Package Insert: Information for the Patient

Bonjesta 20 mg/20 mg Modified-Release Tablets

Hydrogen Succinate of Doxylamine/Pyridoxine Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Bonjesta and for what it is used

2. What you need to know before starting to take Bonjesta

3. How to take Bonjesta

4. Possible adverse effects

5. Storage of Bonjesta

6. Contents of the package and additional information

What is Bonjesta

Bonjesta20 mg/20 mgmodified-release tablets contain two active ingredients called: “doxylamine hydrochloride” and “pyridoxine hydrochloride”.

• Doxylamine hydrochloride: belongs to the group of medicines called “antihistamines”.
• Pyridoxine hydrochloride: also known as Vitamin B6.

What is Bonjesta used for

This medicine is used in pregnant women to treat nausea and vomiting. It is used when changes in diet or other non-medicinal treatments have not worked.

Women who experience severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, should be treated by a specialist.

Do not take Bonjesta if:

• You are allergic to doxylamine succinate or other antihistamines (such as diphenhydramine), pyridoxine hydrochloride, or any of the other ingredients in this medication (listed in section 6).
• You are taking medications for depression called "monoamine oxidase inhibitors" (MAOIs) or have taken MAOIs in the last 14 days.
• You have porphyria (a rare metabolic disorder).

Do not take this medication if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication if you have ever had:

• Asthma or other respiratory conditions such as chronic bronchitis (persistent inflammation of the bronchi) and emphysema (a disease that affects the lungs and makes it difficult to breathe).
• Increased eye pressure.
• A narrow-angle glaucoma eye problem.
• Stomach ulcer.
• Obstruction in the intestine, between the stomach and the small intestine.
• Bladder blockage.
• Liver and/or kidney disease.
• Prolonged QT interval syndrome (a heart disease).
• Epilepsy.
• Low levels of potassium in the blood or other electrolyte imbalances.

Also, talk to your doctor or pharmacist before taking this medication if:

• You are taking medications for cough or cold, sleep, or certain pain relievers (see section "Other medications and Bonjesta").
• You have been drinking alcohol.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before taking this medication.

If you have severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, you should be treated by a specialist.

This medication may increase sensitivity to light, so it is not recommended to take the sun during treatment.

This medication may increase dehydration and cause heatstroke due to decreased sweating.

You should be aware of any signs of abuse or dependence on this treatment. Talk to your doctor if you have any substance use disorders (alcohol, medications, or others).

In urine drug tests, taking this medication may give false-positive results for methadone, opioids, and phencyclidine (PCP) with some test assays. If this happens, a more specific test can be performed.

This medication may give false-negative results in skin tests that use allergenic extracts (allergy tests). You should stop taking this medication for several days before the test.

Be aware of the following side effects:

• This medication may cause drowsiness; do not drive, ride a bike, or use tools or machines while taking this medication. Also, do not do other things that require your full attention, unless your doctor tells you that you can.

• Do not take this medication while taking medications for cough and cold, sleep, certain pain relievers, or if you have been drinking alcohol. If you take Bonjesta with other medications that affect the "central nervous system," it may cause excessive sleep; potentially causing a fall or other accidents.

Children and adolescents

This medication is not recommended for use in children under 18 years due to a lack of clinical data.

Vitamin B

Talk to your doctor or pharmacist before taking any additional vitamin B. This may be through your diet, supplements, or multivitamins.

Other medications and Bonjesta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal medications.

Particularly, do not take this medication and inform your doctor or pharmacist if you are taking any of the following medications:

