Bonjesta

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bonjesta, 20 mg + 20 mg, modified-release tablets
doxylamine succinate + pyridoxine hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Bonjesta is and what it is used for
2. What you need to know before taking Bonjesta
3. How to take Bonjesta
4. Possible side effects
5. How to store Bonjesta
6. Contents of the pack and other information

1. What Bonjesta is and what it is used for

What Bonjesta is
Bonjesta is a medicine in the form of modified-release tablets with a strength of 20 mg + 20 mg, containing 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 B .

What Bonjesta is used for
Bonjesta is used in pregnant women to treat nausea and vomiting. It is used when dietary changes or other non-pharmacological treatments have not been effective.
Women who experience severe nausea and vomiting during pregnancy, a condition known as hyperemesis gravidarum, should be treated by a specialist.

2. Important Information Before Using Bonjesta

When Not to Use Bonjesta

• if the patient is 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);
• if the patient is taking antidepressants known as "monoamine oxidase inhibitors" (MAOIs) or has taken MAOIs within the last 14 days;
• if the patient has porphyria (a very rare metabolic disorder).

Do not use Bonjesta if any of the above conditions apply to the patient. If in doubt, discuss this with a doctor or pharmacist before using Bonjesta.

Warnings and Precautions

Before starting treatment with Bonjesta, consult a doctor or pharmacist if the patient has ever had:

• asthma or other breathing disorders such as chronic bronchitis and emphysema (a lung disease causing difficulty in breathing);
• increased pressure in the eye;
• a condition of the eye called "narrow-angle glaucoma";
• peptic ulcer;
• intestinal obstruction between the stomach and the small intestine;
• urinary bladder obstruction;
• liver and/or kidney disease;
• long QT syndrome (a heart condition);
• epilepsy (seizures);
• low blood potassium levels or other electrolyte imbalances.

Also, speak with a doctor or pharmacist before taking Bonjesta if:

• the patient is taking cough or cold medicines, sleeping medicines, or certain pain relievers (see also section "Bonjesta and Other Medicines" below);
• the patient drinks alcohol.

If any of the above conditions apply to the patient (or if the patient is unsure), consult a doctor or pharmacist before using Bonjesta.

Women experiencing severe nausea and vomiting during pregnancy, a condition known as hyperemesis gravidarum, should be managed by a specialist.

Bonjesta may increase sensitivity to light; therefore, sunbathing is not recommended during treatment.

Bonjesta may increase the risk of dehydration and heat stroke due to reduced sweating.

Be vigilant for any signs of misuse or dependence on this medication. If the patient has a history of substance abuse (alcohol, drugs, or others), discuss this with the doctor.

When undergoing urine drug screening tests, taking Bonjesta may result in "false-positive" results for methadone, opioids, and phencyclidine (PCP) when certain testing methods are used. If this occurs, a more specific test can be performed.

This medicine may cause false-negative results in skin allergy tests using allergen extracts. The medicine should be discontinued a few days before such testing.

Adverse Effects to Be Aware Of

• Bonjesta may cause drowsiness — do not drive, ride a bicycle, or operate any tools or machinery while taking this medicine. Do not perform other activities requiring full attention unless the doctor advises it is safe.
• Do not take Bonjesta while using cough suppressants, cold medicines, sleeping medicines, certain pain relievers, or after consuming alcohol. Taking Bonjesta together with other medicines that act on the central nervous system may cause pronounced drowsiness, which could lead to falls or other accidents.

Children and Adolescents

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

Vitamin B

Before taking any vitamin B from any additional source — food, dietary supplement, or multivitamin preparation — consult a doctor, pharmacist, or nurse.

Bonjesta and Other Medicines

Inform the doctor, pharmacist, or nurse about all medicines currently used or recently taken, as well as any medicines the patient plans to use. This includes over-the-counter medicines and herbal remedies.

