Dormirel Forte 25 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dormirel Forte 25 mg film-coated tablets
Doxylamine hydrogen succinate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine contained in this leaflet or those provided 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 effects 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.
Leaflet contents
- What Dormirel Forte is and what it is used for
- What you need to know before taking Dormirel Forte
- How to take Dormirel Forte
- Possible side effects
- How to store Dormirel Forte
- Contents of the pack and other information
1. What Dormirel Forte is and what it is used for
Dormirel Forte is a medicine containing the active substance doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines, which have sedative properties and are effective in inducing sleep.
This medicine is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age, particularly when there is difficulty falling asleep, frequent awakenings during the night, or early morning awakening.
2. What you need to know before taking Dormirel Forte
Do not take Dormirel Forte:
- 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.
- If you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dormirel Forte.
-
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 blood potassium levels 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
-
benign prostatic hyperplasia (abnormal enlargement of the prostate)
-
peptic ulcer (erosion of the stomach or duodenal wall), 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 the medicine earlier to ensure at least 8 hours pass before waking up.
-
Alcohol consumption should be avoided during treatment.
-
If you are over 65 years of age, you may be more susceptible to side effects.
-
Dormirel Forte may worsen symptoms of dehydration and heat stroke due to reduced sweating.
Other medicines and Dormirel Forte
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take Dormirel Forte together with the following medicines, as their effects may be enhanced:
- Epinephrine (used to treat low blood pressure).
- Medicines affecting the heart, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents (medicines to reduce fat in the blood), 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 Dormirel Forte.
- Certain diuretics (medicines that increase urine production).
- 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 alpha-methyldopa.
- Other anticholinergic drugs, such as medicines for depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), antimuscarinic drugs for treating spasms, or disopyramide (used for certain heart conditions).
- If you are taking other medicines that cause ototoxicity (ear toxicity), such as carboplatin or cisplatin (cancer treatments), chloroquine (used to treat or prevent malaria), or certain antibiotics (medicines for infections) such as erythromycin or injectable aminoglycosides, Dormirel Forte may mask the toxic effects of these medicines; therefore, you should have your hearing checked regularly.
Interference with diagnostic tests
Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to stop treatment with Dormirel Forte at least three days before undergoing such tests.
Taking Dormirel Forte with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment with Dormirel Forte. See section 3. How to take Dormirel Forte.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Dormirel Forte if you are pregnant, planning to become pregnant, or breastfeeding.
There are no data available on the potential effects of Dormirel Forte on human fertility.
Driving and using machines
The effect of Dormirel Forte 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.
Sodium content of Dormirel Forte
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially "sodium-free".
3. How to take Dormirel Forte
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults (over 18 years of age)
The recommended dose is 1 tablet (25 mg) taken 30 minutes before going to bed. If daytime drowsiness occurs, it is recommended to reduce the dose to half a tablet (12.5 mg) or to take the dose earlier to ensure at least 8 hours pass before waking time. It should not be used for longer than 7 days without consulting your doctor.
Do not take more than 1 tablet (25 mg) per day.
The tablet may be divided into equal doses.
Use in elderly patients
Patients over 65 years of age are more likely to have other medical conditions that may require a dose reduction. If unwanted adverse effects occur, a dose reduction to 12.5 mg daily is recommended.
Use in patients with liver or kidney disease
These patients require an adjusted dose depending on the severity of their condition, as determined by the physician.
Use in children and adolescents
Dormirel Forte is not recommended for use in individuals under 18 years of age and should therefore 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).
Dormirel Forte may be taken with or without food.
Duration of treatment
Treatment duration should be as short as possible. In general, treatment may last from a few days up to one week. It should not be used for longer than 7 days without consulting your doctor.
If you take more Dormirel Forte 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 breathing, 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 whether it is necessary to induce vomiting, perform gastric lavage, or prescribe medications to increase blood pressure if needed.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Dormirel Forte
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 stop taking Dormirel Forte
If you have any further questions about the use of this medicine, consult 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, being more common 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, diarrhoea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (low blood pressure due to postural changes), diplopia (double vision), dyspepsia (stomach discomfort), sensation of relaxation, nightmares, and dyspnoea (difficulty breathing).
Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in children and elderly patients), tremor, seizures, or blood disorders such as haemolytic anaemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells).
Adverse effects with unknown frequency (cannot be estimated from available data): malaise.
Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (abnormal heart rhythm), 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 disorder (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.
Patients over 65 years of age 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dormirel Forte
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.
This medicine does not require any special storage conditions.
Do not use any pack that is damaged or open.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused packs and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packs and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dormirel Forte
The active substance is doxylamine hydrogen succinate. Each tablet contains 25 mg of doxylamine hydrogen succinate.
The other components are:
- Tablet core: microcrystalline cellulose (E-460i), mannitol (E-421), sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica and magnesium stearate.
- Tablet coating: indigotine (E-132), hypromellose (E-464), titanium dioxide (E-171) and polyethylene glycol.
Appearance of the product and contents of the pack
Dormirel Forte is available as cylindrical, biconvex, film-coated, blue tablets with a score line and marked with the code “D25”.
It is supplied in ALU/ALU blisters. Each pack contains 16 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: February 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72235/P_72235.html
QR code link: https://cima.aemps.es/cima/dochtml/p/72235/P_72235.html