EFRACEA 40 mg modified-release hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxycycline

Available from:

Galderma International

ATC code:

J01AA02

INN (International Name):

Doxycycline

Dosage:

40 milligram(s)

Pharmaceutical form:

Modified-release capsule, hard

Therapeutic area:

doxycycline

Authorization status:

Marketed

Authorization date:

2009-01-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFRACEA 40 MG MODIFIED RELEASE HARD CAPSULES
DOXYCYCLINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Efracea is and what it is used for
2.
What you need to know before you take Efracea
3.
How to take Efracea
4.
Possible side effects
5.
How to store Efracea
6.
Contents of the pack and other information
1.
WHAT EFRACEA IS AND WHAT IT IS USED FOR
Efracea is a medicine containing the active substance doxycycline. It
is used in adults to reduce the
pimples or red bumps on the face caused by a condition called rosacea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFRACEA
DO NOT TAKE EFRACEA
-
if you are allergic (hypersensitive) to any medicinal product in the
tetracycline family,
including doxycycline or minocycline, or to any of the other
ingredients of this medicine
(listed in section 6.)
-
if you are pregnant Efracea should not be used from the 4th month of
pregnancy because it
may harm the unborn child. If you suspect or learn that you are
pregnant whilst taking
Efracea, contact your doctor immediately.
-
in combination with retinoids (drugs used in the treatment of certain
skin disorders such as
severe acne) administered by the oral route (see section Other
medicines and Efracea).
-
if you have a condition causing absence of acid in the stomach
(achlorhydria) or if you have
had surgery on the upper part of the gut (called the duodenum).
Efracea must not be taken by infants or children under the age of 12,
because it may cause permanent
discolouratio

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2022
CRN00D5C9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
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).
Excipients with known effect: 102 – 150 mg of sucrose and 26.6 -
29.4 microgram of Allura red AC
aluminium lake (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release hard capsule
Beige capsule, No. 2 size, bear the marking “GLD 40”.
4 CLINICAL PARTICULARS
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_
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.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substanc