BONJESTA 20 mg/20 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Bonjesta 20 mg/20 mg Modified Release Tablets

doxylamine succinate/pyridoxine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Bonjesta and what is it used for

What is Bonjesta

Bonjesta 20 mg/20 mgmodified release tablets contain two active substances (ingredients) called doxylamine succinate and pyridoxine hydrochloride.

• Doxylamine succinate: belongs to a group of medicines called antihistamines.
• Pyridoxine hydrochloride: is also known as Vitamin B6.

What Bonjesta is used for

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

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

2. What you need to know before you take Bonjesta

Do not take Bonjesta if:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine, if you have ever had:

• Asthma or other respiratory problems such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a disease that affects the lungs making it difficult to breathe).
• Increased eye pressure.
• An eye problem called narrow-angle glaucoma.
• Stomach ulcer.
• Obstruction in the intestine, between the stomach and the small intestine.
• Blockage in the bladder.
• Liver and/or kidney disease.
• Long QT syndrome (a heart disease).
• Epilepsy
• Low potassium levels in the blood or other electrolyte disturbances.

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

• You are taking cough or cold medicines, sleep aids, or certain pain relievers (see section "Other medicines 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 medicine.

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

This medicine may increase sensitivity to light, so it is not recommended to sunbathe during treatment.

This medicine may increase dehydration and cause heat stroke 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 disorder (alcohol, drugs, or others).

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

This medicine may give false negatives in skin tests using allergenic extracts (allergy tests). You should stop taking this medicine several days before performing the test.

Pay attention to the following side effects:

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

• Do not take this medicine while taking cough and cold medicines, sleep aids, certain pain relievers, or if you have been drinking alcohol. If you take Bonjesta with other medicines that affect the "central nervous system" it may cause you to feel very sleepy; this can cause you to fall or have other accidents.

Children and adolescents

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

Vitamin B

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

Other medicines and Bonjesta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription and herbal medicines.

In particular, do not take this medicine and inform your doctor or pharmacist if you are taking any of the following medicines:

• Anticholinergics such as antidepressants or medicines for the treatment of Parkinson's disease, monoamine oxidase inhibitors or MAOIs (treatment for depression), antipsychotics (medicines for the treatment of mental disorders), atropine for the treatment of spasms or disopyramide (for the treatment of certain heart problems) as these may increase toxicity.
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazine or sodium oxybate).
• Antihypertensives (medicines for the treatment of high blood pressure) with a central nervous system effect such as guanabenz, clonidine, or alpha-methyldopa.
• If you are taking other medicines that produce ear toxicity, such as carboplatin or cisplatin (medicines for cancer treatment), chloroquine (medicine for the treatment or prevention of malaria), and some antibiotics (medicines for infection treatment) such as erythromycin or injectable aminoglycosides, among others, as this medicine could mask the toxic effects of these medicines, so you should periodically review the condition of your ears.
• Medicines that decrease the elimination of other medicines, such as some antifungals (terbinafine), some antidepressants (fluoxetine and fluvoxamine), some medicines for heart rhythm problems (amiodarone), some medicines used to reduce lipids (gemfibrozil), or some medicines used to treat stomach ulcers (cimetidine), as they may increase the effect of this medicine.
• Any diuretic (medicines that increase urine elimination).
• Medicines with an effect on the heart, such as those used for the treatment of arrhythmias (heart rhythm problems), some antibiotics, certain antimalarial medicines, certain antihistamines, certain medicines used to reduce lipids (fats) in the blood, or certain neuroleptics (medicines for the treatment of mental disorders).
• Medicines that produce a photosensitization reaction (exaggerated skin reaction when exposed to sunlight) such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, among others), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, among others), some anti-inflammatory medicines (piroxicam, naproxen, among others), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide), as additive photosensitizing effects may occur.
• Levodopa, as the pyridoxine contained in this medicine may decrease its effect.
• Medicines for the treatment of epilepsy (phenobarbital, phenytoin), as pyridoxine may decrease their levels in the blood.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, as along with pyridoxine, they may increase the need for Vitamin B6.

Taking Bonjesta with alcohol

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

Pregnancy and breastfeeding

Bonjesta is indicated for pregnant women.

