Noofen 500

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOOFEN® 500 (Noofen 500)

Composition:

Active substance: phenibut;

1 sachet contains phenibut 500 mg;

Excipients: aspartame (E951), mannite (E421), orange flavoring agent Durarom [containing, among others, sucrose, mono- and diglycerides of citric and fatty acids (E472c)].

Dosage form. Oral powder for solution.

Main physicochemical properties: white to light cream-colored powder; yellow specks may be present.

Pharmacotherapeutic group. Psychostimulants and nootropic agents. ATC code N06BX.

Pharmacological Properties

Pharmacodynamics

Noofen® 500 is a derivative of γ-aminobutyric acid and phenylethylamine.

Its primary effects are anti-hypoxic and anti-amnesic. Noofen® 500 improves memory and attention, enhances learning processes, and increases physical and mental performance. Psychological parameters (speed and accuracy of sensorimotor responses) improve under the influence of Noofen® 500. It has been established that Noofen® 500 enhances the neuron's energy potential by improving mitochondrial function.

Noofen® 500 also possesses tranquilizing properties: it alleviates psychoemotional tension, anxiety, fear, emotional lability, irritability, improves sleep, and prolongs and enhances the effects of hypnotics, narcotic agents, neuroleptics, and anticonvulsants. Noofen® 500 binds exclusively to GABA-ß receptors in the brain, thus exerting a moderate calming effect without causing undesirable sedative effects such as drowsiness, dizziness, reduced attention, or impaired performance. The drug prolongs the latent period and reduces the duration and intensity of nystagmus, and exhibits antiepileptic activity. It does not affect cholinergic or adrenergic receptors.

Noofen® 500 significantly reduces manifestations of asthenia and vasovegetative symptoms, including headache and a sensation of heaviness in the head. In patients with asthenia and emotionally labile individuals, Noofen® 500 improves well-being without causing excitation.

In patients with psychogenic erectile dysfunction, Noofen® 500, by exerting tranquilizing, anti-asthenic, and psychoenergizing effects, activates central pro-erectile mechanisms.

Pharmacokinetics

The drug is rapidly absorbed after oral administration and penetrates all tissues of the body, completely crossing the blood-brain barrier. Distribution in the liver and kidneys is close to uniform, while in the brain and blood it is lower than uniform. Three hours after administration, a significant amount of Noofen® 500 is detectable in urine, while the drug concentration in brain tissue does not decrease and remains detectable in the brain for up to 6 hours. The following day, Noofen® is detectable only in urine; it can still be found in urine up to 2 days after intake, though the amount detected constitutes only 5% of the administered dose. The highest binding of Noofen® 500 occurs in the liver (80%), and this binding is non-specific. No accumulation is observed upon repeated administration.

Clinical characteristics.

Indications.

Asthenic and anxiety-neurotic states (emotional lability, impaired memory, decreased attention span), restlessness, fear, anxiety, obsessive neurosis.

In elderly patients – insomnia, nocturnal restlessness.

Prevention of stress conditions prior to surgeries or painful diagnostic procedures.

Meniere’s disease, dizziness associated with vestibular dysfunction, prevention of motion sickness.

As an adjunctive agent in the treatment of alcohol withdrawal syndrome.

Treatment of erectile dysfunction of psychogenic and mixed origin in men – as monotherapy, as well as part of combined therapy.

Contraindications. Hypersensitivity to the components of the drug. Acute renal failure.

The drug contains aspartame, a source of phenylalanine. Its use is contraindicated in patients with phenylketonuria.

Interaction with other medicinal products and other forms of interaction.

Noofen®500 can be used concomitantly with other medicinal products, including psychotropic drugs – tranquilizers and neuroleptics (effects are mutually enhanced).

Special precautions for use.

Patients with gastrointestinal disorders should be cautious due to the irritant effect of Noofen®500. Lower doses should be prescribed to such patients.

