• 150 mg valerian root dry extract (3-6:1); Extraction agent: ethanol 70% (V/V)
• 80 mg passion flower dry extract (4-7:1); Extraction agent: ethanol 50% (V/V)
• 30 mg hop cone dry extract (4-8:1); Extraction agent: ethanol 40% (V/V)

• stearic acid
• maltodextrin
• hypromellose
• montan glycol wax
• clay, white
• Silica, colloidal
• cellulose powder
• cellulose, microcrystalline
• Glucose Syrup Solids
• Povidone K25
• Magnesium stearate (vegetable)
• sucrose
• lactose-1 water
• Macrogol 6000
• titanium dioxide
• Arabic gum
• indigo carmine
• Glycerol 85%
• calcium carbonate
• talc

indication

• The preparation is a herbal medicine for use in restlessness and nervous insomnia.

dosage

• Always take the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the usual dose is:
  • To treat restlessness:
    • Children from 3 years take 1 dragee 1-2 times a day, adults and children over 12 years take 1 dragee up to 3 times a day.
  • For the treatment of nervous-related insomnia:
    • Children from 3 years and adults take 1 dragee 1/2 to 1 hour before bedtime. If necessary, 1 additional dragee can be taken earlier in the evening.
• Use in children under 3 years is not intended.
• For people suffering from kidney or liver disease: There is insufficient data for specific dosage recommendations in the case of impaired kidney/liver function.

• How long should you take the medicine?
  • Due to the gradual onset of the effect, the preparation is not suitable for the acute treatment of restlessness and problems falling asleep. In order to achieve optimal treatment success, it is recommended to adhere to continuous use for 2 - 4 weeks.
  • If symptoms do not improve or worsen after two weeks of continuous use of the drug, a doctor should be consulted.

• If you take more than you should
  • If you accidentally take 1 or 2 more tablets than intended, this usually has no adverse consequences. In this case, continue taking it as described in the dosing instructions or as directed by your doctor. If you have significantly overdosed this medicine, you should consult a doctor.
  • In one individual case, the intake of valerian root in a dosage of more than 20 g led to the following symptoms: tiredness, abdominal cramps, tightness in the chest, feeling of emptiness in the head, trembling of the hands and dilation of the pupils.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose, but go on with the next dose.

• If you stop taking the dragees:
  • Interrupting or prematurely ending the treatment is harmless.

way

• The dragees are taken whole with plenty of liquid (preferably a glass of drinking water).

side effects

• Like all medicines, the preparation has side effects, although not everyone gets them. The list includes all known side effects from treatment with valerian root, hop cones and passion flower herb, including those with higher doses or long-term therapy.
• The evaluation of side effects is based on the following frequency information:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Very rare: affects less than 1 in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• Because the following possible adverse reactions are based on spontaneous reports from extensive post-marketing use, it is not possible to precisely estimate their frequency. Therefore, the frequency is classified as "not known".
• Significant side effects or signs to look out for and actions to take if affected:
  • If you are affected by any of the side effects listed below, stop taking the medicine and contact your doctor as soon as possible.
  • As with all oral medicinal products, systemic hypersensitivity reactions can occur. These can manifest themselves, for example, in the form of skin reactions (e.g. reddening of the skin, skin rashes, hives, itching), hypersensitivity reactions of the gastrointestinal tract (e.g. abdominal pain, vomiting), the cardiovascular system (e.g. fluctuations in blood pressure, tachycardia) or the respiratory tract (e.g. shortness of breath). to express.
• Other possible side effects
  • dizziness
  • headache
  • Inner unrest
  • nervousness
  • restlessness
• Please tell your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects that are not listed.

interactions

• When taking the preparation with other medicines:
  • Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
  • No interaction studies have been performed with the drug. There is limited data on the pharmacological interactions of valerian, hop and passionflower herb preparations with other medicinal products. The combination with synthetic sedatives requires medical diagnosis and monitoring.
• Taking the medicine with food and drink:
  • Avoid drinking alcohol while using this medicine. Drugs with a sleep-promoting effect can, in principle, change the ability to react, even when used as intended; This applies even more in combination with alcohol.

Contraindications

• The medicine must not be taken
  • if you are allergic (hypersensitive) to valerian, hops, passion flower or any of the other ingredients of the preparation.

pregnancy and breast feeding period

• Safety during pregnancy and lactation has not been adequately studied. The drug is not recommended for pregnant and breastfeeding women.

patient notes

• Particular caution is required when taking the preparation
  • in children under 3 years of age, as there are no adequate studies available. It should therefore not be used in children under 3 years of age.
  • in people suffering from kidney or liver disease.

• Driving and using machines
  • Even when used as directed, the drug can impair the ability to drive and operate machines. In this case, you are not allowed to drive motor vehicles, operate machines or carry out other dangerous activities. This applies to a greater extent in combination with alcohol.