Actigrip 2.5mg/60mg/500mg 12 tablets

Actigrip 2.5mg/60mg/500mg 12 tablets is a medicine formulated for the treatment of cold symptoms . Each tablet contains a combination of triprolidine hydrochloride , pseudoephedrine hydrochloride and paracetamol , which work synergistically to relieve nasal obstruction , watery rhinorrhea , headache and fever . This formulation is designed to offer fast and effective relief from common cold symptoms, thanks to its combined action of decongestant, antihistamine and analgesic. Actigrip is available in packs of 12 tablets, making it a practical choice for those looking for a complete treatment for cold symptoms.

ACTIVE INGREDIENTS

Active ingredients contained in Actigrip 2.5mg/60mg/500mg 12 tablets - What is the active ingredient in Actigrip 2.5mg/60mg/500mg 12 tablets?

Each tablet contains: • active ingredients: triprolidine hydrochloride 2.5 mg (triprolidine free base 2.091 mg); pseudoephedrine hydrochloride 60.0 mg (pseudoephedrine free base 49.154 mg); paracetamol 500.0 mg; For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Actigrip 2.5mg/60mg/500mg 12 tablets - What does Actigrip 2.5mg/60mg/500mg 12 tablets contain?

Each tablet contains: pregelatinized maize starch, povidone, crospovidone, stearic acid, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

DIRECTIONS

Therapeutic indications Actigrip 2.5mg/60mg/500mg 12 tablets - Why is Actigrip 2.5mg/60mg/500mg 12 tablets used? What is it used for?

Treatment of cold symptoms characterized by nasal obstruction, watery rhinorrhea, headache and/or fever.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Actigrip 2.5mg/60mg/500mg 12 tablets - When should Actigrip 2.5mg/60mg/500mg 12 tablets not be used?

• Hypersensitivity to the active substances, to other antihistamines or to any of the excipients listed in section 6.1. • Children under 12 years of age. • During pregnancy and breastfeeding (see section 4.6). • Patients being treated with monoamine oxidase inhibitors (MAOIs) or within two weeks of such treatment. In such cases, concomitant use of Actigrip may cause an increase in blood pressure or hypertensive crisis (see section 4.5) and in the treatment of lower respiratory tract diseases, including bronchial asthma. • Combination with indirect sympathomimetic drugs, alpha sympathomimetics (oral and/or nasal) (see section 4.5 Interactions with other medicinal products and other forms of interaction). • Due to its anticholinergic effects, do not use in cases of glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or stenosis of other parts of the gastrointestinal and urogenital system. • Patients with pre-existing cardiovascular disease, in particular those with coronary heart disease, hypertension and thyroid disease. • In patients with a history of stroke or who have risk factors for stroke, due to the alphasympathomimetic activity of the vasoconstrictor, § Epilepsy. • Diabetes. • Severe liver and kidney disease. • Paracetamol-based medicines are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and in those affected by severe haemolytic anaemia. • Severe hepatocellular insufficiency.

DOSAGE

Quantity and method of taking Actigrip 2.5mg/60mg/500mg 12 tablets - How to take Actigrip 2.5mg/60mg/500mg 12 tablets?

Dosage. Adults : one tablet 2 - 3 times a day, for a maximum of 5 days of therapy. Paediatric population (children over 12 years up to 18 years) : one tablet 2 - 3 times a day, for a maximum of 3 days of therapy. Do not exceed the recommended doses ; in particular, elderly patients should adhere to the minimum dosages indicated above. Method of administration: Take the tablets orally. The medicine must be taken on a full stomach.

CONSERVATION

Storage Actigrip 2.5mg/60mg/500mg 12 tablets - How to store Actigrip 2.5mg/60mg/500mg 12 tablets?

Store in a dry place, at a temperature not exceeding 25°C.

