Actigrip Day & Night 12+ 4 Tablets

WARNINGS
Concomitant use should be avoided with analgesics, antipyretics or other NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment that is needed to control symptoms. High doses or prolonged administration of the paracetamol, present in the product, or in other drugs containing paracetamol, can cause high-risk liver disease and alterations in the kidney and blood, including severe and severe adverse reactions. In adults and children over 12 years of age, the total dose of paracetamol should not exceed 4 g per day. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh> 9), acute hepatitis, concomitant treatment with drugs that impair liver function, deficiency of glucose-6-phosphate dehydrogenase, haemolytic anemia. Gastrointestinal safety. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. In particular, in the case of simultaneous treatment with anticoagulant or antiplatelet drugs, the dosages must be reduced. When gastrointestinal bleeding or ulceration occurs in patients taking the drug, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Skin safety: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal necrolysytotoxic, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Cardiovascular and cerebrovascular safety: caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). . Patients should be advised that treatment should be discontinued if the following symptoms associated with the pseudoephedrine content occur: arterial hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any neurological signs (onset or exacerbation of headache). After 3 days of continuous use without appreciable results or if a high fever or other side effects appear, stop treatment and consult your doctor or pharmacist. In the rare cases of allergic reactions, administration should be discontinued. Paracetamol should be used with caution in subjects with renal and hepatocellular insufficiency. For the paracetamol content, the administration of the drug can interfere with the determination of uricaemia (by means of the phosphotungstic acid method) and with that of glycaemia (by means of the glucose-oxidasiperoxidase method). Attention for those who carry out sports activities: the product contains substances prohibited for doping.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics: paracetamol in combination.
STORAGE
Store at a temperature not exceeding 25 degrees C. Store in the original package in order to protect the medicine from light and moisture.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients. Children under 12. Known or suspected pregnancy, breastfeeding. Severe heart failure, cardiovascular disease, hypertension, glaucoma. Patients with a history of stroke or predisposing risk factors. tenosis of the gastrointestinal tract. Patients with a history of gastrointestinal bleeding or perforation related to previous active treatments or a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Hyperthyroidism, diabetes. Prostatic hypertrophy, urogenital stenosis Asthma Patients treated with monoamine oxidase inhibitors (MAOIs) and in the two weeks following this treatment; patients with a history of seizures, epilepsy. Furthermore, due to the paracetamol content, the drug is contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase.
NAME
ACTIGRIP DAY & NIGHT TABLETS
EXCIPIENTS
One white tablet (day) contains: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate, povidone, crospovidone, stearic acid. One blue coated tablet (night) contains: microcrystalline cellulose, maize starch, sodium amidoglycolate, hydroxypropylcellulose, pregelatinised maize starch, croscarmellose sodium, stearic acid, magnesium stearate, hypromellose, propylene glycol, Opaspray M-1F-4315B.
SIDE EFFECTS
Very common side effects. Gastrointestinal disorders: abdominal or stomach pain, dyspepsia, nausea, diarrhea and vomiting, dry mouth and throat. CNS disorders: headache, drowsiness, sedation, excitement, increased sweating, sleep disturbances. Visual disturbances: impaired vision. Disorders of the skin and skin adnexa: skin rash, urticaria. Respiratory system disorders: dry nose. Common side effects. Disorders of the skin and skin appendages: itching, contact dermatitis, inflammation of the skin or mucous membranes. Cardiac disorders: orthostatic / postural hypotension, arrhythmia, tachycardia. CNS disorders: nervousness and dizziness, tinnitus, ataxia, euphoria and tremors. Hypotension, decreased mucous secretions. Visual disturbances: diplopia, impaired vision, glaucoma, closed angle glaucoma. Gastrointestinal disorders: disorders of the epigastrium. Respiratory system disorders: dyspnoea. Urinary system disorders: urinary retention. Metabolism and nutrition disorders: hyperamylasemia. Systemic disorders: fatigue, asthenia. Hepatobiliary disorders: liver function disorders. Uncommon side effects. Disorders of the skin and skin appendages: fixed drug eruption (FDE), erythema