Actigrip day & night - treating cold and flu symptoms 12 + 4 tablets

Product Description

Actigrip Day & Night Tablets are used to treat cold and flu symptoms.

Dosage and Directions for Use

Actigrip Day & Night Notte is administered in the following doses:

• 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.

Contraindications

• Hypersensitivity to the active ingredients or to any of the excipients.
• Children under 12 years of age.
• Confirmed or suspected pregnancy, breastfeeding.
• Severe heart failure, cardiovascular disease, hypertension, glaucoma.
• Patients with a history of stroke or predisposing risk factors. Gastrointestinal tract stenosis.
• Patients with a history of gastrointestinal bleeding or perforation related to previous active treatments or a history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Hyperthyroidism, diabetes.
• Prostatic hypertrophy, urogenital tract stenosis.
• Asthma.
• Patients being treated with monoamine oxidase inhibitors (MAOIs) and within two weeks of such treatment.
• Patients with a history of seizures, epilepsy.
• Patients with manifest glucose-6-phosphate dehydrogenase deficiency.

Special warnings

Avoid concomitant use 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 duration necessary to control symptoms. High doses or prolonged administration of paracetamol, present in the product, or in other paracetamol-containing medications, can cause high-risk liver disease and alterations to the kidneys and blood, including serious 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 alter liver function, glucose-6-phosphate dehydrogenase deficiency, or hemolytic anemia. 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 with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcers, particularly if complicated with hemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients taking low-dose 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 (especially gastrointestinal bleeding), particularly in the initial stages of treatment.

Caution should be exercised in patients taking concomitant medications that could 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, doses of the drug should be reduced when concomitant treatment with anticoagulants or antiplatelet agents is used. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Use with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Discontinue treatment at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Caution is advised in patients with a history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy. Treatment should be discontinued if the following symptoms associated with pseudoephedrine content occur: arterial hypertension, tachycardia, palpitations or cardiac arrhythmia, nausea, or any neurological signs (onset or exacerbation of headache). In the rare cases of allergic reactions, administration should be discontinued. Paracetamol should be used with caution in patients with renal and hepatocellular insufficiency. Due to its paracetamol content, administration of the medicine may interfere with the determination of uric acid levels (using the phosphotungstic acid method) and blood glucose levels (using the glucose oxidase-peroxidase method). The product contains substances prohibited for doping.

Pregnancy and breastfeeding

Pregnancy

The product is contraindicated in cases of confirmed or suspected pregnancy, and during breastfeeding. Inhibition of prostaglandin synthesis may affect pregnancy and/or embryo/fetal development. Epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, 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 may expose the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction, which may progress to renal failure with oligo-hydroaminotransferases. The mother and newborn, at the end of pregnancy, may experience a possible prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses, and inhibition of uterine contractions, resulting in delayed or prolonged labor.

Breastfeeding

Paracetamol, pseudoephedrine, and diphenhydramine are secreted in breast milk; therefore, the medicine is contraindicated during breastfeeding.

Expiry and storage

Check the expiry date indicated on the package. The expiration date indicated on the packaging refers to the product in its intact packaging, stored correctly.

Caution: Do not use the medicine after the expiration date indicated on the packaging.

Composition

Actigrip Day & Night contains:
Active ingredient: paracetamol 500 mg, pseudoephedrine hydrochloride mg, paracetamol 500 mg, diphenhydramine hydrochloride 25 mg.
Excipients: microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, magnesium stearate, povidone, crospovidone, stearic acid, microcrystalline cellulose, corn starch, sodium starch glycolate, hydroxypropylcellulose, pregelatinized corn starch, croscarmellose sodium, stearic acid, magnesium stearate, hypromellose, propylene glycol, Opaspray M-1F-4315B.

Format

Packaging with 12 tablets per day + 4 tablets per night.