RACIUM

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Capsules

Size 0 hard gelatin capsules. Body color ranges from white to grayish or yellowish-brown. Cap color is blue.

Each capsule contains:
Active ingredients: valerian root powder 100 mg, melissa powder 50 mg, and peppermint leaf powder 50 mg.
Excipients: anhydrous lactose, povidone, magnesium stearate, and potato starch.
Capsule shell composition: gelatin, brilliant blue CFC (E133), and titanium dioxide (E171).

Other hypnotics and sedatives

N05CM

RACIUM has sedative, hypnotic, and antispasmodic effects.
Finely ground valerian root powder has a sedative effect, and improves sleep quality and duration.
Melissa powder has sedative and antispasmodic effects.
Peppermint leaf powder has antispasmodic and moderate sedative effects.

Complex therapy of mild functional disorders in central nervous system (neurasthenia and sleep disorders).
Medication is based solely on long-term experience of traditional consumption.

Adults and children over 12 years old
For the relief of nervosism and/or irritability take 1-3 capsules 2-3 times a day. For insomnia take 1-3 capsules 1 hour before bedtime.
It is recommended to take capsules orally during meals with a full glass of lukewarm pre-boiled water.

RACIUM is not recommended for children younger than 12 years old due to the lack of data on its safety and efficacy (see Section Warnings and precautions).
The effect of taking RACIUM develops gradually. It is recommended to take the medicinal product for at least 14 days to achieve the optimal effect. Upon treatment completion, there is no development of RACIUM dependence symptoms or withdrawal syndrome.

You must consult a doctor if your symptoms worsen or do not improve after taking the medicinal product for 14 days.

Frequency Grouping
Very common (≥1/10);
Common (≥1/100 to <1/10);
Uncommon (≥1/1000 to <1/100);
Rare (≥1/10000 to < 1/1000);
Very rare (< 1/10000);
Frequency not known (cannot be estimated from available data).

This medicinal product may cause allergic reactions.

Gastrointestinal Disorders
Frequency is not known for nausea and spasmodic abdominal pains.
This medicinal product may increase the symptoms of gastroesophageal reflux (heartburn).
In case of adverse reactions, including those not listed in the patient information leaflet, you should consult a doctor.

Hypersensitivity to the medicinal product components, children under 12 years, and arterial hypotension.

An overdose of RACIUM may cause fatigue, stomach cramps, tight feeling in the chest, dizziness, hand tremor, and dilated pupils. These symptoms may naturally disappear within 24 hours.
In case of overdose, it is advisable to pump up the stomach and consult a doctor.
It was experimentally proved that a single administration of RACIUM into laboratory animals 15 and 30 times higher than the therapeutic dose did not have any harmful effect neither on the nervous, cardiovascular, hematopoietic, excretory, and respiratory systems, nor on metabolism.

There is limited information on RACIUM interactions with other medicinal products. It might increase the effect of antihypertensive, analgesic, and depressant medicinal products.
Before taking other medicines, a 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 RACIUM with synthetic sedatives (e.g. benzodiazepines) is not recommended and allowed only under medical supervision.

Patients with gastroesophageal reflux (heartburn) should avoid taking medicinal products containing mint due to a possible aggravation of heartburn symptoms.
Patients with chololithiasis (gallstone disease), and other diseases of the gallbladder and bile ducts should not consume peppermint leaves without medical supervision.

RACIUM is not recommended for children younger than 12 years old due to the lack of data on its safety and efficacy.

Patients with the following problems should not take RACIUM:

• rare hereditary intolerance to galactose and/or fructose;
• Lapp lactase deficiency;
• glucose and/or galactose malabsorption syndrome;
• sucrase-isomaltase deficiency.

Safety of administration during pregnancy and lactation has not been established. Administration during pregnancy and lactation is not recommended due to the lack of data.

Administration of RACIUM may impair the ability to drive and use machines. It is not recommended to drive and use machines during treatment.

21 hard gelatin capsules in a blister pack. 2 blister packs and a patient information leaflet in a carton pack.

Protect from light and moisture. Store in the temperature range from 15°С to 25°C.
Keep out of the reach of children.

2 years. Do not use after the expiry date mentioned on the packaging.

State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus,
Phone / Fax +375 17 268-63-64
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en