Natures Aid Sleepeeze Valerian Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Dostępny od:

Clonmel Healthcare Ltd

Kod ATC:

V03AX

Forma farmaceutyczna:

Film-coated tablet

Dziedzina terapeutyczna:

Other therapeutic products

Status autoryzacji:

Not marketed

Data autoryzacji:

2022-08-26

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NATURES AID SLEEPEEZE
Valerian tablets
VALERIAN ROOT EXTRACT
READ ALL 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 or nurse
has 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 or
nurse. 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 NATURES AID SLEEPEEZE IS AND WHAT IT IS USED FOR.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATURES AID SLEEPEEZE.
3. HOW TO TAKE NATURES AID SLEEPEEZE.
4. POSSIBLE SIDE EFFECTS.
5. HOW TO STORE NATURES AID SLEEPEEZE.
6. CONTENTS OF THE PACK AND OTHER INFORMATION.
1. WHAT NATURES AID SLEEPEEZE IS AND WHAT IT IS USED FOR.
Natures Aid Sleepeeze is a traditional herbal medicinal product used
for the relief of mild mental
stress and to aid sleep exclusively based on long standing use.
Each film-coated tablet contains 150mg of extract (as dry extract)
from Valerian root (
_Valeriana _
_officinalis_
L.) equivalent to 750-900mg of Valerian root. Extraction solvent:
ethanol 70%v/v.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATURES AID SLEEPEEZE.
DO NOT TAKE NATURES AID SLEEPEEZE IF:

You are allergic to Valerian root or any of the other ingredients of
this traditional herbal
medicinal product listed in section 6.

You are already taking medicine which can cause drowsiness

You are pregnant or breastfeeding
WARNINGS AND PRECAUTIONS.

Do not exceed the stated dose.

This product contains glucose
.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor b

Charakterystyka produktu

Health Products Regulatory Authority
26 August 2022
CRN008WMH
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Natures Aid Sleepeeze Valerian Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 150mg of extract (as dry extract)
from _Valeriana officinalis _L. radix (Valerian root) (equivalent
to 750mg - 900mg of Valerian root).
Extraction solvent: ethanol 70 %v/v.
Excipients with known effect:
Each tablet contains glucose (dextrose) 2.4mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
A brown circular convex film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of mild
symptoms of mental stress and to aid sleep exclusively based
on long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short term use only.
ADULTS AND THE ELDERLY:
FOR RELIEF OF MILD SYMPTOMS OF MENTAL STRESS one to two tablets to be
taken daily.
TO AID SLEEP, one tablet to be taken 30-60 minutes before bedtime. One
additional tablet can be taken earlier in the evening if
necessary.
Not recommended for children or adolescents under 18 years (see
Section 4.4).
MAXIMUM DOSE: 3 tablets per day
DURATION OF USE:
As treatment effects may not be apparent immediately, the tablets
should be taken continuously for 2 weeks.
If symptoms worsen, persist or do not improve after 2 weeks, a
qualified healthcare professional e.g. a doctor or a pharmacist
should be consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to Valerian root or to any of the excipients listed
in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
The use of this product is not recommended in children and adolescents
below the age of 18 years because data are not
sufficient and medical advice should be sought.
If symptoms worsen, persist or do not improve after 2 weeks, a
qualified healthcare professional e.g. doctor or
pharmacistshould be consulted.
Each t