Dormiplant x50 coated tablets Dr. Willmar Schwabe

DORMIPLANT tablets * 50
Leaflet: patient information Dormiplant 160/80 mg coated tablets Valerian, dry root extract / Melissa, dry leaf extract Dormiplant 160/80 mg coated tabletsValerianae radix extractum siccum/ Melissae folium extractum siccum Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better after 14 days or your condition worsens, you should seek medical advice.
What this leaflet contains: 1. What Dormiplant is and what it is used for 2. What you need to know before you take Dormiplant 3. How to take Dormiplant 4. Possible side effects 5. How to store Dormiplant 6. Contents of the pack and other information
1. What is Dormiplant and what is it used for? Dormiplant is a herbal medicinal product for the treatment of anxiety and sleep disorders due to nervous conditions. If you do not feel better after 14 days or your condition worsens, you should seek medical attention.
2. What you need to know before you take Dormiplant Do not take Dormiplant:

if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking Dormiplant.
Children: Not recommended for use in children under 6 years of age.
Other medicines and Dormiplant Dormiplant may increase the effect of synthetic sedatives (tranquilizers). If you are taking synthetic sedatives, contact your doctor before using this medicine. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Dormiplant with food and drink: Taking the product does not depend on meals.
Pregnancy and breast-feeding If you are pregnant or breast-feeding; think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist before using this medicine. As a precautionary measure, due to insufficient data, the use of Dormiplant during pregnancy and breast-feeding is not recommended.
Driving and using machines This medicine may impair your ability to drive and use machines. Therefore, it should not be taken less than 2 hours before driving or using machines.
Dormiplant contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Dormiplant Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children over 6 years of age: The recommended dose is 2 coated tablets twice daily. The coated tablets are taken unchewed with a little liquid in the morning and evening. The intake does not depend on meals.
Use in children Dormiplant should not be given to children under 6 years of age.
Dormiplant is very well tolerated. The duration of use is generally unlimited. If symptoms do not improve or worsen after two weeks of use, you should consult a doctor.
If you take more Dormiplant than you should If you have accidentally taken one or two coated tablets more than prescribed, this usually has no harmful consequences. Taking more than 27 coated tablets Dormiplant at once (corresponding to 20 g of valerian roots) may lead to the following symptoms: easy fatigue, abdominal cramps, a feeling of tightness in the chest, a feeling of emptiness in the head, tremor of the hands and dilated pupils. These symptoms usually disappear after 24 hours. However, if these symptoms persist, it is recommended to consult a doctor.
If you forget to take Dormiplant Do not take a double dose to make up for a forgotten dose. Continue treatment as instructed in this leaflet.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency criteria are used to assess adverse drug reactions:

Very common: (> 1/10);
Common: (>1/100 to 1/1,000 to 1/10,000 to <1/1,000); Very rare: (<1/10,000); Unknown: (cannot be estimated from the available data). Gastrointestinal disorders: Gastrointestinal complaints may occur rarely. Reporting of side effects If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, at: The Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel. +35 928903417, website: www.bda.bg. By reporting side effects, you can contribute to obtaining more information on the safety of this medicine. 5. How to store Dormiplant Store below 30°C. Protect from moisture. The product has undergone radiation control. Keep out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Dormiplant contains The active substances are: Valerianae radix exxractum siccum (valerian, dry root extract) (3-6:1) - 160 mg. Extracting agent: ethanol 62%. Melissae folium extractum siccum (lemon balm, dry leaf extract) (4-6:1) - 80 mg. Extracting agent: ethanol 30%. The other ingredients are: Microcrystalline cellulose, crospovidone, magnesium stearate, hydrogenated castor oil, sucrose, colloidal silicon dioxide, talc, indigo carmine E132, titanium dioxide E171, hydroxypropyl methylcellulose, stearic acid, vanillin, sodium saccharin, simethicone, methylcellulose, sorbic acid. What Dormiplant looks like and contents of the pack Dormiplant tablets are coated, round, blue in color. Dormiplant is available in packs of 50 and 100 coated tablets. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer: Dr. Willmar Schwabe GmbH & Co. KG, Germany. Date of last revision of this leaflet: 10/2016.