Holland & Barrett Hypericum Hard Capsules

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Holland & Barrett International Limited

INN (Jina la Kimataifa):

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

Kipimo:

.

Dawa fomu:

Capsule, hard

Dawa ya aina:

Product not subject to medical prescription

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2016-11-11

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET
HYPERICUM HARD CAPSULES
ST. JOHN’S WORT EXTRACT
IMPORTANT NOTES
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully before you use this traditional
herbal
medicine because it contains important information for you:
u
Always take this traditional herbal medicine exactly as described
in this leaflet or as your doctor or pharmacist has told you
u
Keep this leaflet, you may need to read it again
u
Ask a healthcare professional e.g. a doctor or a pharmacist if
you need more information or advice
u
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
u
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
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
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.
Do not take this traditional herbal medicine if:
u
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).
u
You are taking any of the medicines listed in the table below
u
You are taking medicines for depression or migraine
u
You are taking medicines to suppress your immune system
after transplant surgery
u
You are pregnant or breastfeeding
u
You have skin that is sensitive to sunlight or are having light
treatment
u
You are about to undergo surgery
Warnings and Precautions
Talk to your doctor before taking this traditional herbal medicine if:
u
You are taking any prescribed medicines
u
You think you may be suffering from depression
u
You have a history of bipolar disorder/manic depression or
any other psychiatric illness
If you think you may

Tabia za bidhaa

Health Products Regulatory Authority
20 January 2020
CRN009KHR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett 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 thefull 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 migrai