Do not take Bonjesta and consult a doctor or pharmacist, especially if the patient is taking any of the following medicines:

• Anticholinergic drugs, such as antidepressants or drugs used in Parkinson’s disease, monoamine oxidase inhibitors (MAOIs) (used to treat depression), antipsychotics (used to treat psychiatric disorders), atropine (used to treat spasms) or disopyramide (used to treat certain heart conditions), as these may increase toxicity.
• Medicines that depress the central nervous system (e.g., barbiturates, sleeping medicines, sedatives, anxiolytics, opioid pain relievers, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensive medicines (medicines that lower blood pressure) affecting the central nervous system, such as guanabenz, clonidine, or methyldopa.
• Other medicines toxic to the ear, such as carboplatin or cisplatin (used in cancer treatment), 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 their toxic effects. Hearing should be monitored periodically.
• Medicines that reduce the excretion of other drugs, such as certain antifungal medicines (terbinafine), certain antidepressants (fluoxetine and fluvoxamine), medicines used to treat heart rhythm disorders (amiodarone), certain lipid-lowering medicines (gemfibrozil), or certain medicines used to treat stomach ulcers (cimetidine), as they may enhance the effect of this medicine.
• Certain diuretics (medicines that increase urine production).
• Medicines that may affect the heart, such as medicines used to treat heart rhythm disorders (irregular heartbeat), certain antibiotics, certain antimalarial medicines, certain antihistamines, certain medicines used to lower blood lipid (fat) levels, or certain neuroleptics (used to treat psychiatric disorders).
• Medicines causing photosensitivity (increased skin reaction to sunlight), such as certain antiarrhythmics (amiodarone, quinidine), certain antibiotics (including tetracyclines, fluoroquinolones, azithromycin, and erythromycin), certain antidepressants (imipramine, doxepin, amitriptyline), certain antifungals (griseofulvin), antihistamines (including promethazine, chlorpheniramine, and diphenhydramine), certain nonsteroidal anti-inflammatory drugs (including piroxicam and naproxen), certain antivirals (amantadine, ganciclovir), or certain diuretics (furosemide, hydrochlorothiazide), as this medicine may further increase photosensitivity.
• Levodopa, because the pyridoxine in this medicine may reduce its effectiveness.
• Medicines used to treat epilepsy (phenobarbital, phenytoin), because pyridoxine may reduce their blood levels.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, because their concurrent use with pyridoxine may cause vitamin B6 deficiency.

Bonjesta and Alcohol

Do not consume alcohol while taking Bonjesta. Information about using Bonjesta is provided in section 3.

Pregnancy and Breastfeeding

Bonjesta is indicated for use in pregnant women.

If the patient is breastfeeding, a decision should be made in consultation with the doctor whether to discontinue breastfeeding or to stop taking the medicine, as Bonjesta may pass into human milk and could harm the infant.

Driving and Operating Machinery

Do not drive, ride a bicycle, or operate any tools or machinery while taking this medicine. This is because Bonjesta may cause drowsiness. In such cases, do not perform other activities requiring full attention unless the doctor advises it is safe.

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, meaning the medicine is considered "sodium-free."

3. How to take Bonjesta

This medicine should always be taken exactly as directed by the physician, pharmacist, or nurse.
If in doubt, consult the physician, pharmacist, or nurse.
How much medicine to take

The physician will start treatment with a low dose and may increase it depending on how the
medicine works for the patient.
How to start taking Bonjesta and how to increase the dose if necessary:

• Day 1.
• Take 1 tablet orally at bedtime.
• Day 2.
• Take 1 tablet orally at bedtime.
• If nausea and vomiting have subsided or are controlled by Day 2, continue taking 1 tablet every evening at bedtime.
• Day 3.
• If nausea and vomiting persist on Day 2, on Day 3 take 1 tablet in the morning and 1 tablet at bedtime (total of 2 tablets per day). Do not take more than 2 tablets per day (1 in the morning and 1 at bedtime).

In some women, symptom control may be achieved with intermediate doses of 30 mg + 30 mg.
Such doses cannot be obtained using Bonjesta 20 mg + 20 mg tablets. Other medicinal products
containing doxylamine succinate and pyridoxine hydrochloride are available, which allow greater
flexibility in dose adjustment according to symptom severity.
For Bonjesta 20 mg + 20 mg 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.
• The tablet should be swallowed whole with a glass of water.
• Do not crush, chew, or divide the tablets before swallowing. If the patient cannot swallow the Bonjesta tablet whole, inform the physician or pharmacist.

Use in children and adolescents
Bonjesta is not recommended for use in children and adolescents under 18 years of age due to
lack of clinical data.
If you take more Bonjesta than recommended
If more Bonjesta has been taken than recommended, stop taking it immediately and contact a
physician or go to a hospital without delay. Bring the medicine packaging with you. The following
symptoms may occur: restlessness, drowsiness or dizziness, dry mouth, enlargement of the 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,
serious kidney problems may also occur. This may even lead to death. If such symptoms occur,
stop taking Bonjesta immediately and contact a physician or go to a hospital.
Stopping Bonjesta
Do not stop taking Bonjesta without consulting the physician. If this medicine is stopped suddenly,
nausea and vomiting may return. The physician will advise the patient on how to gradually discontinue
this medicine to avoid such symptoms.
If there are any further questions about the use of this medicine, consult the physician, pharmacist,
or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.

