Oracea 40 mg Kapsel med modifierad frisättning, hård

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

doxycyklinmonohydrat

Dostupné s:

Paranova Läkemedel AB

ATC kód:

J01AA02

INN (Mezinárodní Name):

doxycycline monohydrate

Dávkování:

40 mg

Léková forma:

Kapsel med modifierad frisättning, hård

Složení:

allurarött AC aluminiumlack Hjälpämne; sockersfärer Hjälpämne; propylenglykol Hjälpämne; doxycyklinmonohydrat 10,42 mg Aktiv substans; doxycyklinmonohydrat 31,2 mg Aktiv substans

Druh předpisu:

Receptbelagt

Stav Autorizace:

Avregistrerad

Datum autorizace:

2016-04-13

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFRACEA/ORACEA/ORAYCEA 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 you 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/Oracea/Oraycea
is and what it is used for
2.
What you need to know before you take Efracea/Oracea/Oraycea
3.
How to take Efracea/Oracea/Oraycea
4.
Possible side effects
5.
How to store Efracea/Oracea/Oraycea
6.
Contents of the pack and other information
1.
WHAT EFRACEA/ORACEA/ORAYCEA
IS AND WHAT IT IS USED FOR
Efracea/Oracea/Oraycea
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/ORACEA/ORAYCEA
DO NOT TAKE EFRACEA/ORACEA/ORAYCEA
-
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/Oracea/Oraycea
should not be used from the 4
th
month of pregnancy
because it may harm the unborn child. If you suspect or learn that you
are pregnant
whilst taking
Efracea/Oracea/Oraycea
, 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/Oracea/Oraycea).
-
if you have a condition causing absence of acid in the stomach
(achlorhydria) or if you have

Charakteristika produktu

1.
NAME OF THE MEDICINAL PRODUCT
Efracea/Oracea/Oraycea 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 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/Oracea/Oraycea 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/Oracea/Oraycea 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/Oracea/Oraycea 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 excipien