WARNINGS

Warnings Actigrip 2.5mg/60mg/500mg 12 tablets - About Actigrip 2.5mg/60mg/500mg 12 tablets it is important to know that:

The use of Actigrip should be avoided if you are already using any other medicine containing paracetamol. Patients suffering from alcoholism should consult their doctor before taking paracetamol. Patients with liver disease should consult their doctor before taking Actigrip. Patients with migraine treated with ergotamine alkaloid vasoconstrictors should consult their doctor before taking Actigrip (see section 4.5). Serious skin reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely in patients treated with paracetamol. Patients should be informed of the signs of serious skin reactions and use should be discontinued at the first signs of skin rash or any other sign of hypersensitivity. Patients appear to be at highest risk in the early stages of therapy: the onset of the reaction occurs in the majority of cases in the early stages of treatment. Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported very rarely with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from a widespread oedematous erythema and located mainly in the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as formation of numerous small pustules with or without pyrexia or erythema are observed, ACTIGRIP should be discontinued (see section 4.8). If fever persists for more than three days or if symptoms do not improve or new symptoms appear within five days or are accompanied by high fever, rash, excessive mucus and persistent cough, consult your doctor before continuing administration. Due to the presence of pseudoephedrine, patients should be advised to discontinue treatment if they experience: hypertension, tachycardia, palpitations or cardiac arrhythmia, nausea or any neurological signs (such as onset or exacerbation of headache). If sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop (see section 4.8), pseudoephedrine should be discontinued and a physician should be consulted. Ischaemic optic neuropathy: Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, such as scotoma. The use of antihistamines may mask the early signs of ototoxicity of certain antibiotics. Patients with respiratory diseases such as emphysema and chronic bronchitis should be advised to consult a physician before using triprolidine. May cause drowsiness (see section 4.8). Triprolidine may increase the sedative effects of substances that depress the central nervous system such as alcohol, sedatives, tranquilizers (see section 4.5). Patients should be informed that they should avoid drinking alcohol during treatment with Actigrip and that they should consult their doctor before taking Actigrip in conjunction with medicinal products that depress the central nervous system. Patients with reduced kidney function should not take Actigrip unless advised by their doctor. High or prolonged doses of the medicine may cause high-risk liver disease and even serious kidney and blood disorders. In case of renal and hepatocellular insufficiency, use only if strictly necessary and under direct medical supervision. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Overdose may lead to liver damage. Careful medical supervision is therefore necessary for both adults and children even if no obvious signs or symptoms appear. Invite the patient to contact the doctor before combining any other drug (see section 4.5). It is not advisable to use the medicinal product if the patient is being treated with anti-inflammatory drugs. Special populations: Consult the doctor to determine the dose in the elderly due to their greater sensitivity to the drug.

INTERACTIONS

Interactions Actigrip 2.5mg/60mg/500mg 12 tablets - Which medicines or foods can modify the effect of Actigrip 2.5mg/60mg/500mg 12 tablets?

