MODAL CAPSULES

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

SULPIRIDE

제공처:

RAFA LABORATORIES LTD

ATC 코드:

N05AL01

약제 형태:

CAPSULES

구성:

SULPIRIDE 50 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

치료 그룹:

SULPIRIDE

치료 영역:

SULPIRIDE

치료 징후:

Anti - dopaminergic agent for use in vertigo and prepsychotic states.

승인 날짜:

2022-11-30

환자 정보 전단

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine is sold with a doctor's prescription only
MODAL
CAPSULES
MODAL FORTE
TABLETS
ACTIVE INGREDIENT:
Each Modal capsule contains: Sulpiride 50 mg
Each Modal Forte tablet contains: Sulpiride 200 mg
For the list of inactive ingredients, please see section 6. See also
'Important information
about some of the medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if you think their medical condition is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Modal: an antidopaminergic medicine for treatment of vertigo
(dizziness) and
prepsychotic states.
Modal Forte: an antidopaminergic medicine for treatment of vertigo
(dizziness) and
prepsychotic states. At high doses, for treatment of depression and
apathy in psychiatric
patients.
THERAPEUTIC GROUP: benzamides 2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

Do not use if you are sensitive (allergic) to the active ingredient or
to any of the other
ingredients the medicine contains (for a list of inactive ingredients,
please see section
6).

Do not use if you suffer from pheochromocytoma (tumor of the adrenal
gland),
prolactin-dependent cancerous tumors, e.g, pituitary gland cancer or
breast cancer,
or porphyria (a rare metabolic disease).

Do not use the medicine if you are taking levodopa or ropinirole (or
other medicines
for treatment of Parkinson's disease).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Patients aged 65 and over may be more sensitive to the effects of the
medicine.

Be careful not to become overheated during physical exercise, in hot
weather and
in a hot shower (may cause a heatstroke). If you become overheated,
contact your
doctor.
�

제품 특성 요약

Modal-DL-Jun 2023-02
Doctor leaflet
1. NAME OF THE MEDICINAL PRODUCT
CAPSULES
®
MODAL
FORTE TABLETS
®
MODAL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Each capsule of Modal contains sulpiride 50 mg.
Each tablet of Modal Forte contains sulpiride 200mg.
Excipient with known effect:
Modal Forte contains approximately 27 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Modal: white powder in light-blue (sea blue) capsules.
Modal Forte: white tablets with scoreline, imprinted with Modal F.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
:
Modal Capsules
Anti - dopaminergic agent for use in vertigo and prepsychotic states.
:
Modal Forte Tablets
Anti - dopaminergic agent.
1) For use in vertigo and prepsychotic states.
2) At high doses - in psychiatric patients for treatment of depression
and apathy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
VERTIGO
Average dosage:
The treatment is initiated with low dosages in adults, with 50-100mg
per day,
in divided doses.
As a rule, the maintenance dose for adults is 150-300 mg per day, in
divided
doses.
Severe cases:
The dosage may be increased. The duration of treatment should not be
less
than 15 days and should be continued for several weeks if necessary.
_ _
PSYCHIATRY
Initial dose of 200-400 mg twice daily, increasing if necessary to a
maximum
of 1200 mg twice daily. Maintenance dose 600-800 mg per day in divided
doses.
Psychiatry - Elderly:
The same dose ranges may be required in the elderly, but, as a general
rule
with the use of psychotropics in elderly patients, starting doses
should be
lower and increased gradually, particularly in those with renal
impairment.
Psychiatry - Children aged above 6 years old:
3-5 mg/kg body weight/day in devided doses
2
Renal Failure_: _
Sulpiride is primarily excreted renally, and dose adjustments have
been
suggested in renal insufficiency.
-
creatinine clearance 30 to 60 mL/minute – 50% of normal dose
-
creatinine clearance 10 to 30 mL/minute – 30% of normal dose
-
creatinin