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KIRA LOWMOOD RELIEF

Active substance(s): ST JOHNS WORT EXTRACT / ST JOHNS WORT EXTRACT

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a company of

Patient Information Leaflet

Kira

®

Certification
Mark

LowMood relief
film-coated tablets
St. John’s Wort extract 450 mg

24 004 045 GB 04P0816 5694

Read all of this leaflet carefully before you start
taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– 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 do not feel better or
if you feel worse after 6 weeks.
What is in this leaflet
1. What Kira® LowMood relief is and what it is used for
2. What you need to know before you take Kira®
­LowMood relief
3. How to take Kira® LowMood relief
4. Possible side effects
5. How to store Kira® LowMood relief
6. Contents of the pack and other information
1. What Kira LowMood relief is and what it is
used for
This product is a traditional herbal medicinal product
containing St. John’s Wort extract. Each film-coated
tablet contains 450 mg extract (as dry extract) from
St. John’s Wort aerial parts (Hypericum perforatum L.)
®

1

(3-6:1) (equivalent to 1350–2700 mg of St. John’s
Wort). Extraction solvent: Methanol 80 % v/v.

– Stop using it at least 10 days prior to undergoing
any surgery.

Kira® LowMood relief is a traditional herbal medicinal
product used to relieve the symptoms of slightly low
mood and mild anxiety. This usage is based on tradi­
tional use only.
You must talk to a doctor if you do not feel better or if
you feel worse after 6 weeks.

Driving and using machines
St. John’s Wort may make you feel dizzy or sleepy. If
affected do not drive or use machines.

2. What you need to know before you take Kira
LowMood relief
Do not take Kira® LowMood relief if:
– You are allergic to peanut and soya
– You are allergic to St. John’s Wort or any of the
other ingredients (listed in section 6)
– You are under 18 years of age
– You are pregnant or breast-feeding
– Your skin is exceptionally sensitive to sunlight
(photosensitive)
– You are having light treatment (phototherapy) for
any condition
– You are suffering from depression (see below)
Warnings and precautions
Are you suffering from depression?
Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, sleep changes, loss
of energy and difficulty concentrating. If your doctor
has told you that you are suffering from depression
do not take this product. If you think you are suffering from d
­ epression you should tell your doctor.
This product contains lactose and soy polysaccharides. Tell your doctor before taking this product if you
have an intolerance to some sugars (see section 6).
Patients who are allergic to peanut or soya must not
use this medicinal product.
While you are taking this product:
– Avoid excessive sunbathing or the use of sunbeds/
solariums

2

Bezeichnung:

GI Kira LowMood relief

Größe:

Inhalt:

30 überzogene Tabletten

Material:

Artikel-Nr.:

570424

Teile-Nr.:

24 004 045

Druck-Kennz.:

04P0816

Laetus-Code:

5694

EAN-Code:

Other medicines and Kira LowMood relief
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Therefore it is important that you do not take St.
John’s Wort if you are using any of the medicines
­listed in the following table.

DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES
All hormonal contraceptives

The birth control “Pill”, emergency contraception (known as ‘the
morning after pill‘), hormonal implants, creams, patches, intra-uterine
devices with hormones

All medicines for depression/anxiety

Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram,
fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine

All hormonal replacement therapy (HRT)
treatments

HRT tablets, patches, gels, vaginal rings

All medicines for thinning the blood
(anticoagulants)

Warfarin, acenocoumarol

All medicines for epilepsy

Carbamazepine, phenobarbitone, phenytoin, primidone, sodium
valproate

All immunosuppressant medicines

Ciclosporin, tacrolimus

All medicines for HIV infections

Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir,
nelfinavir, ritonavir, saquinavir, tipranavir, efivarenz, nevirapine,
delavirdine

Some medicines for cholesterol

Simvastatin, atorvastatin

Some medicines for cancer

Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib,
etoposide, mitotane

Some medicines for heart disease

Digoxin, ivabradine, amiodarone

Some medicines for migraines

Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
sumatriptan, zolmitriptan

Some medicines for high blood pressure

Amlodipine, nifedipine, felodipine, verapamil

A medicine for regulating mood

Lithium

A thyroid hormone

Thyroxine

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297 x 148 mm

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45 °

Lackaussparung:

Datum: 23.08.2016 Versions-Nr.: 02

Sachbearbeiter G+G

Verwendete Schriften:

I)-

Prüfung und Freigabe Köln:

Andreas Ueberschär

Helvetica LT 55

II)-

q Frei

überprüft durch:

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Andreas Ueberschär

VAG Rounded Bold

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Prüfung und Freigabe Berlin:

Geprüft durch PPC:

q Frei

q Ja

PZN-Code:
Land:

St. John’s Wort can affect the way some medicines
work and reduce their effectiveness. Medicines that
can be affected by St. John’s Wort in­clude prescrip­
tion medicines, and those that you may have bought
yourself without a prescription.

