Lofepramine 70mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Lofepramine hydrochloride

Tilgængelig fra:

Zentiva Pharma UK Ltd

ATC-kode:

N06AA07

INN (International Name):

Lofepramine hydrochloride

Dosering:

70mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04030100; GTIN: 5060222600391

Indlægsseddel

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 Lofepramine is and what it is used for
2. What you need to know before you take
Lofepramine
3. How to take Lofepramine
4. Possible side effects
5. How to store Lofepramine
6. Contents of the pack and other information
1. WHAT LOFEPRAMINE IS AND WHAT IT IS
USED FOR
Lofepramine belongs to a group of medicines
called tricyclic antidepressants.
Lofepramine is used to treat symptoms of
depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE LOFEPRAMINE
DO NOT TAKE LOFEPRAMINE IF YOU:
•
are allergic to lofepramine or any of the
other ingredients of this medicine (listed in
section
6)
•
are allergic to other tricyclic antidepressants
such as clomipramine and imipramine
•
suffer from any mental illness other than
depression (known as mania)
•
have serious liver or kidney problems
•
suffer from any serious heart problems,
including irregular heart rhythms or have
recently had a heart attack
•
have untreated glaucoma (raised pressure
of the fluid inside the eye)
•
suffer from prostate problems with urinary
retention
•
suffer from chronic constipation
•
are currently suffering from alcohol or drug
poisoning or deliria
•
are taking or have taken any other medicine
such as monoamine oxidase inhibitors for
your depression within the last 14 days
(see “Other medicines and Lofepramine”
section).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Lofepramine if you:
•
have a history of, or you suffer from any
hea

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lofepramine 70 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 76.10 mg lofepramine hydrochloride, equivalent to
70.0
mg lofepramine.
Excipient(s) with known effect
Each tablet contains 126.05 mg lactose (as lactose monohydrate) and
1.15 mg
Cochineal Red (E124).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Red to violet, round tablet, biconvex on both sides with a dividing
score on
one side, approximately 10 mm in diameter.
The score line is only to facilitate breaking for ease of swallowing
and not to
divde into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lofepramine 70 mg Tablets is indicated in adults and the elderly for
the treatment of
symptoms of depressive illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_: The usual dose is 70 mg twice daily (140 mg) or three times
daily (210 mg)
depending upon the patient’s response.
_Elderly patients_: Elderly patients may respond to lower doses in
some cases.
_Paediatric population_: No data are available. The use of Lofrepamine
70 mg Film-
coated Tablets is not recommended in children and adolescents under
the age of 18.
Route of administration
Lofrepamine 70 mg Tablets are for oral administration only
4.3
CONTRAINDICATIONS
Hypersensitive to the active substance or to any of the excipients
listed in section 6.1.
Lofrepamine must not be used in patients hypersensitive to
dibenzazepines.
Lofepramine must not be used in patients:
•
with mania
•
with severe liver impairment
•
with severe renal impairment
•
with heart block
•
with cardiac arrhythmias
•
in the recovery phase following a myocardial infarction
•
with untreated narrow angle glaucoma
•
with prostatic hypertrophy with urinary retention.
•
at risk for paralytic ileus.
Lofepramine must not be administered with or within 2 weeks of
cessation of therapy with
monoamine oxidase inhibitors.
Lofepramine must not be administered in patie