• Anticholinergics such as antidepressants or medications for Parkinson's disease, monoamine oxidase inhibitors (MAOIs) or IMAOs (treatment for depression), antipsychotics (medications for mental alterations), atropine for spasms or disopyramide (for certain heart problems) as these may increase toxicity.
• Central nervous system inhibitors (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazepine, or oxibate sodium).
• Antihypertensives (medications for high blood pressure) with central nervous system effects such as guanabenz, clonidine, or alpha-methyldopa.
• If you are taking other medications that produce ototoxicity (toxicity in the ear), such as carboplatin or cisplatin (cancer medications), chloroquine (malaria medication), and some antibiotics (infection medications) such as erythromycin or aminoglycosides, as this medication may mask the effects of these medications, so you should regularly check your ear status.
• Medications that decrease the elimination of others, such as some antifungals (terbinafine), some antidepressants (fluoxetine and fluvoxamine), some medications for heart rhythm problems (amiodarone), some medications used to reduce lipids (gemfibrozil), or some medications used to treat stomach ulcers (cimetidine), as they may increase the effect of this medication.
• Some diuretics (medications that increase urine elimination).
• Medications with heart effects, such as those used to treat arrhythmias (heart rhythm problems), some antibiotics, certain malaria medications, certain antihistamines, certain medications used to reduce lipids in the blood, or certain neuroleptics (medications for mental alterations).
• Medications that produce photosensitization reactions (exaggerated skin reactions when exposed to sunlight), such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, etc.), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, etc.), some anti-inflammatory medications (piroxicam, naproxen, etc.), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide), etc., as they may cause additive photosensitization effects.
• Levodopa, as the pyridoxine in this medication may decrease its effect.
• Medications for epilepsy (phenobarbital, phenytoin) as pyridoxine may decrease their blood levels.
• Medications such as hydroxyzine, isoniazid, or penicillamine, as they may increase the need for vitamin B6 when taken with pyridoxine.

Taking Bonjesta with alcohol

Do not drink alcohol while taking this medication. See section 3 for information on how to take Bonjesta.

Pregnancy and breastfeeding

Bonjesta is indicated for pregnant women.

If you are breastfeeding, your doctor should decide whether to stop breastfeeding or stop treatment. This is because this medication may pass into breast milk and harm your baby.

Driving and using machines

Do not drive, ride a bike, or use tools or machines while taking this medication. This is because it may cause drowsiness after taking it. If this happens, do not do other things that require your full attention, unless your doctor tells you that you can.

This medication contains red Allura AC (E129), a synthetic azo dye that may cause allergic reactions.

Bonjesta contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

Your doctor will start with the lowest dose and possibly increase it. This will depend on the action the medication has on you.

How to start treatment with this medication and 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 improve or are controlled on day 2, continue taking 1 tablet at bedtime.
• Day 3
• • If day 2 continues with nausea and vomiting, take 1 tablet in the morning and 1 tablet at bedtime orally on day 3 (a total of 2 tablets per day).

Do not take more than 2 tablets per day (1 tablet in the morning and 1 tablet at bedtime).

Some women may be able to control symptoms with intermediate doses of 30 mg/30 mg. This dose cannot be achieved with this medication. Other presentations of doxylamine hydrochloride/hydrochloride pyridoxine are available that offer greater flexibility to adjust the dose according to the severity of symptoms. With Bonjesta 20 mg/20 mg in modified-release tablets, the maximum recommended daily dose is 40 mg/40 mg, consisting of only two tablets per day.

How to take this medication

• Takethis medicationon an empty stomach.
• Swallow the tablet whole, with a glass of water.
• Do not crush, chew, or break the tablets before swallowing.

If you cannot swallow the tabletsof this medicationwhole, inform your doctor or pharmacist.

Use in childrenand adolescents

This medication is not recommended for use in children under 18 years due to a lack of clinical data.

If you take more Bonjesta than you should

If you take more medication than you should, stop taking this medication and consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: feeling of restlessness, sleepiness, dizziness, dry mouth, larger black part of the eyes (dilated pupils), confusion, rapid heart rate.

If the amount in your body is very high, you may also have seizures, muscle pain or weakness, or sudden severe kidney problems. These can even cause death. If you have these symptoms, stop taking this medication and consult your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you interrupt treatment with Bonjesta

Do not stop takingthis medicationwithout consulting your doctor first. If you stop taking this medication suddenly, you may feel nausea and vomiting again. Your doctor will tell you how to stop taking this medication, gradually, over time, to help prevent it.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

• Feeling very sleepy

Common: may affect 1 in 10 people

• Feeling dizzy
• Feeling tired
• Increased bronchial secretion
• Dry mouth

Uncommon:may affect up to 1 in 100 people

• Confusion
• Eye problems: glaucoma, double vision (diplopia)
• Ringing in the ears (tinnitus)
• Rotatory vertigo due to change in posture (getting up quickly from a seated or lying position)
• Nausea, vomiting
• Photosensitivity reactions
• Swelling of arms and legs
• Weakness

