Quiet Life Tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

即購入

ダウンロード 製品の特徴 (SPC)
09-06-2024

有効成分:

PASSIFLORA INCARNATA, HUMULUS LUPULUS, VALERIANA OFFICINALIS, LACTUCA VIROSA, LEONURUS CARDIACA

から入手可能:

G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom

ATCコード:

N05CM

INN(国際名):

PASSIFLORA INCARNATA 58 mg HUMULUS LUPULUS 75 mg VALERIANA OFFICINALIS 50 mg LACTUCA VIROSA 29 mg LEONURUS CARDIACA 34 mg

医薬品形態:

COATED TABLET

構図:

PASSIFLORA INCARNATA 58 mg HUMULUS LUPULUS 75 mg VALERIANA OFFICINALIS 50 mg LACTUCA VIROSA 29 mg LEONURUS CARDIACA 34 mg

処方タイプ:

OTC

治療領域:

PSYCHOLEPTICS

認証ステータス:

Withdrawn

承認日:

2005-12-23

情報リーフレット

                                READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, 
you still need to take Quiet Life Tablets carefully to get the 
best results from them.
•  Keep this leaflet. You may need to read it again.
•  Ask your pharmacist if you need more information or 
advice.
•  You must contact a doctor if your symptoms worsen or 
do not improve after 4 weeks.
•  If you notice any side effect, please tell your doctor or 
pharmacist.
In this leaflet:     
1.  What Quiet Life Tablets are and what they are used for
2. Before you take Quiet Life Tablets
3. How to take Quiet Life Tablets
4. Possible side effects
5. How to store Quiet Life Tablets
6. Further information
6. FURTHER INFORMATION
What Quiet Life Tablets contain
The active substances per tablet are:
Motherwort herb (_Leonurus cardiaca_ L.) ........... 34mg
Hop strobiles (_Humulus
lupulus_ L.) ........................ 75mg 
Passion Flower herb (_Passiflora incarnata_ L.) ... 58mg
Dry extract from Wild Lettuce (_Lactuca virosa_ L.)
(equivalent to 29 mg of Wild Lettuce leaf)
Extraction
solvent: Water ....................................... 5.8mg
Dry extract from Valerian root (_Valeriana officinalis_ L.)
(equivalent to 50 mg of Valerian root)
Extraction solvent: Ethanol 60%V/V .............. 12.5mg
Thiamine Hydrochloride (Vit B1) ...................... 0.71mg
Riboflavin (Vit
B2) ....................................................... 0.57mg
Nicotinamide
................................................................. 4.49mg
The other ingredients are:
Core: Acacia, Icing Sugar, Magnesium Stearate, Silicon 
Dioxide, Sodium Starch Glycolate, Stearic Acid.
Coating: Acacia, Calcium Carbonate, Carnauba Wax, 
 
Mastercote Pink SP0415G, Purified Talc, Shellac 
 
Varnish, Sucrose, Titanium Dioxide, Yellow Beeswax.
What Quiet Life Tablets look like and contents of 
 
the pack
Quiet Life Tablets are 
                                
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製品の特徴

                                 
Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 
 
1. 
NAME OF THE MEDICINAL PRODUCT 
 
Quiet Life Tablets 
 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Ingredients 
mg/tablet 
Motherwort_ _herb (_Leonurus cardiac L._) 
34.00 
Dry extract from_ _Wild Lettuce (_Lactuca virosa_ 
L.) (equivalent to 29 mg of Wild Lettuce leaf) 
Extraction solvent: Water 
5.80 
Hop strobiles (_Humulus lupulus _L.) 
75.00 
Dry extract from Valerian root (_Valeriana _
_officinalis_ L. _s.l_.,) 
(equivalent to 50 mg of Valerian root) 
Extraction solvent: Ethanol 60%V/V 
12.50 
Passion Flower herb (_Passiflora incarnata_ L.) 
58.00 
Thiamine Hydrochloride 
0.71 
Riboflavin 
0.57 
Nicotinamide 
4.49 
 
Excipient: Each coated tablet contains 89 mg of sucrose. 
 
For a full list of excipients, see section 6.1. 
 
3. 
PHARMACEUTICAL FORM 
 
Coated tablet. 
Pink circular, biconvex, sugar coated tablet. 
 
4. 
CLINICAL PARTICULARS 
 
4.1 
THERAPEUTIC INDICATIONS 
 
A traditional medicinal product:  
(i)
 
To relieve periods of worry, irritability, and exogenous stresses and strains. 
(ii)
 
To promote natural sleep. 
 
 
Page 2 of 5 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
 
For oral use. 
Adults: Swallow 2 tablets twice per day with water after meals plus 3 tablets at bedtime. 
Not recommended for children or adolescents under 18 years old. 
 
4.3 
CONTRAINDICATIONS 
 
Hypersensitivity to the active substances or to any of the excipients. 
Patients  with  rare  hereditary  problems  of  fructose  intolerance,  glucose-galactose 
malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 
The product should not be used in children or adolescents under 18 years of age. 
 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
 
As  treatment  effects  m
                                
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