SIDROGA

SIDROGA St. John's Wort Tea Filter Bags

Important notes (mandatory information)

Sidroga Johanniskraut, herbal tea. Areas of application: to support the treatment of nervous restlessness and sleep disorders.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Sidroga Johanniskraut, herbal tea for use in adults and children aged 6 and over
Active ingredient: St. John's wort

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Sidroga Johanniskraut must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after several weeks of use, you must consult a doctor.
• If any of the side effects listed significantly affect you or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS SIDROGA JOHANNISKRAUT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SIDROGA JOHANNISKRAUT?
3. HOW SHOULD SIDROGA JOHANNISKRAUT BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SIDROGA JOHANNISKRAUT BE STORED?
6. FURTHER INFORMATION

1. WHAT IS SIDROGA JOHANNISKRAUT AND WHAT IS IT USED FOR?

Sidroga Johanniskraut is a herbal medicine for calming. Sidroga Johanniskraut is used to support the treatment of nervous restlessness and sleep disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SIDROGA JOHANNISKRAUT?

Sidroga Johanniskraut must not be taken:

• if you are hypersensitive (allergic) to St. John's wort.
• if you are taking medicines with the following active ingredients at the same time: coumarin-like anticoagulant active ingredients (phenprocoumon, warfarin), immunosuppressants such as ciclosporin, indinavir and other protease inhibitors in anti-HIV treatment, cytostatics such as imatinib, midazolam and medicines for hormonal contraception (birth control pill).
• if you have known photosensitivity of the skin.

Special care should be taken when taking Sidroga Johanniskraut:

• if symptoms worsen or occur more frequently or persist for a longer period of time. Consultation with a doctor is recommended here.
• in fair-skinned people. After taking St. John's wort preparations and subsequent exposure to sunlight, skin reactions such as sunburn-like skin redness can occur. Light-sensitive people should therefore protect themselves from prolonged direct sunlight during the period of use and avoid visiting solariums.
• if you are taking other medicines at the same time. Here you should observe the following information and seek the advice of your doctor.

When taking Sidroga Johanniskraut with other medicines

In individual cases, a reduction in the effectiveness of the following medicines has been observed when taken together with St. John's wort preparations:

• Medicines for inhibiting blood clotting (anticoagulants) of the coumarin type such as phenprocoumon, warfarin
• Medicines for suppressing rejection reactions to transplants (immunosuppressants) such as ciclosporin, tacrolimus for internal use, sirolimus
• Medicines for treating HIV infections or AIDS such as indinavir and other protease inhibitors
• Cytostatics such as imatinib
• Antidepressants such as amitriptyline and nortriptyline
• hormonal medicines for contraception
• digoxin
• theophylline
• midazolam.

When taken together with certain medicines for treating depression (paroxetine, sertraline, nefazodone), their effectiveness may be increased. If medicines are taken that cause photosensitivity (photosensitization), the photosensitivity may be increased. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Children

Children between 6 and 12 years of age should only take Sidroga Johanniskraut under medical supervision.

Pregnancy and breast-feeding

There are no adequate studies on the use of St. John's wort during pregnancy and breast-feeding. It is therefore recommended that Sidroga Johanniskraut only be used during pregnancy and breast-feeding after consulting a doctor. Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and operating machinery

No special precautions are required.

3. HOW SHOULD SIDROGA JOHANNISKRAUT BE TAKEN?

Always take Sidroga Johanniskraut exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, regularly drink 1 to 2 cups of the tea infusion prepared as follows in the morning and evening. Preparation: Pour boiling water (approx. 150 ml) over 1 to 2 Sidroga Johanniskraut filter bags, let steep for about 10 minutes and remove the filter bags. For children between 6 and 12 years of age, the tea infusion is prepared with 1 Sidroga Johanniskraut filter bag per infusion.

Duration of use

To achieve an effect, use over several weeks and months is usually necessary. If the symptoms persist unchanged, you should consult a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Sidroga Johanniskraut is too strong or too weak.

If you have taken a larger amount of Sidroga Johanniskraut than you should and you notice symptoms due to the higher dosage, please notify your doctor. He/she can decide on any necessary measures.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Sidroga Johanniskraut can have side effects, although not everybody gets them.

Possible side effects

Rarely (in less than 1 in 1000 patients, but more than 1 in 10000 patients), gastrointestinal complaints, allergic reactions, fatigue or restlessness may occur. Especially in fair-skinned people, increased sensitivity of the skin to sunlight (photosensitization) can occasionally (in less than 1 in 100 patients, but more than 1 in 1000 patients) lead to sunburn-like reactions of the skin areas that were exposed to strong sunlight (sun, solarium).

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 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.

5. HOW SHOULD SIDROGA JOHANNISKRAUT BE STORED?

Keep the medicine out of the reach of children. Please do not use the medicine after the expiry date stated on the envelope/folding box after < usable until >. The expiry date refers to the last day of the month. Storage conditions: Please store the medicine in the original packaging to protect the contents from light and moisture.

6. FURTHER INFORMATION

What Sidroga Johanniskraut contains

The active ingredient is: St. John's wort. 1 filter bag (at 1.75 g) contains 1.75 g of St. John's wort.

What Sidroga Johanniskraut looks like and contents of the pack

Original pack with 20 filter bags at 1.75 g each.

Pharmaceutical entrepreneur and manufacturer

Sidroga Gesellschaft für Gesundheitsprodukte mbH
56119 Bad Ems
Tel.: 02603-96 04 710
Fax: 02603 - 96 04 711
info@sidroga.com

This leaflet was last revised in January 2014.

Source: Information from the package leaflet
Status: 04/2017
Areas of application: to support the treatment of nervous restlessness and sleep disorders.