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This medicinal product may cause somnolence due to the anticholinergic properties of doxylamine hydrogen succinate, an antihistamine (see Adverse Reactions).
Use of this medicinal product is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol (see Interactions).
This medicinal product has anticholinergic properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and bladder-neck obstruction as the anticholinergic effects of this medicinal product may worsen these conditions.
This medicinal product should also be used with caution in patients with asthma or other breathing disorders, such as chronic bronchitis and pulmonary emphysema. It has been demonstrated that antihistamines reduce the volume of bronchial secretions and increase their viscosity, thereby making bronchial expectoration more difficult. This may result in respiratory obstruction, which may worsen these conditions. As such, care should be taken in these patients.
This medicinal product should be used with caution in patients with hepatic or renal impairment. No data are available. However, the metabolism of doxylamine and pyridoxine may theoretically be reduced in the presence of hepatic impairment. Also, there could be a theoretical metabolite accumulation in the presence of renal impairment.
This medicinal product contains pyridoxine hydrochloride, a vitamin B6 analog, therefore additional levels from diet and vitamin B6 supplements should be assessed.
There is limited evidence in cases of hyperemesis gravidarum for the combination doxylamine/pyridoxine. These patients should be treated by a specialist. Early treatment of symptoms related to morning sickness typically in pregnancy, is recommended to prevent progression to hyperemesis gravidarum. Caution should be taken with patients with hyperemesis gravidarum as this combination has not been studied in these cases (see Indications/Uses).
Photosensitivity reactions: Although not noted with doxylamine, an increased sensitivity of the skin to sunlight, with photodermatitis, has been observed with some antihistamines; thus, sunbathing should be avoided during treatment.
Ototoxic medications: Sedating antihistamines of the ethanolamine class, like doxylamine, could mask the warning signs of damage caused by ototoxic drugs such as antibacterial aminoglycosides, carboplatin, cisplatin, chloroquine and erythromycin, among others.
Care should be taken in epileptic patients as antihistamines have occasionally been associated with paradoxical hyperexcitability reactions, even at therapeutic doses.
Due to decreased sweating caused by anticholinergic effects, antihistamines may aggravate symptoms of dehydration and heat stroke.
Special precautions should be adopted in patients with long QT syndrome, as several antihistamines may prolong the mentioned QT interval, although this effect has not been observed specifically with doxylamine at therapeutic dose.
Hypokalemia or other electrolyte disturbances.
The risk of abuse and drug dependence of doxylamine is low. The occurrence of signs suggestive of abuse or dependence should be carefully monitored, especially in patients with a history of drug use disorders
Interference with allergy skin testing: Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.
There have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine hydrogen succinate/pyridoxine hydrochloride use (see Interactions).
This medicinal product contains Allura Red AC aluminum lake which may cause allergic reactions.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: This medicinal product may cause somnolence and blurred vision, especially during the first few days of treatment.
Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using this medicinal product until cleared to do so by their healthcare provider.
