Dobrocam^® (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substance

Bromcamphor (Grouping name)

Dosage Form

Dobrocam^®

Tablets 250 mg: 20, 25, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or grayish-white in color with inclusions of bromcamphor crystals, flat-cylindrical in shape, with a score and a bevel, and have a characteristic camphor odor.

	1 tab.
Bromcamphor	250 mg

Excipients: potato starch – 34 mg, lactose monohydrate – 8 mg, talc – 5 mg, colloidal silicon dioxide – 3 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; other hypnotics and sedatives

Pharmacological Action

Sedative agent. Facilitates the onset of natural sleep, normalizes cardiac activity.

Pharmacokinetics

Easily absorbed in the gastrointestinal tract. Penetrates through histohematic barriers, including the placental barrier. Hydroxylated in the liver to oxymetabolites, which are excreted by the kidneys in the form of glucuronides.

Indications

Increased excitability, asthenia, cardioneuroses (cardialgia, tachycardia, labile blood pressure).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F45.3	Somatoform dysfunction of the autonomic nervous system
F48.0	Neurasthenia
R00.0	Tachycardia, unspecified (including nodal (sinus) NOS)
R03	Abnormal blood-pressure reading, without diagnosis
R07.2	Pain in the heart region
R45.1	Restlessness and agitation

ICD-11 code	Indication
6A8Z	Affective disorders, unspecified
6C20.Z	Bodily distress disorder, unspecified
MB24.F	Restlessness
MC80.Z	Abnormal blood-pressure reading, without diagnosis, unspecified
MC81.Z	Abnormalities of heart rhythm, unspecified
MC86	Precordial pain

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. The standard adult dosage is 1-2 tablets taken 2-3 times per day.

Adjust the frequency and number of tablets based on the clinical response and tolerability of the patient. The typical treatment course lasts 10 to 15 days.

Adverse Reactions

Monitor for central nervous system effects, including lethargy and drowsiness.

Gastrointestinal disturbances ( dyspeptic phenomena) may occur. Be aware of the potential for allergic reactions.

Contraindications

Hepatic failure and/or renal failure.
Pregnancy and breastfeeding.
Children under 7 years of age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 7 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in elderly patients.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer