Tenoten for children

Tenoten for children

Instructions
for use


Read this information carefully before using this medicine.

Ask your doctor or pharmacist if you need further information.

 

TENOTEN FOR CHILDREN

Orodispersible tablets

 

Registration License No XXXXXXX

Trade name: Tenoten for children

Pharmaceutical form: Orodispersible tablets.

Composition: Each orodispersible tablet contains:

Active ingredient: Affinity purified antibodies to brain specific S-100 protein − 3 mg*.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

* Water-ethanol mixture of the active substance dilutions with concentration not more than      10-16 ng/g used for saturation of lactose monohydrate.

Description:

White to off-white, round, flat, scored on one side and beveled tablets, marked MATERIA MEDICA on one side and TENOTEN KID on the other.

Pharmacotherapeutic group

Anxiolytics, nootropics.

ATC codes: N05BX, N06BX.

Pharmacological properties

Pharmacodynamics:

The medicine has a sedative, antianxiety (anxiolytic) action, producing no undesirable hypnogenic and myorelaxant effects. Tenoten for children promotes tolerance to psychoemotional stress. It has stress-protective, nootropic, antiamnestic, antihypoxic, neuroprotective, antiasthenic, and antidepressant effects.

In conditions of intoxication, hypoxia, and states following acute cerebral circulation impairment, the medicine produces a neuroprotective effect, limits the damage area, and restores learning and memory processes in the central nervous system (CNS).

Tenoten for children inhibits lipid peroxidation.

It modifies the functional activity of S-100 proteins responsible for the integration of metabolic and synaptic (information transmission) processes. By exerting GABA-mimetic and neurotrophic effects, Tenoten for children enhances the activity of stress-limiting systems and promotes neuronal plasticity restoration.

Pharmacokinetics: The sensitivity of contemporary physicochemical methods (gas-liquid chromatography, high performance liquid chromatography and mass spectrometry) does not allow to assess the content of ultralow doses of antibodies in biological fluids, organs and tissues; that makes technically impossible to investigate the pharmacokinetic properties of Tenoten for children.

Therapeutic indications

Neurotic and neurosis-like states coupled with increased excitability, irritability, anxiety, behavioral and memory disorders and autonomic disturbances.

Attention deficit/hyperactivity disorder.

Contraindications

Individual hypersensitivity to components of the medicine, children under 3 years of age.

Posology and method of administration

Oral route.

One or two tablets per intake (the tablet should be held in the mouth until it is completely dissolved, not during the meal). If required, the tablet may be dissolved in a small volume of drinking water of room temperature.

 

Neurotic and neurosis-like states: to be taken at a dose of 1 tablet from 1 to 3 times daily for total treatment duration of 1-3 months. If necessary, the treatment may be continued up to 6 months or repeated after a 1-2-month period.

Attention deficit/hyperactivity disorder: to be taken at a dose of 2 tablets 2 times daily for total treatment duration of 1-3 months.

If no sustainable improvement is achieved within 3-4 weeks of treatment initiation, medical care should be sought.

Undesirable effects

No side effects have been reported for the medicine used in accordance with the specified indications in the recommended doses.

Individual hypersensitivity to components of the medicine is possible.

Inform doctors of any unwanted effects related to drug use.

Overdose

No cases of overdose have been reported.

Effects on ability to drive and use machines

Tenoten for children has no influence on the ability to drive and use machines.

Interaction with other medicinal products and other forms of interaction

Cases of incompatibility with other medicines have not been reported.

Special warnings and precautions for use

Medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Due to the presence of activating properties in the activity range of Tenoten for children, the last daily dose should not be taken later than 2 hours before bed time.

Use in Pregnancy and lactation

There were no special clinical studies of Tenoten for children on woman in period of pregnancy or lactation. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition of postnatal development. Caution should be exercised when prescribing to pregnant women.

Nature and contents of container

20 orodispersible tablets in PVC/Aluminum blister. 2 blisters are inserted into a cardboard box with leaflet.

Storage conditions

Store in dry light-protected place at temperature below 30 0C.

Store in the original package.

Keep out of reach of children.

Dispensing rules

Over the counter.

Shelf life

3 years since the manufacturing date. Do not use after the expiry date indicated on the package.

Specification: Manufacturer’s standard (In-house).

Manufacturer:

OOO “NPF “MATERIA MEDICA HOLDING”

9, 3rd Samotyochny per., Moscow, Russia, 127473

Tel./Fax: +7 (495) 684-43-33