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
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 1350 - 2700 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:
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:
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.
DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES
|All hormonal contraceptives||The birth control “Pill”, emergency contraception, 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|
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:
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:
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.
If any of the above side effects become serious or if other side effects not mentioned above occur, a doctor or pharmacist should be consulted.
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 if 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.) (3-6:1) (equivalent to 13502700 mg of St. John’s Wort). Extraction solvent: Methanol 80 % v/v.
This product also contains the following ingredients:
Lactose monohydrate, silica colloidal anhydrous
Cellulose microcrystalline, silica colloidal anhydrous, soy polysaccharides, long-chain partial glycerides
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
Manufacturer of this product
Klosterfrau Berlin GmbH
Motzener Strasse 41
Traditional herbal registration number: THR 29860/0004
You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am2pm Monday Friday).
If you would like further information about this product, please contact:
Ceuta Healthcare Ltd.,
41 Richmond Hill,
BOURNEMOUTH BH2 6HS,
Telephone: 01202 780558
Fax: 01202 780559
This leaflet was prepared in October 2011.
For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd.