10 mg/10 mg enteric tablet er
doxylamine hydrogen succinate/pyridoxine hydrochloride
What Xonvea is and what it is used for
What Xonvea is
Xonvea contains two medicines (active substances): doxylamine hydrogen succinate and pyridoxine hydrochloride.
- Doxylamine belongs to the drug group antihistamines.
- Pyridoxine hydrochloride is another name for vitamin B 6.
What Xonvea is used for
Xonvea is used for nausea and vomiting in pregnant women. It is used when diet or other non-medical treatments have not worked.
Doxylamine hydrogen succinate and pyridoxine hydrochloride found in Xonvea may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Xonvea
Do not take Xonvea
- if you are allergic to doxylamine hydrogen succinate or other antihistamines (eg diphenhydramine), pyridoxine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
- if you are taking monoamine oxidase inhibitors ( MAOIs ) to treat depression.
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, pharmacist, or nurse before taking Xonvea if you have or have had:
- asthma
- increased eye pressure
- an eye disease called narrow-angle glaucoma
- gastric ulcer
- constipation, i.e. an obstruction between the stomach and the small intestine
- obstruction in the neck of the bladder.
Also talk to your doctor, pharmacist, or nurse before taking Xonvea if:
- you take medicines for colds or coughs, sleeping medicines, or certain pain-relieving medicines
- you have drunk alcohol.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before taking Xonvea.
If you suffer from severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, you must be treated by a specialist.
If you provide urine for a drug test, some test methods may give false positive results for methadone, opiates, and phencyclidine phosphate (PCP) after taking Xonvea. If this occurs, a test with better specificity can be used.
Reporting of side effects are
- Xonvea may make you feel drowsy. Do not drive, ride a bicycle, or use tools or machines while taking this medicine. Also, don’t do activities that require your full attention, unless your doctor says it’s okay.
- Do not take Xonvea while taking cough and cold medicines, sleeping medicines, certain pain relievers, or if you have been drinking alcohol. Taking Xonvea with other medicines that affect the central nervous system can make you very tired, which can cause falls or other accidents.
- Xonvea contains trace amounts of the azo dye E129. This dye can cause allergic reactions.
Do not stop taking Xonvea without first talking to your doctor. If you stop treatment with this medicine suddenly, nausea and vomiting may return. Your doctor will tell you how to slowly taper off the medicine to avoid this.
Children and young people
Xonvea is not intended for children under 18 years of age. It is not known whether Xonvea is safe and effective in this age group.
B vitamins
Talk to your doctor, pharmacist, or nurse before taking additional B vitamins. This can be through food, supplements, or multivitamins.
Other medicines and Xonvea
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
It is especially important that you do not take Xonvea and that you tell your doctor, pharmacist, or nurse if you are taking any of the following:
- monoamine oxidase inhibitors ( MAOIs ) to treat depression. Using these medicines together with Xonvea can make side effects worse and last longer.
- medicines such as cough and cold medicines, sleeping medicines, and certain painkillers (so-called CNS depressants). Using these together with Xonvea can make you very tired. This may cause falls or other accidents.
Xonvea with alcohol
Do not drink alcohol while taking Xonvea. See section 3 for information on how to take Xonvea.
Pregnancy, breastfeeding, and fertility
Xonvea is intended for use in pregnant women.
If you are breastfeeding, a decision should be made in consultation with your doctor whether to discontinue breastfeeding or treatment. The reason for this is that Xonvea can pass into breast milk and can harm your baby.
Driving ability and use of machinery
Do not drive, ride a bicycle, or use tools or machines while taking this medicine. This is because you may feel tired after taking Xonvea. If this happens, don’t do activities that require your full attention, unless your doctor says it’s okay.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Xonvea contains carnauba wax, croscarmellose sodium, hypromellose (E464), indigo carmine aluminum lake (E132), macrogol (400, 8000) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (1:1), microcrystalline cellulose, Allura red AC aluminum lake (E129), polysorbate 80 (E433), propylene glycol (E1520), colloidal anhydrous silica, shellac, simethicone emulsion, sodium bicarbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.
How to take Xonvea
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Consult a doctor, pharmacist, or nurse if you are unsure.
How much to take
The doctor will start the treatment with a low dose which may be increased, depending on how well the medicine works for you.
How treatment with Xonvea is started and how the dose is increased if necessary:
- Day 1
- Take 2 tablets orally at bedtime.
- Day 2
- Take 2 tablets orally at bedtime.
- If nausea and vomiting have improved or are under control on day 2, continue to take 2 tablets each evening at bedtime. This will be your usual dose unless your doctor, pharmacist, or nurse tells you otherwise.
- Day 3
- If you still experienced nausea and vomiting on day 2, take 3 tablets by mouth on day 3 (1 tablet in the morning and 2 tablets at bedtime).
- Day 4
- If nausea and vomiting were better or under control on day 3, continue taking 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). This will be your usual dose unless your doctor, pharmacist, or nurse tells you otherwise.
