Per 100 ml of the product
active ingredient – doxylamine succinate 2.5 g,
excipients: 96% ethanol, purified water, mint oil.

• symptomatic treatment of periodic sleep disturbances (disturbances of falling asleep and maintaining sleep) in adults.

Note:
Not all sleep disturbances require drug treatment. Sleep disturbances are often associated with health deterioration or mental disorders and can be improved by other methods or treatment of the underlying disease. Doxylamine-KM should not be used for long-term treatment of chronic sleep disturbances (including disturbances of falling asleep or maintaining sleep) without medical advice.

For oral administration.
Unless otherwise prescribed by the physician, the single dose of Doxylamine-KM for adults shall be 7-13 drops (equivalent to 7.5-15 mg of doxylamine succinate). For persistent sleep disturbances, the patient may take up to 26 drops of Doxylamine-KM (30 mg of doxylamine succinate), which is the maximum dose. The maximum daily dose should not be exceeded.
Patients with impaired renal or hepatic function, elderly and fragile patients who may be more sensitive to the action of doxylamine, should use a lower dose of the drug.
Pediatric Patients
Doxylamine-KM should not be prescribed for children and adolescents <18 years of age due to the lack of studies on the efficacy and safety of doxylamine for the treatment of sleep

Contraindications-   hypersensitivity (allergy) to the active ingredient or other ingredients of the drug
-   hypersensitivity (allergy) to antihistamines
-   acute asthma attack
-   angle-closure glaucoma
-   congenital long QT syndrome
-   pheochromocytoma
-   prostatic hypertrophy with obstructed urine outflow
-   acute intoxication with alcohol, sedatives, analgesics, or psychotropic drugs (neuroleptic agents, antianxiety agents, antidepressants, lithium medications)
-   alcohol abuse
-   epilepsy
-   treatment with monoamine oxidase inhibitors
-   children and adolescents <18 years of age
-   pregnancy and lactation
-   hepatic disorders.

Warnings and Precautions
Doxylamine-KM should be used with caution in
- hepatic impairments
- heart failure and arterial hypertension
- chronic shortness of breath and bronchial asthma
- gastroesophageal reflux
- pylorostenosis
- esophageal achalasia.

20 ml of the drug is placed into brown glass vials with a vertical polyethylene dropper and polypropylene screw cap.
One vial together with the Patient Information Leaflet in the state and Russian languages is placed in a cardboard package.

Do not store above 25°C.
Keep out of reach of children.

4 years
Once opened, the vial should be used within 6 months.
Do not use the product beyond the expiry date.

Krewel Meuselbach GmbH,
2 Krewelstrasse
53783 Eitorf
Germany
Tel.: +49 2243 / 87-0
Fax: +49 2243 / 87-175