Boniesta

Leaflet attached to the packaging: patient information

Bonjesta, 20 mg + 20 mg, tablets with modified release

doxylamine succinate + pyridoxine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Bonjesta and what is it used for
• 2. Important information before taking Bonjesta
• 3. How to take Bonjesta
• 4. Possible side effects
• 5. How to store Bonjesta
• 6. Package contents and other information

1. What is Bonjesta and what is it used for

What is Bonjesta

Bonjesta is a modified-release tablet containing 20 mg + 20 mg of two active substances: doxylamine succinate and pyridoxine hydrochloride.

• Doxylamine succinate belongs to a group of medicines called "antihistamines".
• Pyridoxine hydrochloride is another name for vitamin B6.

What is Bonjesta used for

Bonjesta is used in pregnant women to prevent nausea and vomiting. It is used when dietary changes or other non-medicinal methods have not been effective. Women with severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, should be treated by a specialist.

2. Important information before taking Bonjesta

When not to take Bonjesta

Do not take Bonjesta if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before taking Bonjesta.

Warnings and precautions

Before starting Bonjesta, discuss with your doctor or pharmacist if you have ever had:

• asthma or other breathing problems, such as chronic bronchitis and emphysema (a lung disease that causes breathing difficulties);
• increased eye pressure;
• an eye disease called "narrow-angle glaucoma";
• stomach ulcers;
• blockage of the intestines between the stomach and small intestine;
• blockage of the urinary bladder;
• liver and/or kidney disease;
• a heart condition called "prolonged QT interval";
• epilepsy (seizures);
• low potassium levels in the blood or other electrolyte disturbances.

You should also talk to your doctor or pharmacist before taking Bonjesta if:

• you are taking cough or cold medicines, sleep aids, or certain pain relievers (see also "Bonjesta and other medicines" below);
• you drink alcohol.

If any of the above conditions apply to you (or you are not sure), consult your doctor or pharmacist before taking Bonjesta. Women with severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, should be treated by a specialist. Bonjesta may increase sensitivity to light, so it is not recommended to sunbathe during treatment. Bonjesta may increase dehydration and cause heat stroke due to reduced sweating. Be aware of any signs of abuse or dependence on this treatment. If you have a history of substance abuse (alcohol, drugs, or other), discuss this with your doctor. If you undergo a urine test for narcotics, taking Bonjesta may cause a false positive result for methadone, opiates, or phencyclidine (PCP) with some testing methods. If this happens, a more accurate test can be performed. This medicine may cause false negative results in skin tests using allergen extracts (allergy tests). You should stop taking this medicine a few days before the test.

Side effects to look out for

• Bonjesta may cause drowsiness - do not drive, ride a bike, or operate any tools or machines while taking this medicine. Do not perform other activities that require full attention, unless your doctor tells you it is safe to do so.
• Do not take Bonjesta while taking cough or cold medicines, sleep aids, or certain pain relievers, or after drinking alcohol.

Taking Bonjesta with other medicines that act on the central nervous system may cause excessive drowsiness - this can lead to falls or other accidents.

Children and adolescents

It is not known if Bonjesta is safe and effective in children and adolescents under 18 years of age.

Vitamin B6

Before taking any vitamin B6 from any additional source - food, dietary supplement, or multivitamins - consult your doctor, pharmacist, or nurse.

Bonjesta and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or plan to take. This includes medicines available without a prescription and herbal medicines. Do not take Bonjesta and consult your doctor or pharmacist, especially if you are taking any of the following medicines:

• Anticholinergic medicines, such as antidepressants or medicines used to treat Parkinson's disease, monoamine oxidase inhibitors (MAOIs) or other medicines used to treat depression, antipsychotic medicines (used to treat mental disorders), atropine used to treat spasms or dyphylline (used to treat certain heart conditions), as these medicines may increase toxicity.
• Medicines that act on the central nervous system (such as barbiturates, sleep aids, sedatives, anxiolytics, opioid pain relievers, antipsychotic medicines, procarbazine, or sodium hydrosulfite).
• Antihypertensive medicines (blood pressure lowering medicines) that act on the central nervous system, such as guanabenz, clonidine, or methyldopa.
• Other medicines that are toxic to the ear, such as carboplatin or cisplatin (used to treat cancer), chloroquine (used to prevent and treat malaria), and certain antibiotics (used to treat infections), such as erythromycin or intravenous aminoglycosides, as this medicine may mask the toxic effects of these medicines. Hearing should be monitored periodically.
• Medicines that reduce the elimination of other medicines, such as certain antifungal medicines (terbinafine), certain antidepressants (fluoxetine and fluvoxamine), medicines used to treat heart rhythm disorders (amiodarone), certain medicines that lower lipid levels (gemfibrozil), or certain medicines used to treat stomach ulcers (cimetidine), as they may increase the effect of this medicine.
• Certain diuretic medicines (medicines that increase urine production).
• Medicines that may affect the heart, such as medicines used to treat heart rhythm disorders (arrhythmias), certain antibiotics, certain medicines used to treat malaria, certain antihistamines, certain medicines used to lower lipid levels, or certain neuroleptics (used to treat mental disorders).
• Medicines that cause increased sensitivity to light (such as certain antiarrhythmic medicines (amiodarone, quinidine), certain antibiotics (tetracyclines, fluoroquinolones, azithromycin, and erythromycin), certain antidepressants (imipramine, doxepin, amitriptyline), certain antifungal medicines (griseofulvin), antihistamines (such as promethazine, chlorphenamine, and diphenhydramine), certain anti-inflammatory medicines (such as piroxicam and naproxen), certain antiviral medicines (amantadine, ganciclovir), certain diuretic medicines (furosemide, chlorthiazide), as this medicine may further increase sensitivity to light.
• Levodopa, as the pyridoxine in this medicine may reduce its effect.
• Medicines used to treat epilepsy (phenobarbital, phenytoin), as pyridoxine may reduce their levels in the blood.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, as their concurrent use with pyridoxine may cause a deficiency of vitamin B6.

