Kira® 300 mg Tablets
Product Characteristics
Read all of this leaflet carefully because it contains important information for you.This medicine is available without prescription. However, you still need to take Kira® 300 mg carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
Kira® 300 mg
LLI 160
Active substance: dry extract of St. Johns wort, 300 mg/coated tablet
Composition
1 coated tablet contains:
- Active pharmaceutical ingredient:
dry extract of St. John's wort (3-6:1) 300 mg; Extraction solvent: Methanol 80% (v/v).
- Excipients: highly dispersed silicon dioxide, cellulose powder, lactose monohydrate, magnesium stearate, castor oil, hypromellose, macrogol 6000, saccharose, glucose syrup, talcum, titanium dioxide (E 171), gum arabic, povidone, iron oxide hydrate (E 172), bleached wax, Carnauba wax.
Note: Kira® 300 mg coated tablets do not interfere with sugar metabolism; they are thus safe for diabetics. One coated tablet is equivalent to 0.026 carbohydrate exchanges.
Pharmaceutical form and contents
Kira® 300 mg is available in original packs of 60 coated tablets (N2) or 100 coated tablets (N3).
Substance or indication group
Herbal drug for treatment of depressive mood disorders.
Marketing authorisation holder
Cassella-med GmbH & Co. KG,
Gereonsmühlengasse 1, 50670 Cologne.
Manufacturer
Klosterfrau Berlin GmbH, Motzener Straße 41,
12277 Berlin.
Therapeutic indications
Mild to moderate transient depressive disorders (depressive episodes).
Contraindications
Do not take Kira® 300 mg
Kira® 300 mg must not be taken in combination with the following drugs:
- ciclosporin
- tacrolimus
- indinavir and other protease inhibitors used in anti-HIV (“AIDS”) therapy
- irinotecan and other cell growth inhibiting drugs used in cancer therapy
- other antidepressants.
Do not use this medicine if you are allergic (hypersensitive) to the active pharmaceutical ingredient or to any of the excipients, if you know you are hypersensitive to light, or if you are suffering from severe transient depressive disorders.
Special precautions with regard to pregnancy and breast-feeding
To date, there is no adequate empirical data on the use of this medicine in pregnant women and nursing mothers. Consequently, Kira® 300 mg should be used during pregnancy and breast-feeding only if the doctor considers it absolutely necessary.
Using Kira® 300 mg in children
There is no adequate empirical data on using this medicine in children. It should therefore not be used for children under 12 years of age.
Special warnings and precautions for use
Precautions to be observed
When used in combination with Kira® 300 mg, the effect of coumarin-type anticoagulants (phenprocoumon, warfarin), as well as that of theophylline, ciclosporin, digoxin, and some antidepressants may be diminished. It may therefore be necessary to adjust the dosage of these drugs. Patients who take Kira® 300 mg concurrently with medicinal products containing one of these active substances should therefore consult their attending doctor (see section on “Taking other medicines”).
Exposure to intensive UV radiation (prolonged sunbathing, sunlamps, solarium) should be avoided during therapy with Kira® 300 mg.
Women who are using hormonal contraceptives concurrently with Kira® 300 mg may experience intermenstrual bleeding. They should use additional methods of contraception, as the contraceptive safety of the “pill” may be reduced.
Taking other medicines
Other medicines that affect the effectiveness of Kira® 300 mg, or whose own effectiveness is affected by Kira® 300 mg
In some individual instances, interactions that may potentially cause a reduction in effectiveness were observed with the following drugs:
- coumarin-type anticoagulants (e.g. phenprocoumon, warfarin)
- ciclosporin
- tacrolimus
- digoxin
- indinavir and other protease inhibitors used in anti-HIV (“AIDS”) therapy
- irinotecan and other cell growth inhibiting drugs used in cancer therapy
- amitriptyline, nortriptyline
- midazolam
- theophylline
- medicines used for hormonal contraception
When certain drugs for treatment of depression (nefazodone, paroxetine, sertraline) are used concurrently, their effects may be enhanced. In some individual instances, there may be an increase in adverse effects such as nausea, vomiting, anxiety, restlessness, and confusion.
