DOXILAMINE ESTEVE 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Doxilamina Esteve 12.5 mg Film-Coated Tablets

Doxilamine Hydrogen Succinate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What Doxilamina Esteve is and what it is used for
2. What you need to know before taking Doxilamina Esteve
3. How to take Doxilamina Esteve
4. Possible side effects

5. Storage of Doxilamina Esteve

1. Package Contents and Additional Information

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

Doxilamina Esteve is a medication that contains the active ingredient doxilamine hydrogen succinate. Doxilamine 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 adults over 18 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Doxilamina Esteve

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 (anti-allergic medications).
• If you are breastfeeding.
• If you have respiratory disorders such as asthma, chronic bronchitis (persistent cough that produces sputum and mucus) or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (high eye pressure)
• If you have prostatic hypertrophy (abnormal enlargement of the prostate), vesical neck obstruction (disease of the urinary tract) or difficulty urinating.
• If you have stomach or intestinal erosion or pyloroduodenal 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 that affect the heart, such as those used to treat arrhythmias, certain antivirals, and medications intended to treat fungal infections, some medications that reduce lipid content (fats) in the blood, or quinidine (a medication used to treat convulsions).
• 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 (antihistamines can sometimes cause hyperexcitability and may therefore reduce the convulsive threshold)
• QT interval prolongation (a heart problem that causes a sudden change in heart rate when exercising or under stress)
• low potassium levels in the blood or other electrolyte disturbances
• heart disease and high blood pressure

• If you experience daytime drowsiness, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass until waking time.
• If you are taking other medications that can cause ear toxicity, such as carboplatin or cisplatin (medications for treating cancer), chloroquine (medication for treating or preventing malaria), and some antibiotics (medications for treating infections), such as erythromycin or injectable aminoglycosides, among others, Doxilamina Esteve may mask the toxic effects of these medications, so you should periodically review the condition of your ears.
• Doxilamina Esteve can worsen dehydration and heat stroke symptoms due to decreased sweating, especially in hot weather.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to experiencing side effects. For this reason, pay attention to the effects of treatment (see section 4).
• Grapefruit consumption should be avoided while taking doxilamine.
• Medications such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin should not be taken with doxilamine, as they can cause acute intoxication.

Doxilamina Esteve should not be administered for periods of more than 7 days, unless the doctor considers it advisable.

Children and Adolescents

Doxilamina Esteve is not recommended for use in children under 18 years of age.

Taking Doxilamina Esteve with Other Medications

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

Do not take Doxilamina Esteve in combination with the following medications:

• Monoamine oxidase inhibitors (e.g., medications used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, and tranylcypromine, isocarboxazid, linezolid, methyl blue, procarbazine, rasagiline, and selegiline).
• Medications that affect the heart, such as those used to treat arrhythmias (amiodarone), certain macrolide antibiotics (clarithromycin, erythromycin, and telithromycin), certain medications used to reduce lipids (fat) in the blood (gemfibrozil), certain medications used to treat depression (antidepressants such as fluoxetine, fluvoxamine, paroxetine, or bupropion), antiviral protease inhibitors (indinavir, ritonavir, and telaprevir), and azole antimycotics (fluconazole, ketoconazole, and itraconazole).

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

• Epinephrine (for treating low blood pressure).
• Certain medications for treating malaria or some antihistamines.
• Certain diuretics (medications that increase urine elimination).
• Alcohol or other central nervous system depressants, e.g., barbiturates, hypnotics, sedatives, other sleep or anxiety medications (alprazolam, diazepam, and zolpidem), opioid analgesics (codeine), psychiatric medications (clopromazine, risperidone, amitriptyline, and trazodone), or procarbazine.
• Antihypertensives (medications for treating high blood pressure) with an effect on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medications, such as neuroleptics (medications for treating mental disorders), medications for treating spasms (e.g., atropine and belladonna alkaloids), or disopyramide (for treating certain heart problems).
• Antihistamines applied to the skin (such as diphenhydramine cream, ointment, or spray) and scopolamine.
• Medications where the difference between the therapeutic dose and the toxic dose is very small (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin).

Interference with Diagnostic Tests

Doxilamine may interfere with skin allergy tests using allergens. It is recommended to discontinue treatment with Doxilamina Esteve at least three days before starting such tests.

Taking Doxilamina Esteve with Food, Drink, and Alcohol

Alcoholic beverages should not be consumed during treatment with Doxilamina Esteve.

See section 3. How to Take Doxilamina Esteve

Pregnancy, Breastfeeding, and Fertility

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

There are no adequate data on the use of doxilamine in pregnant women, so Doxilamina Esteve should be avoided during pregnancy.

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

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

Driving and Using Machines

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

Doxilamina Esteve Contains Cochineal Red A

This medication may cause allergic reactions because it contains cochineal red A. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Doxilamina Esteve Contains Sodium

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

3. How to Take Doxilamina Esteve

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

Adults (Over 18 Years Old)

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

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

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

Use in the Elderly

People over 65 years old are more likely to suffer from other conditions that may recommend a dose reduction. The recommended initial dose is 12.5 mg (1 tablet), administered 30 minutes before bedtime. The dose can be increased to 25 mg (2 tablets) if the initial dose does not sufficiently relieve insomnia. In case of unwanted 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 mild renal or hepatic impairment, 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 children under 18 years of age, 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: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations.

Severe overdose can cause delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, and coma, and can be life-threatening.

A serious complication can be rhabdomyolysis (muscle damage), followed by kidney failure.

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91.562.04.20.

If You Forget to Take Doxilamina Esteve

Do not take a double dose to make up for forgotten 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 this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences 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, abdominal pain, fatigue, insomnia, and nervousness.

Uncommon 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 postural changes), 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), tremors, convulsions, or blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, 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 rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic 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), affectation of psychomotor activities (sense-movement 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 can 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 diseases or may be taking other medications simultaneously. These people also have a higher risk of falling.

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

Reporting Side Effects

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

5. Storage of Doxilamina Esteve

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box or blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Doxilamine Esteve

• The active ingredient is doxilamine succinate. Each tablet contains 12.5 mg of doxilamine hydrogen succinate.
• The other components are:

Core excipients:

Dihydrate calcium hydrogen phosphate (E-341)

Microcrystalline cellulose (E-460)

Sodium carboxymethyl starch (type A) of 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)

Hypromellose (E-464)

Titanium dioxide (E-171)

Cochineal red A (E-124)

Macrogol 400

Macrogol 6000

Appearance of the Product and Packaging Content

Doxilamine Esteve is presented in the form of film-coated, elongated pink tablets, in a package containing 7 or 14 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Manufacturer

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona) Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Dormix

Norway: Zonat

Sweden: Zovin

Date of the last revision of this leaflet: December 2020.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/