Descrizione Clinica
Actigrip 12cpr 2.5+60+500mg Acti nasal decongestionants
ACTIGRIP 2.5 MG/ 60 MG/ 500 MG
active ingredients
Each tablet contains: • active ingredients: triprolidine hydrochloride 2,5 mg (triprolidine free base 2,091 mg); pseudoephedrine hydrochloride 60,0 mg (pseudoefedrine free base 49,154 mg); paracetamol 500,0 mg; For the full list of excipients, see paragraph 6.1.Excellent
Each tablet contains: pregelatinized maize starch, povidone, chrospovidone, stearic acid, microcrystalline cellulose, colloidal silica anidra, magnesium stearate.Therapeutic indications
Treatment of cooling symptoms characterized by nasal obstruction, aqueous rhyrrhea, headache and/or fever.Contraindications
• Hypersensitivity to active ingredients, other antihistamines or any of the excipients listed in the paragraph 6.1. • Children under the age of 12. • During pregnancy and nursing (see paragraph 4.6). • Patients in treatment with monoaminoxydase inhibitors (IMAO) or in the two weeks following such treatment. In such cases the concomitant use of Actigrip can cause an increase in blood pressure or hypertensive crisis (see paragraph 4.5) and in the treatment of low respiratory tract diseases, including bronchial asthma. • The association with indirect sympathomimetic drugs, funny mimetic alpha (orally and/or nasal) (see paragraph 4.5 Interactions with other medicines and other forms of interaction). • For its anti-linergical effects do not use in the case of glaucoma, prostatic hypertrophy, in the obstruction of the vescic neck, in the pyloric and duodenal stenosis or of other sections of the gastroenteric and urogenital apparatus. • Patients with pre-existing cardiovascular diseases, especially those with coronary diseases, hypertension and thyroid diseases. • In patients with stroke history or having risk factors for stroke, due to the alphasymimetic activity of vasoconstrictor, § Epilepsy. • Diabetes. • Severe liver and kidney affections. • Paracetamol-based medicines are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and those with severe haemolytic anemia. • Severe hepatocellular failure.Population
Posology. Adults: a tablet 2 - 3 times a day, for a maximum of 5 days of therapy. Pediatric population (children over 12 years until 18 years): a tablet 2 - 3 times a day, for a maximum of 3 days of therapy. Do not exceed the recommended doses; in particular, older patients will have to comply with the above minimum doses. Method of administration: Take tablets by mouth. Intake of the drug must take place on a full stomach.Conservation
Store in a dry place, at a temperature not exceeding 25°C.Warnings
The use of Actigrip must be avoided if you are already using any other medicines containing paracetamol. Persons suffering from alcoholism must contact their physician before taking paracetamol. Patients with liver disease should consult the doctor before taking Actigrip. Patients with migraine treated with ergotamine alkaloids vasoconstrictors should consult the doctor before taking Actigrip (see paragraph 4.5). In patients treated with paracetamol, severe skin reactions were reported very rarely as general acute exantematic pustolosis (PEAG), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Patients should be informed about the signs of serious skin reactions and use should be stopped at the first signs of skin rash appearance or any other sign of hypersensitivity. In the early stages of therapy patients seem to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. Severe skin reactions such as acute and generalized exantematic pustolosis (AGEP) have been reported very rarely with products containing pseudoephedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from a widespread and localized edematous erythema mainly on the skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms are observed as formation of numerous small pustulas with or without pyrexia or erythema, the administration of ACTIGRIP must be interrupted (see paragraph 4.8). If the fever persists for more than three days or if the symptoms do not improve or appear another within five days or are accompanied by high fever, exantema, excessive amount of mucus and persistent cough, consult your doctor before continuing administration. For the presence of pseudo-ephedrine, patients must be informed that the treatment must be interrupted in case of an organ: hypertension, tachycardia, palpitations or heart arrhythmia, nausea or any neurological signs (such as appearance or exacerbation of headaches). If sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis develop (see paragraph 4.8), the pseudophedrine must be interrupted and it is necessary to consult a doctor. Ischemic Optical Neuropatia: Cases of ischemic optical neuropathy have been reported with the pseudoephedrine. The pseudoephedrine should be interrupted if sudden loss of sight or reduction of visual acuity should occur, for example in case of scotoma. The use of antihistamines can mask the first signs of ototoxicity of certain antibiotics. Patients with respiratory disorders such as emphysema and chronic bronchitis should be advised to consult a doctor before using triprolidine. It may cause drowsiness (see paragraph 4.8). Triprolidine can increase the sedative effects of substances that depress the central nervous system as alcohol, sedatives, tranquilizers (see paragraph 4.5). You should inform patients that you should avoid using alcoholic beverages during treatment with Actigrip and that you should consult your doctor before taking Actigrip in conjunction with medicines that depress the central nervous system. Patients with reduced kidney function should not take Actigrip unless recommended by the doctor. High or prolonged doses of the medicinal product may result in high-risk hepatopathy and alterations to the kidney and blood. In case of kidney and hepatocellular insufficiency use only in case of actual need and under direct medical control. During treatment with paracetamol before taking any other medication, check that it does not contain the same active ingredient, as if the paracetamol is taken in high doses severe adverse reactions may occur. Overdose can lead to liver damage. Therefore, careful medical supervision is necessary for both adults and children, even if there are no signs or obvious symptoms. Invite the patient to contact the doctor before associating any other medication (see paragraph 4.5). It is not recommended to use the medicine if the patient is in treatment with anti-inflammatory drugs. Special popularity: Consult the doctor to determine the dose in the elderly for their increased sensitivity to the drug.Interactions
