Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Xonvea 10 mg/10 mg gastro-resistant tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pyridoxine hydrochloride, Doxylamine succinate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Xonvea is Xonvea contains two medicines ('active substances') called: 'doxylamine succinate' and 'pyridoxine hydrochloride'.
- Doxylamine succinate belongs to a group of medicines called 'antihistamines'.
- Pyridoxine hydrochloride is another name for Vitamin B6. What Xonvea is used for Xonvea is used in pregnant women aged 18 years and older, to help stop them feeling sick (nausea) and being sick (vomiting). It is used when changes in diet or other non-medicine treatments have not worked. 2.
What you need to know before you take it
e Xonvea
Do not take Xonvea if:
- you are allergic to doxylamine succinate or other antihistamines (such as diphenhydramine), pyridoxine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- you are taking medicines for depression called 'monoamine oxidase inhibitors' (MAOIs) Do not take Xonvea if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking Xonvea. Warnings and precautions Talk to your doctor or pharmacist or nurse before taking Xonvea if you have ever had:
- asthma
- increased eye pressure
- an eye problem called 'narrow angle glaucoma'
- a stomach ulcer
- a blockage in your gut, between your stomach and small intestine
- a blockage in your bladder.
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Also, talk to your doctor or pharmacist or nurse before taking Xonvea if:
- you are taking cough or cold medicines, sleeping medicines or certain pain medicines
- you have been drinking alcohol. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Xonvea. If you suffer from severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum, you have to be treated by a specialist. If you are having a urine drug screen, taking Xonvea may show 'false positive' results for methadone, opiates, and phencyclidine phosphate (PCP) when some test methods are used. If this happens, a more specific test can be performed.
Children and adolescents Xonvea is not meant for use in children under 18 years old. It is not known if Xonvea is safe and effective in this age group. Vitamin B Talk to your doctor, pharmacist or nurse before taking any additional vitamin B – this could be through your diet, from supplements or multi-vitamins. Other medicines and Xonvea Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines. In particular, do not take Xonvea and tell your doctor or pharmacist or nurse if you are taking any of the following:
- Medicines for depression called 'monoamine oxidase inhibitors' (MAOIs) – using these medicines with Xonvea can make side effects worse and last longer.
- Medicines such as cough and cold medicines, sleeping medicines or certain pain medicines (called central nervous system depressants) – using any of these with Xonvea can make you feel very sleepy. This can make you fall over or cause other accidents. Xonvea with alcohol Do not drink alcohol while taking Xonvea.
Pregnancy and breast-feeding Xonvea is for use in pregnant women. If you are breastfeeding, a decision should be made with your doctor whether to discontinue breastfeeding or to discontinue the drug. This is because Xonvea can pass into your breast milk and may harm your baby. Driving and using machines Do not drive, cycle or use any tools or machines while taking this medicine. This is because you may feel sleepy after taking Xonvea. If this happens do not do other activities that need your full attention unless your doctor tells you it is ok to do so. Xonvea contains Allura red AC aluminium lake (E 129), benzoic acid (E 210) and sodium. LF-DOXPYR-GB-EXELTIS-IA-Batch release
This medicine contains the azo coloring agent Allura red AC aluminium lake (E 129) which may cause allergic reactions. This medicine contains 0.02 micrograms benzoic acid (E 210) in each gastro-resistant tablet. This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially 'sodium-free'.
3.
How to take it
Xonvea
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. How much to take Your doctor will start you on a low dose and possibly increase it – this will depend on how well the medicine works for you. How to start taking Xonvea and increase your dose, if needed:
- Day 1
- Take 2 tablets, by mouth at bedtime. •
Day 2
- Take 2 tablets, by mouth at bedtime.
- If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your doctor, pharmacist or nurse tells you otherwise.
•
Day 3
- If you still had nausea and vomiting on Day 2, take 1 tablet in the morning and 2 tablets at bedtime, by mouth on Day 3.
•
Day 4
- If your nausea and vomiting was better or controlled on Day 3 continue to take 1 tablet in the morning and 2 tablets at bedtime by mouth each day. This will be your usual dose unless your doctor, pharmacist or nurse tells you otherwise.
