EMBAGYN 10 mg/10 mg Enteric-Coated Tablets

Зміст інструкції

1. Embagyn 10 mg/10 mg gastro-resistant tablets
   1. What is Embagyn and what is it used for
   2. What you need to know before taking Embagyn
   3. How to take Embagyn
   4. Possible side effects
   5. How to store Embagyn
   6. Package Contents and Other Information

Embagyn 10 mg/10 mg gastro-resistant 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Embagyn and what is it used for

What is Embagyn
Embagyn contains two medicinal products (“active substances”) called: “doxilamine hydrogen succinate” and
“pyridoxine hydrochloride”.

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

What is Embagyn used for
Embagyn 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 during pregnancy, a condition called hyperemesis
gravidarum, must be treated by a specialist.

2. What you need to know before taking Embagyn

Do not take Embagyn 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)
• you are taking medicines known as ‘potent inhibitors of CYP450 isoenzymes’
• you suffer from porphyria (a very rare metabolic disorder).

Do not take Embagyn if any of the above conditions apply to you. If you have doubts,
consult your doctor or pharmacist before taking Embagyn.

Warnings and precautions
Consult your doctor or pharmacist before taking Embagyn if you have previously had:

• asthma or other respiratory problems such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a lung condition that makes breathing difficult)
• increased pressure in the eye
• an eye problem called ‘narrow-angle glaucoma’
• a gastric ulcer
• a blockage in the intestine, between the stomach and the small intestine
• a blockage in the bladder
• liver and/or kidney diseases
• long QT syndrome (a heart condition)
• epilepsy
• low potassium levels in the blood or other electrolyte imbalances.

Consult your doctor or pharmacist before taking Embagyn also if:

• you are taking medicines for cough or cold, sleeping pills or certain painkillers
• you have drunk alcohol.

If any of the above conditions apply to you (or if you have doubts), consult your doctor or pharmacist before taking Embagyn.
If you suffer from severe nausea and vomiting during pregnancy, a condition called hyperemesis gravidarum, you must
be treated by a specialist.
Embagyn may increase sensitivity to light, so it is not recommended to expose yourself to the sun during
treatment.
Embagyn may increase dehydration and cause heatstroke 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 Embagyn may
lead to ‘false positive’ results for methadone, opioids and phencyclidine phosphate (PCP) when
certain test methods are used. 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

• Embagyn 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 Embagyn while taking medicines for cough and cold, sleeping pills, some painkillers or if you have drunk alcohol. Taking Embagyn 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
The use of Embagyn is not recommended in children under 18 years of age due to the lack of
clinical data.

Vitamin B
Consult your doctor or pharmacist before taking additional vitamin B – this may occur
through diet, supplements or multivitamins.

Other medicines and Embagyn
Tell your doctor or pharmacist 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 Embagyn 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, for example, as this medicine may mask the toxic effects of such medicines; in this case, periodic checks on the auditory apparatus are necessary.
• Medicines that reduce the elimination of other active ingredients such as azole derivatives or macrolides, as they may potentiate 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, for example), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorphenamine and diphenhydramine, for example), some anti-inflammatory agents (piroxicam and naproxen, for example), 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.

Embagyn with alcohol
Do not drink alcohol while taking Embagyn. See section 3 for information on how
to take Embagyn.

Pregnancy and breastfeeding
Embagyn 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 Embagyn can 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 you may feel sleepy after taking Embagyn. If this happens
do not perform other activities that require your full attention - unless your doctor tells you it is okay to do so.
Embagyn contains Allura Red AC aluminium lake (E129)
Embagyn contains 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 Embagyn

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

How much to take
The doctor will start by prescribing a low dose and may increase it – this will depend on the effectiveness
of the medicine in your case.
How to start taking Embagyn and increase the dose, if necessary:

• Day 1
• Take 2 tablets, by mouth before bedtime.
• Day 2
• Take 2 tablets, by mouth before bedtime.
• If on Day 2 nausea and vomiting improve or are controlled, continue to take 2 tablets every evening before bedtime. This will be your usual dose, unless your doctor or pharmacist tells you otherwise.
• Day 3
• If you continue to have nausea and vomiting on Day 2, take 3 tablets, by mouth on Day 3 (1 tablet in the morning and 2 tablets before bedtime).
• Day 4
• If on Day 3 nausea and vomiting improve or are controlled, continue to take 3 tablets every day (1 tablet in the morning and 2 tablets before bedtime). This will be your usual dose, unless your doctor or pharmacist tells you otherwise.
• If you continue to have nausea and vomiting on Day 3, take 4 tablets, by mouth every day (1 tablet in the morning, 1 tablet in the mid-afternoon, and 2 tablets before bedtime). Do not take more than 4 tablets a day (1 in the morning, 1 in the mid-afternoon, and 2 before bedtime). How to take this medicine
• Take Embagyn on an empty stomach.
• Swallow the tablet whole with a glass of water.
• Do not crush, chew or divide the tablets before swallowing. If you cannot swallow Embagyn tablets whole, tell your doctor or pharmacist.

Use in children and adolescents
The use of Embagyn is not recommended in children under 18 years of age due to the lack
of clinical data.

If you take more Embagyn than you should
If you take more medicine than you should, stop taking this medicine and contact your
doctor or go to hospital immediately. Bring the packaging of the medicine 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 this medicine and contact your doctor or
go to hospital immediately.

If you stop taking Embagyn
Do not stop taking Embagyn without consulting your doctor first. If you suddenly stop
taking this medicine, your feeling of unwellness (nausea) and
vomiting may return. The doctor will tell you how to slowly stop taking
this medicine over time to avoid these effects.
If you have any 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

• feeling very sleepy. Common:may affect up to 1 in 10 people
• feelings of dizziness
• feeling tired
• dry mouth. Not known:the 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
• tremors, confused state, convulsions or agitation
• problems with vision or blurred vision or double vision
• ringing in the ears (tinnitus)
• 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
• photosensitivity reactions
• difficulty breathing (dyspnea)
• blood problems such as hemolytic anemia
• dizziness caused by a change in posture
• increased bronchial secretion
• weakness
• swelling of arms and legs

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

• 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 quickly (acute labyrinthitis); difficulty sleeping (insomnia); tremors and nervousness; feeling irritable; involuntary repetitive movements of the face (facial dyskinesia). In addition, a feeling of tightness in the chest, thick mucus in the chest (bronchial secretions); a high-pitched whistling often associated with difficulty breathing (wheezing); nasal congestion; 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 have been reported.
• Rarely, low levels of white blood cells (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 reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 on the safety of
this medicine.

5. How to store Embagyn

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 Embagyn contains

• 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 ingredients are: carnauba wax, sodium croscarmellose, hypromellose (E464), indigotine aluminium lake (E132), macrogol (400, 8000) (E1521), magnesium stearate, magnesium trisilicate, methacrylic acid-ethyl acrylate copolymer (1:1), microcrystalline cellulose, allura red AC aluminium lake (E129), polysorbate 80 (E433), propylene glycol (E1520), anhydrous colloidal silica, shellac (E904), simeticone, simeticone emulsion, sodium hydrogen carbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.

Description of Embagyn’s appearance and package contents

• The gastro-resistant tablets of Embagyn are white, round, film-coated, with a pink image of a pregnant woman on one side.
• Embagyn is available in packs with blisters containing 10, 20, 30, 40, 50 or 60 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 with the
following denominations:
Ireland Doxilamine/Pyridoxine Exeltis 10mg/ 10 mg gastro-resistant tablets
Germany XONVEA 10mg/ 10 mg magensaftresistente Tabletten
France XONVEA 10mg/ 10 mg comprimés gastro-résistants
Spain XONVEA 10mg/ 10 mg comprimidos gastroresistentes
Italy Embagyn
Poland XONVEA