LAIF

LAIF 900 Balance film-coated tablets

Important notes (mandatory information)

Laif 900 Film-coated tablets. Active ingredient: St. John's wort dry extract.

Indications

mild temporary depressive disorders.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Laif 900, 900 mg/film-coated tablet
Active ingredient: St. John's wort dry extract
Herbal medicinal product

Therapeutic group

Herbal medicinal product for depressive mood.

Indications

Mild temporary depressive disorders.

Contraindications

Laif 900 Balance must not be used at the same time as medicinal products which contain one of the following active ingredients or an active ingredient from one of the following groups of substances:

• Medicinal products to suppress rejection reactions to transplants (immunosuppressants): Ciclosporin, Tacrolimus for internal use, Sirolimus.
• Medicinal products to treat HIV infections or AIDS: Indinavir, Nevirapine.
• Cell growth-inhibiting medicinal products (cytostatics): Imatinib, Irinotecan.

Laif 900 Balance must not be taken if you are allergic to St. John's wort or any of the other ingredients.

Note

There is insufficient experience with the use of St. John's wort extracts during pregnancy and breastfeeding. Laif 900 Balance should therefore only be used during pregnancy and breastfeeding after consulting a doctor.

Note

Laif 900 Balance should not be used in children under 12 years of age, as there are no sufficient studies available for this patient group.

Warnings and precautions for use

The simultaneous use of Laif 900 Balance with one of the active ingredients listed under "Interactions with other medicinal products and other agents" can lead to a reduction or increase in the effectiveness of these active ingredients. If you are taking Laif 900 Balance and at the same time medicinal products with one of these active ingredients, you should seek the advice of your doctor. Intensive UV radiation (sunbathing, sunlamps, solariums) should be avoided during the use of Laif 900 Balance. If you are prescribed a medicinal product by your doctor, you should inform your doctor that you are using Laif 900 Balance. If you want to take another medicinal product yourself, you should observe the notes in the section "Interactions with other medicinal products and other agents".

Interactions with other medicinal products and other agents

Medicinal products which, like Laif 900 Balance, contain active ingredients from St. John's wort can potentially interact with other medicinal products. Active ingredients from St. John's wort can accelerate the excretion of other medicinal products and thus reduce the effectiveness of these other substances. However, active ingredients from St. John's wort can also increase the concentration of endogenous substances, such as the so-called "messenger substance" serotonin, together with other medicinal products.

Laif 900 Balance can interact with the following active ingredients, which can lead to a reduction in the effectiveness of these active ingredients:

• Medicinal products to suppress rejection reactions to transplants (immunosuppressants): Ciclosporin, Tacrolimus for internal use, Sirolimus.
• Medicinal products to treat HIV—infections or AIDS: Indinavir, Nevirapine.
• Cell growth—inhibiting medicinal products (cytostatics): Imatinib, Irinotecan.
• Medicinal products to inhibit blood coagulation: Phenprocoumon, Warfarin.
• Digoxin, Midazolam, hormonal contraceptives.
• Tricyclic antidepressants such as Amitriptyline, Nortriptyline.

Laif 900 Balance can interact with certain antidepressants such as Paroxetine, Sertraline, Trazodon, which can lead to an increase in their effectiveness. In individual cases, serotonergic effects (such as nausea, vomiting, anxiety, restlessness, confusion) may be increased when these medicinal products are taken at the same time. When hormonal contraceptives ("the pill") are taken at the same time, breakthrough bleeding may occur and the safety of "the pill" as a contraceptive may be reduced. Further interactions with medicinal products that are metabolised via the cytochrome P 450 enzyme system of the liver are possible.

Dosage, type and duration of use

Unless otherwise prescribed, adults and children aged 12 years and over should take 1 film-coated tablet once a day after breakfast without chewing, with liquid. Since the effect of the medicinal product builds up gradually in the first few days of use, Laif 900 Balance should be taken consistently, with a period of at least 14 days being advisable. The duration of use is not generally limited. However, if there is no improvement after 4 to 6 weeks, a doctor should check whether this form of therapy should be continued.

Overdose and other application errors

If you have taken too much Laif 900 Balance or have forgotten to take it, you should continue taking it as described in the dosage instructions. Acute poisoning symptoms after taking St. John's wort products have not been reported in humans to date. Overdoses may increase the symptoms described under "Side effects".

Side effects

Allergic skin reactions, gastrointestinal complaints, fatigue or restlessness may occur rarely. Rarely, especially in fair-skinned people, increased sensitivity of the skin to intensive UV radiation (sunbathing, sunlamps, solariums) can lead to paraesthesia (tingling, sensitivity to pain and cold, burning) and redness of the irradiated skin areas (photosensitisation). In some cases, the urine may turn a more intense yellow. This is due to the natural colouring agent riboflavin (vitamin B2) in the tablet coating and is therefore harmless. If you observe any of the side effects mentioned, please inform your doctor so that they can decide on the severity and any necessary measures.

Note

No studies have been conducted on the effects on the ability to drive and operate machinery.

Reporting of

side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

Notes and information on the shelf life of the medicinal product

Do not store Laif 900 Balance above +25°C! Store Laif 900 Balance in the original packaging and protect from moisture! Laif 900 Balance must not be used after the expiry date stated on the container and outer packaging. Keep medicinal products out of the reach of children!

Composition

1 film-coated tablet contains the following active ingredient: St. John's wort dry extract (3 - 6 : 1) 900.0 mg (extraction agent: 80 vol.-% ethanol). Other ingredients: Carboxymethyl starch sodium, croscarmellose sodium, Eudragit E 100, highly dispersed silicon dioxide, macrogol 4000, magnesium stearate (vegetable), sodium hydrogen carbonate, riboflavin E 101, talc, titanium dioxide E 171. One film-coated tablet contains less than 0.1 BE.

Pharmaceutical form and contents

Film-coated tablet. Original pack of 20 film-coated tablets, original pack of 60 film-coated tablets and original pack of 100 film-coated tablets.

Pharmaceutical entrepreneur

Bayer Vital GmbH,
Kaiser-Wilhelm-Allee 70
51373 Leverkusen
Germany
Telephone: (0214) 30 51 348
Telefax: (0214) 30 57 209
E-mail address: bayer-vital@bayerhealthcare.com

Manufacturer

Steigerwald Arzneimittelwerk GmbH
Havelstraße 5
64295 Darmstadt
Germany

This package leaflet was last revised in January 2016.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: St. John's wort dry extract. Indications: mild temporary depressive disorders.