Dormidina 12.5 Mg 14 Tablets (doxylamine)

Dormidina 12.5 Mg 14 Tablets (doxylamine)

Sleeping Tablets

You can buy Dormidina Doxylamine 12.5 mg online from UK, Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Sweden (Sverige), Slovakia and Slovenia. U kunt dormidina kopen in onze online apotheek, wij verzenden naar alle EU-landen.

Dormidina is indicated for the symptomatic treatment of occasional insomnia in people over 18 years of age.

When you need it, Dormidine helps you to sleep well at night and to be well during the day because it facilitates a restorative sleep and helps your body rest to face the activity of the following day.

How does Dormidina Doxylamine work?

Dormidina, thanks to its active principle - doxylamine - produces a sedative effect that favours the conciliation of sleep. Dormidina is indicated for the occasional insomnia that can be caused by different reasons: stress situations, personal or professional problems, jetlag etc. That's why Dormidina helps you sleep when you need it.

ACTION AND MECHANISM

- [ANTIALERGIC], [HISTAMINERGIC ANTAGONIST (H-1)]. Doxylamine is a derivative of ethanolamine, which competitively, reversibly and nonspecifically blocks H1 receptors, decreasing the systemic effects of histamine. It leads to vasoconstriction and decreased vascular permeability, reducing redness and edema associated with allergy. It partially alleviates symptoms associated with allergic processes such as eye redness or nasal congestion. It also produces a slight bronchodilator effect and a decrease in dermal pruritus. 
- [HYPNOTIC]. Doxylamine is able to cross the blood-brain barrier, and act on the central H1 receptors, leading to sedation. It appears that the sedative effect may also be due to antagonism of muscarinic and serotonergic receptors. Doxylamine has sedative effects superior to those of other ethanolamines. 
- [MUSCARINIC COLINERGIC ANTAGONIST (M)], [ANTIEMETIC]. Doxylamine is a nonspecific antagonist capable of further blocking other receptors such as central or peripheral muscarinic. Its anticholinergic effects appear to be less potent than those of other ethanolamines. Blockade of H1 receptors and central cholinergics may exert an antiemetic effect, although it is not fully understood.

PHARMACOKINETICS

Orally: 
- Absorption: Doxylamine is well absorbed from the intestine, but it undergoes an intense hepatic first pass effect that reduces bioavailability. Following administration of a 25 mg dose, the Cmax of 100 ng / ml is reached at 2-3 hours. The sedative effects begin after 30 minutes and are maximum at 1-3 hours. The duration of the same is of 6-8 hours. 
- Metabolism: Although not properly studied, doxylamine appears to be metabolized rapidly and almost completely in the liver. 
- Elimination: Doxylamine and its metabolites are excreted in the urine. Its elimination half-life is 10 hours.

INDICATIONS

- [INSOMNIO]. Symptomatic treatment of insomnia, particularly when there is difficulty sleeping, frequent interruptions during sleep or an early wake up in the morning.

POSOLOGY

DOSAGE: 
- Adults, oral: 12.5-25 mg / 24 hours. 
- Children and adolescents under 18 years of age, oral: The safety and efficacy of doxylamine in children and adolescents under 18 years of age have not been evaluated. If it is necessary to use doxylamine in persons under 18 years of age, it is recommended not to use doses greater than 25 mg / 24 hours. 
Treatment over a week should be avoided. 

