PHENERGAN Syrup

In symptomatic treatment of various allergic manifestations:

- rhinitis (seasonal or perennial),

- conjunctivitis,

- urticaria

Dosage

Oral route.

RESERVED FOR ADULTS AND CHILDREN OVER 24 MONTHS OF AGE.

- Adults: 20mL, 4-5 times daily.

- Children over 12 years of age: 10-20mL, 4 times daily but do not exceed 50mL daily.

- Children from 5-12 years: 5-10mL, 2-3 times daily but do not exceed 50mL daily.

- Children 2-5 years: 5mL, thrice daily.

- Allergy to anti-histamines,

- History of agranulocytosis (marked decrease of white blood cell count),

- Risk for urine retention related to prostate hypertrophy,

- Risk for closed angle glaucoma,

- Children under 24 months of age.

In general, THIS MEDICINE SHOULD NOT BE USED in the following cases:

- Concomitant use with alcohol, sultopride,

- Lactating women.

- sedation or drowsiness, more pronounced at the beginning of treatment;

- mucosa dryness, constipation, dilated pupils, palpitation;

- orthostatic hypotension;

- balance disorders, dizziness, memory or concentration disorders;

- loss of motor coordination, tremor (frequently seen in elderly);

- skin erythema, eczema, urticaria with possibility of large wales;

- photosensitivity.

See the package insert about the details below:

Inadvisable combinations:

- Alcohol

- Sultopride

Combinations to be considered with caution:

- Other central nervous system inhibitors: sedative antidepressants, barbiturates, benzodiazepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, anxiolytics

- Atropine and other atropine-like substances (imipramine, antidepressants, anticholinergic antiparkinsonians, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics)

See the package insert about the details below:

Pregnancy

- Avoid taking this medicine during the first trimester of pregnancy. Later on, only low doses may be used restrictively, if necessary, during the last trimester of pregnancy.

- If this medicine is taken during the last trimester of pregnancy, neurological and digestive functions of the newborn should be monitored for a period of time.

Lactation

Do not take this medicine during breast-feeding.

SPECIAL WARNINGS

In case of persistence or aggravation of symptoms (respiratory distress, skin lesions…) or occurrence of signs associated with viral infection, the treatment should be re-evaluated.

PRECAUTIONS FOR USE

Promethazine should be used with caution:

- in elderly subjects with:

- high susceptibility to orthostatic hypotension, vertigo and sedation,

- chronic constipation (risk for paralytic ileus),

- prostate hypertrophy,

- in patients with certain cardiovascular conditions, due to the tachycardia and hypotension effects of promethazine;

- in severe liver and/or kidney failure (due to the risk of drug accumulation).

During treatment, do not take alcoholic beverages or alcohol-containing drugs.

Due to the photosensitizing effect of phenothiazine, avoid exposure to sunlight during treatment.

In case of diabetes or hypoglycemic diet, the saccharose content in this syrup preparation should be taken into account.

Histamine H1-receptor antagonist, phenothiazine with a lateral aliphatic chain and characterized by:

- A pronounced sedative effect at the usual doses due to central histaminergic and adrenolytic effects,

- An anticholinergic effect that causes undesirable peripheral effects,

- A peripheral adrenolytic effect that may have hemodynamic repercussions (possible postural hypotension).

By a mechanism of competitive antagonism that shows varying degrees of reversibility, all the antihistamines have in common the capacity to counter the effects exerted by histamine, particularly on the vessel, the skin, the conjunctive, the bronchi and small intestine.