Bonjesta and alcohol

Do not drink alcohol while taking Bonjesta. Information on taking Bonjesta can be found in section 3.

Pregnancy and breastfeeding

Bonjesta is indicated for use in pregnant women. If you are breastfeeding, you should discuss with your doctor whether to stop breastfeeding or stop taking Bonjesta. This is because Bonjesta may pass into human milk and may harm your baby.

Driving and using machines

Do not drive, ride a bike, or operate any tools or machines while taking this medicine. This is because Bonjesta may cause drowsiness. In this case, do not perform other activities that require full attention, unless your doctor tells you it is safe to do so.

Bonjesta contains Allura Red AC aluminum lake (E 129)

Bonjesta contains the azo dye Allura Red AC, aluminum lake (E 129), which may cause allergic reactions. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Bonjesta

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, consult your doctor, pharmacist, or nurse.

How much to take

Your doctor will start with a low dose and may increase it - this will depend on how the medicine works for you. How to start taking Bonjesta and how to increase the dose if necessary:

• Day 1.
• Take 1 tablet orally before bedtime.
• Day 2.
• Take 1 tablet orally before bedtime.
• If nausea and vomiting have stopped or are under control on day 2, continue taking 1 tablet each day in the evening, before bedtime.
• Day 3.
• If nausea and vomiting were still present on day 2, on day 3 take 1 tablet orally in the morning and 1 tablet before bedtime (a total of 2 tablets per day). Do not take more than 2 tablets per day (1 in the morning and 1 before bedtime).

In some women, control of symptoms is ensured by using intermediate doses of 30 mg + 30 mg. This dose cannot be achieved with Bonjesta 20 mg + 20 mg. Other forms of medicines containing doxylamine succinate and pyridoxine hydrochloride are available, which provide greater flexibility in adjusting the dose according to the severity of symptoms. For Bonjesta 20 mg + 20 mg in modified-release tablets, the maximum recommended daily dose of 40 mg + 40 mg consists of only two tablets per day.

How to take this medicine

• Bonjesta should be taken on an empty stomach.
• Swallow the tablet whole with a glass of water.
• Do not crush, chew, or divide the tablets before swallowing. If you have difficulty swallowing the Bonjesta tablet whole, tell your doctor or pharmacist.

Use in children and adolescents

Bonjesta is not recommended for use in children and adolescents under 18 years of age due to a lack of clinical data.

Taking more than the recommended dose of Bonjesta

If you have taken more than the recommended dose of Bonjesta, stop taking it and contact your doctor or go to the hospital immediately. Take the medicine packaging with you. The following symptoms may occur: restlessness, drowsiness, or dizziness, dry mouth, enlarged black, central part of the eye (dilated pupils), disorientation, rapid heartbeat. If the amount of medicine in the body is very high, seizures, muscle pain or weakness, or sudden, severe kidney problems may also occur. This can even lead to death. If such symptoms occur, stop taking Bonjesta and contact your doctor or go to the hospital immediately.

Stopping Bonjesta

Do not stop taking Bonjesta without consulting your doctor. If you stop taking this medicine suddenly, nausea and vomiting may return. Your doctor will tell you how to gradually stop taking this medicine to avoid these symptoms. If you have any further doubts about taking this medicine, consult 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

• excessive drowsiness.

Common:may affect up to 1 in 10 people

• dizziness
• fatigue
• increased amount of bronchial secretions
• dry mouth.

