Instructions for Relaxil hard capsules blister No. 20
Composition
active ingredients: 1 capsule contains valerian 0.8% dry aqueous-alcoholic extract 125 mg, peppermint dry extract 25 mg, lemon balm dry extract 25 mg;
excipients: microcrystalline cellulose, potato starch, heavy magnesium oxide, colloidal anhydrous silicon dioxide, magnesium stearate;
capsule shell: gelatin, azorubine (E 122), diamond black BN (E 151), patent blue V (E 131), quinoline yellow (E 104), titanium dioxide (E 171).
Dosage form
The capsules are hard.
Main physical and chemical properties: hard gelatin capsules with a green body and cap. Capsule contents – powder or pressed mass from brownish-brown to gray-brown with inclusions.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics
Relaxyl is a herbal medicine with a mild sedative effect.
The combination has a calming effect and is indicated for eliminating transient nervous tension (as a daily sedative for mental stress, excitement, and irritability).
Valerian has a sedative effect. It has a positive effect on well-being with symptoms of irritability, such as restlessness, excitement and tension due to nervous overload. In case of insomnia, it helps to fall asleep faster.
Melissa also has a sedative and antispasmodic effect.
Peppermint is traditionally used in combination with valerian in sedative medicines.
The drug is used for neuroses when the use of strong sedatives is inappropriate. Indications for its use are determined exclusively on the basis of long-term experience of use.
Pharmacokinetics
Data is missing.
Indication
Neuroses accompanied by the following symptoms:
nervous excitement; restlessness; tension caused by stress; sleep disorders.
Contraindication
Hypersensitivity to valerian, lemon balm, peppermint or other components of the drug. Severe arterial hypotension, bronchial asthma. Depression or other conditions accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
Data on interactions with other drugs are limited. Consult a doctor before using the drug simultaneously with other drugs.
No clinically significant interactions with active substances metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 have been identified.
Concomitant use with synthetic sedative drugs (benzodiazepines) without consulting a doctor is not recommended.
With simultaneous use, the effects of other sedatives and hypnotics, antispasmodics, analgesics, anxiolytics, and alcohol may be enhanced.
Application features
The drug should be used with caution in patients who have severe liver dysfunction or have had severe liver disease in the past.
Patients with gastroesophageal reflux (heartburn) should avoid using medicines containing peppermint leaves, as it may worsen their condition.
Patients with gallstone disease or other diseases of the bile ducts and gallbladder should be prescribed medications containing peppermint leaves with extreme caution.
During the period of use of the drug, you should refrain from drinking alcoholic beverages.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may affect the ability to drive and use machines, therefore, during its use, it is recommended to refrain from driving or operating other machinery until individual sensitivity is determined.
Use during pregnancy or breastfeeding
The efficacy and safety of the drug during pregnancy or breastfeeding have not been established, therefore it is not recommended to use Relaxyl during these periods.
Method of administration and doses
Adults and children over 12 years of age: for mental stress, excitement or irritability, it is recommended to take 2 capsules 2 times a day; for sleep disorders - 2 capsules 1 hour before bedtime.
The capsules should be swallowed whole with water, regardless of meals.
The drug is characterized by a gradual onset of action. To achieve optimal treatment effect, it is recommended to use it for at least 14 days.
The duration of treatment is not limited. Even with prolonged use of the drug, addiction is not observed. There is no withdrawal syndrome after discontinuation of treatment.
If no improvement is observed 14 days after the start of treatment, you should consult a doctor.
Children
There are no data on the use of the drug in children under 12 years of age, therefore its use in this category of patients is not recommended.
Overdose
Symptoms. A single dose of approximately 20 g of valerian roots, equivalent to approximately 42 capsules of the drug Relaxil, may cause minor symptoms such as increased fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, dilated pupils. These symptoms disappear within 24 hours. Overdose of drugs containing valerian may also cause headache, drowsiness, lethargy, general weakness, abdominal pain, nausea, decreased hearing and vision, bradycardia/tachycardia, decreased concentration, increased sedative effect.
There are no reports of overdoses from the use of lemon balm and peppermint leaves.
Treatment: symptomatic therapy (gastric lavage, use of activated charcoal).
Adverse reactions
On the part of the digestive tract: frequency cannot be estimated - nausea, abdominal cramps; possible exacerbation of heartburn.
On the part of the immune system: allergic reactions.
Very rarely, drowsiness, asthenic manifestations (weakness, deterioration of mood and decreased performance, suppression of emotional reactions), dizziness, depression have been observed. If other side effects occur (for example, hypersensitivity reactions, including rash, itching, urticaria, redness and swelling of the skin), you should consult a doctor.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister, 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
