BONJESTA 20 mg/20 mg Modified-Release Tablets

Зміст інструкції

1. Bonjesta 20 mg/20 mg modified-release tablets
   1. What is Bonjesta and what is it 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. Package contents and other information

Bonjesta 20 mg/20 mg modified-release tablets

doxylamine hydrogen succinate/pyridoxine hydrochloride

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Bonjesta and what is it used for

What is Bonjesta
Bonjesta 20 mg/20 mgmodified-release tablets contain two medicines (“active substances”)
called: “doxylamine succinate hydrogen” and “pyridoxine hydrochloride”.

• Doxylamine succinate hydrogen belongs to a group of medicines called “antihistamines”.
• Pyridoxine hydrochloride is another name for vitamin B6.

What is Bonjesta used for
Bonjesta is used in pregnant women to help them not feel unwell (nausea) and to feel sick
(vomiting). It is used when dietary changes or other non-medicinal treatments have not
worked.
Women suffering from severe nausea and vomiting in pregnancy, a condition called hyperemesis
gravidarum, must be treated by a specialist.

2. What you need to know before taking Bonjesta

Do not take Bonjesta if:

• you are allergic to doxylamine hydrogen 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 suffer from porphyria (a very rare metabolic disorder).

Do not take Bonjesta if any of the above conditions 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 respiratory problems such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (lung condition that makes breathing difficult)
• increased pressure in the eye
• an eye problem 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 (heart condition)
• epilepsy
• low potassium levels in the blood or other electrolyte imbalances.

Talk to your doctor or pharmacist before taking Bonjesta also if:

• you are taking medicines for cough or cold, sleeping pills or certain pain relievers (see also "Other medicines and Bonjesta” below)
• you have drunk alcohol.

If any of the above conditions apply to you (or if you are unsure), talk to your doctor or
pharmacist before taking Bonjesta.
If you suffer from severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, you must
be treated by a specialist.
Bonjesta may increase sensitivity to light, so it is not recommended to be exposed to the sun during
treatment.
Bonjesta may increase dehydration and cause heat stroke due to decreased
sweating.
Be aware of any signs of abuse or dependence on this treatment. If you have any substance use disorder (alcohol, drugs or other) consult your doctor.
If you are taking a test for the detection of abused substances in urine, taking Bonjesta may lead to ‘false positive’ results for methadone, opioids and phencyclidine phosphate (PCP) when certain methods are used for the test. If this happens, a more specific test can be performed.
This medicine can cause false negative results in skin tests where allergen extracts are used (allergy tests). You should stop taking this medicine several days before
performing the test.

Pay attention to side effects

• Bonjesta can cause drowsiness - do not drive, ride a bicycle or use tools or machinery while taking this medicine. Do not do anything else that requires your full attention - unless your doctor tells you it is okay to do so.
• Do not take Bonjesta while taking medicines for cough and cold, sleeping pills, some pain relievers or if you have drunk alcohol. Taking Bonjesta with other medicines that act on the ‘central nervous system’ can make you feel very sleepy - this can cause you to fall or have other accidents.

Children and adolescents
It is not known whether Bonjesta is safe and effective in children under 18 years of age.

Vitamin B
Talk to 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 tell 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 (for the treatment of depression), antipsychotics (medicines for the treatment of mental disorders), atropine for the treatment of spasms or disopyramide (for the treatment of some heart problems) as this may 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 have an effect on the central nervous system such as guanabenz, clonidine or alpha-methyldopa.
• If you are taking other medicines with a toxic effect on the ear, such as carboplatin or cisplatin (for the treatment of cancer), chloroquine (for the prevention and treatment of malaria) and some antibiotics (medicines for the treatment of infections) such as erythromycin or aminoglycosides administered intravenously, as this medicine may mask the toxic effects of such medicines, in which case periodic checks on the auditory system are necessary.
• Medicines that reduce the elimination of other medicines such as some antimycotics (terbinafine), some antidepressants (fluoxetine and fluvoxamine), some medicines for treating 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.
• Some diuretics (medicines that stimulate increased urine production).
• Medicines that can have an effect on the heart such as those used for the treatment of arrhythmias (irregular heartbeat), some antibiotics, some medicines for the treatment of malaria, some antihistamines, some medicines used to reduce lipids (fats) in the blood or some neuroleptics (medicines for the treatment of mental disorders).
• Medicines with a photosensitizing effect (increased reactivity of the skin in case of exposure to sunlight) such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin and erythromycin, to name a few), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorphenamine and diphenhydramine, to name a few), some anti-inflammatory agents (piroxicam and naproxen, to name a few), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide) as it may cause an additional photosensitizing effect.
• Levodopa as pyridoxine contained in this medicine may reduce its effect.
• Medicines for the treatment of epilepsy (phenobarbital, phenytoin) as pyridoxine may reduce their levels in the blood.
• Medicines such as hydroxyzine, isoniazid or penicillamine, as their combination with pyridoxine may cause vitamin B6 deficiency.

