Bonjesta 20 mg/20 mg modified-release tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Bonjesta 20 mg/20 mg modified-release tablets

doxylamine hydrogen succinate/pyridoxine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

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 adverse 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 20 mg/20 mg modified-release tablets contain two components ("active substances") called: doxylamine succinate and pyridoxine hydrochloride.

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

What Bonjesta is used for

This medicine is used in pregnant women for the treatment of nausea and vomiting. It is used when changes in diet or other non-medicinal 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 taking Bonjesta

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 of this medicine (listed in section 6).
• You are taking medicines for depression called "monoamine oxidase inhibitors" (MAOIs), or have taken MAOIs within the last 14 days.
• You have porphyria (a very rare metabolic disorder).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine if you have ever had:

• Asthma or other respiratory disorders such as chronic bronchitis (persistent inflammation of the bronchi) or pulmonary emphysema (a lung disease that makes breathing difficult).
• Increased eye pressure.
• A condition of the eye called "narrow-angle glaucoma".
• Stomach ulcer.
• Intestinal obstruction between the stomach and the small intestine.
• Blockage in the bladder.
• Liver and/or kidney disease.
• Long QT syndrome (a heart condition).
• Epilepsy.
• Low potassium levels in the blood or other electrolyte imbalances.

Also, speak with your doctor or pharmacist before taking this medicine if:

• You are taking cough or cold medicines, sleep aids, or certain painkillers (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 sun exposure is not recommended during treatment.

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

Be aware of any signs of misuse or dependence on this treatment. Speak with your doctor if you have any substance use disorders (alcohol, medications, or others).

Urine drug screening tests may show "false positive" results for methadone, opioids, and phencyclidine phosphate (PCP) with certain assays when taking this medicine. If this occurs, a more specific test can be performed.

This medicine may cause false negative results in skin tests using allergenic extracts (allergy tests). You should stop taking this medicine several days before undergoing such a test.

Pay attention to the following side effects:

• This medicine may cause drowsiness; do not drive, ride a bicycle, or operate tools or machinery while taking this medicine. Also, avoid other activities requiring full attention unless your doctor tells you otherwise.

• Do not take this medicine if you are also taking cough and cold medicines, sleep aids, certain painkillers, or if you have been drinking alcohol. Taking Bonjesta with other medicines that affect the "central nervous system" may cause excessive drowsiness, increasing the risk of falls or other accidents.

Children and adolescents

Use of this medicine is not recommended 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 may 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 need to take any other medicines. This includes over-the-counter medicines and herbal remedies.

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

• Anticholinergics such as antidepressants or medicines for Parkinson’s disease, monoamine oxidase inhibitors (MAOIs) (used for depression), antipsychotics (medicines for mental disorders), atropine (for spasms), or disopyramide (for certain heart problems), as these may increase toxicity.
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensives (medicines for high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other medicines that cause ototoxicity (ear toxicity), such as carboplatin or cisplatin (cancer treatments), chloroquine (for malaria treatment or prevention), or certain antibiotics (for infections) such as erythromycin or injectable aminoglycosides, as this medicine may mask their toxic effects; therefore, periodic ear examinations are recommended.
• Medicines that reduce elimination of other drugs, such as certain antifungals (terbinafine), certain antidepressants (fluoxetine and fluvoxamine), certain medicines for heart rhythm problems (amiodarone), certain lipid-lowering medicines (gemfibrozil), or certain medicines for gastric ulcers (cimetidine), as they may increase the effect of this medicine.
• Any diuretics (medicines that increase urine output).
• Medicines affecting the heart, such as those used for arrhythmias (heart rhythm problems), certain antibiotics, certain antimalarials, certain antihistamines, certain lipid-lowering medicines (fats in the blood), or certain neuroleptics (medicines for mental disorders).
• Medicines that cause photosensitization reactions (exaggerated skin reaction when exposed to sunlight), such as certain antiarrhythmics (amiodarone, quinidine), certain antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, among others), certain antidepressants (imipramine, doxepin, amitriptyline), certain antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, among others), certain anti-inflammatory medicines (piroxicam, naproxen, among others), certain antivirals (amantadine, ganciclovir), or certain diuretics (furosemide, chlorothiazide), as additive photosensitizing effects may occur.
• Levodopa, as the pyridoxine in this medicine may reduce its effect.
• Medicines for epilepsy (phenobarbital, phenytoin), as pyridoxine may reduce their blood levels.
• Medicines 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 medicine. See section 3 for information on how to take Bonjesta.

Pregnancy and breastfeeding

Bonjesta is indicated for use in pregnant women.