If you are breastfeeding, your doctor will decide whether to stop breastfeeding or stop treatment. This is because this medicine 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 medicine. 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 do so.

This medicine contains Allura Red AC (E129), which is an azoic dye that may cause allergic reactions.

Bonjesta containssodium

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

3. How to take Bonjesta

Follow exactly the administration instructions of this medicine 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 effect the medicine has on you.

How to start treatment with this medicine 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 each night, at bedtime.
• Day 3
• • If on Day 2 you still have 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 achieve control of symptoms with intermediate doses of 30 mg/30 mg. This dose cannot be achieved with this medicine. Other presentations of doxylamine succinate/pyridoxine hydrochloride 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 medicine

• Take this medicine on an empty stomach.
• Swallow the tablet whole, with a glass of water.
• Do not crush, chew, or break the tablets before swallowing them.

If you cannot swallow the tablets of this medicine whole, inform your doctor or pharmacist.

Use in childrenand adolescents

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

If you take more Bonjesta than you should

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

If the amount in your body is very high, you may also have seizures, muscle pain or weakness, or severe kidney problems. These can even cause death. If you have these signs, stop taking this medicine 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Bonjesta

Do not stop taking this medicine without consulting your doctor first. If you stop taking this medicine suddenly, you may experience nausea and vomiting again. Your doctor will tell you how to stop taking this medicine gradually, over time, to help avoid this.

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

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

• Drowsiness

Common: may affect up to 1 in 10 people

• Dizziness
• Fatigue
• Increased bronchial secretion
• Dry mouth

Uncommon: may affect up to 1 in 100 people

• Confusion
• Eyes problems: glaucoma, double vision (diplopia)
• Ringing in the ears (tinnitus)
• Dizziness when changing posture (getting up quickly from a sitting or lying position)
• Nausea, vomiting
• Photosensitivity reactions
• Swelling of arms and legs
• Weakness

Rare: may affect up to 1 in 1,000 people

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

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic reaction)
• Anxiety, difficulty sleeping (insomnia), nightmares, feeling disoriented
• Headache or migraine
• Numbness, tingling, or numbness of the skin
• Restlessness and need to move constantly
• Vision problems, blurred vision
• Dizziness
• Difficulty breathing, feeling heartbeats, or increased heart rate
• Feeling full or bloated, stomach pain, constipation, or diarrhea
• Excessive sweating, skin reaction such as hives or rash
• Difficulty or pain when urinating
• Chest discomfort
• General discomfort or irritability
• Difficulty breathing (dyspnea)

Other side effects reported with medicines of the same group 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; difficulty or pain when urinating; dizziness; vision problems or blurred vision; double vision (diplopia); ringing or noise in the ears (tinnitus); inner ear inflammation that develops in a short time (acute labyrinthitis); difficulty sleeping (insomnia); spasms (tremors) and nervousness; feeling irritable; involuntary repetitive facial movements (facial dyskinesia). Additionally, feeling of chest pressure, thick mucus in the chest (bronchial secretions); high-pitched whistling sound often associated with difficulty breathing (wheezing); nasal congestion; sweating and feeling of chills; early menstruation; altered mental state such as hallucinations, delirium, confusion, and altered thoughts (toxic psychosis); headaches, numbness, tingling, or numbness of the skin; or feeling of fainting have been reported.
• Rarely, low white blood cell counts (leukopenia and agranulocytosis), decreased blood in the body due to increased destruction of red blood cells (hemolytic anemia), decreased blood clotting (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 experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Bonjesta

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 and blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the Sigre collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Bonjesta Composition

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

Product Appearance and Container Content

• The modified-release tablets are pink, round, and film-coated with an image of a pregnant woman in pink 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 pack sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Miralcampo Avenue, 7

Miralcampo Industrial Estate

19200 Azuqueca de Henares.

Guadalajara, Spain

Manufacturer

Liconsa Laboratories,

Miralcampo Avenue, 7

Miralcampo Industrial Estate

19200 Azuqueca de Henares

Guadalajara, Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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 tablets with modified release

Netherlands: Embagyn

Luxembourg: Bonjesta 20/20

Hungary: Vombee 20/20

Date of the last revision of this leaflet:January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).