Leaflet: information for the user

Dormidinadoxilamina25 mg film-coated tablets

Hidrogenosuccinatode doxilamina

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

Follow exactly the administration instructions for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

• You should consult a doctor if you get worse or do not improveafter7 days.

1.What is Dormidinadoxilaminaand what it is used for

2.What you need to know beforestarting totake Dormidinadoxilamina

3.How to take Dormidinadoxilamina

4.Possible side effects

5Storage of Dormidinadoxilamina

6.Contents of the pack and additional information

Dormidinadoxilaminais a medication that contains the active ingredienthydrogen succinate of doxilamina. Doxilamina belongs to a group of medications called antihistamines, which have sedative properties.

It is indicated for the symptomatic treatment of occasional insomnia inindividuals over 18 years old.

You should consult a doctor if it worsens or does not improveafter7days.

Do not take Dormidinadoxilamina

• 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.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormidinadoxilamina.

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

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

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

Taking Dormidinadoxilaminawith other medications

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

Do not take Dormidinadoxilaminawith 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, or certain neuroléptics (medications for mental health disorders).
• Medications that decrease the elimination of other substances such as azole derivatives or macrolides, which may increase the effect of Dormidina doxilamina.
• 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 health 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), or certain antibiotics (infection medications) like eritromicina or aminoglucósidos inyectados, Dormidinadoxilaminamay mask the toxic effects of these medications, so you should regularly check your ear health.

Interference with diagnostic tests

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

Taking Dormidinadoxilaminawith food, drink, and alcohol

Alcohol consumption should be avoided during treatment with Dormidinadoxilamina.

See section 3. How to take Dormidinadoxilamina

Pregnancy,breastfeeding, and fertility

Do not take Dormidinadoxilaminaif you are pregnant, planning to become pregnant, or breastfeeding.

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

Driving and operating machinery

The influence of Dormidinadoxilaminaon the ability to drive and operate 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.

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, consult your doctor or pharmacist.

Adults (18 years and older)

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

If daytime drowsiness occurs, it is recommended to reduce the dose to 12.5 mg per day by takingDormidina doxilamina12.5 mg film-coated tabletsor by taking the dose earlier to ensure that at least 8 hours pass before waking up.

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

Use in the elderly

People over 65 years are more prone to suffering from 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 by takingDormidina doxilamina12.5 mg film-coated tablets.

Use in patients with 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

Dormidina doxilamina 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).

Dormidina doxilamina 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 without consulting the doctor.

If you take more Dormidina doxilamina 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), redness, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, decreased blood pressure, seizures, decreased respiration, loss of consciousness, coma, and death may occur. A serious complication can be rhabdomyolysis (muscle injury), followed by renal failure.

There is no specific antidote for antihistamine overdose, so the 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 Dormidina doxilamina

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 Dormidina doxilamina

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

Like all medications, Dormidina doxilamina may cause side effects, although not everyone will experience them.

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

Frequent 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, upper abdominal pain, fatigue, insomniaandnervousness.

Rare side effects (may affect up to 1 in 100 people):astenia (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),dispepsia (stomach disorders), feeling of relaxation, nightmaresandshortness of breath.

Rare side effects (may affect up to 1 in 1,000 people):agitation (especially in children and the elderly),shaking, convulsions or blood 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 doxilamina, are the following:arrhythmia (alteration of heart frequency), palpitations, duodenogastric reflux, abnormal liver function (jaundice), prolonged QT interval on the electrocardiogram (a cardiac alteration), decreased appetite, increased appetite, myalgia (muscle pain), coordination abnormality, extrapyramidal disorder (movement disorders), paraesthesia (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 diseases or be taking other medications simultaneously. These individuals also have a higher risk of falling.

If you experience side effects, consult your doctor or pharmacist,even if it is side effects that do not appear in this prospectus.

Reporting of side effects:

If you experience any type of side effect, consult your doctor even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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 medication.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dormidinadoxilamina

• The active ingredient is hydrochloride of doxilamina. Each tablet contains 25 mg of hydrochloride of doxilamina.
• The other componentsare:

Core excipients:

Calcium dihydrogen phosphate (E-341)

Microcrystalline cellulose (E-460)

Carboxymethylstarch sodium (type A) from potato

Anhydrous colloidal silica (E-551)

Magnesium stearate (E-572)

Coating excipients:

Microcrystalline cellulose (E-460)

Polyoxyethylene-40 stearate (E-431)

Propylene glycol (E-1520)

Hydroxypropylmethylcellulose (E-464)

Titanium dioxide (E-171)

Polyethylene glycol 8000

Appearance of the product and contents of the packaging

Dormidinadoxilaminais presented in the form of coated tablets with a white elongated film, in a package containing 7 or 14 tablets.

Only some package sizes may be 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

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet August 2012.

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