Package Insert: Information for the User

Dormirel 25 mg Film-Coated Tablets

Doxilamina Hydrogenosuccinate

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

-Keep this package insert, as you may need to refer to it again.

-For advice or more information, consult your pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Dormirel is a medication that contains the active ingredient doxylamine hydrogeosuccinate. Doxylamine belongs to a group of medications called antihistamines, which have sedative properties, being effective in inducing sleep.

This medication is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years old, particularly when there is difficulty falling asleep, frequent interruptions during sleep, or early morning waking.

Do not take Dormirel:

• If you are allergic to doxilamina or any of the other components of this medication (listed in section 6).
• If you are allergic to other antihistamines.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormirel.

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

• Liver and kidney function disorders.
• Epilepsy.
• Prolonged QT interval (a heart problem).
• Low potassium levels in the blood or other electrolyte disorders.
• Heart disease and high blood pressure.
• Asthma, chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a disease that affects the lungs and makes breathing difficult).
• Glaucoma (elevated eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach or intestinal wall), pyloric obstruction (difficulty passing food from the stomach to the intestine), and vesical neck obstruction (urinary tract disease).

• If you experience daytime somnolence, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass before waking up.
• Alcohol consumption should be avoided during treatment.
• People over 65 years may be more susceptible to side effects.
• Dormirel may exacerbate dehydration and heatstroke symptoms due to decreased sweating.

Other medications and Dormirel

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

Do not take Dormirel with the following medications, as they may potentiate its effects:

-Epinephrine (for treating low blood pressure).

-Heart medications such as those used to treat arrhythmias, some antibiotics, certain antimalarial medications, certain antihistamines, certain lipid-lowering medications, and certain neuroléptics (medications for mental disorders).

-Medications that decrease the elimination of other substances such as azole derivatives or macrolides, which may increase the effect of Dormirel.

-Some diuretics (medications that increase urine elimination).

-Central nervous system inhibitors (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).

-Antihypertensive medications with central nervous system effects such as guanabenzo, clonidina, or alpha-metildopa.

-Other anticholinergic medications such as medications for depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroléptics (medications for mental disorders), atropinic medications for spasms, or disopiramida (for certain heart problems).

-If you are taking other medications that cause ototoxicity, such as carboplatino or cisplatino (cancer medications), chloroquina (malaria medication), and some antibiotics (infection medications) like eritromicina or aminoglucósidos inyectados, Dormirel may mask the toxic effects of these medications, so you should regularly check your ear status.

Interference with diagnostic tests

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

Taking Dormirel with food, drink, and alcohol

Alcohol consumption should be avoided during Dormirel treatment. See section 3. How to take Dormirel

Pregnancy, lactation, 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.

Do not take Dormirel if you are pregnant, intend to become pregnant, or are breastfeeding.

No data are available on the possible effects of Dormirel on human fertility.

Driving and operating machinery

The influence of Dormirel on driving and operating machinery is important. 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.

Dormirel sodium content

This medication contains less than 23 mg of sodium (1 mmol) 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, ask your doctor or pharmacist.

Adults (18 years and older)

The recommended dose is 1 tablet (25 mg) administered 30 minutes before bedtime. If daytime drowsiness appears, it is recommended to reduce this dose to half a tablet (12.5 mg) or take it earlier to ensure that at least 8 hours pass until waking up. Do not administer for a period exceeding 7 days without consulting a doctor.

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

The tablet can be divided into equal doses.

Use in elderly patients

People over 65 years are more prone to suffering other pathologies that may recommend a dose reduction. In case of appearance of undesirable side effects, it is recommended to reduce the dose to 12.5 mg per day.

Use in patientswith liver or kidney disease

These patients should take a different dose, adjusted to the degree of their disease, which will be determined by the doctor.

Use in children and adolescents

Dormirel 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.

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

Dormirel can be taken before or after meals.

Treatment duration

The treatment duration should be as short as possible. In general, the treatment duration can range from a few days to a week. Do not administer for a period exceeding 7 days without consulting a doctor.

If you take more dormirel than you should

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 complications may include 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 your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take dormirel

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 dormirel

If you have any other doubts about the use of this medication, 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.

Common side effects (may affect up to 1 in 10 people): drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, vertigo, 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 (respiratory difficulties).

Rare side effects (may affect up to 1 in 1,000 people): agitation (especially in children and elderly patients), tremor, convulsions, or blood-related problems 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 discomfort.

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxilamine, are the following: arrhythmia (heart rate alteration), palpitations, duodenal-gastric 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), psychomotor activity impairment (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 falls.

Reporting of 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use any packaging that is damaged or open.

Medications should not be thrown down the drain or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Dormirel Composition

The active principle is doxylamine hydrogenosuccinate. Each tablet contains 25 mg of doxylamine hydrogenosuccinate.

The other components are:

• Tablet core: microcrystalline cellulose (E-460i), mannitol (E-421), sodium carboxymethyl starch (type A) (from potato), anhydrous colloidal silica, and magnesium stearate.
• Tablet coating: indigotin (E-132), hypromellose (E-464), titanium dioxide (E-171), and polyethylene glycol.

Product appearance and packaging content

dormirel is presented in the form of cylindrical, biconvex, film-coated tablets, scored, blue in color, and marked with the code “D25”.

It is presented in ALU/ALU blisters. Each package contains 16 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2021

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