In case of prolonged use, blood cell counts and liver function tests should be monitored.

Use during pregnancy or breastfeeding.

Noofen®500 is not recommended during pregnancy or breastfeeding due to insufficient data on the use of the drug during these periods.

Ability to influence reaction rate when driving or operating machinery.

Patients who experience drowsiness, dizziness, or other central nervous system disturbances during treatment with the drug should refrain from driving or operating machinery.

Method of Administration and Dosage.

The contents of the sachet should be dissolved in half a glass of boiled water and taken orally before meals. The treatment course lasts 2–6 weeks.

The drug is prescribed at 500 mg 1–3 times daily.

Noofen®500 can be combined with other psychotropic agents, which enhances its efficacy. In such cases, the dosage of Noofen®500 and of other concurrently administered drugs may be reduced.

For treatment of alcohol withdrawal syndrome: during the first days, administer 500 mg 2–3 times during the day and 500 mg at night, gradually reducing the daily dose to the usual adult dose.

For treatment of vertigo due to infectious dysfunction of the vestibular analyzer (otogenic labyrinthitis) and Meniere’s disease: during the acute phase, Noofen®500 is administered at 500 mg four times daily for 5–7 days; as vestibular disturbances subside, reduce to 500 mg 2–3 times daily for 5–7 days, followed by 500 mg once daily for 5 days. In cases of milder disease course, Noofen®500 is administered at 500 mg once daily for 5–7 days, then 100 mg 2–3 times daily for 7–10 days. To achieve the recommended dosage, other dosage forms of the drug should be used.

For treatment of vertigo due to vascular or traumatic dysfunction of the vestibular analyzer: Noofen®500 is prescribed at 500 mg 1–2 times daily for 12 days.

For prevention of motion sickness: a single dose of 500 mg should be taken 1 hour before the expected onset of motion sickness or upon the appearance of the first symptoms.

The effect of Noofen®500 is enhanced with increased dosage. However, in the presence of pronounced symptoms (vomiting, nausea), the drug is poorly effective even at a dose of 1000 mg.

For treatment of erectile dysfunction of psychogenic or mixed origin in men: 500 mg of Noofen®500 once daily. Treatment course: 21–28 days.

If one or more doses have been missed, continue the treatment course according to previously prescribed dosages.

Children.

The use of the drug in this dosage form is contraindicated in children.

Overdose.

Noofen®500 is a low-toxicity drug. Hepatotoxicity may occur only with prolonged administration at daily doses of 7–14 g.

These doses significantly exceed the recommended dose (average therapeutic dose is 500–2000 mg). Eosinophilia and fatty liver degeneration have been observed only at higher doses. When lower doses were used, such changes were not observed.

Symptoms: drowsiness, nausea, vomiting, possible development of arterial hypotension, acute renal failure.

Treatment: gastric lavage. Symptomatic therapy.

In case of complications (arterial hypotension, renal failure), supportive and symptomatic measures should be applied.

Side effects.

From the nervous system: drowsiness (at the beginning of treatment), headache and dizziness (at doses exceeding 2 g per day; the intensity of this adverse effect decreases when the dose is reduced).

From the gastrointestinal tract: nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

From the liver and biliary tract: hepatotoxicity (with prolonged use of high doses).

From the immune system: allergic reactions, including rash, itching, urticaria, skin redness.

Psychiatric disorders: emotional lability, sleep disturbances (these adverse reactions may occur in children when the medicinal product is used contrary to the instructions for use).

If adverse reactions not listed in this instruction appear during treatment, or if any of the listed adverse reactions are particularly severe, please consult your doctor.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging.

2.5 g of the drug in a laminated sachet. 5 sachets per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

JSC "Olfa" / Olpha AS.

Manufacturer's address.

Rupnicu iela 5, Olaine, Olaines novads, LV-2114, Latvia / Rupnicu iela 5, Olaine, Olaines novads, LV-2114, Latvia.