multiforme, rashes. Disorders of the urinary system: acute renal failure, interstitial nephritis, hematuria, anuria. Gastrointestinal disorders: ulcerative stomatitis, constipation, flatulence, peptic ulcers, gastrointestinal perforation or haemorrhage sometimes fatal particularly in the elderly, melaena, haematemesis, exacerbation of colitis and Crohn's disease. Respiratory system disorders: sneezing, dryness of the pharynx and bronchial tree. Disorders of the skin and skin adnexa: photosensitization. CNS disorders: central depression, mental confusion, impaired cognitive function. Undesirable effects rare. Endocrine disorders: hyperthyroidism. Disorders of the urinary system: renal papillary necrosis. CNS disorders: hallucinations and nightmares, secondary mania, anxiety, psychiatric disorders, severe headache. Impaired memory or concentration. Convulsions. Haematological disorders: blood dyscrasias, agranulocytosis, anemia, haemolytic anemia and thrombocytopenia. Hypersensitivity reactions: anaphylactic shock, edema of the larynx. Hepatobiliary disorders: hepatitis. Gastrointestinal disorders: gastritis, pancreatitis. Very rare side effects. Haematological disorders: leukopenia, neutropenia, pancytopenia. Cardiac disorders: heart failure, angina, ST segment increased, myocardial infarction, hypertension, angioedema, edema, Hepatobiliary disorders: hepatotoxicity. Skin and skin adnexa disorders: Bullous reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis. Hypersensitivity reactions: toxic shock syndrome.
PREGNANCY AND BREASTFEEDING
The product is contraindicated in case of confirmed and presumed pregnancy, and during lactation. Inhibition of prostaglandin synthesis may affect pregnancy and / or embryo / fetal development.Results from epidemiological studies suggest an increased risk of diabetes and cardiac malformation and gastroschisis after use of an early stage prostaglandin synthesis inhibitor. of pregnancy. The absolute risk of cardiac malformations increased by less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can 'progress to renal failure with oligo-hydroamine; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Breastfeeding Paracetamol, pseudoephedrine and diphenhydramine are secreted in breast milk; therefore, the drug is contraindicated during lactation.
INDICATIONS
Treatment of cold and flu symptoms.
INTERACTIONS
Concomitant use with tricyclic antidepressants, sympathomimetics, or MAOIs may interfere with catecholamine catabolism and may occasionally cause blood pressure increases. The effects of anticholinergic drugs can be enhanced by concomitant use of the drug. Patients should be advised that additive effects may occur with alcohol, hypnotics, sedatives and tranquilizers which therefore should not be taken at the same time. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The use of antihistamines at the same time as ototoxic certibiotics can mask the first signs of ototoxicity, which can only reveal itself when the damage is irreversible. The habitual intake of anticonvulsant drugs or oral contraceptives can, with an enzyme induction mechanism, accelerate the metabolism of paracetamol, decreasing plasma concentration, increasing the rate of elimination. The rate 'of absorption of paracetamol can' be increased by concomitant intake of metoclopramide and domperidone and decreased by cholestyramine. Treatment with probenecid may lead to a decrease in the clearance of paracetamol and an increase in its half-life in the blood. The use of the product is not recommended if the patient is being treated with other analgesics, antipyretics or non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function, co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible failure. acute renal, usually reversible. These interactions should be considered in patients taking the drug concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. Due to the pseudoephedrine content, the effect of antihypertensive agents that interfere with sympathetic activity can be partially canceled by the drug, which therefore should not be taken at the same time. They should not be taken at the same time as the drug: corticosteroids, because they can cause an increased risk of gastrointestinal ulceration or bleeding; antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), because they can cause an increased risk of gastrointestinal bleeding; anticoagulants such as warfarin and altricumarins, as their effect can be increased by prolonged use of paracetamol with an increased risk of bleeding.
DOSAGE
Adults and children over 12 years of age: one white tablet three times a day, in the morning, at noon and in the afternoon, plus one blue tablet in the evening before bedtime. Do not exceed the recommended dose.
ACTIVE PRINCIPLES
One white tablet (day) contains: paracetamol 500 mg, pseudoephedrine hydrochloride 60 mg. One blue coated tablet (night) contains: paracetamol 500 mg, diphenhydramine hydrochloride 25 mg.