Tolerability
Xonvea® has demonstrated an acceptable tolerability profile.1
Xonvea® was generally well-tolerated by participants during clinical trials. The most common reported adverse events (AEs) in long-term clinical trials of treatment with Xonvea® were somnolence, dizziness, dry mouth and fatigue.1
Possible side effects of Xonvea®
Xonvea® Tolerability
Xonvea is generally well-tolerated. The following list of adverse events is based on clinical trial evidence and/or post-marketing use.1
Adverse Events (AEs) Experienced with Xonvea®1
- Somnolence: Very common
- Dizziness: Common
- Dry mouth: Common
- Fatigue: Common
Very common (≥1/10); common (≥1/100 to <1/10).
Additional AEs of unknown frequency
Hypersensitivity, anxiety, disorientation, insomnia, nightmares, headache, migraine, paraesthesia, psychomotor hyperactivity, blurred vision, visual disturbances, vertigo, dyspnea, palpitation, tachycardia, abdominal distention, abdominal pain, constipation, diarrhoea, hyperhidrosis, pruritus, rash, maculo papular rash, dysuria, urinary retention, chest discomfort, irritability, malaise.1
In the Phase 3 clinical trial, use of Xonvea® was not associated with an increase rate of any AE as compared with placebo (all differences were non-significant).2
Please refer to the Summary of Product Characteristics for more information including possible adverse anticholinergic effects associated with use of antihistamines as a class.1
Contraindications1
Hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the excipients listed in section 6.1 of the Summary of Product Characteristics. Concomitant use with monoamine oxidase inhibitors (MAOIs).
Special warnings and precautions for use1
Limited evidence in cases of hyperemesis gravidarum for the combination doxylamine succinate/pyridoxine hydrochloride. These patients should be treated by a specialist.
May cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine.
Use of Xonvea® is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol.
Xonvea® has anticholinergic properties and, therefore, should be used with caution in patients with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and bladder-neck obstruction.
Xonvea® contains pyridoxine hydrochloride, a vitamin B6 analogue, therefore additional levels from diet and vitamin B6 supplements should be assessed.
There have been reports of false positive urine screening tests for methadone, opiates and phencyclidine phosphate with doxylamine succinate/pyridoxine hydrochloride use.
Xonvea® contains traces of the azo colouring agent Allura Red AC Aluminum Lake (E129) which may cause allergic reactions.
This medicinal product contains 0.02 micrograms benzoic acid (E 210) and less than 1 mmol sodium (23 mg) per gastro-resistant tablet (that is to say it is essentially ‘sodium-free’).
XONVEA® has a moderate to major influence on the ability to drive and use machines. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using XONVEA® until cleared to do so by their healthcare professional.
Reporting Side Effects
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to Exeltis UK Limited by email to pharmacovigilance.uk@exeltis.com
Contact
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Abbreviations: AEs, Adverse Events; MAOIs, Monoamine Oxidase Inhibitors; CNS, Central Nervous System.
References: 1. XONVEA® Summary of Product Characteristics. 2. Koren, G., et al. Am J Obstet Gynecol. 2010. 203(6): 571.e1-571.e7.
