Sedistress 500mg film-coated tablets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Disponibbli minn:

Tilman SA ZI Sud 15, Baillonville, 5377, , Belgium

Kodiċi ATC:

N05CM

INN (Isem Internazzjonali):

PASSIFLORA INCARNATA 500 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

PASSIFLORA INCARNATA 500 mg

Tip ta 'preskrizzjoni:

OTC

Żona terapewtika:

PSYCHOLEPTICS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2024-02-21

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SEDISTRESS 500MG FILM-COATED TABLETS
Passionflower herb dry extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 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 after 2 weeks.
WHAT IS IN THIS LEAFLET :
1.
What Sedistress 500mg is and what it is used for
2.
What you need to know before you take Sedistress 500mg
3.
How to take Sedistress 500mg
4.
Possible side effects
5.
How to store Sedistress 500mg
6.
Contents of the pack and other information
1.
WHAT SEDISTRESS 500MG IS AND WHAT IT IS USED FOR
Sedistress 500mg is a traditional herbal medicinal product containing
Passion flower (
_Passiflora _
_incarnata _
L.) dry extract.
Sedistress 500mg is a traditional herbal medicinal product used in
adults and adolescents over 12 years
of age to relieve the mild symptoms of mental stress, such as
nervousness, worrying or irritability and
to aid sleep.
The product is a traditional herbal medicinal product for use in the
specific indications exclusively
based upon long-standing use.
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEDISTRESS 500MG
DO NOT TAKE SEDISTRESS 500MG
-
if you are allergic to passion flower or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Sedistress 500mg.
CHILDREN AND ADOLESCENTS
The use in children under 12 years of age is not recommended.
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OTHER MEDICINES AND SEDISTRESS 500MG
Tell your doctor

Karatteristiċi tal-prodott

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1.
NAME OF THE MEDICINAL PRODUCT
Sedistress 500mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of extract (as dry extract)
from
_Passiflora incarnata_
L., herba
(equivalent to 2000 mg - 3000 mg of Passion flower).
Extraction solvent: Ethanol 70% V/V.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink to dark pink oblong film-coated tablets of 19 x 9 mm.
For oral use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used to relieve the mild symptoms
of mental stress, such as
nervousness, worrying or irritability and to aid sleep.
The product is a traditional herbal medicinal product for use in the
specific indications exclusively
based upon long-standing use.
Sedistress 500mg is indicated in adults and adolescents from 12 years
of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents from 12 years of age : _
- For relief of temporary mental stress: 1 to 2 tablets per day.
- To aid sleep: 1 tablet in the evening, ½ hour before bedtime. If
required a second tablet can be
taken later.
Dosage may be increased following to your doctor’s or pharmacist’s
instructions (maximum 3
tablets per day).
_Pediatric population _
The use in children under 12 years of age is not recommended (see
section 4.4).
Duration of use
If the symptoms persist longer than 2 weeks during the use of the
medicinal product, a doctor or a
qualified health care practitioner should be consulted.
Method of administration
Oral use.
Swallow the tablets with a large glass of water.
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4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use in children under 12 years of age has not been established due
to lack of adequate data.
If the symptoms worsen during the use of the medicinal product, a
doctor or a qualified health care
practitioner should be consul