Sympathyl tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

eschscholtzia extract, hawthorn extract, magnesium oxide

Available from:

Innothera Chouzy

ATC code:

առկա չէ

INN (International Name):

eschscholtzia extract, hawthorn extract, magnesium oxide

Dosage:

20mg+ 75mg+ 124,35mg

Pharmaceutical form:

tablets film-coated

Units in package:

(40/2x20/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-07-21

Patient Information leaflet

532783-01-18
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMPATHYL®
FILM-COATED TABLET
Eschscholtzia, Hawthorn, Heavy magnesium oxide
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINAL
PRODUCT BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What is SYMPATHYL, film-coated tablet and what it is used for
2.
What you need to know before you take SYMPATHYL, film- coated tablets
3.
How to take SYMPATHYL, film-coated tablets
4.
Possible side effects
5.
How to store SYMPATHYL, film-coated tablets
6.
Contents of the pack and other information
1.
WHAT SYMPATHYL, FILM-COATED TABLET IS AND WHAT IT IS USED FOR
Pharmacotherapeutic
class:
PHYTOTHERAPY
AND
MINERAL
ELEMENTS
WITH
A
SEDATIVE EFFECT.
This medicine is a mild tranquilizer.
It is recommended for adults:
-
to reduce nervousness or in the event of excessive perception of the
heart beat (palpitations)
after any cardiac disease has been excluded;
-
in the event of mild sleep disorders.
You must talk to a doctor if you do not feel better or if you feel
worse.
532783-01-18
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYMPATHYL, FILM-COATED TABLET
NEVER TAKE SYMPATHYL, FILM-COATED TABLET:
-
if you are allergic (hypersensitive) to the active substances or one
of the other constituents of
this medicine listed in section 6.
-
if you suffer from severe renal insufficiency (failure of kidney
functions). This medicine
SHOULD USUALLY NOT BE TAKEN, except advised by your doctor.
-
if you are taking quinidine treatment or quinidine-like drugs
treatment.
IF YOU HAVE ANY DOUBT, PLEASE ASK YOUR DOCTOR OR PHA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SYMPATHYL, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heavy magnesium oxide
124.35 mg
Quantity corresponding to 75 mg of elemental magnesium, i.e.
6.2 mEq
Hawthorn (
_Crataegus monogyna_
Jacq. and/or
_C. laevigata_
DC.)
(dry extract of flowering tops)
7
5.00 mg
Extraction solvent: ethanol 60% v/v
Drug extract ratio: 2.8-3.8: 1
Eschscholtzia (
_Eschscholtzia californica_
Cham.)
(dry extract of flowering aerial parts)
20.00 mg
Extraction solvent: ethanol 60% v/v
Drug extract ratio: 3.5: 1
For one film-coated tablet
Excipients with known effect: azorubine (E122).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
SYMPATHYL, film-coated tablet is indicated to adults.
Traditionally used in:
the symptomatic treatment of neurotonic states in adults, minor sleep
disorders, disorders due to
cardiac erethism in adults with a healthy heart.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For adults only.
The usual dose is 4 tablets per day, 2 in the morning and 2 in the
evening, before meals.
_PEDIATRIC POPULATION _
The safety and efficacy of SYMPATHYL, film-coated tablet in
adolescents and children under 18
years of age have not been established.
_METHOD OF ADMINISTRATION _
Oral route.
The tablets should be taken before meals.
_DURATION OF TREATMENT _
The usual duration of treatment is 30 days.
4.3.
CONTRAINDICATIONS
hypersensitivity to the active substances or any of the excipients
listed in section 6.1;
severe renal impairment (creatinine clearance under 30ml/min/1.73 m
2
)
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This drug contains an azo colouring agent (E122) and may cause
allergic reactions.
This medicinal product should generally not be prescribed in
combination with quinidine (see
section 4.5).
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Combination not recommended:
+ QUINIDINICS
Increased plasma concent