Rare:may affect up to 1 in 1000 people

• Tremors, convulsions, or agitation
• Blood problems such as hemolytic anemia

Frequency not known:cannot be estimated from available data

• Hypersensitivity (allergic reaction)
• Feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disoriented
• Headache or migraines
• Itching, prickling, or numbness of the skin
• Restlessness and constant need to move
• Eye problems, blurred vision
• Feeling of vertigo
• Difficulty breathing, feeling heartbeats, or increased heart rate
• Feeling full or bloated, stomach pain, constipation, or diarrhea
• Excessive sweating, skin reaction such as urticaria or rash
• Difficulty or pain urinating
• Chest discomfort
• General feeling of illness or irritability
• Difficulty breathing (dyspnea)

Other reported adverse effects with medications in the same group as doxilamine

• Anticholinergic effects include (blockage of activity of organs that receive nerve impulses through a substance called acetylcholine): dry mouth, nose, and throat; difficulty or pain urinating; feeling of rotatory vertigo; eye problems or blurred vision; double vision (diplopia); ringing or noise in the ears (tinnitus); acute inflammation of the inner ear; difficulty sleeping (insomnia); spasms (tremors) and nervousness; feeling irritable; involuntary repetitive movements of the face (facial dyskinesia). Additionally, feeling of chest oppression, thick mucus in the chest (bronchial secretions); high-pitched sound often associated with difficulty breathing (sibilance); nasal congestion; sweating and feeling of chills; early menstruation; altered mental state such as hallucinations, delirium, confusion, and altered thoughts (toxic psychosis); headaches, tingling, prickling, or numbness of the skin; or feeling of fainting have been reported.
• In rare cases, low levels of white blood cells (leucopenia and agranulocytosis), decreased blood in the body due to increased destruction of cells (hemolytic anemia), decreased clotting of white blood cells (thrombocytopenia), decreased red and white blood cells, and clotting in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister after “CAD”.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the Sigre point.Ask your pharmacist how to dispose ofthe packaging and medications you no longerneed.By doing so, you will help protect the environment.

Composition of Bonjesta

• The active ingredients are doxylamine hydrochloride (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each tablet contains 20 mg of doxylamine hydrochloride and 20 mg of pyridoxine hydrochloride.
• The other components are:ammonium hydroxide 28% (E527),carnauba wax, croscarmellose sodium, hypromellose (E464),cochineal red(E132), iron oxide red, macrogol(3350)(E1521), magnesium stearate, magnesium trisilicate, copolymer of methacrylic acid and ethyl acrylate (1:1), microcrystalline cellulose, allura red AC (E129), propylene glycol (E1520), poly (vinyl alcohol) (mono 1961), colloidal anhydrous silica, shellac (E904), simethicone, simethicone emulsion, sodium hydrogen carbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171) and triethyl citrate.

Appearance of the product and contents of the package

• The modified-release tablets are pink, round and coated with a pink image of a pregnant woman on one side and the letter “D” on the other.
• Bonjesta is available in blister packs containing 10, 20, 30 or 40 tablets. Not all package sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare, S.L

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares.

Guadalajara, Spain

Responsible for manufacturing

Laboratorios Liconsa,

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares

Guadalajara, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Ireland:Vombee 20mg /20mg modified-release tablets

Estonia:Embagyn

Lithuania:Embagyn 20 mg/20 mg modified-release tablets

Latvia:Embagyn 20 mg/20 mg modified-release tablets

Slovakia:Xonvea

Czech Republic:Xonvea

Spain:Bonjesta 20 mg/20 mg modified-release tablets

France:BONJESTA 20 mg/ 20 mg, modified-release tablet

Italy:Bonjesta

Portugal:Bonjesta

Austria:Xonvea 20 mg/20 mg Tablet with modified-release of active ingredient

Netherlands:Embagyn

Luxembourg:Bonjesta 20/20

Hungary:Vombee 20/20

Last review date of this leaflet:January 2025

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).