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Cinfatos Descongestivo Oral Solution 200 Ml

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€7.92 (tax incl.) €8.80
Reference:
725174
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Description
ACTION AND MECHANISM

- Combination of a central [ANTITUSIVO], a [NASO/FARINGEO DECONGESTANT] and an agent [HISTAMINERGICO ANTAGONIST (H-1)], which can eliminate cough, nasal congestion and rhinorrhea associated with catarral processes.


SPECIAL WARNINGS

- It is recommended to monitor the patient for signs of abuse.- Association with IMAO should be avoided, leaving at least 14 days of rest between administration of both drugs.- It is recommended to periodically monitor blood pressure in hypertensive patients.


ADVICE TO THE PATIENT

- It is recommended not to exceed the recommended daily doses.- It may cause drowsiness, so it is recommended to exercise caution when driving, and not to combine it with drugs or other sedative substances such as alcohol.- The doctor or pharmacist should be advised if the patient has diabetes, heart disease, hypertension or glaucoma, as well as if he is being treated with any other drug.- The doctor should be advised if the patient is being treated with antidepressants.- The patient should be advised if the patient is being treated with antidepressants. to the doctor any change in the patient's behavior or mood.- Treatment should be discontinued and the doctor should be stopping if nervousness, severe headache, dizziness or insomnia appears, if symptoms persist for more than seven days or if high fever appears.- It is advised to drink plenty of water during treatment.- It should not be administered together with other medicines containing nasal decongestants.


CONTRAINDICATIONS

- Hypersensitivity to dextrometorphane, pesudoephedrine or triprolidine, or [OPIOID ALLERGY] or sympathomimetics.- [PORFIRIA]. H1 antihistamines are not considered safe in these patients.- Patients in treatments with IMAO antidepressants within 14 days before starting pseudoephedrine therapy.- IMAO treatments within 14 days before starting therapy or concomitantly. Containing pseudoephedrine may cause an increase in blood pressure; containing dextrometorphane, Serotonin syndrome (see Interactions) could be triggered.- [PRODUCTIVE COUGH], persistent cough, or smoking-associated cough, [PULMONAR ENFISEMA], [ASMA]. Inhibition of cough reflex may cause pulmonary obstruction. - [RESPIRATORY INSUFFICIENCY].- [ULCERATIVE COLITIS].- [GLAUCOMA]- Severe cardiovascular disease (hypertension, coronary or arterial disease) (see Precautions).- [HYPERTIROIDISM]


DOPING

Pseudoephedrine is a banned substance during competition.

It is prohibited when administration results in a concentration in urine greater than 150 mcg/ml.

Detection in a sample during competition of any amount of pseudoephedrine in combination with a diuretic or masking agent shall be considered an adverse analytical result, unless the athlete has obtained an approved therapeutic use authorisation (AUT) for ephedrine, in addition to that granted for the diuretic or masking agent.

It is considered a "specific substance" and, therefore, a violation of the rule in which this substance is involved may result in a reduction in sanction provided that the athlete can demonstrate that the use of the specific substance in question was not intended to increase his athletic performance.



EFFECTS ON DRIVING

This medicinal product may result in light sedation in certain patients, substantially affecting the ability to drive and/or operate machinery. Patients should avoid handling hazardous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.


PREGNANCY

Adequate and well-controlled human studies have not been conducted, so the use of this medicine is only accepted in case of absence of safer therapeutic alternatives.


INDICATIONS

- [COMMON COLD]. Symptomatic treatment of catarral processes that take place with [DRY TOS], especially in those of an irritative or nervous nature, and [CONGESTION NASAL].


INTERACTIONS

- Alcohol. It may enhance the onset of side effects.- Antiarthythmics. Some antiarthythmics may increase the toxicity of dextrometorphane by inhibiting metabolism.- Anticholinergics (antiparkinsonians, tricyclic antidepressants, IMAO, neuroleptics). These drugs could potentiate the anticholinergic effects of triprolidine.- Tricyclic antidepressants. An enhanced cardiac stimulant effects, with hypertension and tachycardia,- Antihypertensives (beta-blockers, diuretics, guanetidine) may occur. Pseudoephedrine could antagonize antihypertensive effects, and even lead to hypertensive seizures when combined with beta-blockers. It is recommended to monitor blood pressure.- Digital. The risk of cardiac arrhythmias may be increased.- Nervous stimulants (amphetamines, cocaine, xanthines). Nerve stimulation could be enhanced, resulting in intense excitability.- Expectorant and mucolytic. Pulmonary obstruction may occur when cough reflex is inhibited.- Thyroid hormones. An enhanced cardiac stimulant effects, with hypertension and tachycardia,- IMAO, may occur. IMAO could lead to severe and potentially fatal pictures when combined with pseudoephedrine (hypertensive crisis) or dextrometorphane (arousal, hypertension). It is recommended not to administer products with pseudoephedrine or dextrometorphane until at least 14 days after treatment with the antidepressant.- SSRS (fluoxetine, paroxetine). Dextrometorphane toxicity may be increased due to inhibition of its metabolism by these drugs.- Methyldopa. Hypertensive seizures may occur after joint administration with pseudoephedrine.- Nitrates. Pseudoephedrine could antagonize the antianginose effects of nitrates.- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Joint administration of antihistamines together with a sedative drug could enhance hypnotic action. Extreme precautions are recommended.- Sympathomimetic. An enhanced side effects may occur.


