Doxylamine Aurovitas 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxilamina Aurovitas 25 mg film-coated tablets

doxylamine, hydrogen succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult a doctor if you get worse or do not improve after 7 days.

Contents of the leaflet:

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

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

Doxilamina Aurovitas is a medicine that contains the active substance doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines which have sedative properties.

This medicine is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age.

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

2. What you need to know before taking Doxilamina Aurovitas

Do not take Doxilamina Aurovitas

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antihistamines (antiallergic medicines).
• If you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxilamina Aurovitas.

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

• impaired liver or kidney function.
• epilepsy.
• QT interval prolongation (a heart condition).
• low blood potassium levels or other electrolyte imbalances.
• heart disease or high blood pressure.
• asthma, chronic bronchitis (persistent inflammation of the bronchi), or pulmonary emphysema (a lung disease that makes breathing difficult).
• glaucoma (increased pressure in the eye).
• urinary retention.
• benign prostatic hyperplasia (abnormal enlargement of the prostate).
• peptic ulcer (erosion of the stomach or duodenal wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or vesical neck obstruction (a urinary tract disorder).

If you experience daytime drowsiness, it may be necessary to reduce the dose or take the medicine earlier to ensure at least 8 hours pass before waking time.

Alcoholic beverages must be avoided during treatment.

If you are over 65 years of age, you may be more susceptible to side effects.

Doxilamina Aurovitas may worsen symptoms of dehydration and heat stroke due to reduced sweating.

Other medicines and Doxilamina Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Doxilamina Aurovitas together with the following medicines, as their effects may be increased:

• epinephrine (used to treat low blood pressure);
• medicines affecting the heart such as those used to treat arrhythmias, certain antibiotics, some antimalarial drugs, certain antihistamines, certain lipid-lowering agents (fats in the blood), or certain neuroleptics (medicines used to treat mental disorders);
• medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, which could increase the effect of Doxilamina Aurovitas;
• certain diuretics (medicines that increase urine output);
• central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, or procarbazine);
• antihypertensives (medicines for high blood pressure) with central nervous system effects such as guanabenz, clonidine, or methyldopa;
• other anticholinergic drugs such as medicines used to treat depression or Parkinson’s disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), antiparkinsonian anticholinergics for treating spasms, or disopyramide (used for certain heart conditions);
• if you are taking other medicines that cause ototoxicity (ear toxicity), such as carboplatin or cisplatin (cancer treatments), chloroquine (for prevention or treatment of malaria), or certain antibiotics (for treating infections) such as erythromycin or injected aminoglycosides; Doxilamina Aurovitas may mask the toxic effects of these medicines, so you should have your hearing checked regularly.

Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to stop treatment with Doxilamina Aurovitas at least three days before undergoing such tests.

Taking Doxilamina Aurovitas with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with Doxilamina Aurovitas.

See section 3. How to take Doxilamina Aurovitas.

Pregnancy, breastfeeding, and fertility

Do not take Doxilamina Aurovitas if you are pregnant, planning to become pregnant, or breastfeeding.

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

Driving and using machines

The effect of Doxilamina Aurovitas on the ability to drive and operate machinery is significant. Do not drive or operate dangerous machinery while taking this medicine, at least during the first few days of treatment, until you know how it affects you.

Sodium content

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

3. How to take Doxylamine Aurovitas

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults (over 18 years of age)

The recommended dose is 1 tablet (25 mg) per day.

If daytime drowsiness occurs, it is recommended to reduce the dose to half a tablet (12.5 mg) per day, or to take the dose earlier to ensure at least 8 hours elapse before waking time.

Do not take more than 1 tablet (25 mg) per day.

Use in patients over 65 years of age

Patients over 65 years are more likely to have other medical conditions that may require a dose reduction. If unwanted adverse effects occur, it is recommended to reduce the dose to half a tablet (12.5 mg) per day.

Use in patients with liver or kidney disease

These patients require a different dose, adjusted according to the severity of their condition, which will be determined by the physician.

Use in children and adolescents

Doxylamine Aurovitas is not recommended for use in individuals under 18 years of age and should not be used in this population.

Route and method of administration

Oral use.

The tablet may be divided into equal doses.

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

Doxylamine Aurovitas may be taken with or without food.

Duration of treatment

Treatment duration should be as short as possible. In general, treatment may last from a few days up to one week.

Do not use for longer than 7 days without consulting your doctor.

If you take more Doxylamine Aurovitas than you should

Symptoms of overdose include: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or irregular heart rate, elevated blood pressure, nausea, vomiting, agitation, impaired gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, decreased blood pressure, seizures, reduced respiration, loss of consciousness, coma, and death may occur. A serious complication may be rhabdomyolysis (muscle damage), followed by renal failure.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Doxylamine Aurovitas

Do not take a double dose to make up for missed doses.

Take your next dose at the usual time the following day.

If you stop treatment with Doxylamine Aurovitas

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Doxilamina Aurovitas may produce adverse effects, although not everyone experiences them.

The adverse effects of doxylamine are generally mild and transient, occurring more frequently during the first days of treatment.

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

Uncommon adverse effects (may affect up to 1 in 100 people): asthenia (weakness), peripheral edema (swelling 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), sensation of relaxation, nightmares, and dyspnea (breathing difficulties).

Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in children and elderly patients), tremor, seizures, or blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells).

Adverse effects with unknown frequency (frequency cannot be estimated from available data): general malaise.

Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (altered heart rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on electrocardiogram (a cardiac abnormality), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorders (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (coordination of senses and movement), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).

The frequency and severity of adverse effects may be reduced by lowering the daily dose.

Patients over 65 years of age are at higher risk of experiencing adverse reactions, as they may have other medical conditions or be taking other medications simultaneously. These individuals also have an increased risk of falls.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxylamine Aurovitas

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxilamina Aurovitas

The active substance is doxylamine. Each tablet contains 25 mg of doxylamine hydrogen succinate.

The other components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).

Appearance of the medicine and contents of the pack

Doxilamina Aurovitas 25 mg is presented as blue, film-coated, oblong, scored tablets. Each pack contains 7 or 14 tablets.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: December 2025

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