Nytol Herbal tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kúpte ho teraz

Stiahnuť Príbalový leták (PIL)
01-05-2019

Aktívna zložka:

Hops extract; Valerian extract; Passion flower extract

Dostupné z:

Omega Pharma Ltd

ATC kód:

n/a

INN (Medzinárodný Name):

Hops extract; Valerian extract; Passion flower extract

Dávkovanie:

200mg ; 160mg ; 130mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Never Valid To Prescribe As A VMP

Prehľad produktov:

BNF: ; GTIN: 5000347029332

Príbalový leták

                                Perrigo component code:
Artwork reference nr:
FOR APPROVAL • Approval needs to be given within AMS. Please verify
this proof carefully concerning lay-out, size, texts and bar code. For
the PMS colours please refer to the latest PMS coulour guide. After
your approval on the above we can proceed to the next stage of your
project.
Graphic Design
Nytol
Tablets
LF23224A
P20821
United Kingdom
125 x 178 mm
Herbal
20tabs
Leaflet
English
LR01293
IVC Brunel
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0
10/05/19
1
16/05/19
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LF23224A - 02
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Black
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P20821 Nytol Leaflet cutter 125x178
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522
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FRONT
125mm
First Bar
Last Bar
17mm
178mm
PROFILE KEYS:
Pharma Code
Copy/Text Free
17mm
BACK
125mm
17mm
178mm
P20821
LF23224A
HERBAL
TABLETS
With extracts of Hop Strobile, Valerian and Passion Flower
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS PRODUCT
BECAUSE IT CONTAINS IMPORTANT INFORMATION YOU NEED TO KNOW.
This product is available without prescription; however, you still
need
to use this product carefully to get the best results from it.
Keep this leaflet as you may need to read it again.
Ask your doctor, pharmacist or qualified healthcare practitioner if
you
need more information or advice.
IN THIS LEAFLET:
1. What this product is and what it is used for.
2. Before you take this product.
3. How to take this product.
4. Possible side effects.
5. How to store this product.
6. Further information.
1. What this product is and what it is used for
THIS MEDICINE CONTAINS EXTRACTS OF:
• hop strobile
• valerian root
• passion flower herb.
A traditional herbal medicinal product used for the temporary relief
of sleep disturbances based on traditional use only.
2. Before you take this product
DO NOT TAKE THIS PRODUCT IF YOU ARE:
• allergic to any of the ingredients (see section 6)
• under 18 years of age
• already taking a medicine for sleep or anxiety
PREGNANCY AND BREAST FEEDING
• DO NOT TAKE this product if you are pregnant or breast feeding,
because there is no evidence that it is safe to do so.
• The e
                                
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Súhrn charakteristických

                                OBJECT 1
NYTOL HERBAL TABLETS
Summary of Product Characteristics Updated 27-Sep-2019 | Omega Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Superdrug Quiet Night Tablets
Sainsbury's Healthcare Sleep Aid Tablets
Tesco Herbal Sleep Aid
Sominex Herbal
Nytol Herbal Tablets
Gerard House Somnus Sleep Aid
Boots Sleepeaze Herbal Plus Tablets
HERBALSTORE Sleep Aid
Wilko Sleep Aid Tablets
Asda Sleep Aid
My Protein Sleep Aid Tablet
Health Essentials Herbal Sleep Aid
2. Qualitative and quantitative composition
EACH FILM COATED TABLET CONTAINS:
Each film coated tablet contains:
34 mg of extract (as dry extract) from Hop strobile (Humulus lupulus
L.) (4- 6:1) Extraction solvent:
Methanol 30% (v/v)
30.8 mg of extract (as dry extract) from Valerian root (Valeriana
officinalis L.) (4.5-6:1) Extraction
solvent: Ethanol 60% (v/v)
18.2 mg of extract (as dry extract) of Passion Flower herb (Passiflora
incarnata L.) (3-7:1) Extraction
solvent: Ethanol 70% (v/v)
For full list of ex
                                
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