Leaflet: information for the user

Doxilamina Esteve 12.5 mg film-coated tablets

Hydrogen succinate of doxilamina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improveafter 7 days

1.What is Doxilamina Esteve and for what it is used

2.What you need to know beforestarting totake Doxilamina Esteve

3.How to take Doxilamina Esteve

4.Possible adverse effects

5Storage of Doxilamina Esteve

6.Contents of the package and additional information

Doxilamina Esteve is a medication that contains the active ingredient doxilamina hydrogenosuccinate. Doxilamina belongs to a group of medications called antihistamines, which have sedative properties.

It is indicated for the short-term symptomatic treatment of occasional insomnia in individuals over 18 years old.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Doxilamina Esteve

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to other antihistamines (allergy medications).
• If you are breastfeeding.
• If you have respiratory problems such as asthma, chronic bronchitis (persistent cough producing mucus and phlegm) or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (high eye pressure).
• If you have benign prostatic hyperplasia (abnormal enlargement of the prostate), bladder neck obstruction (urinary tract disease) or difficulty urinating.
• If you have gastric or intestinal wall erosion or pyloric duodenal obstruction (difficulty passing food from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors.
• If you are taking medications such as antidepressants, certain antibiotics, medications affecting the heart, such as those used to treat arrhythmias, certain antivirals and medications used to treat fungal infections, some medications that reduce blood lipid content or quinidine (a medication used to treat seizures).
• If you have severe kidney or liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxilamina Esteve.

You should consult a doctor before taking this medication if you have:

• Mild to moderate liver and kidney function impairment, as the dose may need to be adjusted.
• Epilepsy (in some cases, antihistamines can cause hyperexcitability and may therefore reduce the seizure threshold).
• Prolonged QT interval (a heart problem that causes a sudden change in heart rate during exercise or in stressful situations).
• Low potassium levels in the blood or other electrolyte imbalances.
• Heart disease and high blood pressure.

• If you experience daytime somnolence, you may need to reduce the dose or take it earlier to ensure at least 8 hours pass before waking up.
• If you are taking other medications that can cause ototoxicity, such as carboplatin or cisplatin (cancer medications), chloroquine (malaria treatment or prevention medication) and certain antibiotics, such as erythromycin or injected aminoglycosides, among others, Doxilamina Esteve may mask the toxic effects of these medications, so you should regularly check your ear status.
• Doxilamina Esteve may exacerbate dehydration and heatstroke symptoms due to decreased sweating, especially in hot weather.
• You should avoid consuming alcoholic beverages during treatment.
• If you are over 65 years old, you may be more susceptible to side effects. Therefore, pay attention to the treatment effects (see section 4).
• You should avoid consuming grapefruits while taking doxilamina.
• You should avoid taking medications such as phenytoin, digoxin, warfarin, lithium, aminoglycosides and vancomycin with doxilamina, as they may cause acute intoxication.

Do not administer Doxilamina Esteve for periods of more than 7 days, unless your doctor recommends it.

Children and adolescents

Do not recommend the administration of Doxilamina Esteve to children under 18 years old.

Taking Doxilamina Esteve with other medications

Inform your doctor or pharmacist that you are taking, have taken recently or may need to take any other medication.

Do not take Doxilamina Esteve with the following medications:

• Monamine oxidase inhibitors (e.g., medications used to treat depression, Parkinson's disease or other diseases, such as moclobemide, phenelzine and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline and selegiline).
• Medications affecting the heart, such as those used to treat arrhythmias (amiodarone), some macrolide antibiotics (clarithromycin, erythromycin and telithromycin), certain medications used to reduce blood lipid content (gemfibrozil), some medications used to treat depression (antidepressants such as fluoxetine, fluvoxamine, paroxetine or bupropion), antiviral protease inhibitors (indinavir, ritonavir and telaprevir) and aloe antimycotics (fluconazole, ketoconazole and itraconazole).

You should avoid taking Doxilamina Esteve with the following medications, as they may potentiate its action or adverse effects:

• Epinephrine (for treating low blood pressure).
• Certain medications for treating malaria or some antihistamines.
• Some diuretics (medications that increase urine elimination).
• Alcohol or other central nervous system depressants, such as barbiturates, hypnotics, sedatives, other sleep or anxiety medications (alprazolam, diazepam and zolpidem), opioid analgesics (codeine), psychiatric medications (clozapine, risperidone, amitriptyline and trazodone) or procarbazine.
• Antihypertensive medications with central nervous system effects, such as guanabenz, clonidine or alpha-methyldopa.
• Other anticholinergic medications, such as neurolleptics (medications for treating mental disorders), medications for treating spasms (e.g., atropine and belladonna alkaloids) or disopyramide (for treating certain heart problems).
• Topical antihistamines (such as creams, ointments or aerosols containing diphenhydramine) and scopolamine.
• Medications with a narrow therapeutic index (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides and vancomycin).

Interference with diagnostic tests

Doxilamina may interfere with skin allergy tests that use allergens. It is recommended to discontinue Doxilamina Esteve treatment at least three days before starting these tests.

Taking Doxilamina Esteve with food, drink and alcohol

Do not consume alcoholic beverages during Doxilamina Esteve treatment.