Bonjesta with 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 should decide with your doctor whether to stop breastfeeding or stop therapy with this medicine. This is because Bonjesta can 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 sleepy after taking Bonjesta. If this happens, do not perform other activities that require your full attention - unless your doctor tells you that
it is okay to do so.

Bonjestacontains Allura Red AC aluminium lake (E129), an azo dye.

Bonjestacontains Allura Red AC aluminium 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 following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask 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 for you.
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 on Day 2, continue to take 1 tablet every evening before bedtime.
• Day 3
• If you continue to have nausea and vomiting on Day 2, take 1 tablet in the morning and 1 tablet before 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 before bedtime).

Some women may achieve symptom control at intermediate doses of 30 mg/30 mg. This
dose is not achievable with Bonjesta 20 mg/20 mg. Other formulations of doxylamine
succinate/pyridoxine hydrochloride are available that provide greater flexibility to adjust the dose
according to the severity of symptoms. With the Bonjesta 20 mg/20 mg modified-release
tablet formulation, 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 cannot 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 the lack of
clinical data.

If you take more Bonjesta than you should
If you take more Bonjesta than you should, stop taking Bonjesta and contact your doctor or
go to hospital immediately. Bring the medicine packaging with you. The following effects may occur: feeling of agitation, drowsiness or dizziness, dry mouth, larger black
part of the eye (dilated pupils), confusion, increased heart rate.
If the amount of medicine in your body is very high, you may also have convulsions, muscle pain
or weakness or sudden serious kidney problems. These can also lead to death. If
you have these signs – stop taking Bonjesta and contact your doctor or go to hospital
immediately.

If you stop taking Bonjesta
Do not stop taking Bonjesta without consulting your doctor first. If you suddenly stop
taking this medicine, your feeling of sickness (nausea) and your state
of sickness (vomiting) may return. Your doctor will tell you how to slowly stop taking this medicine over time
to avoid these effects.
If you have any further questions on the use of 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
• sensations of dizziness
• feeling tired
• increased bronchial secretion
• dry mouth.

Uncommon:may affect up to 1 in 100 people

• confused state
• problems related to the eyes: glaucoma, double vision (diplopia)
• ringing in the ears (tinnitus)
• dizziness caused by changing position (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, convulsions or agitation
• blood problems such as hemolytic anemia

Not known:frequency cannot be estimated based on available data

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

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

• Anticholinergic effects include (blocking the activity of organs that receive nerve impulses through a substance called acetylcholine): dryness of the mouth, nose and throat; difficulty or pain when urinating; feeling dizzy; problems with vision or blurred vision; double vision (diplopia); ringing or whistling in the ears (tinnitus); inflammation of the inner ear that develops rapidly (acute labyrinthitis); difficulty sleeping (insomnia); tremors and nervousness; feeling irritable; involuntary repetitive movements of the face (facial dyskinesia). In addition, oppression in the chest, thick mucus in the chest (bronchial secretions); a high-pitched whistling often associated with difficulty breathing (wheezing); stuffy nose; sweating and chills; early menstruation; altered mental state such as hallucinations, delusions, confusion and disturbed thoughts (toxic psychosis); headache; tingling, prickling or numbness of the skin; or fainting.
• Low levels of white blood cells (leukopenia and agranulocytosis), reduced blood in the body due to increased destruction of blood cells (hemolytic anemia), decreased platelets (thrombocytopenia), decreased red blood cells, white blood cells and platelets in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been rarely reported.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
about 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 which is stated on the package or blister after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredients 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 ingredients are: ammonium hydroxide 28% (E527), carnauba wax, sodium croscarmellose, hypromellose (E464), aluminium lake indigotine (E132), red iron oxide, macrogol (3350) (E1521), magnesium stearate, magnesium trisilicate, acrylic acid and 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 and package contents

• The modified-release tablets of Bonjesta are pink, round and film-coated with a pink image 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 Authorisation 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 authorised in the Member States of the European Economic Area under the following denominations:
Austria: Xonvea 20 mg/20 mg Tabletten 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