BREAST FEEDING

Pseudoephedrine is excreted with human milk, but it is not known whether dextrometorphane and triprolidine do so. Infants may be especially sensitive to the adverse effects of these drugs, so it is recommended to discontinue lactation or avoid administration of this medicine.


CHILDREN

It has been authorized for use in children up to 2 years of age. In children under 6 years of age administer only under medical supervision, due to the risk of paradoxical effects of CNS stimulation. It is not recommended for use in children under 2 years of age due to the absence of data in this population.


RULES FOR PROPER ADMINISTRATION

Measure the amount of the medicine with the dosing cup included in the package. It is recommended to take this medicine at meals. Intake with food or beverages does not affect its effectiveness. It is recommended to drink a large amount of water during treatment. If the medicine was given at night it should be taken a few hours before bedtime, to minimize the possibility of insomnia, especially in patients with difficulty sleeping. Alcoholic beverages should not be consumed during treatment because it may cause side effects. Do not take it in conjunction with grapefruit juice or bitter orange because they may increase side effects. Limit drinks that contain caffeine (coffee, tea, chocolate, and cola beverages). If symptoms get worse, or if they persist for more than 5 days, or are accompanied by high fever, skin rashes or persistent headache, the clinical situation should be evaluated.


DOSAGE

Orally:

- Adults: 10 ml/6-8 h.

- Children > 12 years: 10 ml/6-8 h.

- Children between 6-12 years: 5 ml/6-8 h.

- Children between 2-5 years: only under medical supervision, due to the risk of paradoxical effects of CNS stimulation; 2.5 ml/6-8 h.

- Children < 2 years: Safety and efficacy have not been evaluated, so its use is not recommended.

- Elderly: use adult dosing, but taking into account that dose adjustment may be necessary, as this population is especially sensitive to the adverse effects of pseudoephedrine.

Do not exceed 4 shots in 24 hours.

If symptoms get worse, or if they persist for more than 5 days, or are accompanied by high fever, skin rashes or persistent headache, the clinical situation should be evaluated.



POSOLOGY IN LIVER FAILURE

* A dose adjustment may be necessary as dextrometorphane metabolism may be altered.


POSOLOGY IN RENAL FAILURE

* Moderate or severe: Dose adjustment may be necessary, although no specific studies have been performed.


PRECAUTIONS

- [RENAL INSUFFICIENCY], [HEPATIC INSUFFICIENCY]. An accumulation of the active substances of the medicinal product may occur.

- Patients with [DIABETES], [CORONARY INSUFFICIENCY], [ISQUEMIC CARDIOPATIA], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [FEOCROMOCITOMA], [PROSTATIC HYPERPLASIA] or [URINARY VEJIGA OBSTRUCTION], [MYASTHENIA GRAVE], [ULCERA PEPTICA] estenosante or [INTESTINAL OBSTRUCTION], predisposition to glaucoma. Both pseudoephedrine and triprolidine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.

- [EPILEPSIA]. H1 antihistamines have sometimes been associated with paradoxical hyperexcitability reactions, so they may lower the seizure threshold.

- Patients who present [SEDATION], [ASTENIA], or who are covered up.

- [ATOPIC DERMATITIS]. Administration of dextrometorphane may be associated with the release of histamine, so it should be avoided in these patients.

- Surgical intervention. Discontinuation of treatment at least 24 hours before surgery is recommended.

- Abuse. Cases of abuse with dextrometorphane have been reported, particularly by adolescents. Therefore, this possibility should be taken into account because serious side effects may occur.

- Dependency. Dextrometorphane has sometimes resulted in checkered dependence, so it is recommended to monitor the patient.



PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sodium salts. For the exact sodium content, it is recommended to review the composition. Oral and parenteral pharmaceutical forms with sodium amounts greater than 1 mmol (23 mg)/maximum daily dose should be used with caution in patients with [RENAL INSUFFICIENCY] or sodium-poor diets.



ADVERSE REACTIONS

The components of this medicine do not usually result in significant adverse reactions. Digestives have been described. [NAUSEAS], [VOMITOS], [CLOSE], [DIARREA], [EPIGASTRICO PAIN], [ANOREXIA], [DRY MOUTH].- Neurological/psychological. [NERVIOSISM], [DIZZINESS], [VERTIGO], [EXCITABILITY], [INSOMNIA], [CEFALEA], [SOMNOLENCIA].- Cardiovascular. [CARDIAC ARRHYTHMIA], with [TAQUICARDIA] and [PALPITATIONS], especially at high doses or in predisposed patients. [ARTERIAL HIPERTENSION] may also occur.- Genitourinarias. [URINARY RETENTION].- Allergic/dermatological. Cases of [HYPERSENSITIVITY REACTIONS] have been reported, with [URTICARIA] and [EXANTEMATIC ERUPTIONS].


OVERDOSE

Symptoms: Overdose can sometimes lead to nonspecific gastrointestinal symptoms, such as nausea and vomiting. Cardiac arrhythmias, high blood pressure and excitability symptoms may also occur, with irritability, insomnia and nervousness. Cases of hallucinations have been reported in children. Treatment: It is recommended to institute the usual detoxification measures, with forced emesis, gastric lavage and administration of active charcoal, if a few hours have elapsed since overdose. Forced diuresis removal may be encouraged by acidifying urine, although it is not recommended in severe cases. The patient will then be monitored and symptomatic treatment instituted. In case of seizures, benzodiazepines may be administered intravenously or rectally, depending on age. If respiratory depression occur, naloxone will be administered. If necessary, assisted breathing shall be instituted.

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725174
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