BONJESTA 10 mg/10 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Bonjesta 10 mg/10 mg Gastro-Resistant Tablets

Doxylamine Hydrogen 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. Storage of Bonjesta
6. Contents of the pack and other information

1. What is Bonjesta and what is it used for

What is Bonjesta

Bonjesta contains two active substances called doxylamine hydrogen succinate and pyridoxine hydrochloride:

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

What is Bonjesta 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 you take Bonjesta

Do not take Bonjesta if:

• You are allergic to doxylamine hydrogen 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)
• You are taking medicines known as potent CYP450 isoenzyme inhibitors.
• 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 disorders 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.
• Prolonged QT interval syndrome (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.
• 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, medicines, or others).

In urine drug tests, taking Bonjesta 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:

• Bonjesta 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 Bonjesta 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

Bonjesta is not recommended for use in children under 18 years of age due to the 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 Bonjesta 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 treating cancer), chloroquine (medicine for the treatment or prevention of malaria), and some antibiotics (medicines for treating infections) 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 others, such as azole derivatives or macrolides, as they may increase the effect of this medicine.
• Some diuretics (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 antimalarials, 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 drugs (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 Bonjesta. See section 3 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 Bonjesta 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 can 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.

Bonjesta containsred Allura AC aluminum lacquer (E129)

This medicine may cause allergic reactions because it contains red Allura AC aluminum lacquer (E129).

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it 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 Bonjesta and increase the dose, if necessary:

• Day 1
• • Take 2 tablets at bedtime
• Day 2
• • Take 2 tablets at bedtime
  • If nausea and vomiting improve or are controlled on Day 2, continue taking 2 tablets each night, at bedtime. This will be your usual dose unless your doctor or pharmacist tells you otherwise.
• Day 3
• • If you still have nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
• Day 4
• • If nausea and vomiting improve or are controlled on Day 3, continue taking 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). This will be your usual dose unless your doctor or pharmacist tells you otherwise.
  • If you still have nausea and vomiting on Day 3, take 4 tablets every day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).

Do not take more than 4 tablets per day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).

How to take this medicine

• Take Bonjesta 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 Bonjesta tablets whole, inform your doctor or pharmacist.

Use in children and adolescents

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

If you take more Bonjesta than you should

If you take more Bonjesta 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: feeling of restlessness, sleepiness, or dizziness, dry mouth, enlarged pupils, confusion, rapid heartbeat.

If the amount in your body is very high, you may also experience 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 of Bonjesta, or if you discover that a child has taken it, 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 Bonjesta without consulting your doctor first. If you stop taking this medicine suddenly, you may feel nausea and vomiting again. Your doctor will tell you how to stop taking this medicine slowly, 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, Bonjesta can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• Feeling very sleepy

Common: may affect up to 1 in 10 people

• Feeling dizzy
• Feeling tired
• Dry mouth

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

• Hypersensitivity (allergic reaction)
• Feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disoriented.
• Headache or migraine.
• Numbness, tingling, or numbness of the skin.
• Restlessness and constant need to move.
• Tremors, confusion, seizures, or agitation.
• Vision problems or blurred vision or double vision.
• Ringing in the ears (tinnitus)
• Feeling dizzy
• 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
• Photosensitivity reaction
• Difficulty breathing (dyspnea)
• Blood problems such as hemolytic anemia.
• Dizzy when changing posture
• Increased bronchial secretion
• Weakness
• Swelling of arms and legs.

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; feeling dizzy; vision problems or blurred vision; double vision (diplopia); ringing or noise in the ears (tinnitus); acute inner ear inflammation that develops in a short time (acute labyrinthitis); difficulty sleeping (insomnia); spasms (tremors) and nervousness; feeling irritable; repetitive involuntary facial movements (facial dyskinesia). Additionally, feeling of chest pressure, thick chest mucus (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.
• Rarely, low white blood cell count (agranulocytosis), decreased blood in the body due to increased destruction of blood cells (hemolytic anemia), decreased blood clotting (thrombocytopenia), decreased red, white, and clotting blood cells (pancytopenia), and increased appetite, sometimes with weight gain.

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. Storage of Bonjesta

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Container Content and Additional Information

Bonjesta Composition

• The active ingredients are doxylamine hydrogen succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each tablet contains 10 mg of doxylamine hydrogen succinate and 10 mg of pyridoxine hydrochloride.
• The other components are: carnauba wax, sodium croscarmellose, hypromellose (E464), aluminum lake indigo carmine (E132), macrogol (400, 8000) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid and ethyl acrylate copolymer (1:1), microcrystalline cellulose, aluminum lake red allura AC (E129), polysorbate 80 (E433), propylene glycol (E1520), anhydrous colloidal silica, shellac (E904), simethicone, simethicone emulsion, sodium hydrogen carbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.

Product Appearance and Container Content

• Bonjesta gastro-resistant tablets are white, round, and coated with a film with a pink image of a pregnant woman on one of their faces.
• Bonjesta is available in blister packs containing 10, 20, 30, 40, 50 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Miralcampo Avenue, 7.

Miralcampo Industrial Estate.

19200 Azuqueca de Henares.

Guadalajara.

Spain

Manufacturer

Laboratorios Liconsa.

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 Doxylamine/Pyridoxine Exeltis 10mg/ 10 mg gastro-resistant tablets

Germany XONVEA 10mg/ 10 mg magensaftresistente Tabletten

France XONVEA 10mg/ 10 mg comprimés gastro-résistants

Spain Bonjesta 10 mg/ 10 mg comprimidos gastrorresistentes

Italy Embagyn

Poland XONVEA

Date of the last revision of this leaflet:September 2021

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/)