FENISTIL OS GTT 20ML 1MG/ML

FENISTIL

active ingredients

Fenistil oral drops, solution 1 ml solution contains malato dimetindene 1 mg. Excipients with known effects: benzoic acid, glycol propylene, sodium. Fenistil coated tablets Each coated tablet contains malevolent dimetindene 1 mg lactose, sucrose, wheat starch. For the full list of excipients, see paragraph 6.1

Excellent

Fenistil Oral Drops Sodium phosphate dibasic dodecahydrate;propylene glycol;benzoic acid;disodium edetate;citric acid monohydrate;sodium saccharin;purified water. Fenistil coated tablets Lactose, wheat starch, magnesium stearate, talc, sucrose, calcium carbonate, arabic rubber, titanium dioxide, macrogol.

Therapeutic indications

- Syntomatic treatment of itching of various origins. - Syntomatic treatment of medicated and food allergies.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric, duodenal or other gastrointestinal and urogenital tract stenosis.Asthma and chronic obstructive pulmonary disease.Cardiovascular disease and hypertension.Hyperthyroidism.Epilepsy.Concomitant treatment with monoamine oxidase inhibitors.Newborns under 1 month of age, especially premature infants.

Population

Adults and children over 12 years of age The recommended daily dose is 3-6 mg of malated dimethin per day, divided into three administrations. This corresponds to the administration of: - 1 mg/ml drops: 20-40 drops 3 times a day - 1 mg coated tablets: 1-2 tablets coated 3 times a day. In patients with a tendency to drowsiness, 2 tablets (or 40 drops) are prescribed in the evening, before bedtime and 1 tablet coated (or 20 drops) during breakfast. Pediatric population Children under 12 years of age In children under 12 years use the medicine only after prescription. The recommended daily dose is 0.1 mg/kg body weight/day, i.e. 2 drops per kg body weight per day, divided into three daily administrations. 20 drops = 1 ml = 1 mg of malato dimetindene. Fenistil drops should not be subjected to high temperatures: add drops in the bottle at the last moment, when the content is warm. If the child is able to eat with the spoon, administer the drops not diluted in a teaspoon coffee. Their taste is pleasant. Seniors The safety and effectiveness of dimetindene in patients over 65 years of age have not been systematically assessed. Use only for short periods of treatment.

Conservation

Fenistil coated tablets: store in the original packaging. Fenistil oral drops: keep at a temperature below 25°C. Keep the bottle in the original packaging to protect the medicine from light.

Warnings

Use carefully in patients with severe liver disease. Antihistamines can cause photosensitization: after administration of the drug avoid exposure to sunlight. Use carefully in the elderly as they are more subject to adverse reactions such as agitation and fatigue. Avoid use in elderly patients with mental confusion. Pediatric population Particular attention should be paid to determining the dose in the pediatric population. In children under 12 years use the medicine only after prescription. Caution is recommended in case of administration of any antihistamine to children under the age of 1 year: the sedative effect may be associated with episodes of apnea during sleep. In smaller children, it has been reported that antihistamines can induce excitability. Important information about some excipients: Fenistil tablets contains: - lactose: patients with rare hereditary problems of galactose intolerance, lactase lapp deficiency, or glucose-galactose mal absorption, should not take this medicine. - Sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. - Fruit starch: in this medicine, wheat starch contains only a very small amount of gluten; is very unlikely to cause problems in case of celiac disease. A tablet contains no more than 0.2 micrograms of gluten. People with wheat allergy (different from celiac disease) should not take this medicine. Fenistil oral drops contains: - Benzoic acid: this medicine contains 2 mg of benzoic acid per dose (40 drops) equivalent to 1 mg/ml. - Propilene glycol: this medicine contains 200 mg of glycol propylene per dose (40 drops) equivalent to 100 mg/ml. Clinical monitoring is required for patients with liver or kidney failure due to various adverse events attributed to glycol propylene such as kidney dysfunction (acute tubular necrosis), acute kidney damage and liver dysfunction. - Sodium: this medicine contains less than 1 mmole (23 mg) of sodium per dose (equivalent to 40 drops), i.e. essentially ‘without sodium’.

Interactions

The effect on the central nervous system of depressing drugs of the central nervous system (such as tranquilizers, opioid analgesics, anticonvulsants, antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, purposelamine and alcohol) can be strengthened by malato dimetindene. This can cause undesirable consequences that could jeopardize life. Antidepressants triceclic and anticholinergics (e.g. bronchodilators, gastrointestinal antispastics, midriatics, urologic antimuscarinics) can explicate an additive antimuscarinic effect with that of antihistamines, increasing the risk of an aggravation of glaucoma or urinary retention. To minimize the depression of the SNC and the possible strengthening, the simultaneous administration of procarbazine and antihistamine must be used with caution. The use of antihistamines can mask the first signs of ototoxicity of some antibiotics and can reduce the duration of action of oral anticoagulants.

Effects

Summary of security profile Undesirable effects include drowsiness, especially at the beginning of treatment. In very rare cases, allergic reactions may occur. Table of adverse reactions Undesirable effects are listed below according to the class and frequency organ system. The frequencies are defined as: very common (≥1/10); common (≥1/100, Classification for systems and organs Adverse event Frequency Immune system disorders Very rare Skin rashes Awareness photos Anaphylactoid reactions (including facial edema, pharyngeal edema and dispnea) Psychiatric disorders Rare Action Very rare Signs of excitement (such as euphoria, tremor, insomnia, seizures) Diseases of the nervous system Very common Ease Town Sleep Nervousism Rare Cefa Vertigo Very rare Description Austria Coordination disorders Disorders of vision Respiratory, chest and mediastinic pathologies Very rare Nose dryness Reduction and thickening of bronchial secretion accompanied by sense of chest oppression and respiratory difficulty Gastrointestinal diseases Rare Gastrointestinal disorders Nausea Dry mouth and throat Very rare Anorexia Vote Diarrhea or stipsi Kidney and urinary pathologies Very rare Difficulty in urination Urinary retention You can also check: Pathologies of skin and subcutaneous tissue: Oedema isolated cases, skin rash. Diseases of musculoskeletal system and connective tissue: Muscle spasm. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms In case of overdose, as with other H antihistamines₁ you can manifest the following symptoms: central nervous system depression with drowsiness (especially in adults), central nervous system stimulation and anti-cholinergical effects (especially in children and elderly) with excitement, ataxia, hallucinations, tremors, convulsions, tonic-clonic spasms, midriasis, dry mouth, face heat flushes, urinary retention and fever. It can also appear hypotension, ingravescent coma with cardiorespiratory collapse and death. No lethal outcome was reported following overdose of Fenistil. Management There is no specific antidote in case of overdose of antihistamines; the usual emergency measures must be implemented: induction of vomiting, gastric lavender if you have failed to provoke vomiting, active carbon administration, saline laxatives and the usual cardio-respiratory support measures. No stimulants are given; vasopressor drugs can be used to treat hypotension.

Pregnancy Clinical data in pregnancy are not available for male dimetindene. Animal studies have not shown direct or indirect harmful effects on pregnancy and on fetus/neonate. Safety of use during pregnancy was not assessed in man. Fenistil should be administered during pregnancy only after the doctor assessed the risk/benefit ratio by estimating that the benefit for the mother exceeds the risk for the fetus. Food The use of Fenistil is not recommended during breastfeeding as it is not possible to exclude the excretion of malato dimetindene in breast milk. Fertility Effects on fertility in animal studies have not been observed.

Source: Farmadati