- If you still had nausea and vomiting on Day 3, take 1 tablet in the morning, 1 tablet in the midafternoon, and 2 tablets at bedtime, by mouth on Day 4. This will be your usual dose unless your doctor, pharmacist or nurse tells you otherwise.
Do not take more than 4 tablets each day (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime). Taking this medicine
- Take Xonvea on an empty stomach.
- Swallow the tablet whole with a glass of water.
- Do not crush, chew, or split the tablets before swallowing to preserve the effect of this medicine. If you cannot swallow Xonvea tablets whole, tell your doctor, pharmacist or nurse. If you take more Xonvea than you should If you take more Xonvea than you should, stop taking Xonvea and talk to a doctor or go to a hospital straight away, even if you feel well. Take the medicine pack with you. The following effects may happen: feeling restless, sleepy or dizzy, dry mouth, larger black part of the eye (dilated pupils), confusion, fast heart rate. If the amount of medicine in your body is very high, you may also have fits, muscle pain or weakness or sudden severe kidney problems. These may even be lifethreatening. If you have these signs – stop taking Xonvea and talk to a doctor or go to a hospital straight away.
If you stop taking Xonvea LF-DOXPYR-GB-EXELTIS-IA-Batch release
Do not stop taking Xonvea without talking to your doctor first. If you stop taking this medicine suddenly your feeling sick (nausea) and being sick (vomiting) may come back. Your doctor will tell you how to stop taking this medicine slowly over time to help avoid this. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people • feeling very sleepy. Common: may affect up to 1 in 10 people • feeling dizzy • feeling tired • dry mouth. Not known: frequency cannot be estimated from the available data • • • • • • • • • • • • •
hypersensitivity (allergic reaction) feeling anxious, difficulty in sleeping (insomnia), nightmares, feeling disorientated headaches or migraines tingling, pricking or numbness of skin restlessness and a need to move constantly problems with eyesight or blurred vision sensation of spinning dizziness difficulty breathing, awareness of heartbeat or increased heart rate full or bloated feeling, stomach pains, constipation or diarrhoea excessive sweating, skin reactions such as itchiness or rash difficulties or pain with passing urine discomfort in the chest general discomfort or feeling irritable
Other side effects reported with medicines in the same drug class as doxylamine Anticholinergic effects include (blockage of the activity of organs that receive nerve impulses through a substance called acetylcholine): dry mouth, nose and throat; double vision (diplopia); ringing or humming in the ears (tinnitus); inflammation of the inner ear which develops within a short time (acute labyrinthitis); shaking (tremors) and nervousness; involuntary repetitive movements of the face (facial dyskinesia). In addition, feeling of tightness in the chest, thick mucus in the chest (bronchial secretions); high-pitched whistling sound often associated with difficulty in breathing (wheezing); stuffy nose; feeling chills; early menses; altered state of mind such as hallucinations, delusions, confusion and disturbed thoughts (toxic psychosis); or feeling faint have been reported. Rarely, low levels of white blood cells (agranulocytosis), reduced blood in the body due to increased destruction of blood cells (haemolytic anaemia), decreased clotting blood cells (thrombocytopenia), decreased red, white and clotting cells in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been reported.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Xonvea
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Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Xonvea contains
- The active substances are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each gastro-resistant tablet contains 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride.
- The other ingredients are, carnauba wax, croscarmellose sodium, hypromellose (E 464), indigo carmine aluminium lake (E 132), macrogol (E 1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (1:1), microcrystalline cellulose, Allura red AC aluminium lake (E 129), polysorbate 80 (E 433), propylene glycol (E 1520), colloidal anhydrous silica, shellac, simethicone emulsion (contains benzoic acid (E 210), sodium hydrogen carbonate (E 500), sodium lauril sulfate (E 487), talc (E 553b), titanium dioxide (E 171), triethyl citrate and simethicone. What Xonvea looks like and contents of the pack
- Xonvea gastro-resistant tablets are white, round, and film-coated with a pink image of a pregnant woman on one side.
