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II Hill

KLOSTERFRAU

HEALTHCARE GROUP

Patient Information Leaflet

Kira ®

LowMood relief

film-coated tablets

St. John's Wort extract 450 mg

Please read this leaflet carefully before you start taking these tablets. It contains some important information about Kira® LowMood relief.

Keep this leaflet with the tablets.

You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Side effects

5.    How to store this product

6.    Further information

1. What this product 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.) (3-6:1) (equivalent to 13502700 mg of St. John's Wort). Extraction solvent: Methanol 80 % v/v.

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 traditional use only.

2. Before you take this product

Do not take this product if:

-    You are allergic to peanut and soya

-    You are under 18 years of age

-    You are pregnant or breast-feeding

-    You are allergic to any of the ingredients (see section 6)

-    Your skin is exceptionally sensitive to sunlight (photosensitive)

-    You are having light treatment (phototherapy) for any condition

-    You are suffering from depression (see below)

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 depression 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).

While you are taking this product:

-    Avoid excessive sunbathing or the use of sunbeds / solariums

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

Driving and operating machinery

In rare cases St. John's Wort may make you feel dizzy or sleepy. If affected do not drive or use machines.

Taking this product with other medicines

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 prescription medicines, and those that you may have bought yourself without a prescription.

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.

Bezeichnung:	GI Kira LowMood relief	GroBe:	297 x 148 mm		Lackaussparung:	Datum: 15.06.2015 Versions-Nr.: 00-0	Sachbearbeiter G+G	Verwendete Schriften:
Inhalt:	30 uberzogene Tabletten	Material:			I)-	Prufung und Freigabe Koln:	Bjorn Sund	Helvetica LT 55
Artikel-Nr.:	570424				II)-	□ Frei	uberpruft durch:	Helvetica LT 75
Teile-Nr.:	Mockup	Druckfarbe/	Schwarz	45 °	III)-		Andreas Ueberschar	VAG Rounded Bold
Druck-Kennz.:	02P0615	Winkelung bei einer Rasterweite				□ Neuer Abzug erforderlich
Laetus-Code:	5692					Prufung und Freigabe Berlin:	Gepruft durch PPC:
EAN-Code:		von 175 lpi				□ Frei	□ Ja □ Nein
PZN-Code:							EAN lesbar:
Land:	England					□ Neuer Abzug erforderlich	□ Ja □ Nein	Seite: 1 von 2

II Hill

St. John's Wort may also affect the following medicines. 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)

3. How to take this product

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 too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time, it does not matter if you have missed a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

If your symptoms worsen or persist after 6 weeks or if side effects become serious or if you experience any side effects not mentioned in section 4 of this leaflet, consult your doctor or qualified healthcare practitioner.

4.    Side effects

Like all medicines, this product can have side effects.

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.

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 this product

Do not use your tablets after the expiry date. The expiry date refers to the last day of that month.

The expiry date is printed on the box and the blister pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.

Keep your tablets out of the reach and sight of children. Keep your tablets in the blister pack until it is time to take them.

6. Further information

Each film-coated tablet of this product contains 450 mg of extract (as dry extract) from St. John's Wort aerial parts (Hypericum perforatum L.) (36:1) (equivalent to 1350-2700 mg of St. John's Wort). Extraction solvent: Methanol 80 % v/v.

This product also contains the following ingredients:

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.

Each pack contains 30 or 60 film-coated tablets. The film-coated tablets are yellow with smooth, undamaged surface.

Registration holder for this product

Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50670 Cologne Germany

Manufacturer of this product

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

Traditional herbal registration number:

THR 29860/0004

If you would like further information about this product, please contact:

Ceuta Healthcare Ltd.,

41 Richmond Hill,

BOURNEMOUTH BH26HS,

United Kingdom.

Telephone: 01202 780558

Fax: 01202 780559

Email.: info@ceutahealthcare.com

This leaflet was prepared in May 2015.

For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd.

Cassella-med GmbH is a company of the

KLOSTERFRAU

HEALTHCARE GROUP

Bezeichnung:	GI Kira LowMood relief	GroBe:	297 x 148 mm		Lackaussparung:	Datum: 15.06.2015 Versions-Nr.: 00-0	Sachbearbeiter G+G	Verwendete Schriften:
Inhalt:	30 uberzogene Tabletten	Material:			I)-	Prufung und Freigabe Koln:	Bjorn Sund	Helvetica LT 55
Artikel-Nr.:	570424				II)-	□ Frei	uberpruft durch:	Helvetica LT 75
Teile-Nr.:	Mockup	Druckfarbe/	Schwarz	45 °	III)-		Andreas Ueberschar	VAG Rounded Bold
Druck-Kennz.:	02P0615	Winkelung bei einer Rasterweite				□ Neuer Abzug erforderlich
Laetus-Code:	5692					Prufung und Freigabe Berlin:	Gepruft tlurch PPC:
EAN-Code:		von 175 lpi				□ Frei	□ Ja □ Nein
PZN-Code:							EAN lesbar:
Land:	England					□ Neuer Abzug erforderlich	□ Ja □ Nein	Seite: 2 von 2