Anticoagulant drugs (e.g. warfarin) : Concomitant use of paracetamol with oral anticoagulants may lead to slight changes in INR values. In this case, patients should seek advice from their doctor or pharmacist before using Actigrip if they are already taking blood-thinning drugs, such as warfarin or other coumarin derivatives. Monoamine oxidase inhibitors (MAOIs) : Pseudoephedrine exerts its vasoconstrictor properties by stimulating adrenergic receptors and promoting the release of noradrenaline from neuronal sites. Since MAOIs hinder the metabolism of sympathomimetic amines, increasing the availability of releasable noradrenaline in the nervous system, they may potentiate the pressor effect of pseudoephedrine. Cases of acute hypertensive crisis due to the concomitant use of MAOIs and sympathomimetic amines have been reported in the literature. Substances that depress the CNS (Alcohol, sedatives, tranquilizers) : The medicinal product may interact with alcohol, tricyclic antidepressants, neuroleptics or other drugs that depress the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics that should not be taken during therapy. Related to the presence of pseudoephedrine, associations with indirect sympathomimetics (ephedrine, methylphenidate, phenylephrine) and oral and/or nasal alpha sympathomimetics (naphazoline, oxymetazoline, phenylephrine, tetryzoline, tramazoline, tuaminoheptane) are contraindicated, due to the possible risk of vasoconstriction and/or hypertensive crisis (see paragraph 4.3 "Contraindications"). Concomitant administration of dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide) and vasoconstrictor ergot alkaloids (dihydroergotamine, ergotamine, methylergometrine) may induce vasoconstriction and/or hypertensive crisis. Likewise, antihypertensives, oral hypoglycaemics, metoclopramide, and other substances with anticholinergic action should not be taken at the same time as ACTIGRIP, as they may cause significant interactions. Combinations requiring precautions for use: Halogenated anaesthetic gases: risk of perioperative hypertensive crisis. It is advisable to stop treatment with ACTIGRIP a few days before a scheduled surgery. Furazolidone causes progressive inhibition of monoamine oxidase, so it should not be taken at the same time as ACTIGRIP. The effect of antihypertensives that interfere with sympathetic activity (e.g. methyldopa, alpha and beta blockers, debrisoquine, guanethidine, betanidine and bretylium) can be partially cancelled out by ACTIGRIP, which therefore, also in this case, should not be taken at the same time. The habitual 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 monitoring 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 (e.g. rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The administration of paracetamol may interfere with the determination of uricemia (by the phosphotungstic acid method) and with that of glycemia (by the glucose-oxidase-peroxidase method).

SIDE EFFECTS

Like all medicines, Actigrip 2.5mg/60mg/500mg 12 tablets can cause side effects - What are the side effects of Actigrip 2.5mg/60mg/500mg 12 tablets?

Data from clinical trials : There are insufficient data to report adverse reactions from randomised placebo-controlled trials for the combination of paracetamol, pseudoephedrine and triprolidine. The following adverse reactions were reported with a frequency ≥1%, identified in randomised placebo-controlled trials: - with formulations containing pseudoephedrine as a single active substance: dry mouth, nausea, dizziness, insomnia and nervousness; - with formulations containing paracetamol and pseudoephedrine: nervousness. Data from post-marketing experience : The following adverse events were identified during post-marketing experience with paracetamol, pseudoephedrine, the combination of pseudoephedrine and triprolidine, the combination of pseudoephedrine and paracetamol or the combination of paracetamol, pseudoephedrine and triprolidine. The adverse reactions are listed in Table 1 according to frequency categories using the following convention: Very common (≥ 1/10); Common (≥ 1/100, <1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, <1 / 1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data).

System Organ Classification (SOC) Frequency	Adverse reactions
Psychiatric disorders
Not known	anxiety, nervousness, restlessness, visual hallucination, insomnia
Nervous system disorders
Not known	convulsions, dizziness, excitement, headache (especially in the elderly), cerebrovascular accident.
Heart disease
Not known	Palpitations, myocardial infarction.
Respiratory, thoracic and mediastinal pathologies
Not known	Epistaxis
Skin and subcutaneous tissue disorders
Not known	pruritus, urticaria, acute generalized exanthematous pustulosis, rash, severe skin reactions, including cases of erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis, photosensitization
Kidney and urinary disorders
Not known	Dysuria, urinary retention
Gastrointestinal disorders
Not known	Ischemic colitis
Diagnostic tests
Not known	increased blood pressure
Immune system disorders :	hypersensitivity reactions, anaphylactic reaction
Eye pathologies
Not known	Ischemic optic neuropathy