RULES FOR CORRECT ADMINISTRATION

Doxylamine will be given half an hour before bedtime for its effects.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medicine. There may be cross-reactions with other antihistamines, therefore it is not recommended to use any H1 antihistamine in patients who have hypersensitivity to any compound in the group. 
- [ASTHMATIC CRISIS]. For some authors, doxylamine may worsen asthma, so it is not recommended for use in an acute crisis. 
- [PORFIRIA]. H1 antihistamines have been associated with the onset of porphyric outbreaks, so they are not considered safe in these patients.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. In patients with renal failure, accumulation of metabolites may occur. Because these metabolites may be active, it is recommended to prolong the administration periods in patients with moderate or severe renal insufficiency (CLcr less than 60 ml / minute). 
- [LIVER FAILURE]. Doxylamine is extensively metabolised by hepatic metabolism. In case of hepatic insufficiency an increase of the plasma concentration can occur, with the consequent risk of adverse effects.Dosage adjustment in these patients may be necessary depending on the degree of hepatic function. 
- Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [SERIOUS MIASTENIA], stenosing [ULCERA] stenosing or [INTESTINAL OBSTRUCTION]. Because of the anticholinergic effects of doxylamine, these conditions may worsen, so extreme caution is advised and treatment should be discontinued in the event of a worsening. 
- Diseases of the lower respiratory tree, such as [ASTHMA], [PULMONARY ENFISEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. According to some authors, doxylamine could decrease the volume of bronchial secretions, increasing its viscosity, due to its anticholinergic effects, which could aggravate these pictures. However, there is not much clinical evidence, despite which, extreme caution is recommended in these patients. As a rule, its use is not recommended in patients with asthmatic attacks (see Contraindications). 
- [EPILEPSY]. Caution should be exercised in epileptic patients, since antihistamines have sometimes been associated with paradoxical reactions of hyperexcitability, even at therapeutic doses, and may reduce the seizure threshold. 
- [APPENDICITIS]. Due to its antiemetic effects, it could interfere with the diagnosis of appendicitis. It is recommended to preclude the presence of appendicitis in patients with vomiting of unknown origin. 
- Ototoxicity. Doxylamine may exert a beneficial effect in case of dizziness, tinnitus and dizziness, and may mask ototoxicity induced by ototoxic drugs such as parenteral aminoglycosides, carboplatin, cisplatin, chloroquine and erythromycin among others. 
- Photosensitivity. Doxylamine may give rise to photosensitivity phenomena, so it is recommended not to take the sun during treatment, and protect it by means of sunscreens. 
- Extreme temperatures. H1 antihistamines may aggravate the depletion-dehydration syndrome and heat stroke due to decreased sweating caused by its anticholinergic effects. It is recommended that patients on treatment with these drugs avoid exposure to very high temperatures, especially in the case of young children, the elderly or people with severe chronic illness. It is also advisable to follow appropriate hygienic-dietary measures, such as adequate aeration and hydration.

PATIENT TIPS

- This medicine will be given half an hour before bedtime. 
- Treatments not exceeding one week are recommended. If after this time, insomnia continues or worsens, it is recommended to consult with the doctor. 
- It may cause drowsiness, so caution is advised when driving, and not combined with drugs or other sedatives such as alcohol. 
- Patients on sedative drugs are not advised to self-medicate with doxylamine products without consulting a physician. 
- It is advised not to take the sun during treatment. 
- Any chronic pathology presented by the patient should be notified to the physician before starting treatment. 
- Exposure to extreme temperatures during the use of this medication should be avoided, keeping in a cool environment, properly hydrated. 

SPECIAL WARNINGS

- Doxylamine could mask the ototoxic effects of some drugs, so it is recommended to periodically evaluate the acoustic functionality in patients treated with these drugs. 
- Before using this medication in patients with vomiting of unknown origin it is recommended to rule out the presence of appendicitis. 
- It is recommended to monitor the hydration of the patient in case of a heat wave, and especially if the patient is a small child, an elderly person or a person with a serious illness. 
- Due to the antiallergic effects of this medication, it could give false negatives in dermal tests of hypersensitivity to antigenic extracts. It is recommended to stop taking this medication at least 72 hours before the test.

INTERACTIONS

Doxylamine may mask ototoxic drug-induced symptoms by decreasing vertigo or dizziness. In the same way, it could enhance the photosensitizing effects of other active principles that give rise to photosensitivity reactions. In addition, drug interactions have been described with the following active substances: 
- Ethyl alcohol. Co-administration of alcohol and doxylamine may enhance the sedative effects of both substances. It is recommended to avoid drinking alcohol during treatment. 
- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Administration of doxylamine together with other anticholinergic drugs may potentiate the anticholinergic effects, so avoidance of association is recommended. 
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Co-administration of doxylamine together with a sedative drug may enhance hypnotic action. It is recommended to extreme precautions.

PREGNANCY

Category B FDA. In studies with rats at doses 125 times higher than human doses have not shown any risk to the fetus. However, when administering doses 125-375 times the maximum doses in humans, the occurrence of skeletal abnormalities, characterized by ribbing of the ribs, and diaphragmatic hernias have been observed. Doxylamine crosses the placenta. There is great controversy about the teratogenic effects of doxylamine. This drug has often been used for the prevention of gestational nausea and vomiting. Epidemiological studies have not shown adverse effects on the fetus, although in some cases the administration of doxylamine during the first trimester of pregnancy was associated with cases of palatal cleft. However, a causal relationship with doxylamine has not been established and these effects have not been observed in other studies, which is why the FDA considers that doxylamine is unlikely to be teratogenic. However, due to the absence of adequate and well-controlled studies in humans, it can not be ruled out that it is weakly teratogenic. This medication should therefore be used in pregnant women with caution, and only if the benefits outweigh the possible risks.

LACTATION

Doxylamine may inhibit lactation because of its anticholinergic effects. It is not known whether doxylamine is excreted in breast milk, but other antihistamines do. Because children are more sensitive to anticholinergic reactions, and may have more frequent paradoxical reactions of hyperexcitability, it is recommended to discontinue breast-feeding or avoid the administration of this drug.

CHILDREN

The efficacy and safety of doxylamine as a sedative in children under 18 years of age has not been evaluated. Because anticholinergic symptoms and hyperexcitability are more common in these patients, their use is not recommended.

