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Dr. Willmar Schwabe GmbH & Co.KG

Sleep disorders, EUVEGAL Balance

Sleep disorders, EUVEGAL Balance

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EUVEGAL Balance 500 mg film-coated tablets

Areas of application:
- Nervous restlessness
- Sleep disorders Instructions for



use Sleep disorders, EUVEGAL Balance:


The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water).

Duration of use?
You should not use the medicine for more than 2 weeks without medical advice. You should see your doctor if you have persistent or recurring symptoms.

overdose?
There are currently no known signs of overdose. If in doubt consult your doctor.

Forgot to take?
Continue taking it as normal (i.e. not double the amount) at the next prescribed time.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.



Mode of action Sleep disorders, EUVEGAL Balance:




Contraindications:
What speaks against an application?

- Hypersensitivity to the ingredients

Which age group should be considered?
- Children under 12 years of age: The medicine should not normally be used in this age group.

What about pregnancy and lactation?
- Pregnancy: According to current knowledge, the drug should not be used.
- Breast-feeding: According to current knowledge, it is not recommended to use it. You may be to consider a weaning.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects:
What side effects can occur?

No side effects are currently known for the drug.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Important Sleep disorders, EUVEGAL Balance information:
What should you consider?
- The ability to react can also be impaired when used as intended, especially in higher doses or in combination with alcohol. Be particularly careful when driving or using machines (including household ones) that could injure you.
- Beware of allergies to spices, essential oils and turpentine oil!
- Beware of allergies to cinnamon, birch, poplar buds, propolis, valerian, turmeric and rosin!
- Be careful if you are allergic to binding agents (e.g. carboxymethyl cellulose with the E number E 466)!
- Be careful if you are allergic to the solvent propylene glycol (E number E 477)!
- Be careful if you are allergic to the sweetener saccharin (E number E 954) or to sulfonamides!
- Be careful if you are allergic to the preservative sorbic acid (E number E 200, E 201, E 202, E 203)!
- Be careful if you are allergic to talc!
- Be careful if you are allergic to phenol (e.g. pyrogallol, triclosan and vanillin)!
- Beware of allergies to dyes (e.g. indigo carmine with the E number E 132)!


For medicines: Read the leaflet on the risks and side effects and ask your doctor or pharmacist.

Euvegal ® Balance 500 mg film-coated tablet

For adults and adolescents aged 12 and over.

Active ingredient: Valerian root dry extract.

Areas of application: states of restlessness. Nervous sleep disorders.

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

rest at night. strength for the day.

active Sleep disorders, EUVEGAL Balance ingredients

  • 500 mg valerian root dry extract (3-6:1); Extraction agent: ethanol 70% (V/V)

Sleep disorders, EUVEGAL Balance excipients

  • cellulose, microcrystalline
  • Croscarmellose sodium
  • hypromellose
  • Magnesium stearate (vegetable)
  • methyl cellulose
  • Castor oil, hydrogenated
  • Sodium saccharine
  • silica, precipitated
  • Simeticon
  • sorbic acid
  • stearic acid
  • talc
  • vanillin
  • titanium dioxide
  • Indigodisulfonic acid, aluminum salt

Sleep disorders, EUVEGAL Balance indication

  • The preparation is a herbal medicine for sedation.
  • The medicine is applied
    • with slight nervous tension,
    • with sleep disorders.

dosage Sleep disorders, EUVEGAL Balance 

  • Always take the preparation 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:
    • In the case of slight nervous tension, adults and adolescents from the age of 12 should take 1 film-coated tablet once a day, if necessary up to 3 times a day.
    • To treat insomnia, adults and adolescents over the age of 12 should take 1 film-coated tablet half an hour to 1 hour before bedtime. If necessary, an additional 1 film-coated tablet can be taken earlier in the evening.
    • The dosages mentioned correspond to 2.25 - 6.75g valerian root per day. The maximum daily dose is 4 single doses, corresponding to 4 film-coated tablets.
  • It is not intended for use in children under the age of 12.
  • There is insufficient data for specific dosage recommendations in the case of impaired kidney function/liver function.

 

  • duration of use
    • Due to the gradual effect, valerian root is not suitable for the acute treatment of mild nervous tension and sleep disorders. 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 of the medicine than you should:
    • If you accidentally take one or two more film-coated tablets than you should, 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 the preparation, you should consult a doctor.
    • In one individual case, after taking valerian root in a dosage of approx. 20g (equivalent to taking approx. 9 film-coated tablets of the preparation at once), symptoms such as: tiredness, abdominal cramps, tightness in the chest, feeling of emptiness in the head, trembling hands occurred and dilation of the pupils. These complaints were no longer present after 24 hours. If such symptoms occur, a doctor should be consulted.

 

  • If you forget to take the medicine:
    • Do not take a double dose, but continue to take it as described in the dosing guide or as directed by your doctor.

way

    • To take.
    • Do not take the medicine lying down. Please take the preparation whole with sufficient liquid (preferably a glass of drinking water). It can be taken independently of meals.

 

side effects

  • Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after taking preparations made from valerian roots. The frequency is not known.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

  • Interactions with other medicines
    • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
    • No studies have been conducted with the medicine. There is limited data on pharmacological interactions of valerian preparations with other medicinal products. The combination with synthetic sedatives requires medical diagnosis and monitoring.
  • Taking the drug with food and drink
    • Avoid drinking alcohol while using this medicine.

Contraindications

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

pregnancy and breast feeding period

  • pregnancy and breast feeding period
    • Safety during pregnancy and lactation has not been adequately studied. The preparation is not recommended for pregnant and breastfeeding women.

patient notes

  • Special care is required when taking the drug
    • with children.
      • There are no adequate studies on the use of the drug in children. It should therefore not be used in children under the age of 12.

 

  • 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.

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