Undesirable effects related to the presence of Paracetamol: Skin and subcutaneous tissue disorders: itchy rash, angioedema. Systemic disorders and conditions related to the site of administration: asthenia. Blood and lymphatic system disorders : thrombocytopenia, leukopenia, neutropenia, anemia, agranulocytosis. Hepatobiliary disorders: liver function disorders, hepatitis. Renal and urinary disorders : renal alterations, acute renal failure, interstitial nephritis, hematuria. Gastrointestinal disorders : dry mouth, abdominal discomfort, constipation, nausea, vomiting, diarrhea. Diagnostic tests : increased transaminases*. ^* a slight increase in transaminase levels may occur in some patients taking recommended doses of paracetamol. These cases are not accompanied by liver failure and generally resolve with the continuation or suspension of therapy with paracetamol. Undesirable effects related to the presence of Pseudoephedrine: Psychiatric disorders: hallucinations. Nervous system disorders: paraesthesia, psychomotor hyperactivity, tremors, cerebrovascular accident. Cardiac disorders: arrhythmia, tachycardia, myocardial infarction. Skin and subcutaneous tissue disorders: angioedema. Systemic disorders and conditions related to the site of administration: sweating. Gastrointestinal disorders: ischemic colitis. Undesirable effects related to the presence of Triprolidine: Psychiatric disorders: euphoria. Nervous system disorders: drowsiness. Gastrointestinal disorders : dry mouth, abdominal discomfort, constipation, nausea, vomiting, diarrhea. Cardiac disorders : hypotension (especially in the elderly). Respiratory, thoracic and mediastinal disorders: increased hyperviscosity of bronchial secretions. Eye disorders: acute attack of closed-angle glaucoma, mydriasis, blurred vision. In isolated cases, haemorrhagic stroke has occurred in patients who have used drugs containing pseudoephedrine. In particular, these cerebrovascular accidents have occurred during overdose, misuse and/or in patients with vascular risk factors. Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Actigrip 2.5mg/60mg/500mg 12 tablets - What are the risks of Actigrip 2.5mg/60mg/500mg 12 tablets in case of overdose?

In case of pseudoephedrine overdose, nausea, vomiting, marked depressant or stimulating effects on the central nervous system, insomnia, tremors, mydriasis, anxiety, agitation, hallucinations, palpitations, tachycardia, reflex bradycardia, drowsiness, lethargy, respiratory depression, hypertension, irritability, convulsions are generally observed. Other effects may include dysrhythmia, hypertensive crisis, intracerebral hemorrhage, myocardial infarction, psychosis, rhabdomyolysis, hypokalemia and ischemic infarction of the intestine. In children, the dominant action is exciting with marked tremors, drowsiness, insomnia, hyperactivity and convulsions. Pallor, anorexia, nausea and vomiting are frequently the first signs of paracetamol overdose. Hepatic necrosis is a complication related to paracetamol overdose. Liver enzymes may become elevated and prothrombin time prolonged for 12 to 48 hours but clinical signs may not appear until 6 days after ingestion. Alcohol may enhance the hepatotoxicity of paracetamol overdose and may have contributed to acute pancreatitis in a patient who had taken excessive quantities of paracetamol. In case of overdose, paracetamol, contained in ACTIGRIP, may cause hepatic cytolysis and may progress to massive and irreversible necrosis. Keep out of the reach of children. In case of overdose, seek medical help or contact a poison control center immediately. Management • Immediate transfer of the patient to hospital. • Obtain a plasma sample to determine the initial dosage of paracetamol. • Rapid evacuation of the ingested product by gastric lavage. • Acidify the urine by administering ammonium chloride (to increase the elimination of pseudoephedrine). • Treatment of overdose usually involves administration of the antidote N-acetylcysteine ​​intravenously or orally as soon as possible and, if possible, within 10 hours. • Symptomatic treatment.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Actigrip 2.5mg/60mg/500mg 12 tablets.

ACTIGRIP is contraindicated during pregnancy and breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Actigrip 2.5mg/60mg/500mg 12 tablets before driving or using machines - Does Actigrip 2.5mg/60mg/500mg 12 tablets affect driving or using machines?

At common therapeutic doses, antihistamines present side effects that vary greatly from subject to subject and from compound to compound. The most frequent side effect is sedation that can manifest itself with drowsiness; this must be warned by those who may drive motor vehicles or attend to operations that require integrity of the degree of alertness.