Dulsueños 25 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dulsueños 25 mg film-coated tablets
doxylamine succinate
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Dulsueños is and what it is used for
- What you need to know before taking Dulsueños
- How to take Dulsueños
- Possible adverse effects
- How to store Dulsueños
- Contents of the pack and other information
1. What Dulsueños is and what it is used for
Dulsueños is a medicine containing the active substance doxylamine succinate. Doxylamine belongs to a group of medicines called antihistamines that have sedative properties.
This medicine is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age.
You should consult a doctor if your condition 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 doxylamine or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other antihistamines (antiallergy medicines).
- If you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Dulsueños.
You should consult a doctor before taking this medicine if you have:
- Impaired liver or kidney function.
- Epilepsy.
- QT interval prolongation (a heart condition).
- Low potassium levels in the blood or other electrolyte imbalances.
- Heart disease or high blood pressure.
- Asthma, chronic bronchitis (persistent inflammation of the bronchi), or pulmonary emphysema (a lung disease that makes breathing difficult).
- Glaucoma (increased pressure in the eye).
- Urinary retention.
- Prostatic hypertrophy (abnormal enlargement of the prostate).
- Peptic ulcer (erosion of the stomach or beginning of the intestine), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or vesical neck obstruction (a urinary tract disorder).
If you experience daytime drowsiness, it may be necessary to reduce the dose or take it earlier to ensure at least 8 hours pass between taking the medicine and waking up.
Alcoholic beverages should be avoided during treatment.
If you are over 65 years old, you may be more susceptible to side effects.
Dulsueños may worsen symptoms of dehydration and heat stroke due to reduced sweating.
Children and adolescents
The administration of Dulsueños is not recommended 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 need to take any other medicines.
Do not take Dulsueños together with the following medicines, as their effects may be enhanced:
- Epinephrine (used to treat low blood pressure).
- Medicines that act on the heart, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents (medicines to reduce blood fats), or certain neuroleptics (medicines used to treat mental disorders).
- Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, which could increase the effect of Dulsueños.
- Certain diuretics (medicines that increase urine output).
- Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, or procarbazine).
- Antihypertensives (medicines for high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or methyldopa.
- Other anticholinergic drugs, such as medicines used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), atropine-like medicines for treating spasms, or disopyramide (used for certain heart conditions).
- If you are taking other medicines that cause ear toxicity, such as carboplatin or cisplatin (cancer treatments), chloroquine (a medicine for treating or preventing malaria), or certain antibiotics (medicines for treating infections) such as erythromycin or injectable aminoglycosides, among others; Dulsueños could mask the toxic effects of these medicines, so you should have your hearing checked regularly.
Interference with diagnostic tests
Doxylamine may interfere with skin allergy tests using allergens. It is recommended to stop treatment with Dulsueños at least three days before undergoing such tests.
Taking Dulsueños with food, drinks, and alcohol
Alcoholic beverages must 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, planning to become pregnant, or breastfeeding.
There are no data available on the possible effects of Dulsueños on human fertility.
Driving and using machines
The effect of Dulsueños on the ability to drive and operate machinery is significant. Do not drive or operate dangerous machinery while taking this medicine, at least during the first few days of treatment, until you know how it affects you.
Dulsueños contains the colour additive Orange Yellow S (E-110)
This medicine may cause allergic reactions because it contains Orange Yellow S (E110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Dulsueños
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults (over 18 years of age)
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 (other medicines with a lower dose are available), or to take the dose earlier to ensure at least 8 hours elapse before waking time.
Do not take more than 1 tablet (25 mg) per day.
Use in patients over 65 years of age
Patients over 65 years of age are more likely to have other medical conditions that may require a dose reduction. If undesirable adverse effects occur, 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 severity of their illness, as determined by the physician.
Use in children and adolescents
Dulsueños is not recommended for use in individuals under 18 years of age and should not be used in this population.
Route and method of administration
Oral use.
The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).
Duration of treatment
Treatment duration should be as short as possible. In general, treatment may last from a few days to one week.
It should not be administered for longer than 7 days without consulting a doctor.
If you take more Dulsueños than you should
Symptoms of overdose include: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or irregular heart rate, elevated blood pressure, nausea, vomiting, agitation, impaired gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, low blood pressure, seizures, reduced respiration, loss of consciousness, coma, and death may occur. A serious complication may be rhabdomyolysis (muscle injury), followed by kidney failure.
There is no specific antidote for antihistamine overdose; therefore, 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, contact the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Dulsueños
Do not take a double dose to make up for missed doses.
Take your next dose at the usual time the following day.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects of doxylamine are generally mild and transient, occurring more frequently during the first days of treatment.
Common adverse 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, insomnia, and nervousness.
Uncommon adverse effects (may affect up to 1 in 100 people): asthenia (weakness), peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to postural changes), diplopia (double vision), dyspepsia (stomach discomfort), sensation of relaxation, nightmares, and dyspnea (breathing difficulties).
Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in children and elderly), tremor, seizures, or blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells).
Adverse effects with unknown frequency (cannot be estimated from available data): general malaise.
Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (altered heart rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on electrocardiogram (a cardiac abnormality), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorders (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor performance (coordination of senses and movement), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).
The frequency and severity of adverse effects may be reduced by lowering the daily dose.
People aged 65 years and older have a higher risk of experiencing adverse reactions, as they may have other medical conditions or may be taking other medications simultaneously. These individuals also have an increased risk of falling.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide 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 refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dulsueños
The active substance is doxylamine. Each tablet contains 25 mg of doxylamine succinate.
The other components are:
- Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium carboxymethylstarch (Type A), colloidal silicon dioxide, and magnesium stearate.
- Tablet coating: Opadry II blue (hypromellose, titanium dioxide, polydextrose, talc, maltodextrin, medium-chain triglycerides, indigo carmine aluminum lake E132, and sunset yellow FCF aluminum lake E110).
Appearance of the product and contents of the pack
Dulsueños 25 mg is presented as 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 No. 40, 8th floor
28046 Madrid
Spain
Manufacturer
Toll Manufacturing Services S.L.
Calle Aragoneses 2
28108 - Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: September 2016
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/