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EAN lesbar:
England

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St. John’s Wort may also affect the following medi­­
cines. Therefore do not take this product with these
medicines unless a doctor has said it is safe to do so:
• Fentanyl, propofol, sevoflurane and midazolam
(anaesthetics/pre-operative medicines)
• Tramadol (an analgesic)
• Erythromycin, clarithromycin and telithromycin
(antibiotics)
• Itraconazole and voriconazole (antifungals)
• Artemether and lumefantrine (antimalarials)
• Rasagiline (anti-Parkinson’s medicine)
• Aripiprazole (antipsychotic medicine)
• Buspirone (anxiolytic)
• Aprepitant (to treat vomiting)
• Butobarbital and Phenobarbital (barbiturates)
• Methyl phenidate (central nervous system or CNS
stimulant)
• Exemestane (hormone antagonist)
• Eplerenone (diuretic)
• Lansoprazole and omeprazole (proton pump
inhibitors)
• Theophylline (bronchodilator)
• Gliclazide (antidiabetic medicine)

24 004 045 GB 04P0816 5694

3. How to take Kira® LowMood relief
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults and the elderly
Take 1 tablet daily. Swallow the tablet whole with
some water or other liquid. Do not chew the tablets.
Do not exceed the stated dose.
If you take more Kira® LowMood relief than you
should
If you take more than the recommended dose, speak
to a doctor, pharmacist or healthcare practitioner and
take this leaflet with you.

5

If you forget to take Kira® LowMood relief
Do not take a double dose to make up for a forgotten
tablet.
If you have any questions, or are unsure about
anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
– gastrointestinal disorders such as indigestion, loss
of appetite, nausea, diarrhoea, constipa­tion
– fatigue
– restlessness
– allergic skin reactions such as rash, hives or itching of the skin. If you experience allergic skin
reactions, stop taking the product and consult
your doctor.
Also sunburn-like reactions on skin exposed to strong
sunlight or strong ultraviolet (UV) irradiation e.g. solarium have been reported, particularly in fair skinned
individuals.
Other side effects that have been reported include
headaches, nerve pain or tingling, anxiety, dizziness
and mania.
The frequency of these effects occuring is not known.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly
via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Kira® LowMood relief
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is

6

Bezeichnung:

GI Kira LowMood relief

Größe:

Inhalt:

30 überzogene Tabletten

Material:

Artikel-Nr.:

570424

Teile-Nr.:

24 004 045

Druck-Kennz.:

04P0816

Laetus-Code:

5694

EAN-Code:

stated on the carton and blister. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer longer use. These
measures will help to protect the environment.
Store the tablets in a cool dry place.
Do not store above 25° C.
Store in original package.

Manufacturer
Klosterfrau Berlin GmbH
Motzener Strasse 41
12277 Berlin
Germany

Keep your tablets in the blister pack until it is time to
take them.

Traditional herbal registration number:
THR 29860/0004

6. Contents of the pack and other information
What Kira® LowMood relief contains
– The active substance is 450 mg of extract (as dry
extract) from St. John’s Wort aerial parts
(Hypericum perforatum L.) (3–6:1) (equivalent to
1350–2700 mg of St. John’s Wort). Extraction solvent: Methanol 80 % v/v.

If you would like further information about this
product, please contact:
Ceuta Healthcare Ltd.,
41 Richmond Hill,
BOURNEMOUTH BH2 6HS,
United Kingdom.

– The other ingredients are:
Extract excipients: Lactose monohydrate, silica colloidal anhydrous
Tablet core: Cellulose microcrystalline, silica colloidal
anhydrous, soy polysaccharides, long-chain partial
glycerides
Film-coating: Hypromellose, cellulose microcrystalline, stearic acid, titanium dioxide (E171), iron oxide
hydrate E 172 (yellow iron oxide), vanillin.
Each film-coated tablet contains 19.15 mg of lactose
and 42 mg of soy polysaccharides.
What Kira® LowMood looks like and contents of
the pack
Each pack contains 30 or 60 film-coated tablets. The
film-coated tablets are yellow with smooth, undam­
aged surface.

Telephone: 01202 780558
Fax: 01202 780559
Email.: info@ceutahealthcare.com
This leaflet was last revised in July 2016.
For a large print, Braille or audio version of this leaflet,
call Ceuta Healthcare Ltd.

Cassella-med GmbH is a company of the

7

297 x 148 mm

Druckfarbe/
Schwarz
Winkelung bei
einer
Rasterweite von
175 lpi

45 °

Lackaussparung:

Datum: 23.08.2016 Versions-Nr.: 02

Sachbearbeiter G+G

Verwendete Schriften:

I)-

Prüfung und Freigabe Köln:

Andreas Ueberschär

Helvetica LT 55

II)-

q Frei

überprüft durch:

Helvetica LT 75

Andreas Ueberschär

VAG Rounded Bold

III)-
q Neuer Abzug erforderlich
Prüfung und Freigabe Berlin:

Geprüft durch PPC:

q Frei

q Ja

X Nein
q

EAN lesbar:

PZN-Code:
Land:

Traditional Herbal Registration Holder
Cassella-med GmbH & Co.KG
Gereonsmuehlengasse 1
50670 Cologne
Germany

England

q Neuer Abzug erforderlich

q Ja

q Nein

Seite: 2 von 2

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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