If you are breastfeeding, your doctor will decide whether to discontinue breastfeeding or discontinue the treatment. This is because this medicine may pass into breast milk and harm your baby.

Driving and operating machinery

Do not drive, ride a bicycle, or use tools or machinery while taking this medicine. This is because it may cause drowsiness after taking it. If this occurs, do not perform other activities requiring full attention unless your doctor tells you otherwise.

This medicine contains Allura Red AC (E129), an azo dye which may cause allergic-type reactions.

Bonjesta contains sodium

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

3. How to take Bonjesta

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

Your doctor will start with the lowest dose and may increase it, depending on how the medicine affects 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 nausea and vomiting persist on Day 2, 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 symptom control with intermediate doses of 30 mg/30 mg. This dose cannot be achieved with this medicine. Other formulations of doxylamine succinate/pyridoxine hydrochloride are available that offer greater flexibility in dose adjustment according to the severity of symptoms. With Bonjesta 20 mg/20 mg 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 split the tablets before swallowing.

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

Use in children and adolescents

The use of this medicine is not recommended 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 a hospital immediately. Take the medicine packaging with you. The following effects may occur: restlessness, drowsiness or dizziness, dry mouth, enlarged 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 sudden severe kidney problems. These may even lead to death. If you have these signs, stop taking this medicine and consult your doctor or go immediately to the hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Bonjesta

Do not stop taking this medicine without first consulting your doctor. If you stop taking this medicine suddenly, your nausea and vomiting may return. Your doctor will advise you on how to stop taking this medicine gradually over time to help prevent this.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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-related problems: glaucoma, double vision (diplopia)
• Ringing in the ears (tinnitus)
• Spinning dizziness upon change of posture (when standing 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 disorders such as haemolytic anaemia

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic reaction)
• Feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disoriented
• Headache or migraines
• Tingling, pricking, or numbness of the skin
• Restlessness and need to keep moving
• Vision problems, blurred vision
• Feeling of dizziness
• Difficulty breathing, awareness of heartbeat, or increased heart rate
• Feeling of fullness or bloating, stomach pain, constipation or diarrhoea
• Excessive sweating, skin reactions such as hives or rash
• Difficulty or pain when urinating
• Chest discomfort
• General malaise or irritability
• Difficulty breathing (dyspnoea)

Other adverse effects reported with medicines in the same group as doxylamine

• Anticholinergic effects include (blockade of organ activity receiving nerve impulses via a substance called acetylcholine): dryness of mouth, nose, and throat; difficulty or pain when urinating; sensation of spinning dizziness; vision problems or blurred vision; double vision (diplopia); ringing or noise in the ears (tinnitus); sudden-onset inflammation of the inner ear (acute labyrinthitis); difficulty sleeping (insomnia); spasms (tremors) and nervousness; feeling irritable; involuntary repetitive facial movements (facial dyskinesia). In addition, chest tightness, thick mucus in the chest (bronchial secretions), high-pitched whistling sound often associated with difficulty breathing (wheezing), nasal congestion, sweating, and chills, early menstruation, altered mental state such as hallucinations, delusions, confusion, and disturbed thinking (toxic psychosis), headaches, tingling, pricking, or numbness of the skin, or feeling faint have been reported.
• Rarely, low levels of white blood cells (leucopenia and agranulocytosis), reduced blood due to increased destruction of red blood cells (haemolytic anaemia), reduced blood clotting due to low white blood cells (thrombocytopenia), reduced red blood cells, white blood cells, and blood clotting (pancytopenia), increased appetite, sometimes with weight gain, have been reported.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bonjesta

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a Sigre collection point. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bonjesta

• The active substances are doxylamine hydrogen succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each tablet contains 20 mg of doxylamine hydrogen succinate and 20 mg of pyridoxine hydrochloride.
• The other components are: ammonium hydroxide 28% (E527), carnauba wax, sodium croscarmellose, hypromellose (E464), indigo carmine (E132), iron oxide red, macrogol (3350) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (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 bicarbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171) and triethyl citrate.

Appearance of the product and contents of the pack

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

Marketing Authorization Holder

Exeltis Healthcare, S.L
Avenida de Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara, Spain

Manufacturer

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 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, comprimé à libération modifiée
Italy: Bonjesta
Portugal: Bonjesta
Austria: Xonvea 20 mg/20 mg Tablette mit veränderter Wirkstofffreisetzung
Netherlands: Embagyn
Luxembourg: Bonjesta 20/20
Hungary: Vombee 20/20

Date of the most recent revision of this leaflet: January 2025

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