ACTION AND MECHANISM Association of orexigenic (appetite stimulant) and amino acids. The appetite stimulating effect is mainly due to the antiserotonergic action of cyproheptadine, by antagonizing the 5-HT2 (S2) serotonin receptors. It also has antihistamine H1 and anticholinergic (M) actions. ELDERLY Elderly patients receiving antihistamines are more likely to experience dizziness, sedation, confusion, and hypotension; and a paradoxical reaction characterized by hyperexcitability may also occur. Geriatric patients are more sensitive to the anticholinergic side effects of antihistamines, such as dry mouth and urinary retention. If these effects persist or are severe, the medication will probably be discontinued.CONTRAINDICATIONS- Allergy to cyproheptadine or other components of the formula.- [ASTHMA ATTACK].- Pregnancy, breastfeeding, and children under 2 years of age.- Malignant [CANCER] (may promote its development).DOPINGThis medication contains alcohol. Its intake is prohibited during competition in certain sports. Detection will be performed by breath and/or blood analysis. The threshold for anti-doping rule violation (hematological value) is 0.1 g/l in the following sports: aeronautics, motor racing, motorcycling, power boating, and archery. Alcohol is considered a specified substance, and therefore, a rule violation involving this substance may result in a reduced sanction provided the athlete can demonstrate that the use of the specified substance in question was not intended to enhance athletic performance.PREGNANCYFDA Category B. Studies in rats have not shown any teratogenic effects. There are no adequate or well-controlled studies in humans. However, there have been isolated cases of children with cleft lip and hypospadias using cyproheptadine during the first trimester, although a causal relationship cannot be established. Cyproheptadine has been used to prevent spontaneous abortion in patients with elevated serotonin production and in the treatment of Cushing's syndrome, with no congenital problems observed. The use of this medicine is only accepted in the absence of safer therapeutic alternatives. INDICATIONS - [ANOREXIA], [ASTHENIA]. - [CONVALESCENCE], antifatigue. INTERACTIONS - Alcohol: there are studies with other antihistamines (chlorpheniramine, diphenhydramine, promethazine) in which alteration of motor and/or mental function has been recorded due to the possible addition of their central depressant effects. - Antidepressants (fluoxetine, phenelzine, paroxetine): there are studies in which inhibition of the antidepressant effect has been recorded. The mechanism has not been established although it is suggested that cyproheptadine may antagonize the serotonergic effects of antidepressants. BREASTFEEDING It is unknown whether this medicine is excreted in significant quantities in breast milk, and whether this could affect the child. It is recommended to stop breastfeeding or avoid taking this medicine. CHILDREN The safety and efficacy of cyproheptadine have not been established in children under 2 years of age. Its use is not recommended in premature babies or newborns because they are more sensitive to the anticholinergic side effects of antihistamines, such as CNS excitation. In older children undergoing treatment with antihistamines, a paradoxical reaction characterized by hyperexcitability may occur. RULES FOR CORRECT ADMINISTRATION Take 1 hour before meals. DOSAGE Adults: 1 spoonful (10 ml) 3 times a day. Children: From 2 to 6 years: 1 spoonful (5 ml) 1-2 times a day. From 6 to 14 years: 1 spoonful (10 ml) 2 times a day.PRECAUTIONS- Due to its anticholinergic effects, special clinical monitoring should be carried out in patients with [EPILEPSY], chronic [ASTHMA], [CHRONIC OBSTRUCTIVE PULMONARY DISEASE], [GLAUCOMA], [INTESTINAL OBSTRUCTION] or [OBSTRUCTIVE UROPATHY], [URINARY RETENTION], [PROSTATIC HYPERPLASIA], [HYPERTHYROIDISM], [ARTERIAL HYPERTENSION].- Driving vehicles or operating dangerous or precision machinery under its effect is not advisable (it may reduce the ability to concentrate and reflexes).- The elderly and weakened patients are more sensitive to the anticholinergic effects (greater predisposition to experience sedation, dizziness and hypotension).PRECAUTIONS RELATING TO EXCIPIENTS- This medicine contains ethanol. It is recommended to check the composition to know the exact amount of ethanol per dose.* Amounts less than 100 mg/dose are considered small and are not usually harmful, especially in children.* Amounts greater than 100 mg/dose may be harmful to people with [CHRONIC ALCOHOLISM], and should also be taken into account in pregnant and lactating women, children, and in high-risk groups, such as patients with [LIVER DISEASE] or [EPILEPSY].* Amounts greater than 3 g/dose may decrease the ability to drive or operate machinery, and may interfere with the effects of other medications.ADVERSE REACTIONSThe adverse effects of cyproheptadine are generally mild and transient. The most characteristic adverse reactions are:-Occasionally (1-9%): drowsiness, dry mouth, blurred vision.-Rarely (<1%): constipation, mydriasis, accommodation disorders, mental confusion in the elderly, excitement and insomnia in young children, urinary retention, palpitations, hypotension, headache, rashes, urticaria, photodermatitis.COMPOSITIONCARNITINE: 62.5 MILLIGRAMS - HYDROCHLORIDECYPROHEPTADINE: 0.5 MILLIGRAMS - HYDROCHLORIDELYLYSINE: 1.25 MILLIGRAMS - HYDROCHLORIDEETHYL ALCOHOL (EXCIPIENT): 48.9 MILLIGRAMSSUCROSE (EXCIPIENT): 300 MILLIGRAMSPROPYL PARAHYDROXYBENZOATE (E-216) (EXC: 0.1 MILLIGRAMS - SODIUM (SALT)AMARANTH (E-123) (EXCIPIENT): 8.25 MICROGRAMS