- If you still experienced nausea and vomiting on day 3, take 4 tablets by mouth each day (1 tablet in the morning, 1 tablet in the middle of the day, and 2 tablets at bedtime).
Do not take more than 4 tablets each day (1 in the morning, 1 in the middle of the day, and 2 at bedtime).
How to take this medicine
- Take Xonvea on an empty stomach.
- Swallow the tablet whole with a glass of water.
- The tablet should not be crushed, chewed, or divided before swallowing.
Tell your doctor, pharmacist, or nurse if you cannot swallow Xonvea tablets whole.
If you have taken too much Xonvea
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you. The following effects may occur restlessness, sleepiness or dizziness, dry mouth, dilated pupils, confusion, and fast heart rate.
If the amount of medicine in your body is very high, you may also have seizures, muscle pain or weakness, or sudden serious kidney problems. These can even be life-threatening. If you have these signs – stop taking Xonvea and contact a doctor or hospital immediately.
If you stop taking Xonvea
Do not stop taking Xonvea without first talking to your doctor. If you stop treatment with this medicine suddenly, nausea and vomiting may return. Your doctor will tell you how to taper off the medicine slowly to avoid this.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
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 users):
- severe sleepiness
Common (may affect up to 1 in 10 users):
- dizziness
- fatigue
- dry mouth
Has been reported (occurring in an unknown number of users):
- hypersensitivity ( allergic reaction )
- anxiety, difficulty sleeping (insomnia), nightmares, disorientation
- headache or migraine
- tingling, tickling, and numbness of the skin
- restlessness and a need to be in constant motion
- vision problems or blurred vision
- a feeling that the surroundings are spinning
- difficulty breathing, palpitations, or increased heart rate
- feeling the full or bloated stomach, stomach pain, constipation, or diarrhea
- profuse sweating, skin reactions such as itching or rash
- Difficulty urinating or that it hurts when you urinate
- chest discomfort
- general discomfort or irritability
Other side effects have been reported with drugs in the same drug group as doxylamine
- Anticholinergic effects (blocking of activity in organs that receive nerve impulses via the signaling substance acetylcholine ): dryness of the mouth, nose, and throat; difficulty urinating or pain when urinating; dizziness; difficulty seeing or blurred vision; double vision ( diplopia ); ringing in the ears or ringing in the ears ( tinnitus ); inflammation of the inner ear that occurs quickly ( acute otitis media); difficulty sleeping (insomnia); tremors and nervousness; irritability and involuntary repetitive movements ( dyskinesia) in the face. In addition, have a feeling of tightness in the chest; thick mucus in the lungs (pulmonary secretions); high-pitched wheezing often accompanied by difficulty breathing (wheezing); nasal congestion; sweating and chills; early menstruation; altered state of mind such as hallucinations, delusions, confusion and thought disorders (toxic psychosis ); headache; tingling, tickling, and numbness of the skin and fainting have been reported.
- Rare cases of a low number of white blood cells ( agranulocytosis ), reduced blood volume in the body due to increased breakdown of blood cells ( hemolytic anemia ), reduced number of blood platelets ( thrombocytopenia ), reduced number of red and white blood cells and platelets (pancytopenia) and increased appetite, sometimes with weight gain has been reported.
How to store Xonvea
Store out of sight and reach of children.
Use before the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are doxylamine hydrogen succinate (an antihistamine ) and pyridoxine hydrochloride (vitamin B 6 ). Each tablet contains 10 mg of doxylamine hydrogen succinate and 10 mg of pyridoxine hydrochloride.
- Other ingredients are Carnauba wax, croscarmellose sodium, hypromellose (E464), indigo carmine aluminum lacquer (E132), macrogol (400, 8000) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (1:1), microcrystalline cellulose, Allura red AC aluminum lacquer (E129 ), polysorbate 80 (E433), propylene glycol (E1520), colloidal, anhydrous silica, shellac, simethicone emulsion, sodium bicarbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.
Appearance and package sizes of the medicine
- Xonvea gastro-resistant tablets are white, round, and film-coated tablets with a pink picture of a pregnant woman on one side.
- Xonvea is available in blister cards containing 20, 30, or 40 tablets. Not all pack sizes may be marketed.
Manufacturer
Elara Pharmaservices Europe Limited
239 Blanchardstown
Corporate Park
Ballycoolin
Dublin
D15 KV21
Ireland
This medicine is approved in the European Economic Area and the United Kingdom (Northern Ireland) under the names
Denmark Xonvea 10 mg/10 mg enteric tablet
Finland Xonvea 10 mg/10 mg gastro-resistant tablet
United Kingdom Xonvea 10 mg/10 mg gastro-resistant tablets
Ireland Xonvea 10 mg/10 mg gastro-resistant tablets
Iceland Xonvea 10 mg/10 mg magasyüruľonnar tavrel
The Netherlands Xonvea 10 mg/10 mg gastric-resistant tablet
Norway Xonvea 10 mg/10 mg enteric tablet