- Xonvea is available in blister packs containing 20, 30 or 40 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Exeltis Healthcare, S.L. Avda. de Miralcampo 7, Pol. Ind. Miralcampo, 19200 Azuqueca de Henares (Guadalajara) Spain Manufacturer Laboratorios Liconsa S.A. Avda. Miralcampo, 7, Pol. Ind. Miralcampo, Azuqueca de Henares, 19200 Guadalajara Spain
This leaflet was last revised in July 2024
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Frequently asked questions about Xonvea 10 mg/10 mg gastro-resistant tablets
How do I take Xonvea 10 mg/10 mg gastro-resistant tablets?
Xonvea 10 mg/10 mg gastro-resistant tablets comes as tablet containing 10mg / 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Xonvea 10 mg/10 mg gastro-resistant tablets?
The active substance in Xonvea 10 mg/10 mg gastro-resistant tablets is pyridoxine hydrochloride, doxylamine succinate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Xonvea 10 mg/10 mg gastro-resistant tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Xonvea 10 mg/10 mg gastro-resistant tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: pyridoxine hydrochloride, doxylamine succinate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Xonvea is indicated for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant women ≥18 years who do not respond to conservative management (i.e., lifestyle and diet change).
4.2. Posology and method of administration
Posology
The recommended starting dose is two tablets (Total dose: 20 mg doxylamine succinate/20 mg pyridoxine hydrochloride) at bedtime (Day 1). If this dose adequately controls symptoms the next day, the patient can continue taking two tablets at bedtime. However, if symptoms persist into the afternoon of Day 2, the patient should continue the usual dose of two tablets at bedtime (Day 2) and on Day 3 take three tablets (one tablet in the morning and two tablets at bedtime). If these three tablets do not adequately control symptoms on Day 3, the patient can take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).
The maximum recommended daily dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime).
Xonvea should be taken as a daily prescription and not on an as needed basis. Continued need for Xonvea should be reassessed as the pregnancy progresses.
To prevent a sudden return of nausea and vomiting of pregnancy symptoms, a gradual tapering dose of Xonvea is recommended at the time of discontinuation.
Paediatric population
Xonvea is not indicated for use in children under 18 years of age. The safety and efficacy of Xonvea has not been established in that population (see section 5.1). No data are available.
Method of administration
Xonvea should be administered on an empty stomach with a glass of water (see section 4.5). Gastro-resistant tablets should be swallowed whole and should not be crushed, split or chewed to preserve the gastro-resistant properties.
4.3. Contraindications
Hypersensitivity to doxylamine succinate, other ethanolamine-derivative antihistamines, pyridoxine hydrochloride or any of the excipients listed in section 6.1.
Concomitant use with monoamine oxidase inhibitors (MAOIs) (see section 4.5).
4.4. Special warnings and precautions for use
Xonvea may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine (see section 4.8).
Use of Xonvea is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol (see section 4.5).
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 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.
There have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine succinate/pyridoxine hydrochloride use (see section 4.5).
Excipients
This medicinal product contains the azo colouring agent Allura red AC aluminium lake (E 129) which may cause allergic reactions.
This medicinal product contains 0.02 micrograms benzoic acid (E 210) in each gastro-resistant tablet.
This medicinal product contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors
Monoamine oxidase inhibitors (MAOIs) prolong and intensify the anticholinergic effects of antihistamines and concomitant treatment with MAOIs is contraindicated (see section 4.3).
Central nervous system depressants
Concurrent use with central nervous system (CNS) depressants including alcohol, hypnotic sedatives and tranquilizers is not recommended. The combination may result in severe drowsiness (see section 4.8).
Food
A food-effect study has demonstrated that the delay in the onset of action of Xonvea may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, Xonvea should be taken on an empty stomach with a glass of water (see section 4.2). +
Interference with Urine Screen for Methadone, Opiates and PCP
False positive urine drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. Confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm the identity of the substance in the event of a positive immunoassay result.
4.6. Fertility, pregnancy and lactation
Pregnancy
Xonvea is intended for use in pregnant women.
A large amount of data on pregnant women, including two meta-analyses with over 168,000 patients and 18,000 exposures to the doxylamine/pyridoxine combination during first trimester, indicates no malformative nor feto/neonatal toxicity of doxylamine succinate and pyridoxine hydrochloride.
