Theralene 10mg 50 tablSANOFI AVENTIS BELGIUM
Symptomatic treatment of various allergic symptoms: rhinitis, conjunctivitis, urticaria.
Adjuvant symptomatic treatment of itchy skin conditions (eczema, prurigo,). The role of antihistamines in pruritus, skin conditions attributed to non-allergic origin, has not been proved.
Banale rhinitis, skin diseases and asthma, which is not allergic in nature, are no indications for a H 1 -antihistamine.
Qualitative and quantitative composition:
Theralene 10 mg tablet alimemazine tartrate = 10 mg base.
Theralene drops: alimemazine tartrate = 40 mg base in 1 ml (= 40 drops).
For excipients, see section 'List of excipients.
Theralene 10 mg: round, pink, fragile film-coated tablets.
Theralene drops: potable solution droplets.
Posology and method of administration:
The symptomatic treatment should be short term (several days).
The intakes should as needed during the day are repeated, in accordance with an interval of 4 hours and not exceed 4 intakes per day.
The tablets are reserved for adults.
Per Intake: ½ or 1 tablet to 10 mg or 5 to 10 drops.
Never take more than 10 mg / dose or 40 mg per 24 h.
Children over 2 years.
Per Intake: 0.125 to 0.25 mg / kg.
1 drop = 1 mg Theralene (the drops may be given a glass of sugar water) .
intake by no more than 5 mg take.
Not more than 20 mg per 24 hours taken.
Because of the strong sedative effect alimemazine, it is recommended Theralene evening to take .
If the condition of the patient is not improved after three days, it is doubtful whether this treatment is suitable and treatment should be re-evaluated.
This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
In conjunction with The anticholinergic effect: - closed-angle glaucoma - risk of urinary retention.
Hypersensitivity to phenothiazines or one of the components of Theralene.
History of agranulocytosis associated with other phenothiazines.
Since phenothiazines are regarded as hypothetical risk factors for the occurrence of apnea in infants, it is contraindicated for these derivatives for use in children less than two years, with victims of an attack of apnea or brothers and sisters of children one unexplained sudden death died.
Special warnings and precautions for use:
Drinking alcohol during treatment is not recommended and so is any substance that suppresses the central nervous system.
In hepatic impairment, caution .
Administration after meals, the frequency of gastro-intestinal disturbances decrease.
Precautions regarding the excipients:
Diabetes: Theralene drops contain 4.5 mg of sucrose (sucrose) per drop.
Theralene drop should not be administered to patients with hereditary fructose intolerance, a galactose / glucose malabsorption or a deficiency sucrase-/isomaltase.
Theralene The tablets contain lactose and should not be administered to patients with a lactase insufficiency, galactosaemia or glucose / galactose malabsorption disease.
Theralene drop containing para-hydroxybenzoates as preservatives. Derivatives of para-hydroxybenzoates may cause urticaria. Usually refers to the delayed-type reactions such as contact dermatitis. In some rare cases, respondents included the immediate-type, accompanied with urticaria and bronchospasm.
There may a paradoxical stimulation of the central nervous system. This risk are children, patients with insomnia, nervousness, euphoria, irritability and trembling and in rare cases, patients who suffer from nightmares, hallucinations and convulsions.
After taking phenothiazines extrapyramidal symptoms may occur. Caution is advised when Theralene administered to patients with Parkinson's disease.
In epilepsy patients, a greater clinical and possibly electrical monitoring is needed because the chance of a reduction of the epileptogenic threshold by the phenothiazines.
Theralene must caution be used when: 1
.) Elderly patients with: - a greater susceptibility to orthostatic hypotension, dizziness and sedation - chronic constipation (risk of paralytic ileus) - a possible prostatic hypertrophy.
2.) Patients with certain hartpathologieën (risk of hypotension and tachycardia).
3.) Patients with severe hepatic or renal impairment (risk of accumulation).
Phenothiazines possess photo sensitizing properties, therefore exposure to the sun should be avoided.
Pregnancy and lactation:
Top of pregnancy.
