Nature’s Bounty Lemon Balm Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DRY EXTRACT FROM MELISSA OFFICINALIS L. FOLIUM (LEMON BALM LEAF)

Available from:

Holland & Barrett International Limited

INN (International Name):

DRY EXTRACT FROM MELISSA OFFICINALIS L. FOLIUM (LEMON BALM LEAF)

Dosage:

.

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

2014-09-05

Patient Information leaflet

LEMON BALM HARD CAPSULES
MELISSA LEAF DRY EXTRACT
More information on back panel
P A C K A G E L E A F L E T :
I N F O R M A T I O N F O R T H E P A T I E N T
IMPORTANT NOTES
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE
THIS TRADITIONAL HERBAL MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU:
• Always take this traditional herbal medicine
exactly as described in this leaflet or as your
doctor or pharmacist has told you
• Keep this leaflet. You may need to read it again
• Ask a healthcare professional e.g. a doctor or a
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
• You must talk to a doctor if you feel worse or do
not feel better after taking this traditional
herbal medicine
WHAT IS IN THIS LEAFLET
1
What this traditional herbal medicine is and
what it is used for
2
What you need to know before you take this
traditional herbal medicine
3
How to take this traditional herbal medicine
4
Possible side effects
5
How to store this traditional herbal medicine
6
Contents of the pack and other information
1 -
WHAT THIS TRADITIONAL HERBAL MEDICINE IS
AND WHAT IT IS USED FOR
Nature’s Bounty Lemon Balm Hard Capsules is a
traditional herbal medicinal product used for the
temporary relief of symptoms of mild mental stress,
to aid sleep and for mild digestive complaints such
as bloating and flatulence. This is exclusively based
upon long-standing use.
2 -
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
THIS TRADITIONAL HERBAL MEDICINE
Do not take this traditional herbal medicine if you
are allergic to Lemon Balm Leaf or to any of the
ingredients in this traditional herbal medicinal
product (listed in section 6 of this leaflet).
CHILDREN AND ADOLESCENTS
Do not give this traditional herbal medicine to
children or adolescents under 18 years as it is not
known if it is safe to do so.
OTHER MEDICINES AND NATURE’S BOUNTY LEMON
BALM HARD CAPSULES
Always remember to tell your doct

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2020
CRN009KHR
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nature’s Bounty Lemon Balm Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
171 mg of extract (as dry extract) from _Melissa officinalis _L.,
folium (equivalent to 684 mg – 1026 mg of Lemon Balm leaf).
Extraction solvent: Ethanol 50 % v/v
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Two piece clear hard capsules with green/brown fill.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the temporary relief
of symptoms of mild mental stress, to aid sleep and for
mild digestive complaints such as bloating and flatulence, exclusively
based upon long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short-term use only
_ADULTS AND OLDER PEOPLE_
Take 2 capsules 3 times daily.
Swallow the whole capsule with water.
Do not exceed the stated dose.
DURATION OF USE:
If symptoms persist, worsen or do not improve after 2 weeks use of
Nature’s Bounty Lemon Balm Hard Capsules, a qualified
healthcare professional e.g. a doctor or pharmacist should be
consulted.
Not recommended for use in children under 18 years (see 4.4 Special
warnings and precautions for use).
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Lemon Balm or to any
of the excipientslisted in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Do not exceed the stated dose

The use in children and adolescents under 18 years of age has not been
established due to lack of adequate data.

If symptoms worsen or persist, or if new symptoms develop whilst
taking this medicinal product, a qualified
healthcare professional e.g. a doctor or pharmacist should be
consulted.
Health Products Regulatory Authority
20 January 2020
CRN009KHR
Page 2 of 3
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Although no data is available addit