See section 3. How to take Doxilamina Esteve

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There are no adequate data on the use of doxilamina in pregnant women, so you should avoid taking Doxilamina Esteve during pregnancy.

Due to the risks associated with administering antihistamines to young children, women who are breastfeeding should not take Doxilamina Esteve.

There are no data on the possible effects of Doxilamina Esteve on human fertility.

Driving and operating machinery

The influence of Doxilamina Esteve on the ability to drive and operate machinery is important, as it causes drowsiness. Do not drive or operate hazardous machinery while taking this medication, at least during the first few days of treatment until you know how it affects you.

Doxilamina Esteve contains Red 33 Lake.

This medication may cause allergic reactions because it contains Red 33 Lake. It may cause asthma, especially in patients allergic to aspirin.

Doxilamina Esteve contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults (18 years and older)

The recommended dose is 1 to 2 tablets (12.5 mg to 25 mg) per day, taken 30 minutes before bedtime.

If daytime somnolence occurs, it is recommended to reduce the dose to 1 tablet (12.5 mg) or take it earlier to ensure at least 8 hours pass before waking up.

Do not take more than 2 tablets (25 mg) per day.

Use in the elderly

People over 65 years are more prone to other pathologies that may recommend a dose reduction. The initial recommended dose is 12.5 mg (1 tablet), taken 30 minutes before bedtime. The dose can be increased to 25 mg (2 tablets) if the initial dose does not sufficiently alleviate insomnia. In case of appearance of undesirable side effects, the dose will be 1 tablet (12.5 mg) per day. For this reason, pay attention to the effect caused by the treatment (see section 4).

Use in patients with liver or kidney disease

In patients with renal or hepatic insufficiency, it is recommended to reduce the dose to a maximum daily intake of 12.5 mg.

Use in children and adolescents

Doxilamina Esteve is not recommended for use in minors under 18 years, so the medication should not be used in this population.

Route and method of administration

Oral route.

The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).

Doxilamina Esteve can be taken before or after meals.

Duration of treatment

The duration of treatment should be as short as possible. In general, the duration of treatment can range from a few days to a week.

It should not be administered for a period exceeding 7 days, unless the doctor advises taking it for a longer period.

If you take more Doxilamina Esteve than you should

If you take more Doxilamina Esteve than you should, consult your doctor or pharmacist immediately.

The symptoms of an overdose are: somnolence, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), redness, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations.

Severe intoxication can cause delirium, psychosis, decreased blood pressure, seizures, decreased respiration, loss of consciousness, and coma, and may pose a risk to life.

A severe complication can be rhabdomyolysis (muscle injury), followed by renal failure.

There is no specific antidote for antihistamine overdose, so treatment is symptomatic and supportive. Your doctor will evaluate the need to induce vomiting, perform a gastric lavage, or prescribe medications to increase blood pressure if necessary.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91.562.04.20.

If you forget to take Doxilamina Esteve

Do not take a double dose to compensate for the missed doses.

Take your dose at the usual time the next day.

If you interrupt treatment with Doxilamina Esteve

If you have any other doubts about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of doxilamine are generally mild and transient, being more frequent in the first days of treatment.

Very common side effects (may affect more than 1 in 10 people): drowsiness.

Common side effects (may affect up to 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, upper abdominal pain, fatigue, insomnia, and nervousness.

Rare side effects (may affect up to 1 in 100 people): asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to changes in posture), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (breathing difficulties).

Rare side effects (may affect up to 1 in 1,000 people): agitation (especially in the elderly), tremor, convulsions, or blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (decrease in certain blood cells).

Side effects of unknown frequency (cannot be estimated from available data): general malaise.

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxilamine, are the following:arrhythmia (alteration of heart frequency), palpitations, gastroesophageal reflux, abnormal liver function (jaundice), prolonged QT interval on the electrocardiogram (a cardiac alteration), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (sensory-motor coordination), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).

The frequency and magnitude of side effects may be reduced by decreasing the daily dose.

People over 65 years old have a higher risk of experiencing adverse reactions, as they may have other underlying diseases or be taking other medications simultaneously. These individuals also have a higher risk of experiencing a fall.

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus.

Adverse Effect Notification

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box or blister packafter CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment..

Composition of Doxilamina Esteve

• The active ingredient is doxylamine succinate. Each tablet contains 12.5 mg of doxylamine hydrochloride.
• The other componentsare:

Core excipients:

Calcium dihydrogen phosphate (E-341)

Microcrystalline cellulose (E-460)

Sodium carboxymethyl starch (type A) from potato

Anhydrous colloidal silica (E-551)

Magnesium stearate (E-572)

Coating excipients:

Microcrystalline cellulose (E-460)

Macrogol-40 stearate type I (E-431)

Propylene glycol (E-1520)

Hydroxypropyl methylcellulose (E-464)

Titanium dioxide (E-171)

Red C (E-124)

Macrogol 400

Macrogol 6000

Appearance of the product and content of the container

Doxilamina Esteve is presented in the form of coated tablets with a pink elongated film, in a container containing 7 or 14 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Responsible for manufacturing

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona) Spain

This medicine is authorized in the member states of the European Economic Area with the following names;

Finland: Dormix

Norway: Zonat

Sweden: Zovin

Revision date of this leaflet: December 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/