Nature’s Bounty Hypericum Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

St. john's wort dry extract (as dry extract) from st. john's wort aerial part (hypericum perforatum l)

Available from:

Holland & Barrett International Limited

INN (International Name):

St. john's wort dry extract (as dry extract) from st. john's wort aerial part (hypericum perforatum l)

Dosage:

.

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Authorization status:

Not marketed

Authorization date:

2016-11-11

Patient Information leaflet

HYPERICUM HARD CAPSULES, ST. JOHN’S WORT EXTRACT
More information on back panel
P A T I E N T
I N F O R M A T I O N
L E A F L E T
IMPORTANT NOTES
Please read this leaflet carefully before you use 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.
See section 4
•
You must talk to a doctor if you feel worse or if you do not feel
better after 4 weeks of 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
Further information
1 - WHAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR
This traditional herbal medicine contains St. John’s Wort
(_Hypericum perforatum _L.) Extract. It is a traditional herbal
medicinal product used to relieve the symptoms of slightly low
mood in adults, 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 St. John’s Wort or any of the ingredients in
this traditional herbal medicinal product (listed in Section 6 of
this leaflet).
•
You are taking any of the medicines listed in the table below
•
You are taking medicines for depression or migraine
•
You are taking medicines to suppress your immune system
after transplant surgery
•
You are pregnant or breastfeeding
•
You have skin that is sensitive to sunlight or are

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2020
CRN009KHR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nature’s Bounty Hypericum Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 284 mg of extract (as dry extract) from St.
John’s Wort aerial parts (Hypericum perforatum L.)
(5-7:1), corresponding to: 0.3 – 0.9 mg of total hypericins; not
less than 18 mg of flavonoids, expressed as rutin; maximum 1 mg
hyperforin.
Extraction solvent: ethanol 60% v/v.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Clear, hard, two piece capsules with green brown fill.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to relieve the symptoms of
slightly low mood in adults, exclusively based upon
long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short term use only.
ADULTS ANDOLDER PEOPLE:
Take 1 capsule daily. Swallow the whole capsule with water.
DURATION OF USE:
If symptoms worsen or persist after 4 weeks of using the medicinal
product, a qualified healthcare professional e.g. a doctor or
pharmacist should be consulted.
St John’s wort should not be used in the treatment of children and
adolescents under the age of 18 years (see section 4.4).
4.3 CONTRAINDICATIONS

Hypersensitivity to St. John’s wort or any of the excipients listed
in section 6.1

This product should not be taken concomitantly with any of the
medicines specified in section 4.5. This is because
St. John’s wort (
_Hypericum perforatum _
) has been shown to induce the cytochrome P450 isoenzymes CYP1A2,
CYP2C9, CYP2C19 and CYP3A4 as well as the transport protein,
P-gycoprotein. This results in pharmacokinetic
interactions with a large number of medicines including a possible
decrease in the effectiveness of those medicines

Clinically significant pharmacodynamic interactions have been
identified with the SSRI antidepressants and the
triptan group of medicines used to treat migr