Prospect: information for theuser

Dormidinadoxilamina12,5mg coated tablets

Hidrogenosuccinatode doxilamina

Read this prospect carefullybefore starting to take this medication, because it contains important information for you

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

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

• Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

• You should consult a doctor if you worsen or do not improveafter 7 days

1.What is Dormidinadoxilaminaand what is it used for

2.What you need to know beforestarting totake Dormidinadoxilamina

3.How to take Dormidinadoxilamina

4.Possible adverse effects

5Storage of Dormidinadoxilamina

6.Contents of the package 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.
• Prolongation of the 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 beginning of the intestine), pyloric obstruction (difficulty passing food from the stomach to the intestine) and urethral stricture (disease of the urinary tract).

• If you experience daytime drowsiness, 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.
• If you are over 65 years old, you may be more susceptible to experiencing side effects.
• Dormidinadoxilaminamay exacerbate dehydration and heatstroke symptoms due to decreased sweating.

TakingDormidinadoxilaminawith other medications

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

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

• Epinephrine (for treating low blood pressure).
• Medications affecting the heart, such as those used to treat arrhythmias, certain antibiotics, some antimalarial medications, certain antihistamines, certain lipid-lowering medications, or certain neuroleptics.
• 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 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 mental disorders), atropine medications for spasms, or disopyramide (for certain heart problems).
• If you are taking other medications that cause ototoxicity, such as carboplatin or cisplatin (cancer medications), chloroquine (malaria medication), or certain antibiotics like erythromycin or injected aminoglycosides, Dormidinadoxilaminamay mask the toxic effects of these medications, so you should regularly check your ear health.

Interference with diagnostic tests

Doxilamine may interfere with skin allergy tests that use allergens. It is recommended to suspend treatment with Dormidina doxilamina for 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,breastfeedingand 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.

Dormidinadoxilaminacontains Red Iron Oxide A.

This medication may cause allergic reactions due to the presence of Red Iron Oxide A. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

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,consultyour doctor or pharmacist.

Adults (18 years and older)

The recommended doseis1 to 2 tablets(12.5mg to 25mg) per day.

If daytime somnolence occurs, it is recommended to reduce the dose to1 tablet (12.5 mg)or take it earlier to ensure that at least 8 hours pass until waking up.

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

Use in the elderly

Peopleover 65 yearsare more prone to suffering from other pathologies that may recommend a dose reduction.In case of appearance of undesirable side effects, the dose will be 1 tablet (12.5 mg) per day.

Use in patients with liver or kidney disease

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

Use in childrenand adolescents

Dormidinadoxilaminais not recommended foruse in individuals under 18 years,so the medication should not be used in this population.

Route and method of administration

Oral route.

The tabletsshould be taken 30 minutes before bedtime with a sufficient amount of liquid (preferablywater).

Dormidinadoxilaminacan 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 a doctor.

If you take more Dormidinadoxilaminathan you should

The symptoms of an overdose are: somnolence, 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 delirium, psychosis, decreased blood pressure, seizures, decreased respiration, loss of consciousness, coma, and death. A serious complication can be rhabdomyolysis (muscle injury),followed byrenal 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 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 forgot to take Dormidinadoxilamina

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 Dormidinadoxilamina

If you have any other doubts about the use of thismedication, ask your doctor orpharmacist.

Like all medications, Dormidina doxilamina can produce 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.

Less frequent 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),gastrointestinal disturbances, 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-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 notobserved 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), abnormal coordination, 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 oldpresent a higher risk of experiencing adverse reactions, as they may suffer from other diseases or be taking other medications simultaneously. These individuals also have a higher risk of experiencing a fall.

If you experience side effects, consultyour doctor or pharmacist,even if it is about 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 about 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat 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..

Dormidina Compositiondoxilamine

• The active ingredient is doxilamine hydrogenosuccinate. Each tablet contains 12.5 mg of doxilamine hydrogenosuccinate.
• The other componentsare:

Core excipients:

Calcium dihydrogen phosphate (E-341)

Microcrystalline cellulose (E-460)

Sodium carboxymethylcellulose (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)

Cochineal Red A (E-124) (see section 2“Dormidinadoxilaminecontains Cochineal Red A”)

Polyethylene glycol 400

Polyethylene glycol 6000

Appearance of the product and contents of the packaging

Dormidinadoxilamineis presented in the form of coated, elongated, pink tablets, in a package containing 7 or 14 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible manufacturer

Towa Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona) Spain

Last review date of this leaflet August 2012.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/