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Notta® (Tablets, Drops) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Clinical-Pharmacological Group

Homeopathic preparation used for increased nervous excitability and sleep disorders

Pharmacotherapeutic Group

Homeopathic medicinal product

Pharmacological Action

A complex homeopathic medicinal product with anxiolytic action.

It helps to improve tolerance to psychoemotional stress and normalizes the physiological rhythm of sleep.

Indications

Use for the management of the following conditions in adults and children over 3 years of age, associated with neurotic and psychosomatic disorders, excluding endogenous and severe organic pathology.

  • Anxiety disorders, including fear and autonomic lability (increased sweating, palpitations).
  • Sleep disorders and nonorganic disturbances of the sleep-wake schedule.
  • Increased irritability, mood lability, restlessness, and agitation.
  • Fatigue, asthenia, mental tension, and malaise.
  • Attention deficit and increased excitability in the pediatric population.

ICD codes

ICD-10 code Indication
F40 Phobic anxiety disorders (including agoraphobia, social phobias)
F41.9 Anxiety disorder, unspecified
F45.3 Somatoform dysfunction of the autonomic nervous system
F48.0 Neurasthenia
F51.2 Nonorganic disorders of the sleep-wake schedule
F90.0 Disturbance of activity and attention
R45.1 Restlessness and agitation
R45.4 Irritability and anger
R53 Malaise and fatigue
ICD-11 code Indication
6A05.Z Attention deficit hyperactivity disorder, with unspecified presentation
6A8Z Affective disorders, unspecified
6B0Z Anxiety or fear-related disorders, unspecified
6C20.Z Bodily distress disorder, unspecified
7B2Z Sleep-wake cycle disorders, unspecified
MB24.C Irritability
MB24.F Restlessness
MG22 Asthenia
MG25 Malaise

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Individualize the dosage based on the specific indication, the patient’s age, and the clinical presentation.

For tablets, allow to dissolve under the tongue. For drops, administer the prescribed number of drops directly into the mouth or mix with a small amount of water immediately before use.

Adhere strictly to the dosing schedule prescribed by a healthcare professional.

Tablets, Drops

For oral administration.

The dosage regimen is individual, depending on the indications, the patient’s age, and the clinical situation.

Adverse Reactions

Monitor for potential adverse effects during treatment. Allergic reactions are possible, which may include skin rash, itching, or urticaria.

Discontinue use immediately and consult a physician if any signs of hypersensitivity appear.

Contraindications

  • Hypersensitivity to any component of the formulation.
  • Pregnancy and lactation (breastfeeding).
  • Use in children under 12 years of age for the tablet formulation.

Do not administer to patients with a known history of severe allergic reactions to homeopathic preparations.

Drug Interactions

Formal drug interaction studies have not been conducted. Exercise caution when co-administering with other centrally acting drugs, including sedatives, hypnotics, or anxiolytics, due to a potential additive effect.

Inform your physician about all concomitant medications, including over-the-counter products and herbal remedies.

Overdose

No specific antidote is known. In case of suspected overdose, discontinue the medication immediately.

Provide symptomatic and supportive care. Gastric lavage or administration of activated charcoal may be considered if ingestion was recent.

Consult a poison control center or physician for further management advice.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

The oral drops form contains natural herbal ingredients; during storage, slight turbidity of the solution or weakening of the odor and taste may be observed, which does not lead to a decrease in the effectiveness of the drug.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Richard Bittner, AG (Austria)

Dosage Form

Bottle OTC Icon Notta® Homeopathic sublingual tablets: 12, 24, 36 or 48 pcs.

Dosage Form, Packaging, and Composition

Homeopathic sublingual tablets round, flat-cylindrical, with a score and a bevel, white with a yellowish tint, with inclusions and marbling, odorless.

1 tab.
Avena sativa (Oats) D1 74.5 mg
Phosphorus D12 37.2 mg
Chamomilla recutita (Chamomile) D12 37.2 mg
Coffea arabica (Coffee) D12 37.2 mg
Zincum valerianicum D12 37.2 mg

Excipients: lactose monohydrate, potato starch, magnesium stearate.

12 pcs. – blisters (1) – carton packs.
12 pcs. – blisters (2) – carton packs.
12 pcs. – blisters (3) – carton packs.
12 pcs. – blisters (4) – carton packs.

Marketing Authorization Holder

Zentiva, k.s. (Czech Republic)

Manufactured By

Richard Bittner, AG (Austria)

Dosage Form

Bottle OTC Icon Notta® Homeopathic drops for oral administration: bottle 20 ml, 50 ml or 100 ml with dropper

Dosage Form, Packaging, and Composition

Homeopathic drops for oral administration in the form of a transparent liquid, from colorless with a yellowish tint to greenish-yellow in color, without a specific odor.

100 ml
Avena sativa (Avena) D1 20 ml
Phosphorus D12 10 ml
Chamomilla recutita (Chamomilla) D12 10 ml
Coffea arabica (Coffea) D12 10 ml
Zincum valerianicum D12 10 ml

Excipients: ethyl alcohol (ethanol) 43% (by weight) – 40 ml.

20 ml – brown glass bottles with a dropper (1) – carton packs.
50 ml – brown glass bottles with a dropper (1) – carton packs.
100 ml – brown glass bottles with a dropper (1) – carton packs.

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