Women who are using hormonal contraceptives concurrently with Kira® 300 mg may experience intermenstrual bleeding.
When other medicines that increase the light sensitivity of the skin are used concurrently, adverse effects on the skin may be enhanced (see section on “Side effects”).
Please tell your doctor if you are taking any other medicines.
Posology and method of administration
The following information applies unless your doctor gives you other instructions for using Kira® 300 mg.
Please follow the instructions for use; otherwise Kira® 300 mg will not be fully effective!
How often to take Kira® 300 mg, and how much
Unless otherwise prescribed, adults and children from 12 years of age should take 1 film-coated tablet three times per day.
How and when to take Kira® 300 mg
Take Kira® 300 mg in the morning, at noon, and in the evening, preferably with your meals; swallow the tablet whole with some liquid (e.g. a gulp of water).
How long to take Kira® 300 mg
Experience has shown that a treatment period of 4-6 weeks is required to achieve a distinct improvement of symptoms. If disease symptoms persist longer than 4 weeks without any change, or become even worse despite using the medicine as directed, you should again see your doctor.
Incorrect use and overdose
What to do if you have taken too much Kira® 300 mg (either on purpose or accidentally)
To date, there have been no reports of acute poisoning caused by St. John's wort preparations in humans.
In cases of severe overdose, affected patients should be protected against exposure to sunlight and other UV radiation for 1-2 weeks (spend as little time outdoors as possible, wear appropriate sun protection such as long-sleeved clothing and high SPF sunscreen (so-called sun blockers)).
There may be an increased occurrence of the side effects described here.
What to do if you took too little Kira® 300 mg or if you missed a scheduled dose
Continue taking your medicine in accordance with your dosage regimen, or as prescribed by your doctor (i.e., do not take the coated tablets more often or in greater amounts).
What to keep in mind when interrupting or prematurely discontinuing treatment with Kira® 300mg
Please talk to your doctor before interrupting or prematurely discontinuing treatment with Kira® 300 mg.
Side effects
What side effects can occur during treatment with Kira® 300 mg, and what countermeasures can be recommended?
Excessive exposure to sunlight during treatment with Kira® 300 mg may cause sunburn-like skin reactions, especially in fair-skinned individuals.
There may be some rare instances of gastrointestinal complaints, allergic skin reactions (redness, itching), fatigue, or restlessness.
If you experience any of these side effects, you should consult your doctor, who will then decide whether your treatment with the medicine has to be discontinued.
If you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.
Notes and information on shelf life of the medicinal product
The expiry date of this medicine is printed on the cardboard box. Do not use Kira® 300 mg after that date!
Please be sure to keep Kira® 300 mg coated tablets out of the reach of children at all times!
This leaflet was last approved in
September 2006.
Storage
Do not store above 25°C.
For sale in pharmacies only
Marketing authorisation No.: 37039.00.00
Properties
Kira® 300 mg is a herbal preparation containing an extract of the flowers and leaves of St. John's wort. It is used for treatment of mild to moderate transient depressive disorders. Such episodes of emotional disorder may also be triggered by stressful events.
Die antidepressant effect of Kira® 300 mg causes a brightening of the mood and an increase in vitality. This can help to restore motivation and performance in daily activities at home and at work.
Kira® 300 mg does not cause fatigue. However, patients may notice a distinct improvement in their night's sleep due to the relaxing and balancing effects on physical and emotional well-being.
Kira® 300 mg should be taken on a regular basis to benefit from the full effectiveness of St. John's wort.
back
Countries
Kira® 300 mg Tablets is available in the following countries:
More information
neo-angin® sugarfree throat lozenges cherry