Uncommon:may affect up to 1 in 100 people

• disorientation
• eye problems: cataract, double vision
• ringing in the ears (tinnitus)
• dizziness related to changes in body position (getting up quickly from a sitting or lying position)
• nausea, vomiting
• reactions to light
• swelling of hands and feet
• weakness.

Rare:may affect up to 1 in 1000 people

• tremors, seizures, or excitement
• blood disorders, such as hemolytic anemia.

Frequency not known:frequency cannot be estimated from the available data

• hypersensitivity (allergic reaction)
• restlessness, difficulty sleeping (insomnia), nightmares, disorientation
• headaches or migraines
• tingling, prickling, or numbness of the skin
• restlessness and need for constant movement
• vision problems, blurred vision
• dizziness with a feeling of spinning
• breathing difficulties, palpitations, or rapid heartbeat
• feeling of fullness or bloating, stomach pain, constipation, or diarrhea
• excessive sweating, skin reactions, such as itching or rash
• difficulty or pain when urinating
• discomfort in the chest
• general discomfort or feeling of irritation
• breathing difficulties (dyspnea).

Other side effects reported for medicines in the same class as doxylamine

• Anticholinergic effects (blocking the action of organs that receive nerve impulses through a substance called acetylcholine), which may cause: dry mouth, nose, and throat; difficulty or pain when urinating; dizziness with a feeling of spinning; vision problems or blurred vision; double vision (diplopia); ringing or buzzing in the ears (tinnitus); inner ear inflammation, which develops quickly (acute labyrinthitis); difficulty sleeping (insomnia); tremors (seizures) and nervousness; irritability; involuntary repetitive movements of the face (facial dyskinesia). Additionally, the following may occur: feeling of pressure in the chest; thick mucus in the bronchi (bronchial secretions); high-pitched whistling sound when breathing, often associated with difficulty breathing (wheezing); stuffy nose; increased sweating and chills; early menstrual periods; mental disorders, such as hallucinations, delusions, disorientation, and thought disturbances (toxic psychosis); headaches; tingling, prickling, or numbness of the skin; and fainting.
• Rarely, a small number of white blood cells (leukopenia and agranulocytosis), decreased blood in the body due to increased destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), decreased number of red and white blood cells and platelets in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C; 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bonjesta

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bonjesta contains

• The active substances are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each tablet contains 20 mg of doxylamine succinate and 20 mg of pyridoxine hydrochloride.
• The other ingredients are: ammonium hydroxide 28%, carnauba wax, sodium croscarmellose, hypromellose type 2910, indigo carmine aluminum lake (E 132), iron oxide red (E 172), iron oxide yellow, macrogol 3350, magnesium stearate, magnesium silicate, methacrylic acid and ethyl acrylate copolymer (1:1), microcrystalline cellulose (type 102), Allura Red AC aluminum lake (E 129); propylene glycol, polyvinyl alcohol, partially hydrolyzed, silica colloidal anhydrous, shellac, simethicone, simethicone emulsion 30%, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide (E 171), triethyl citrate.

What Bonjesta looks like and contents of the pack

• Bonjesta is available in the form of pink, round, film-coated tablets with modified release, with a pink image of a pregnant woman on one side and the letter "D" on the other side.
• Bonjesta is available in blisters containing 10, 20, 30, or 40 tablets, packed in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]

Manufacturer/Importer

Laboratorios Liconsa S.A.
Avenida de Miralcampo 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Xonvea 20 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung
Belgium:
Bonjesta 20 mg/20 mg tabletten met gereguleerde afgifte
Bonjesta 20 mg/20 mg comprimés à libération modifiée
Bonjesta 20 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung
Czech Republic:
Xonvea
Estonia:
Xonvea 20 mg/20 mg toimeainet modifitseeritult vabastavad tabletid
France:
Xonvea 20 mg/20 mg, comprimé à libération modifiée
Spain:
Bonjesta 20 mg/20 mg comprimidos de liberación modificada
Netherlands:
Embagyn 20 mg/20 mg tabletten met gereguleerde afgifte
Ireland:
Xonvea MR 20/20 modified-release tablets
Lithuania:
Xonvea 20mg /20mg modifikuoto atpalaidavimo tabletės
Luxembourg:
Bonjesta 20 mg/20 mg tabletten met gereguleerde afgifte
Bonjesta 20 mg/20 mg comprimés à libération modifiée
Bonjesta 20 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung
Latvia:
Xonvea 20 mg/20 mg modificētās darbības tabletes
Poland:
Bonjesta
Portugal:
Bonjesta
Slovakia:
Xonvea 20 mg/20 mg tablety s riadeným uvoľňovaním
Hungary:
Vombee 20 mg/20 mg módosított hatóanyagleadású tabletta
Italy:
Bonjesta 20 mg/20 mg compresse a rilascio modificato
Date of last revision of the leaflet:24.01.2025