Ratsium

INSTRUCTIONS

(information for patients)

on medical use of a medicinal product

 

Ratsium

Registration number: No. 15/07/2209

Trade name: RATSIUM

International Nonproprietary Name: -

Dosage form: capsules

Composition: each capsule contains:

Active substances: rhizome powder with valerian roots 100 mg, melissa herb powder 50 mg, peppermint leaves powder 50 mg.

Excipients: lactose anhydrous, povidone, magnesium stearate, potato starch.

The composition of the shell capsule: gelatin, a brilliant diamond blue E-133, titanium dioxide E 171.

Description: capsules are hard gelatinous, number 0, body from white to grayish or yellowish-brownish color, cap - blue.

Pharmacotherapeutic group: Other sleeping pills and sedatives.

ATX Code: N05CM.

Pharmacological properties

The drug has a calming, sleeping, spasmolytic effect.

Fine powder of rhizomes with valerian roots has a calming effect, and also improves the quality and duration of sleep.

Melissa herb powder - soothing and spasmolytic, powder of peppermint leaves - spasmolytic, moderate soothing effect.

Indications for use

In the complex therapy of non-severe functional disorders of the central nervous system (neurasthenia and sleep disturbances).

The use of the drug is based solely on the experience of traditional long-term use.

Dosing and Administration

Adults and children over 12 years of age

With increased nervous excitability, irritability - 1-3 capsules 2-3 times a day; with insomnia should take 1-3 capsules 1 hour before bedtime.

It is recommended to take orally during meals, with a full glass of boiled water at room temperature.

Due to the lack of data on the safety and efficacy, taking Ratsium  by children under the age of 12 years is  not recommended (see section "Special instructions").

The effect of taking the drug Ratsium develops gradually. To achieve the optimal effect, it is recommended to take the medication for at least 14 days. After discontinuation of treatment, there is no development of symptoms of dependence or withdrawal syndrome.

If symptoms persist with medication for fourteen days or if the condition worsens, consult a doctor.

Side effect

The incidence of adverse reactions listed below is very often (≥1/10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10000 to < 1/1000), very rarely (<1/10000), is not known (can not be estimated based on available data).

May develop an allergic reaction

Gastrointestinal disorders

It is not known: nausea, pain of a spastic nature in the abdominal cavity.

There may be an increase in symptoms of gastroesophageal reflux (heartburn).

In case of adverse reactions, including those not listed in the instructions for use, you should consult your doctor.

Contraindications

Hypersensitivity to the components of the drug, children under 12 years of age, arterial hypotension.

Overdose

Overdose of the Ratsium may cause a feeling of fatigue, cramps in the stomach, a feeling of contraction in the chest, dizziness, trembling of hands, dilated pupils that can disappear on their own within 24 hours.

When overdosing, it is advisable to wash the stomach and consult a doctor.

In the experiment, a single administration of Ratsium to laboratory animals at doses 15 and 30 times higher than the therapeutic dose does not have a harmful effect on the nervous, cardiovascular, haematopoietic, excretory, respiratory systems, metabolism.

Interaction with other drugs

Information on interactions between the drug Ratsium and other drugs is limited. It is possible to strengthen the effect of hypotensive, analgesic and drugs for depressant functions of the central nervous system.

Before taking other medications, the patient should consult a doctor. Clinically significant interactions with substances that are metabolized by CYP 2D6, CYP 3A4 / 5, CYP 1A2 and CYP 2E1 have not been observed. Simultaneous administration of the drug Ratsium with synthetic sedatives (for example, benzodiazepines) is not recommended and is allowed only under the supervision of a physician.

Special instructions

Patients with gastroesophageal reflux (heartburn) should avoid taking medications containing peppermint because of the possible increase in heartburn.

Patients with cholelithiasis, other diseases of the gallbladder and biliary tract should not take peppermint leaves without seeing a doctor.

Due to the lack of data on the safety and efficacy of taking the drug, Ratsium is not recommended for children under the age of 12 years.

Patients with rare hereditary problems of galactose intolerance, fructose, deficiency of Lappa lactase, glucose / galactose malabsorption syndrome, insufficiency of sucrose-isomaltase should not take the drug Ratsium.

Application in pregnancy and lactation

Safety of use during pregnancy and lactation is not established. Due to the lack of data it is not recommended to apply during pregnancy and lactation.

Impact on the ability to drive and potentially dangerous machinery

Ratsium  intake can degrade the ability to drive and work with machinery. During treatment it is not recommended to drive and work with machines.

Form of issue

Capsules hard gelatinous. For 21 capsules in a blister pack. 2 blister packs  together with instructions for medical use in a cardboard pack.

Storage conditions

In a place protected from light and moisture at a temperature of 15 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date printed on the package.

Pharmacy purchasing terms

 Without recipe.