DORMIREL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

dormirel 25 mg film-coated tablets

Doxylamine 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.

• 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Package Leaflet Contents

1. What is dormirel and what is it used for
2. What you need to know before taking dormirel
3. How to take dormirel
4. Possible side effects
5. Storage of dormirel
6. Package Contents and Additional Information

1. What is dormirel and what is it used for

dormirel is a medication that contains the active ingredient doxylamine hydrogen succinate. Doxylamine belongs to a group of medications called antihistamines, which have sedative properties and are effective in inducing sleep.

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

2. What you need to know before taking dormirel

Do not take dormirel:

• If you are allergic to doxylamine 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, making breathing difficult)
• glaucoma (increased eye pressure)
• urinary retention
• prostatic hypertrophy (abnormal enlargement of the prostate)
• peptic ulcer (erosion of the stomach or intestinal wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), and vesical neck obstruction (a disease of the urinary tract)

• If you experience drowsiness during the day, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass until waking time.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to side effects.
• dormirel may worsen dehydration and heat stroke symptoms due to decreased sweating.

Other Medications and dormirel

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

Do not take dormirel with the following medications, as their effects may be enhanced:

• Epinephrine (for low blood pressure).
• Medications that affect the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial medications, certain antihistamines, certain medications used to reduce lipids (fat) in the blood, or certain neuroleptic agents (medications for treating mental disorders).
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of dormirel.
• Certain diuretics (medications that increase urine elimination).
• Central nervous system inhibitors (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensives (medications for high blood pressure) with a central nervous system effect, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medications, such as those used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroleptics (medications for treating mental disorders), atropine-like medications for treating spasms, or disopyramide (for certain heart problems).
• If you are taking other medications that can cause ear toxicity, such as carboplatin or cisplatin (medications for cancer), chloroquine (a medication for malaria), or certain antibiotics (medications for infections) like erythromycin or injectable aminoglycosides, among others, dormirel may mask the toxic effects of these medications, so you should periodically review the condition of your ears.

Interference with Diagnostic Tests

Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to discontinue treatment with dormirel at least three days before starting such tests.

Taking dormirel with Food, Drink, and Alcohol

Alcoholic beverages should not be consumed during treatment with dormirel. See section 3. How to take dormirel

Pregnancy, Breastfeeding, and Fertility

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

Do not take dormirel if you are pregnant, plan to become pregnant, or are breastfeeding.

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

Driving and Using Machines

The influence of dormirel on the ability to drive and use machines is significant. Do not drive or use hazardous machinery while taking this medication, at least during the first 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".

3. How to Take dormirel

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

Adults (over 18 years old)

The recommended dose is 1 tablet (25 mg) administered 30 minutes before bedtime. If drowsiness occurs during the day, 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 time. It should not be administered for more than 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 old are more likely to suffer from other conditions that may require a dose reduction. In case of unwanted side effects, it is recommended to reduce the dose to 12.5 mg per day.

Use in Patients with Liver or Kidney Disease

These patients should take a different dose, adjusted according 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 children under 18 years old, so this 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).

dormirel 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 more than 7 days without consulting a doctor.

If You Take More dormirel Than You Should

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. Delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, coma, and death may occur. 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take dormirel

Do not take a double dose to make up for forgotten doses. Take your dose at the usual time the next day.

If You Stop Taking dormirel

If you have any other questions 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 will experience them.

The side effects of doxylamine 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, 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 (decreased blood pressure due to posture 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 children and elderly patients), 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 doxylamine, are the following: arrhythmia (heart rate alteration), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (a cardiac disorder), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), psychomotor activity impairment (senses-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 be taking other medications simultaneously. These individuals also have a higher risk of falls.

Reporting Side Effects

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

5. Storage of dormirel

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

Do not use this medication after the expiration date shown 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 disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

dormirel Composition

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

The other ingredients are:

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

Product Appearance and Package Contents

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 Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:February 2021

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