Bonjesta

Package leaflet: Information for the patient

Bonjesta 20 mg/20 mg modified-release tablets

doxylamine hydrogen succinate/pyridoxine hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 20 mg/20 mg modified-release tablets contains two medicines ("active substances") called: "doxylamine hydrogen succinate" and "pyridoxine hydrochloride".

• Doxylamine hydrogen succinate belongs to a group of medicines called "antihistamines".
• Pyridoxine hydrochloride is another name for vitamin B(_6).

What Bonjesta is used for
Bonjesta is used in pregnant women to help relieve discomfort (nausea) and sickness (vomiting). It is used when changes in diet or other non-medicinal treatments have not worked.
Women suffering from severe nausea and vomiting in pregnancy, a condition called hyperemesis gravidarum, should be managed by a specialist.

2. What you need to know before taking Bonjesta

Do not take Bonjesta if:

• you are allergic to doxylamine succinate or to other antihistamines (such as diphenhydramine), 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 within the last 14 days
• you have porphyria (a very rare metabolic disorder).

Do not take Bonjesta if any of the conditions listed above apply to you. If you have any doubts,
consult your doctor, pharmacist, or nurse before taking Bonjesta.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bonjesta if you have previously had:

• asthma or other breathing problems such as chronic bronchitis (persistent inflammation of the bronchi) or pulmonary emphysema (a lung condition that makes breathing difficult)
• increased pressure in the eye
• a condition of the eye called 'narrow-angle glaucoma'
• a stomach ulcer
• a blockage in the intestine, between the stomach and the small intestine
• a 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 talk to your doctor or pharmacist before taking Bonjesta if:

• you are taking cough or cold medicines, sleeping pills, or certain painkillers (also refer to "Other medicines and Bonjesta" below)
• you have consumed alcohol.

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or
pharmacist before taking Bonjesta.
If you suffer from severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, you should be treated by a specialist.
Bonjesta may increase sensitivity to light; therefore, sun exposure is not recommended during treatment.
Bonjesta 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. If you have any substance use disorder (alcohol, drugs, or other), consult your doctor.
If you are undergoing a urine test for substance abuse, taking Bonjesta may lead to 'false positive' results for methadone, opiates, and phencyclidine phosphate (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 tests using allergenic extracts (allergy testing). You should stop taking this medicine several days before undergoing such a test.
Pay attention to side effects

• Bonjesta may cause drowsiness – do not drive, ride a bicycle, or operate tools or machinery while taking this medicine. Do not perform other activities requiring full attention unless your doctor tells you it is safe to do so.
• Do not take Bonjesta while taking cough and cold medicines, sleeping pills, certain painkillers, or after consuming alcohol. Taking Bonjesta together with other medicines that act on the 'central nervous system' may make you very drowsy – this could lead to falls or other accidents.

Children and adolescents
It is not known whether Bonjesta is safe and effective in children under 18 years of age.
Vitamin B
Consult your doctor, pharmacist, or nurse before taking additional vitamin B – this may occur through diet, supplements, or multivitamins.
Other medicines and Bonjesta
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained 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 Parkinson’s disease, monoamine oxidase inhibitors (MAOIs) (for treating depression), antipsychotics (medicines for treating mental disorders), atropine (for treating spasms), or disopyramide (for treating certain heart conditions), as this could increase their toxicity.
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensives (medicines for controlling blood pressure) that affect the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Medicines with ototoxic effects (toxic to the ear), such as carboplatin or cisplatin (for cancer treatment), chloroquine (for prevention and treatment of malaria), and certain antibiotics (medicines for treating infections) such as erythromycin or intravenous aminoglycosides, as this medicine may mask their toxic effects; in such cases, regular hearing checks are necessary.
• Medicines that reduce the elimination of other drugs, such as certain antifungals (terbinafine), certain antidepressants (fluoxetine and fluvoxamine), certain medicines for heart rhythm disorders (amiodarone), certain lipid-lowering medicines (gemfibrozil), or certain medicines for stomach ulcers (cimetidine), as they may increase the effect of this medicine.
• Certain diuretics (medicines that increase urine production).
• Medicines that may affect the heart, such as those used to treat arrhythmias (irregular heartbeat), certain antibiotics, certain antimalarials, certain antihistamines, certain lipid-lowering medicines, or certain neuroleptics (medicines for treating mental disorders).
• Medicines with photosensitizing effects (increased skin reactivity upon exposure to sunlight), such as certain antiarrhythmics (amiodarone, quinidine), certain antibiotics (tetracyclines, fluoroquinolones, azithromycin, and erythromycin, among others), certain antidepressants (imipramine, doxepin, amitriptyline), certain antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, and diphenhydramine, among others), certain anti-inflammatory agents (piroxicam and naproxen, among others), certain antivirals (amantadine, ganciclovir), and certain diuretics (furosemide, chlorothiazide), as they may cause additional photosensitization.
• Levodopa, because the pyridoxine contained in this medicine may reduce its effect.
• Medicines for epilepsy (phenobarbital, phenytoin), because pyridoxine may reduce their blood levels.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, because their combination with pyridoxine may lead to vitamin B6 deficiency.