Although no teratogenic effects in animal experiments revealed, is the lack of clinical data in man (and by analogy with the phenothiazines with a risk of malformations was reported) recommended not to prescribe this medicine during pregnancy.
end of pregnancy.
By analogy with other phenothiazines, with prolonged treatment of the mother at risk of drowsiness or hyperexcitabiliteit the newborn.
Without data on the transition in breast milk, not used during the lactation (see section 'Contraindications').
Blood and lymphatic system.
Leucopenia, neutropenia, thrombocytopenia, hemolytic anemia and exceptionally agranulocytosis.
Mental confusion or excitation in the elderly.
disorders of the nervous system.
Drowsiness day ranging from one individual to another and according to age. To reduce risk of drowsiness, it will start increasing the dose progressively.
Dizziness, headache, and sedation.
Ding Reduce the concentration and memory.
Cases of tardive dyskinesia have been described after prolonged administration of alimemazine (extrapyramidal disorder, tremor, hypertonia).
Excitatiefenomenen in child and infant: restlessness, nervousness, insomnia. Use in children under 2 years: see section 'Contraindications.
Disorders of the eye.
Disorders the heart.
disorders of the respiratory system.
Increase the viscosity of bronchial secretions (atropine effect).
disorders of the gastrointestinal tract.
Nausea, risk of mouth dryness and constipation (atropine effect).
Skin and subcutaneous tissue.
Allergic skin disorders, photosensitization.
disorders of the kidneys and urinary tract.
Urinary retention (atropine effect).
Allergic reactions: edema, rare: angioneurotic edema, anaphylactic shock.
Effects on ability to drive and use machines:
Among drivers of vehicles and users of machinery should take into account the risk of drowsiness associated with this treatment, especially in the beginning.
attentive to the potentiating effect of alimemazine substances on the central nervous system depressants (hypnotics, alcohol).
The clinical picture is dominated by the excitation, with agitation, hallucination, ataxia, incoordination, and convulsions Athetosis. The latter appear intermittently. Beven and athetotische movements can be of the Prodromi.
Rigid and dilated pupils, redness of the tegumenta (face) and hyperthermia are common signs that the atropine intoxication reminiscent. The final stage involves a coma that is exacerbated by a cardiorespiratory collapse.
Here the clinical picture is different: the depression and coma may precede a stage of excitation and convulsions. Fever and redness of his exceptionally tegumenta.
symptomatological with a severe intoxication, with appropriate ventilation and anticonvulsants (diazepam to control seizures to keep). This treatment is done in the hospital.
As with all antihistamines have little value in a mostly emetic intoxication.
Gastric lavage can be considered if the patient soon after the ingestion of massive doses in the hospital.
Vomiting in conscious individuals, activated carbon.
Caution in combination with barbiturates because of the possibility of cumulative toxicity.
List of excipients:
Theralene 10 mg tablet.
Lactosum monohydricum - amylum tritici - colloidalis hydrica Silica - Silica colloidalis anhydrica - Magnesii stearas - Erythrosinum pro tabletta una compressa - Butyl acetoricinoleas. - Zeinum obducta.
Coccin. Novus - Acidum citricum monohydricum - Rubi idaei essent. - Aethanolum - Glycerinum - Mentholum - Sodium cyclamas - Saccharum - Methylis parahydroxybenzoas - Propylis parahydroxybenzoas - Aqua qs purificata ad. 1 ml. (Gtti = 40).
The following form contains sugar Theralene:
Theralene drops: 4.5 mg per drop.
Interaction with other medicinal products and other forms of interaction:
Potentiation of substances which affect the central nervous system depressants (hypnotics, anesthetics, alcohol).
The combination with other anticholinergic agents avoided (other antihistamines, neuroleptics, anti-Parkinson's disease, anticholinergics, antispasmodics atropinische, disopyramide, tricyclic antidepressants).
In simultaneous intake of a MAO inhibitor may increase the risk of the extrapyramidal effects are not excluded.
Concomitant intake of tramadol increases the risk of seizures.
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