Breast-feeding
The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnoea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Xonvea resulting in worsening of their apnoea or respiratory conditions.
Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.
A risk to breastfed infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Xonvea therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
Xonvea caused no impairment of fertility or reproductive performance in rats (see section 5.3). No human data available.
4.7. Effects on ability to drive and use machines
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 provider.
4.8. Undesirable effects
a. Summary of the safety profile
Adverse event information is derived from clinical trials and worldwide post-marketing experience.
There has been clinical experience regarding the use of the Xonvea combination (doxylamine succinate and pyridoxine hydrochloride). The incidence of treatment-emergent adverse events was similar for both treatment and placebo groups. The most frequently reported adverse reaction (≥5% and exceeding the rate in placebo) was somnolence.
b. Tabulated list of adverse reactions
The following listing of adverse reactions is based on clinical trial experience and/or post-marketing use.
Undesirable effects are displayed by MedDRA System Organ Classes and use the following conventions for frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known".
System Organ Class
Undesirable Effect
Frequency
Immune system disorders
hypersensitivity
Not known
Psychiatric disorders
anxiety, disorientation, insomnia, nightmares
Not known
Nervous system disorders
somnolence
Very common
dizziness
Common
headache, migraines, paresthesia, psychomotor hyperactivity
Not known
Eye disorders
vision blurred, visual disturbances
Not known
Ear and labyrinth disorders
vertigo
Not known
Cardiac disorders
dyspnea, palpitation, tachycardia
Not known
Gastrointestinal disorders
dry mouth
Common
abdominal distention, abdominal pain, constipation, diarrhoea
Not known
Skin and subcutaneous tissue disorders
hyperhidrosis, pruritus, rash, rash maculo-papular
Not known
Renal and urinary disorders
dysuria, urinary retention
Not known
General disorders and administration site conditions
fatigue
Common
chest discomfort, irritability, malaise
Not known
c. Description of selected adverse reactions
Severe drowsiness may occur if Xonvea is taken along with CNS depressants including alcohol (see sections 4.4 and 4.5).
Anticholinergic effects of Xonvea may be prolonged and intensified by monoamine oxidase inhibitors (MAOIs) (see sections 4.3 and 4.5).
Possible adverse anticholinergic effects associated with the use of antihistamines as a class in general include: dryness of mouth, nose and throat; dysuria; urinary retention; vertigo, visual disturbances, blurred vision, diplopia, tinnitus; acute labyrinthitis; insomnia; tremors, nervousness; irritability; and facial dyskinesia. Tightness of chest, thickening of bronchial secretions, wheezing, nasal stuffiness, sweating, chills, early menses, toxic psychosis, headache, faintness and paresthesia have occurred.
Rarely, agranulocytosis, haemolytic anaemia, leukopenia, thrombocytopenia, and pancytopenia have been reported in a few patients receiving some antihistamines. Increased appetite and/or weight gain also occurred in patients receiving antihistamines.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Xonvea is a delayed-release formulation; therefore, signs and symptoms may not be apparent immediately.
Symptoms
Signs and symptoms of overdosage may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia.
At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.
Management
In the event of an overdose, treatment consists of activated charcoal, whole bowel irrigation and symptomatic treatment. Management should be in accordance with established treatment guidelines.
Paediatric population
Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest. Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3-year-old child died 18 hours after ingesting 1,000 mg doxylamine succinate. However, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- NUPERAL 10 mg/10 mg prescriptionCOMBINATII (DOXYLAMINUM+PYRIDOXINUM) · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Pyridoxine hydrochloride, Doxylamine succinate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Vitaminum B6 Teva partial — not the same combinationPyridoxini hydrochloridum · taken by mouth
- Xonvea partial — not the same combinationDoxylamini hydrogenosuccinas + Pyridoxini hydrochloridum · taken by mouth
- Bonjesta partial — not the same combinationDoxylamini hydrogenosuccinas + Pyridoxini hydrochloridum · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Xonvea 10 mg/10 mg gastro-resistant tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.