Bonjesta and alcohol
Do not drink alcohol while taking Bonjesta. See section 3 for information on how to take Bonjesta.
Pregnancy and breastfeeding
Bonjesta is used in pregnant women.
If you are breastfeeding, you and your doctor must decide whether to stop breastfeeding or to stop treatment with this medicine. This is because Bonjesta may pass into breast milk and harm your baby.
Driving and using machines
Do not drive, ride a bicycle, or use tools or machinery while taking this medicine. This is because you may feel drowsy after taking Bonjesta. If this occurs, do not perform other activities requiring full attention unless your doctor tells you it is safe to do so.
Bonjesta contains Allura Red AC aluminum lake (E129), an azo dye.
Bonjesta contains Allura Red AC aluminum lake (E129), which may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. How to take Bonjesta

Take this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
How much to take
Your doctor will start by prescribing a low dose and may increase it—this will depend on how effective the medicine is in your case.
How to start taking Bonjesta and increase the dose if necessary:

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

Some women may achieve symptom control at intermediate doses of 30 mg/30 mg. This dose cannot be achieved with Bonjesta 20 mg/20 mg. Other formulations of doxylamine succinate hydrochloride/pyridoxine hydrochloride are available that provide greater flexibility in dose adjustment according to the severity of symptoms. With the 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

• Take Bonjesta 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 are unable to swallow Bonjesta tablets whole, inform your doctor or pharmacist.

Use in children and adolescents
The use of Bonjesta 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 Bonjesta than you should, stop taking Bonjesta immediately and contact your doctor or go to hospital right away. Take the medicine pack with you. The following effects may occur: feeling restless, drowsiness or dizziness, dry mouth, enlarged black part of the eye (dilated pupils), confusion, rapid heartbeat.
If the amount of medicine in your body is very high, you may also experience seizures, muscle pain or weakness, or sudden severe kidney problems. These may lead to death. If you have any of these symptoms—stop taking Bonjesta immediately and contact your doctor or go to hospital without delay.
If you stop taking Bonjesta
Do not stop taking Bonjesta without first consulting your doctor. If you suddenly stop taking this medicine, your nausea and vomiting may return. Your doctor will advise you on how to gradually discontinue this medicine over time to avoid these effects.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

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

• feeling very sleepy.
  Common: may affect up to 1 in 10 people

• dizziness

• 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)
• dizziness caused by change in posture (upon 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

Not known: frequency cannot be estimated from the available data

• hypersensitivity (allergic reaction)
• feeling of anxiety, difficulty sleeping (insomnia), nightmares, feeling disoriented
• headache or migraine
• tingling, pricking or numbness of the skin
• restlessness and need to move constantly
• vision problems, blurred vision
• feeling dizzy
• difficulty breathing, awareness of heartbeat (palpitations) or increased heart rate
• feeling of fullness or bloating, stomach pain, constipation or diarrhoea
• excessive sweating, skin reactions such as itching or rash
• difficulty or pain when urinating
• chest discomfort
• general discomfort or feeling irritable
• difficulty breathing (dyspnoea)

Other side effects reported with medicines of the same class as doxylamine

• Anticholinergic effects include (blockade of activity in organs receiving nerve impulses via a substance called acetylcholine): dryness of mouth, nose and throat; difficulty or pain when urinating; feeling dizzy; vision problems or blurred vision; double vision (diplopia); ringing or noises in the ears (tinnitus); acute inflammation of the inner ear (acute labyrinthitis); difficulty sleeping (insomnia); 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, delirium, confusion and disturbed thinking (toxic psychosis), headache, tingling, pricking or numbness of the skin, or fainting have been reported.
• Rarely, low levels of white blood cells (leucopenia and agranulocytosis), reduced blood due to increased destruction of blood cells (haemolytic anaemia), reduced platelets (thrombocytopenia), reduced red blood cells, white blood cells and platelets in the blood (pancytopenia), increased appetite, sometimes with weight gain, have been reported.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help 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 carton or blister pack after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bonjesta contains

• 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, croscarmellose sodium, hypromellose (E464), indigo carmine aluminium lake (E132), red iron oxide, macrogol (3350) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (1:1), microcrystalline cellulose, allura red AC aluminium lake (E129), propylene glycol (E1520), partially hydrolysed polyvinyl alcohol, anhydrous colloidal silica, shellac (E904), simethicone, simethicone emulsion, sodium hydrogen carbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.

Description of Bonjesta’s appearance and packaging

• Bonjesta modified-release tablets are pink, round, film-coated tablets 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 pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios Liconsa, S.A.
Avenida Miralcampo 7,
Poligono 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:
Austria: Xonvea 20 mg/20 mg Tablette mit veränderter Wirkstofffreisetzung
Czech Republic: Xonvea 20mg/20mg tablety s řízeným uvolňováním
Estonia: Xonvea 20 mg/20 mg, toimeainet modifitseeritult vabastavad tabletid
France: XONVEA 20 mg/ 20 mg, comprimé à libération modifiée
Hungary: Vombee 20 mg/20 mg módosított hatóanyagleadású tabletta
Ireland: Xonvea MR 20 mg/20 mg modified-release tablets
Italy: Bonjesta 20 mg/20 mg compresse a rilascio modificato
Latvia: Xonvea 20 mg/20 mg modificētās darbības tabletes
Lithuania: Xonvea 20mg /20mg modifikuoto atpalaidavimo tabletės
Luxembourg: Bonjesta 20 mg/20 mg comprimés à libération modifiée
Bonjesta 20 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung
Portugal: Bonjesta 20 mg/20 mg comprimidos de libertação modificada
Slovakia: Xonvea 20 mg/20 mg tablety s riadeným uvoľňovaním
Spain: Bonjesta 20 mg/20 mg comprimidos de liberación modificada
Netherlands: Embagyn 20 mg/20 mg tabletten met gereguleerde afgifte
Belgium: Bonjesta 20 mg/20 mg comprimés à libération modifiée
Bonjesta 20 mg/20 mg tabletten met gereguleerde afgifte
Bonjesta 20 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung
Poland: Bonjesta, 20 mg + 20 mg, tabletki o zmodyfikowanym uwalnianiu