Anticoagulant drugs (e.g. warfarin): Concurrent use of paracetamol with oral anticoagulants can lead to slight variations in INR values. In this case, patients should ask for advice to the doctor or pharmacist before using Actigrip if they are already taking medications to fluidize blood, such as warfarin or other cumarinic derivatives. Monoaminoxydase inhibitors (IMAO): The pseudoephedrine exercises its vasoconstrictor properties by stimulating adrenergic receptors and encouraging the release of norepinephrine from neuronal sites. Since IMAOs hinder the metabolism of sympathomimetic amines by increasing the availability of releasing norepinephrine in the nervous system, they can enhance the diary effect of pseudoephedrine. In literature, cases of hypertensive acute crises were reported due to the concomitant use of IMAO and sympathomimetic amines. Substances depressing the SNC (Alcol, sedatives, tranquilizers): The drug may interact with alcohol, triceclinical antidepressants, neuroleptics or other depressive drugs on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics that should not be taken during therapy. Related to the presence of pseudoephedrine, associations are contraindicated with indirect sympathomimetics (ephedrine, methylfenidate, phenylphrine) and sympathomimetic alpha by mouth and/or nasal (nafazoline, oxytazoline, phenylphrine, tetrizoline, plotzoline, yourminoeptano), for the possible risk of vasoconstriction and. Concurrent administration of hergot dopaminergic alkaloids (bromocriptin, cabergoline, lisuride, pergolide) and vasoconstrictor alkaloids of hergot (dihydroergotamine, ergotamine, methylrgometrine) can induce vasoconstriction and/or hypertensive crisis. Also should not be taken simultaneously to ACTIGRIP, being able to cause significant interactions, antihypertensives, oral hypoglycemizers, metoclopramide, other substances with anti-linergical action. Associations requiring precautions for use: Halogenated anesthetic gases: risk of hypertensive perioperative crisis. It is advisable to stop the treatment with ACTIGRIP a few days before a scheduled surgery. Furazolidone causes progressive inhibition of monoaminoxydasis, so it should not be taken simultaneously to ACTIGRIP. The effect of antihypertensives that interfere with the activity of the sympathetic (e.g. methyldopa, alpha and betabloccanti, debrisochina, guanetidina, betanidina and bretilio) can be partially canceled by ACTIGRIP, which therefore, even in this case, should not be taken simultaneously. The usual ingestion of anticonvulsant drugs or oral contraceptives can, with an enzyme induction mechanism, accelerate the metabolism of paracetamol. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). Paracetaminol administration may interfere with the determination of uricemia (by means of the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).Effects
Data from clinical trial: There is no sufficient data available to report adverse reactions of randomized placebo controlled trials for the combination of parcetamol, pseudophedrine and triprolidine. Below are the reported adverse reactions reported with a frequency ≥1%, identified in randomized studies controlled with placebo: - with formulations containing pseudophedrine as a single active substance: dry mouth, nausea, dizziness, insomnia and nervousness; - with formulations containing paracetamol and pseudophedrine: nervousness. Data from post-marketing experience: Below are the adverse events identified during the post marketing experience with paracetamol, pseudo-phedrine, the combination of pseudo-phedrine and triprolidine, the combination of pseudo-phedrine and paracetaminophen or the combination of paracetamol, pseudophedrine and triprolidine. Adverse reactions are shown in Table 1 according to the frequency categories using the following convention: Very common (≥ 1/10); Common (≥ 1/100,Overdosing
In case of overdose by pseudo-ephedrine, nausea, vomiting, strong depressive or stimulating effects on the central nervous system, insomnia, tremors, midriasis, anxiety, agitation, hallucinations, palpitations, tachycardia, reflex bradycardia, drowsiness, letargy, respiratory depression, hypertension, irritability, convulsions are generally observed. Other effects may include dysrithmia, hypertensive crisis, intracerebral hemorrhage, myocardial infarction, psychosis, rhabdomiolisis, hypocalemia and ischemic infarction of the intestine. In children the dominant action is the exciting action with accentuated tremors, drowsiness, insomnia, hyperactivity and seizures. Pallore, anorexia, nausea and vomiting are frequently the first signs of paracetamol overdose. Hepatic necrosis is a complication related to paracetamol overdose. Hepatic enzymes can become high and prolonged protrombine time at a time between 12 and 48 hours but clinical signs may not occur until the 6th day from ingestion. Alcohol can enhance the hepatosity of paracetamol overdose and may have contributed to determining acute pancreatis in a patient who had taken excessive amounts of paracetamol. In case of hyperdosage, the paracetamol, contained in ACTIGRIP, can cause liver cytolysis and can evolve towards massive and irreversible necrosis. Keep out of reach of children. In case of overdose, ask your doctor for help or contact a poison center immediately. Management • Instant transfer of the patient to the hospital. • Relief of a plasma sample to determine the initial dose of paracetamol. • Rapid evacuation of the product ingested by gastric lavender. • Acidify urine by administering ammonium chloride (to increase the elimination of pseudoephedrine). • Usually the treatment of overdose includes the administration as soon as possible of the N-acetylcysteine antidote intravenously or by mouth and, if possible, before the tenth hour. • Syntomatic treatment.ACTIGRIP is contraindicated during pregnancy and nursing.
Source: Farmadati
