lower risk of promoting antibiotic resistance compared with higher-dose doxycycline
  • Suitable for longer-term management of inflammatory rosacea under medical supervision

Indications

  • Reduction of papulopustular lesions in adult patients with facial rosacea
  • Treatment of inflammatory lesions (papules and pustules) associated with rosacea in adults

Composition

  • Active ingredient: Doxycycline 40 mg (as doxycycline monohydrate) per modified-release hard capsule
  • Capsule contents excipients: Hypromellose, methacrylic acid–ethyl acrylate copolymer (1:1), triethyl citrate, talc, hypromellose (additional), titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80, sugar spheres (maize starch, sucrose)
  • Capsule shell excipients: Gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
  • Printing ink excipients: Shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, Allura Red AC aluminium lake (E129), Brilliant Blue FCF aluminium lake, D & C Yellow No. 10 aluminium lake

Formulation

  • Pharmaceutical form: Modified-release hard capsule for oral use
  • Strength: 40 mg doxycycline (as monohydrate) per capsule
  • Dosage form characteristics: Beige No. 2 hard capsule marked with product strength

Packaging

  • Aluminium/PVC/Aclar blister strips
  • Pack size: 14 capsules (1 blister strip of 14 capsules)
  • Outer carton labelled with Efracea branding and Galderma details

Usage

  • Adults (including older people): Take one 40 mg capsule once daily.
  • Take the capsule in the morning on an empty stomach, preferably at least one hour before or two hours after food.
  • Swallow the capsule whole with a full glass of water; do not crush or chew.
  • Take while sitting or standing upright and avoid lying down for at least 30 minutes after dosing to reduce risk of oesophageal irritation or ulceration.
  • Avoid taking at the same time as dairy products, antacids or supplements containing calcium, magnesium, aluminium, iron, or bismuth; separate such products by 2–3 hours.
  • Use exactly as prescribed by a healthcare professional and do not exceed the recommended dose.
  • If a dose is missed, take it when remembered unless it is close to the time of the next dose; do not double dose.

Contraindications

  • Hypersensitivity to doxycycline, other tetracycline-class antibiotics, or any excipient in the formulation
  • Infants and children up to 12 years of age (risk of permanent tooth discolouration and effects on bone development)
  • Use during the second and third trimesters of pregnancy
  • Concomitant treatment with oral retinoids (e.g. isotretinoin) due to risk of intracranial hypertension
  • Known or suspected achlorhydria (absence of gastric acid)
  • History of surgery that bypasses or excludes the duodenum
  • Patients with rare hereditary problems of fructose intolerance, glucose–galactose malabsorption or sucrase–isomaltase insufficiency (due to sucrose content)

Adverse Effects

  • Common adverse reactions reported with Efracea in clinical trials include nasopharyngitis, sinusitis, fungal infection, anxiety, sinus headache, hypertension or increased blood pressure, diarrhoea, upper abdominal pain, dry mouth, back pain, pain, and increases in liver enzymes (e.g. ASAT) or blood glucose.
  • Class-related adverse reactions with tetracyclines may include nausea, vomiting, anorexia, diarrhoea, glossitis, dysphagia, enterocolitis, oesophagitis and oesophageal ulceration, hepatotoxicity, photosensitivity reactions, maculopapular or erythematous rashes, urticaria, exfoliative dermatitis, angioedema, and photo-onycholysis.
  • Haematological effects reported rarely with tetracyclines include thrombocytopenia, neutropenia, eosinophilia and, very rarely, haemolytic anaemia.
  • Immune system reactions may include hypersensitivity reactions such as anaphylaxis and anaphylactoid purpura.
  • Nervous system effects may include benign intracranial hypertension, headache, and very rarely bulging fontanelle in infants (not relevant to this contraindicated population).
  • Other reported effects with tetracyclines include pericarditis, brown-black microscopic discolouration of thyroid tissue with long-term use, exacerbation of systemic lupus erythematosus, and increased blood urea.
  • Photosensitivity: increased sensitivity to sunlight or artificial UV light, with risk of sunburn or phototoxic reactions; patients should avoid excessive UV exposure and discontinue treatment if photosensitivity occurs.

Storage Conditions

  • Store in the original package in order to protect from light.
  • Keep blister strips inside the outer carton until use.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the packaging.

Duration

Patients should usually be evaluated after approximately 6 weeks; if there is no clinical response, treatment should be reconsidered. In clinical trials, Efracea was used for around 16 weeks, with follow-up after stopping treatment. Actual duration should be determined by the prescribing clinician based on response.

Onset

Improvement in inflammatory rosacea lesions may be seen within 2\u20134 weeks of starting treatment, with maximal benefit often reached within about 3 months of consistent once-daily use.

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