Leaflet: information for the user

Dulsueños 25 mg film-coated tablets

doxilamina succinato

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.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

1. What Dulsueños is and for what it is used

2. What you need to know before starting to take Dulsueños

3. How to take Dulsueños

4. Possible side effects

5. Storage of Dulsueños

6. Contents of the pack and additional informational

Dulsueños is a medication that contains the active ingredient doxilamina succinate. Doxilamina belongs to a group of medications called antihistamines that have sedative properties.

This medication is indicated for the symptomatic treatment of occasional insomnia in individuals over 18 years old.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Dulsueños:

• 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 (antiallergics).
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dulsueños.

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 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 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 somnolence, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass before waking up.

It is recommended to avoid consuming alcoholic beverages during treatment.

If you are over 65 years old, you may be more susceptible to experiencing side effects.

Dulsueños may exacerbate dehydration and heatstroke symptoms due to decreased sweating.

Children and adolescents

Dulsueños is not recommended for children and adolescents under 18 years old.

Taking Dulsueños with other medications

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

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

• Epinephrine (for treating low blood pressure).
• Medications that affect the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial medications, certain antihistamines, certain lipid-lowering medications, or certain neuroléptics (medications for treating mental disorders).
• Medications that decrease the elimination of other substances, such as azole derivatives or macrolides, which may increase the effect of Dulsueños.
• 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 treating depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroléptics (medications for treating mental disorders), atropinic medications for treating spasms, or disopiramida (for treating certain heart problems).
• If you are taking other medications that cause ototoxicity, such as carboplatino or cisplatino (medications for treating cancer), cloroquina (medication for treating or preventing malaria), and some antibiotics (medications for treating infections) such as eritromicina or aminoglucósidos inyectados, among others; Dulsueños 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 Dulsueños treatment at least three days before starting these tests.

Taking Dulsueños with food, drinks, and alcohol

Do not consume alcoholic beverages during Dulsueños treatment. See section 3. How to take Dulsueños.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

The influence of Dulsueños on 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 days of treatment until you know how it affects you.

Dulsueños contains the yellow-orange colorant S (E-110)

This medication may cause allergic reactions because it containsthe yellow-orange colorant(E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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) per day.

If daytime drowsiness appears, it is recommended to reduce the dose to 12.5 mg per day (other medications with a lower dose are available), or take the dose earlier to ensure that at least 8 hours pass until waking up.

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

Use in patients 65 years and older

Patients 65 years and older are more prone to 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 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

Dulsueños is not recommended for use in patients 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).

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.

It should not be administered for a period exceeding 7 days without consulting the doctor.

If you take more Dulsueños 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. Seizures, decreased blood pressure, convulsions, 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 treatment is symptomatic and supportive. Your doctor will evaluate 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, indicating the medication and the amount ingested.

If you forgot to take Dulsueños

Do not take a double dose to compensate for the missed doses.

Take your dose at the usual time the next day.

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

Like all medicines, this medicine 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, 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 the elderly), 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 doxilamina, are the following: arrhythmia (heart rate alteration), palpitations, duodenogastroesophageal reflux, abnormal liver function (cholestatic 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 suffer from other diseases or be taking other medications simultaneously. These individuals also have a higher risk of experiencing a fall.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special conservation conditions are required.

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.

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 point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Dulsueños

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

The other components are:

• Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium carboxymethylcellulose (Type A), colloidal silicon dioxide, and magnesium stearate.
• Tablet coating: Opadry II blue (hypromellose, titanium dioxide, polydextrose, talc, maltodextrin, medium-chain triglycerides, aluminum lake of indigo carmine E132, and aluminum lake of yellow-orange S E110).

Appearance of the product and content of the packaging

Dulsueños 25 mg is presented in the form of blue-coated, round tablets. Each package contains 7 or 14 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana nº40, 8th floor

28046 Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L.

c/ Aragoneses 2

28108 - Alcobendas, Madrid

Spain

Last review date of this leaflet: September 2016

Other sources of information

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