EFRACEA Modified-release hard capsule Ref.[27645] Active ingredients: Doxycycline

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

No dosage adjustment is necessary in patients with renal impairment.

Patients with hepatic impairment

Efracea should be administered with caution to patients with hepatic impairment or to those receiving potentially hepatotoxic medicinal products (see section 4.4).

Paediatric population

Efracea is contraindicated in children below 12 years of age (see section 4.3).

Method of administration

The capsule should be taken in the morning, on an empty stomach, preferably at least one hour prior to or two hours after the meal.

The capsule should be taken with adequate amounts of water in order to reduce the risk of oesophageal irritation and ulceration (see section 4.4).

Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment. In clinical trials patients were treated for 16 weeks. Upon discontinuation, lesions tended to reappear at 4 weeks follow-up. Therefore, it is recommended that patients should be assessed 4 weeks after stopping treatment.

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 parenchymatous hepatic and renal damage and of pancreatitis.

Treatment

The usual dose of Efracea is less than half the usual doses of doxycycline used for antimicrobial therapy. Therefore clinicians should bear in mind that in many cases overdose is likely to produce blood concentrations of doxycycline within the therapeutic range for antimicrobial treatment, for which there is a large quantity of data supporting the safety of the medicinal product. In these cases observation is recommended. In cases of significant overdose, doxycycline therapy should be stopped immediately and symptomatic measures undertaken as required.

Intestinal absorption of unabsorbed doxycycline should be minimised by administering magnesium or calcium salt-containing antacids to produce non-absorbable chelate complexes with doxycycline. Gastric lavage should be considered.

Dialysis does not alter serum doxycycline half-life and thus would not be of benefit in treating cases of overdose.

2 years.

Store in the original package in order to protect from light.

Aluminium/PVC/Aclar blister.

Pack size:

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.

No special requirements.