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Vertidisan®

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Package Leaflet

Read this entire package leaflet carefully before you start using this medical device, as it contains important information. Keep this leaflet — you may need to read it again. If you have further questions, ask your doctor. This medical device has been prescribed for you personally. Do not pass it on to others. If you notice any side effects, tell your doctor and also report them to us as the manufacturer (address below).

Vertidisan® – Package Leaflet for Patients

Contents: Vestibular exercise programme

1. What is Vertidisan® and what is it used for?

Vertidisan® is a medical device and digital programme in the form of a smartphone/tablet app for patients with vertigo due to a disorder of the peripheral balance system (peripheral vestibular system), including patients at risk of falling due to such a disorder.

The peripheral balance system comprises the balance organ in the inner ear and the vestibular nerve. Vertidisan® conveys scientifically established methods and exercises for vestibular training, behavioural therapy, health counselling, and muscle relaxation and training — all well-researched forms of treatment. The therapy is complemented by health education and relaxation.

The focus is on vertigo training, which leads to the so-called central compensation of balance system disorders. The therapeutic aim of Vertidisan®'s exercises is the reorganisation of residual neural information for maintaining body balance after disturbances in the balance system. Where there is a risk of falling, muscle training — particularly of the upper and lower leg — is a further therapeutic objective.

The programme is intended as a supplement to standard medical treatment (e.g. by a GP, neurologist or ENT specialist) for patients aged at least 18 years. When used for the first time, Vertidisan® is intended for self-use by the patient for 90 days.

Dosage form / Platform

Vertidisan® is an Android- or Apple-based application ("app"). An internet-capable device and internet access are required. An e-mail address is also required.

Properties

No additional devices required. Available language: German.

Indicated for

Vertigo due to disorders of peripheral vestibular function, potentially including a tendency to fall. This encompasses diseases of the balance organ in the inner ear (labyrinth) and diseases of the vestibular nerve. According to the international disease classification (ICD-10), these include:

  • Ménière's disease
  • Benign paroxysmal vertigo
  • Vestibular neuronitis
  • Chronic vestibular syndrome / phobic vertigo / persistent postural-perceptual dizziness (PPPD)
  • Tendency to fall, not elsewhere classified (incl. tendency to fall due to other unclear conditions; tendency to fall in elderly persons)
  • Other peripheral vertigo (incl. vertigo: ear / otogenic / peripheral NOS)
  • Other disorders of vestibular function; disorder of vestibular function, unspecified (incl. vertigo syndrome NOS)

The following clinical pictures are also included:

  • Benign paroxysmal positional nystagmus (BPPN), positional vertigo
  • Trauma (e.g. labyrinthine concussion/contusion, skull base injuries)
  • Labyrinthitis (toxic, bacterial, viral)
  • Functional vertigo, PPPD, phobic vertigo, chronic vestibular syndrome
  • Tumours of the skull base and cerebellopontine angle, acoustic neuroma
  • Age-related vertigo, presbyvertigo
  • Ménière's disease, Lermoyez syndrome
  • Vestibular migraine
  • Superior semicircular canal dehiscence
  • Acute vestibular syndrome
  • Vestibular neuronitis
  • Vestibular paroxysmia (neurovascular compression syndrome of the 8th cranial nerve)
  • Bilateral vestibulopathy (bilateral hypoexcitability, bilateral vestibular failure)
  • Unilateral vestibulopathy (unilateral hypoexcitability, unilateral vestibular failure)
  • Sudden hearing loss with vertigo (acute idiopathic sensorineural hearing loss with vestibular involvement)
  • Toxic vestibulopathy (drug side effects, toxic chemicals)
  • Idiopathic vertigo, vertigo not otherwise specified

2. Side Effects

All therapeutic procedures may have side effects; however, these do not occur in every patient. Before this app was used for the treatment of diseases and complaints, clinical evaluations and studies were carried out on the efficacy, hazards and side effects of the app's therapeutic programme.

Known hazards and side effects

Hazards: No hazards have been observed to date.

Side effects:

  • Temporary vertigo, increase in vertigo or balance disturbance. An exercise may initially trigger vertigo or unsteadiness of gait, which soon subsides.
  • Temporary nausea, loss of appetite (possible cause: exercises)
  • Temporary fatigue (possible cause: exercises)
  • Temporary headaches (possible cause: exercises)
  • Temporary neck pain (possible cause: exercises)
  • Temporary blurred or tunnel vision (possible cause: exercises)
  • Temporary musculoskeletal pain
  • Muscle or back tension
  • Temporary knee pain
  • Temporary tinnitus (possible cause: exercises)
  • Occasionally prolonged increase in vertigo (possible cause: exercises)

Expected but not yet observed hazards and side effects

Hazards: Incorrect performance of exercises due to text that is too small, confusing descriptions, or unclear handling/operation.

Side effects:

  • Falls
  • Cardiovascular syncope
  • Rise in blood pressure
  • Connective tissue or muscle injuries
  • Oedema (swelling)
  • Reduced appetite
  • Nasal mucosa inflammation
  • Aversion to psychotherapy

Reporting a hazard or side effect

You can report side effects to the German Federal Institute for Drugs and Medical Devices (www.bfarm.de) or to the manufacturer at meldung@digitineers.com (note: e-mails may be misdirected and are therefore possibly not confidential) or by post (also anonymously):

Digitineers GmbH & Co. KG
– MEDICAL MATTER –
August-Bebel-Str. 9
72072 Tübingen, Germany

3. Contraindications and Warnings

Contraindications

Vertidisan® must not be used in the presence of:

  • Cervical spine and neck disorders
  • Acute inflammatory diseases
  • Febrile condition
  • Heart failure (cardiovascular decompensation)
  • Respiratory failure (pulmonary insufficiency)
  • Motor disorders
  • Seizure disorders (e.g. epilepsy)
  • Spinal cord injury
  • Psychoses
  • Cutaneous sensory disorders with impaired mobility
  • Pregnancy
  • Thrombosis
  • Coagulation disorders, including anticoagulant therapy
  • Large skin defects
  • Burns requiring hospitalisation
  • Metastases from malignant tumours
  • Significant visual impairment
  • Frailty / frailty syndrome

Warnings

Please observe the warnings in the Instructions for Use. They relate to complaints or conditions for which it is important that you have discussed them with your treating physician, as special attention is required in these cases.

Interactions

No interactions between Vertidisan® and additionally used medicines, food or dietary supplements are known. Nevertheless, Vertidisan® should not be used together with medicines whose intake is associated with a risk of falling. Ask your doctor or pharmacist.

Pregnancy

Vertidisan® must not be used during pregnancy.

Driving and operating machinery

As long as Vertidisan® does not trigger vertigo, the app does not lead to any restriction on driving or operating machinery. Vertigo may lead to restrictions on participation in road traffic or on operating machinery.

Document reference: 01032023HPZ-REV