Sympathyl 20mg+75mg+124,35mg tablets film-coated

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Download Productkenmerken (SPC)
21-07-2015

Werkstoffen:

eschscholtzia extract, hawthorn extract, magnesium oxide

Beschikbaar vanaf:

Innothera Chouzy

ATC-code:

N05CM

INN (Algemene Internationale Benaming):

eschscholtzia extract, hawthorn extract, magnesium oxide

Dosering:

20mg+75mg+124,35mg

farmaceutische vorm:

tablets film-coated

Eenheden in pakket:

(40/2x20/) blisters

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2015-07-20

Productkenmerken

                                Validated 18/04/2011 PP
DARP
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SYMPATHYL, film-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Eschscholtzia (dry aqueous extract) ..
....................................................................................
20.00 mg
Hawthorn (dry hydro-alcoholic extract of the flower)
............................................................ 75.00 mg
Heavy magnesium oxide …
..................................................................................................
124.35 mg
Equivalent to 75 mg elemental magnesium, i.e.
......................................................................
6.2 mEq
For one film-coated tablet
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS
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. 4.3. CONTRAINDICATIONS
This medicinal product MUST NEVER be prescribed in the following
cases:

hypersensitivity to any of the constituents;

severe renal impairment (creatinine clearance under 30ml/min/1.73 m
2
)
This medicinal product MUST NORMALLY NOT be prescribed in the
following
cases:

in combination with quinidinics (see section 4.5).
Validated 18/04/2011 PP
DARP 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This drug contains an azo colouring agent (E122) and may cause
allergic reactions. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Combination not recommended:
+ QUINIDINICS
Increased plasma concentrations of quinidine and risk of overdose
(decreased renal
excretion of quinidine because of urine alkalinisation).
4.6. PREGNANCY AND LACTATION
PREGNANCY:
There are no reliable data on tera
                                
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