Very common: may affect more than 1 in 10 people

• severe drowsiness

Common: may affect less than 1 in 10 people

• dizziness
• feeling of fatigue
• increased bronchial secretions
• dry mouth

Uncommon: may affect less than 1 in 100 people

• disorientation
• eye problems: cataract, double vision
• ringing in the ears (tinnitus)
• dizziness related to change in body position (rapid standing from sitting or lying position)
• nausea, vomiting
• light sensitivity
• swelling of hands and feet
• weakness

Rare: may affect less than 1 in 1,000 people

• tremor, convulsions or agitation
• blood disorders such as haemolytic anaemia

Frequency unknown: frequency cannot be estimated from the available data

• hypersensitivity (allergic reaction)
• feeling of anxiety, difficulty sleeping (insomnia), nightmares, feeling of disorientation
• headache or migraine
• tingling, pricking or numbness of the skin
• restlessness and need to keep moving
• vision problems, blurred vision
• dizziness with sensation of spinning
• difficulty breathing, palpitations or faster heartbeat
• feeling of fullness or bloating, abdominal pain, constipation or diarrhoea
• excessive sweating, skin reactions such as itching or rash
• difficulty or pain during urination
• discomfort in the chest
• general discomfort or feeling of irritability
• difficulty breathing (dyspnoea)

Other adverse effects reported for medicines belonging to the same class as
doxylamine

• Anticholinergic effects (blocking organ functions that receive nerve impulses via a substance called acetylcholine), which may cause: dry mouth, nose and throat; difficulty or pain during urination; dizziness with sensation of spinning; vision problems or blurred vision; double vision (diplopia); ringing or noise in the ears (tinnitus); inner ear inflammation developing rapidly (acute labyrinthitis); difficulty sleeping (insomnia); tremor (convulsions) and nervousness; feeling of irritability; involuntary repetitive facial movements (facial dyskinesia). In addition, the following may occur: feeling of pressure in the chest, thick mucus in the bronchi (bronchial secretion); high-pitched, whistling breathing sound, often associated with difficulty breathing (wheezing); nasal congestion; increased sweating and chills; early menstruation; psychiatric disorders such as hallucinations, delusions, disorientation and thought disorders (toxic psychosis); headache; tingling, pricking or numbness of the skin, and fainting.

• Rarely reported: low white blood cell count (leukopenia and agranulocytosis), reduced blood volume due to increased destruction of blood cells (haemolytic anaemia), reduced platelet count responsible for blood clotting (thrombocytopenia), reduced number of red blood cells, white blood cells and platelets in the blood (pancytopenia), and increased appetite, sometimes associated with weight gain.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Bonjesta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bonjesta contains

• The active substances are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B). Each tablet contains 20 mg of doxylamine succinate and 20 mg of pyridoxine hydrochloride.
• The other ingredients are: microcrystalline cellulose, magnesium trisilicate, sodium croscarmellose, magnesium stearate, anhydrous colloidal silicon dioxide, triethyl citrate, simethicone emulsion 30%, Carnauba wax.
  Coating Opadry Clean 020190000: hypromellose (E 464), triethyl citrate.
  Coating Acryl-Eze Clear 93A19326: copolymer of methacrylic acid and ethyl acrylate (1:1), talc, anhydrous colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate.
  Coating Opadry II Pink 85F94320: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc, iron oxide red (E 172), iron oxide black (E 172).
  Printing ink Opacode S-1-100003 Purple: shellac, Allura red AC aluminium lake (E 129), propylene glycol (E 1520), indigo carmine aluminium lake (E 132), simethicone, concentrated ammonium hydroxide.

What Bonjesta looks like and contents of the pack

• Bonjesta is a pink, round, film-coated modified-release tablet with a pink image of a pregnant woman on one side and the letter "D" on the other side.
• Bonjesta is available in blister packs containing 10, 20, 30 or 40 tablets, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, the country of export:
Exeltis Healthcare S.L.
Avda. De Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara, Spain
Manufacturer:
Laboratorios Liconsa
Avda. De Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara, Spain
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Portugal, the country of export: 5876305
Parallel import authorisation number: 385/25
This medicinal product is authorised 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