LAIF 600

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HYPERICUM PERFORATUM

Available from:

BAYER ISRAEL LTD

Pharmaceutical form:

FILM COATED TABLETS

Composition:

HYPERICUM PERFORATUM 612 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

STEIGERWALD ARZNEIMITTELWERK GMBH, GERMANY

Therapeutic indications:

Symptoms of mild to moderate depression. Treatment is recommended for up to 24 weeks.

Authorization date:

2017-08-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
LAIF® 600
FILM-COATED TABLETS
NAME OF THE MEDICINE, ITS FORM AND STRENGTH:
NAME OF THE MEDICINE: Laif® 600
FORM: Film-coated tablets.
ACTIVE INGREDIENT AND ITS QUANTITY PER DOSAGE UNIT: Each film-
coated tablet contains 612 mg of dry extract of St. John’s Wort.
The plant St. John’s Wort is also called _Hypericum perforatum_.
For a list of allergenic and inactive ingredients in the medicine -
see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them, even if it
seems to you that their ailment is similar.
The medicine is intended for adults and adolescents aged 12 years
and above. The medicine is not intended for children under the
age of 12 and infants.
SUMMARY OF VITAL INFORMATION ABOUT THE MEDICINE:
-
The medicine is intended to alleviate symptoms of mild
to moderate depression, accompanied by anxiety, tension,
restlessness or nervousness, depressed moods, changing
moods, difficulties in falling asleep and difficulty in staying
asleep for the entire night.
-
The medicine is intended for adults and adolescents aged 12
years and above.
-
This medicine is not intended for children and infants.
-
The usual dosage, unless otherwise indicated by the doctor:
one tablet a day, in the morning.
-
Swallow the medicine with some water, during or after the
meal. Do not chew. If you have difficulty in swallowing the
tablet whole, the tablet may be halved along the score line
marked on the tablet. Take the two halves one after the other.
Do not take half a tablet as a single dose.
1) WHAT IS THE MEDICINE INTENDED FOR?
This medicine belongs to the group of antidepressants. The medicine
is intended to a

Summary of Product characteristics

be avoided during administration of
LAIF
®
600
.
The patient is advised in the package insert that they should
inform their physician if they are taking
LAIF
®
600
and have
been prescribed a further medicine. If the patients wish to
take a further medicine themselves, they should heed the
instructions in the section “Interactions with other medicines
and other agents”.
LAIF
®
600
contains lactose. Patients with rare hereditary
problem of galactose intolerance, lac-tase deficiency or
glucose-galactose malabsorption should not take
LAIF
®
600
.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER
INTERACTIONS:
Medicines, containing active substances of St. John's wort
like
LAIF
®
600
does, may possibly interact with other
medicinal substances. Active constituents of St. John’s Wort
can cause accelerated excretion of other medicinal substances
and thereby reduce the efficacy of these other substances.
Active constituents of St. John’s Wort, administered together
with other medicines, can raise also the concentration of
transmitters (e.g. serotonin).
LAIF
®
600
can interact with the following active substances
and thereby diminish the effect of these active substances:
- Immunsuppressants: Cyclosporine, tacrolimus for internal
application, sirolimus.
- Antiretroviral medications: Indinavir, nevirapin.
- Cytostatic agents: Imatinib, Irinotecan.
- Anticoagulants such as phenprocoumon, warfarin,
Rivaroxaban.
- Digoxin, midazolam, simvastatin, ivabradine, verapamil,
hormonal contraceptives.
- Tricyclic antidepressants such as amitriptyline, nortriptyline.
- monoamine oxidase (MAO) inhibitors such as rasagiline for
the treatment of Parkinson disease.
Drug interactions leading to enhanced effect are possible
when
LAIF
®
600
is taken concomitantly with certain
antidepressants such as paroxetine, sertraline and trazodone.
Concomitant intake of these medicines can result in
increasing occurrence of serotoninergic effects (e.g. nausea,
vomiting, anxiety, restlessness and confusion) in isolated
cases. In woman