ELDERLY

Elderly people are more sensitive to the adverse effects of antihistamines, such as dizziness, sedation, confusion, hypotension and hyperexcitability, as well as anticholinergic effects (dry mouth, urinary retention, precipitation of glaucoma). Antihistamines may be used in patients over 65 years of age, but extreme caution should be exercised. If side effects persist or are severe, treatment is advised to be discontinued.

EFFECTS ON DRIVING

Doxylamine can substantially affect the ability to drive and / or operate machinery. Patients should avoid handling dangerous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them.

ADVERSE REACTIONS

The side effects of doxylamine are usually mild and transient, being more frequent during the first days of treatment. Like other ethanolamines, doxylamine mainly results in drowsiness and anticholinergic phenomena, but there is great inter-individual variability with respect to the frequency and intensity of symptoms, affecting mainly young and old children. The most common adverse reactions are: 
- Digestive. [NAUSES], [VOMITING], [STORAGE], [DIARRHEA], [EPIGASTRIC PAIN], [ANOREXIA], [MOUTH SEQUITY]. 
- Neurological / psychological. The appearance of [SOMNOLENCIA] is frequent, especially at the beginning of treatment, and usually decreases after 2-3 days. You may also see [DISORINATION], [PSYCHOTHERAPY DISCOORDINATION], [MIASTENIA], [VERTIGO], [ASTENIA], [CEFALEA]. Exceptionally, cases of paradoxical [EXCITABILITY] have been observed, especially in young children. This hyperexcitability applies to [INSOMNY], [NERVOUSISM], [TREBLE], [IRRITABILITY], [EUFORIA], [DELIRIO], palpitations and even [CONVULSIONS]. 
- Cardiovascular. Occasionally, and in case of overdose, [TACHYCARDY], [PALPITATIONS] and other [CARDIAC ARRHYTHMIA] may occur as [EXTRASISTOLE] or [HEART LOCK]. These effects may be due to anticholinergic activity. In some cases [HYPOTENSION] or [HYPERTENSION] have been described. 
- Respiratory. Occasionally an increase in the viscosity of bronchial secretions may occur, which may make it difficult to breathe. 
- Genitourinary. [URINARY RETENTION] and [SEXUAL IMPOTENCE] may appear due to cholinergic block. 
- Hematologic. Rare [HEMOLITIC ANEMIA], [AGRANULOCYTOSIS], [LEUCOPENY], [TROMBOCYTOSIS] or [PANCITOPENIA] have been described. 
- Eyepieces. Due to anticholinergic activity, a [GLAUCOMA] and [VISION DISORDERS] may be produced as [VISION BORROSA] or [DIPLOPIA]. [OTOTOXICITY] ([TINNITUS]) may also occur. 
- Allergic / dermatological. [HYPERSENSITIVITY REACTIONS] may occur following systemic administration of antihistamines, albeit with a lower frequency than if applied topically. [PHOTOSENSIBILITY REACTIONS] may also appear after intense exposure to sunlight, with [DERMATITIS], [PRURITO], [EXANEMATIC ERUPTIONS] and [ERITEMA].

OVERDOSE

Symptoms: Symptoms usually appear after 30 minutes to 2 hours, and are usually variable, presenting greater severity in children and over 65 years. Moderate nervous depression, with sedation and apnea, cardiovascular collapse, hyperexcitability with insomnia, hallucinations, tremors or convulsions, and anticholinergic symptoms such as dry mouth, blurred vision, and urinary retention have been reported. Fever above 41.8 ° C may also occur. 
In more severe cases, especially in children, the symptoms may be aggravated, with hypotension, seizures, respiratory depression, loss of consciousness coma and death. However, doxylamine intoxication rarely compromises the patient's life, and recovery is complete within 24-48 hours. 
Treatment: The treatment will consist of the usual measures intended to favor the elimination of the drug. If less than 3 hours have passed since ingestion, emetics may be administered, taking precautions to avoid aspiration, especially in children and the elderly. It is not recommended to induce vomiting in comatose or unconscious individuals. If emesis is contraindicated, a stomach lavage and activated charcoal may be administered. Saline laxatives such as magnesium sulfate may be used. 
Symptoms of intoxication may be eliminated with the following drugs. 
- Central anticholinergic effects. Intravenous physostigmine. 
- Seizures. Slow intravenous infusion of diazepam at a dose of 0.1 mg / kg in patients who do not respond to physostigmine. 
- Hypotension. Administer norepinephrine, phenylephrine or dopamine, avoiding the administration of adrenaline, which may worsen hypotension. 
- Ventricular arrhythmias. Propranolol. 
If necessary, intubation and assisted breathing may be used. The use of analeptics is not recommended as they may induce seizures.

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