Embagen

Package leaflet: Information for the patient

Embagyn 10 mg/10 mg gastro-resistant tablets

doxylamine hydrogen succinate/pyridoxine hydrochloride
Please read 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, consult your doctor or pharmacist.
• 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Embagyn is and what it is used for

What Embagyn is
Embagyn 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 B₆.

What Embagyn is used for
Embagyn 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 during pregnancy, a condition called hyperemesis gravidarum, should 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 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)
• 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 any 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) or pulmonary emphysema (a lung disease that makes breathing difficult)
• increased pressure in the eye
• a condition of the eye called 'narrow-angle glaucoma'
• a gastric ulcer
• a blockage 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 consult your doctor or pharmacist before taking Embagyn if:

• you are taking cough or cold medicines, sleeping pills, or certain painkillers
• 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 Embagyn.
If you suffer from severe nausea and vomiting in pregnancy, a condition called hyperemesis gravidarum, you must be treated by a specialist.
Embagyn may increase light sensitivity, therefore sun exposure during treatment is not recommended.
Embagyn may increase dehydration and cause heat stroke due to reduced sweating.
Be aware of any signs of abuse or dependence on this treatment. If you have any substance use disorder (alcohol, drugs, or others), consult your doctor.
If you are undergoing a urine test for drug abuse, taking Embagyn 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 tests). You must stop taking this medicine several days before undergoing such a test.
Pay attention to side effects

• Embagyn 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 either – unless your doctor tells you it is safe to do so.
• Do not take Embagyn while taking cough and cold medicines, sleeping pills, certain painkillers, or if you have consumed alcohol. Taking Embagyn 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
The use of Embagyn is not recommended in children under 18 years of age due to 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
Inform 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 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 to control blood pressure) that act on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Other medicines that are ototoxic (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 could mask the toxic effects of these drugs; in such cases, regular hearing checks are necessary.
• Medicines that reduce the elimination of other active substances, such as azole or macrolide derivatives, as they could enhance 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 antimalarial medicines, certain antihistamines, certain lipid-lowering medicines (to reduce fats in the blood), 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), certain antidepressants (imipramine, doxepin, amitriptyline), certain antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, and diphenhydramine), certain anti-inflammatory agents (piroxicam and naproxen), certain antivirals (amantadine, ganciclovir), and certain diuretics (furosemide, chlorothiazide), as they may cause additional photosensitizing effects.
• Levodopa, as the pyridoxine contained in this medicine may reduce its effect.
• Medicines for the treatment of epilepsy (phenobarbital, phenytoin), as pyridoxine may reduce their blood levels.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, as their combination with pyridoxine may cause vitamin B6 deficiency.

Embagyn and 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 must decide with your doctor whether to stop breastfeeding or stop treatment with this medicine. This is because Embagyn 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 Embagyn. If this happens, do not perform other activities requiring your full attention – unless your doctor tells you it is safe 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 exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
Your doctor will start by prescribing a low dose, which may be increased later – this will depend on how effective
the medicine is in your case.
How to start taking Embagyn and increase the dose if necessary:

• Day 1
• Take 2 tablets orally before going to bed.
• Day 2
• Take 2 tablets orally before going to bed.
• If nausea and vomiting improve or are controlled by Day 2, continue taking 2 tablets every evening before going to bed. This will be your usual dose, unless your doctor or pharmacist advises 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 before going to bed).
• Day 4
• If nausea and vomiting improve or are controlled by Day 3, continue taking 3 tablets daily (1 tablet in the morning and 2 tablets before going to bed). This will be your usual dose, unless your doctor or pharmacist advises otherwise.
• If you still have nausea and vomiting on Day 3, take 4 tablets daily (1 tablet in the morning, 1 tablet in the mid-afternoon, and 2 tablets before going to bed). Do not take more than 4 tablets per day (1 in the morning, 1 in the mid-afternoon, and 2 before going to bed).
  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 split the tablets before swallowing. If you are unable to swallow Embagyn tablets whole, inform 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 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. 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, increased heart rate.
If the amount of medicine 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 experience these symptoms – stop taking this medicine and contact your doctor or go to hospital immediately.
If you stop taking Embagyn
Do not stop taking Embagyn without first consulting your doctor. If you suddenly stop taking this medicine, your feeling of discomfort (nausea) and vomiting may return. Your doctor will advise you on how to gradually stop taking this medicine over time to avoid these effects.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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
• dry mouth. Not known: frequency cannot be estimated from the available data
• hypersensitivity (allergic reaction)
• feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disoriented
• headache or migraine
• tingling, itching or numbness of the skin
• restlessness and need to keep moving
• tremors, confusion, seizures or agitation
• vision problems, blurred vision or double vision
• ringing in the ears (tinnitus)
• dizziness
• breathing difficulties, 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 malaise or feeling irritable
• photosensitivity reactions
• breathing difficulties (dyspnoea)
• blood disorders such as haemolytic anaemia
• dizziness caused by change in posture
• increased bronchial secretion
• weakness
• swelling of arms and legs

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

• Anticholinergic effects include (blockade of organ activity receiving nerve impulses through a substance called acetylcholine): dryness of mouth, nose and throat; difficulty or pain when urinating; dizziness; vision problems or blurred vision; double vision (diplopia); ringing or noises in the ears (tinnitus); sudden 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 breathing difficulties (wheezing); nasal congestion; sweating and chills; early menstruation; altered mental state such as hallucinations, delirium, confusion and disturbed thinking (toxic psychosis); headache; tingling, itching or numbness of the skin; or fainting have been reported.
• Rarely, low white blood cell count (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 experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 Embagyn

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 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 Embagyn contains

• The active substances 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), indigo carmine 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), simethicone, simethicone emulsion, sodium hydrogen carbonate (E500), sodium lauryl sulfate (E487), talc (E553b), titanium dioxide (E171), triethyl citrate.

Description of the appearance of Embagyn and contents of the pack

• Embagyn gastro-resistant tablets are white, round, film-coated tablets 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 European Economic Area countries under the following names:
Ireland Doxilamina/Piridossina 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