SEDARISTON Tropfen

Important notes (mandatory information)

Sedariston drops. Areas of application: for improving well-being in case of nervous strain, for supporting sleep. Warning: Contains 53% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sedariston drops, oral solution for use in adults
Active ingredients: valerian root extract, St. John's wort extract and lemon balm leaf extract
Traditional herbal medicinal product

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 weeks, talk to your doctor.

What this package leaflet contains

1. WHAT ARE SEDARISTON DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SEDARISTON DROPS?
3. HOW TO TAKE SEDARISTON DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SEDARISTON DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE SEDARISTON DROPS AND WHAT ARE THEY USED FOR?

Sedariston drops is a traditional herbal medicinal product for improving well-being in case of nervous strain, for supporting sleep. The medicine is a traditional medicinal product that is registered exclusively on the basis of long-term use for the areas of application. If you do not feel better or if you feel worse after 2 weeks, talk to your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SEDARISTON DROPS?

Sedariston drops must not be taken if you are allergic to valerian root, St. John's wort or lemon balm leaves or any of the other ingredients of this medicine listed in section 6, if you know that your skin is hypersensitive to light.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Sedariston drops. Intensive UV radiation (long sunbathing, sunlamps, solariums) should be avoided during the use of Sedariston drops. If symptoms of illness persist or if side effects other than those mentioned in the package leaflet occur, a doctor or other qualified person in a medical profession should be consulted.

Children and adolescents under 18 years of age

There are no sufficient studies on the use of this medicine in children and adolescents under 18 years of age. It should therefore not be used in this age group and because of the alcohol content.

Taking Sedariston drops with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Studies with Sedariston drops on interactions with other medicines have not been conducted. The simultaneous use of Sedariston drops with centrally depressant medicines such as sleeping pills, sedatives or anaesthetics should be avoided.

Taking Sedariston drops with food and drink

You should avoid drinking alcohol while taking this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Safety during pregnancy and breast-feeding has not been studied. Sedariston drops are not recommended for pregnant and breast-feeding women. It should be noted that use in women of childbearing age who are not using contraception must also be carefully considered, as a possible pregnancy may not yet be known.

Driving and using machines

Taking Sedariston drops can impair your ability to drive and use machines. In this case, you must not drive, operate machinery or perform other hazardous activities.

Sedariston drops contain alcohol

This medicine contains 53% alcohol by volume.

3. HOW TO TAKE SEDARISTON DROPS?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is The usual dose for adults is: 20 drops 3 times a day. The single dose corresponds to 0.74 ml (0.69 g), the daily dose to 2.22 ml (2.07 g). The use in children and adolescents under 18 years of age is not recommended due to insufficient studies. Persons with impaired liver or kidney function There are no sufficient data for specific dosage recommendations in case of impaired liver or kidney function.

Method of administration

Please take the drops diluted in a little liquid (preferably half a glass of water) before or with meals. As a sleep aid, please take a single dose of Sedariston drops half to one hour before going to bed, as well as another single dose earlier in the evening, if necessary.

Duration of use

If your symptoms worsen or do not improve after 2 weeks, a doctor or other qualified person in a medical profession should be consulted.

Please talk to your doctor or pharmacist if you have the impression that the effect of Sedariston drops is too strong or too weak.

If you have taken more Sedariston drops than you should

An overdose is usually without consequences. If you have significantly overdosed on this medicine, you should consult a doctor. If you have accidentally taken twice or three times the intended dosage [equivalent to 1.5 - 2.25 ml (= 40 - 60 drops) of this medicine], this will usually have no adverse effects, except that you will also be taking up to 0.9 g of alcohol at the same time. This corresponds to a quantity of approx. 22 ml of beer or 10 ml of wine. In this case, continue taking the medicine as described in the dosage instructions or as prescribed by your doctor. In the event of accidental drinking of Sedariston drops by children or toddlers, nausea, vomiting, dizziness and unconsciousness may occur - due to the alcohol content. In this case, a doctor should be contacted immediately.

If you forget to take Sedariston drops

Do not take double the amount to make up for a forgotten dose, but continue taking the medicine as described in this package leaflet or as prescribed by your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects (frequency not known)

When taking Sedariston drops, especially in fair-skinned people, increased sensitivity of the skin to UV light (photosensitisation) can lead to sunburn-like reactions of the skin areas that are exposed to strong radiation (sun, solarium). In addition, allergic skin rashes, gastrointestinal complaints, fatigue or restlessness may occur more frequently when taking Sedariston drops.

Special notes

As a rule, it is sufficient to stop taking the medicine in order for the side effects to disappear again. At the first signs of a hypersensitivity reaction, this medicine must not be taken again.

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 on the safety of this medicine.

5. HOW TO STORE SEDARISTON DROPS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or container. The expiry date refers to the last day of the month indicated. Storage conditions: Store in the original package. Keep bottle tightly closed. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment. Note on shelf life after opening: Sedariston drops should not be used for more than 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sedariston drops contain

1 ml (= 27 drops) of liquid contains: The active ingredients are: 0.186 g extract of valerian root (1:9-11), extraction solvent: ethanol 55% (V/V), 0.186 g extract of St. John's wort (1:9-11), extraction solvent: ethanol 55% (V/V), 0.188 g extract of lemon balm leaves (1:4-6), extraction solvent: ethanol 55% (V/V). The other ingredients are: Purified water, ethanol. Contains 53% alcohol by volume.

What Sedariston drops look like and contents of the pack

The brown to green-brown liquid is available in brown glass bottles with a dropper insert and screw cap in packs of 20, 50 and 100 ml.

Pharmaceutical entrepreneur and manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Phone: +49 30 71094 4200
Fax: +49 30 71094 4250

This leaflet was last revised in March 2015.

Source: Information from the package leaflet
Status: 02/2018
Areas of application: for improving well-being in case of nervous strain, for supporting sleep. Warning: Contains 53% alcohol by volume!