Cipralex 20mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Escitalopram oxalate

Dostępny od:

Lexon (UK) Ltd

Kod ATC:

N06AB10

INN (International Nazwa):

Escitalopram oxalate

Dawkowanie:

20mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04030300

Ulotka dla pacjenta

Tell your doctor if you are taking any of the following
medicines:
•
”Non-selective monoamine oxidase inhibitors
(MAOIs)”, containing phenelzine, iproniazid,
isocarboxazid, nialamide, and tranylcypromine as
active ingredients. If you have taken any of these
medicines you will need to wait 14 days before you
start taking Cipralex. After stopping Cipralex you must
allow 7 days before taking any of these medicines.
•
“Reversible, selective MAO-A inhibitors”, containing
moclobemide (used to treat depression).
•
“Irreversible MAO-B inhibitors”, containing selegiline
(used to treat Parkinson’s disease). These increase the
risk of side effects.
•
The antibiotic linezolid.
•
Lithium (used in the treatment of manic-depressive
disorder) and tryptophan.
•
Imipramine and desipramine (both used to treat
depression).
•
Sumatriptan and similar medicines (used to treat
migraine) and tramadol (used against severe pain).
These increase the risk of side effects.
•
Cimetidine, lansoprazole and omeprazole (used
to treat stomach ulcers), fluconazole (used to treat
fungal infections), fluvoxamine (antidepressant) and
ticlopidine (used to reduce the risk of stroke). These
may cause increased blood levels of escitalopram.
•
St. John's Wort (Hypericum perforatum) - a herbal
remedy used for depression.
•
Acetylsalicylic acid and non-steroidal anti-inflammatory
drugs (medicines used for pain relief or to thin the
blood, so called anti-coagulant). These may increase
bleeding-tendency.
•
Warfarin, dipyridamole, and phenprocoumon
(medicines used to thin the blood, so called anti-
coagulant). Your doctor will probably check the
coagulation time of your blood when starting and
discontinuing Cipralex in order to verify that your dose
of anti-coagulant is still adequate.
•
Mefloquine (used to treat Malaria), bupropion (used
to treat depression) and tramadol (used to treat severe
pain) due to a possible risk of a lowered threshold for
seizures.
•
Neuroleptics (medicines to treat schizophrenia,
psychosis) and

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CIPRALEX 20 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Cipralex 20 mg: Oval, white, scored, film-coated tablet of 11.5 x 7
mm,
marked with "E” and “N" on each side of the score on one side of
the tablet.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Safety of daily doses above 20 mg has not been demonstrated.
_Major depressive episodes _
Usual dosage is 10 mg once daily. Depending on individual patient
response,
the dose may be increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the
symptoms resolve, treatment for at least 6 months is required for
consolidation
of the response.
_Panic disorder with or without agoraphobia _
An initial dose of 5 mg is recommended for the first week before
increasing
the dose to 10 mg daily. The dose may be further increased, up to a
maximum
of 20 mg daily, dependent on individual patient response.
Maximum effectiveness is reached after about 3 months. The treatment
lasts
several months.
_Social anxiety disorder _
Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to
obtain
symptom relief. The dose may subsequently, depending on individual
patient
response, be decreased to 5 mg or increased to a maximum of 20 mg
daily.
Social anxiety disorder is a disease with a chronic course, and
treatment for 12
weeks is recommended to consolidate response. Long-term treatment of
responders has been studied for 6 months and can be considered o