Efracea 40mg modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxycycline monohydrate

Available from:

Galderma (UK) Ltd

ATC code:

J01AA02

INN (International Name):

Doxycycline monohydrate

Dosage:

40mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010300; GTIN: 5020465200277 5020465200567

Patient Information leaflet

_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
DIELINES
Artwork approved by:
Date:
Signature:
_40 MG MODIFIED RELEASE HARD CAPSULES_
WHOLE TEXT
, including barcodes,
pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
Product code: P25883-1
Product description: EFRACEA 40MG
Market: GBR
Article: Leaflet
Flat size: 180x315
Font size: 9 pt
Specification n° MT.09.MPS.1893
PMS 432U
MT.09.DRA.2375.R00.2
NOTICE EGERKINGEN RECTO
180x315
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 discolouration of the teeth or problems
with tooth development.
WARNINGS AND PRECAUTIONS
Efracea must not be us

Summary of Product characteristics

OBJECT 1
EFRACEA 40MG MODIFIED RELEASE HARD CAPSULES
Summary of Product Characteristics Updated 16-Nov-2017 | Galderma
(U.K) Ltd
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 μg of Allura red AC aluminium
lake (E129).
For thefull 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).
_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 substance, to other tetracyclines or to
any of the excipients listed in section