DULSUENOS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dulsueños 25 mg Film-Coated Tablets

doxilamine succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, 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 it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Dulsueños and what is it used for
2. What you need to know before taking Dulsueños
3. How to take Dulsueños
4. Possible side effects
5. Storage of Dulsueños
6. Contents of the pack and other information

1. What is Dulsueños and what is it used for

Dulsueños is a medicine that contains the active ingredient doxilamine succinate. Doxilamine belongs to a group of medicines called antihistamines with sedative properties.

This medicine is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Dulsueños

Do not take Dulsueños:

• If you are allergic to doxilamine or any of the other components of this medicine (listed in section 6).
• If you are allergic to other antihistamines (anti-allergics).
• 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 medicine if you have:

• Liver and kidney function disorders.
• Epilepsy.
• QT interval prolongation (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 duodenum wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), and obstruction of the vesical neck (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 experiencing side effects.

Dulsueños may worsen dehydration symptoms and heat stroke due to decreased sweating.

Children and adolescents

Dulsueños is not recommended for use in children and adolescents under 18 years of age.

Taking Dulsueños with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do not take Dulsueños with the following medicines, as their effects may be enhanced:

• Epinephrine (for low blood pressure treatment).
• Medicines that act on the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents, or certain neuroleptics (medicines for treating mental disorders).
• Medicines that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of Dulsueños.
• Certain diuretics (medicines that increase urine elimination).
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensives (medicines for treating high blood pressure) with a central nervous system effect, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic drugs, such as medicines for treating depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for treating mental disorders), antispasmodic atropine-like medicines, or disopyramide (for treating certain heart problems).
• If you are taking other medicines that produce ear toxicity, such as carboplatin or cisplatin (cancer medicines), chloroquine (a medicine for treating or preventing malaria), and some antibiotics (medicines for treating infections) such as erythromycin or injected aminoglycosides, among others; Dulsueños may mask the toxic effects of these medicines, so you should periodically review the condition of your ears.

Interference with diagnostic tests

Doxilamine may interfere with skin allergy tests using allergens. It is recommended to suspend treatment with Dulsueños at least three days before starting such tests.

Taking Dulsueños with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

Dulsueños' influence on the ability to drive and use machines is significant. Do not drive or use hazardous machinery while taking this medicine, 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 medicine may cause allergic reactions because it contains the yellow-orange colorant(E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Dulsueños

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

Adults (over 18 years)

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

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

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

Use in adults over 65 years

People over 65 years old are more likely to suffer from other diseases that may recommend 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 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 children and adolescents under 18 years of age, so this medicine 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).

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 Dulsueños 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 gastric lavage, or prescribe medicines to increase blood pressure if necessary.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dulsueños

Do not take a double dose to make up for forgotten doses.

Take your dose at the usual time the next day.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of doxilamine are, in general, 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, pain in the upper abdominal area, 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 the elderly), tremor, 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 the available data): general malaise.

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, 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), impairment of psychomotor activities (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 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 may be taking other medicines simultaneously. These people also have a higher risk of falling.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dulsueños

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dulsueños

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

The other ingredients are:

• Core of the tablet: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium carboxymethyl starch (Type A), colloidal silicon dioxide, and magnesium stearate.
• Coating of the tablet: Opadry II blue (hypromellose, titanium dioxide, polydextrose, talc, maltodextrin, medium-chain triglycerides, aluminum lake of carmine E132, and aluminum lake of yellow-orange S E110).

Appearance of the product and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing authorization holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana nº40, 8ª planta

28046 Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L.

c/ Aragoneses 2

28108 - Alcobendas, Madrid

Spain

Date of the last revision of this leaflet: September 2016

Other sources of information

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