ACTIGRIP Day & Night 12 + 4 Tablets

ACTIGRIP Day & Night Tablets - Medical Device

What is Actigrip tablets used for?

How to take Actigrip Tablets?

Contraindications

Special warnings

Pregnancy and breastfeeding

Expiry and correct storage

Contained elements

Side effects

Format

What is Actigrip tablets used for?

Actigrip Day & Night Tablets are indicated for the effective treatment of cold and flu symptoms . Thanks to its special formulation this medicine is able to counteract all the hassles of the flu syndrome such as sore throat , fever and cold .

How to take Actigrip Tablets?

In a very simple way, Actigrip Day & Night can be taken by adults and children over 12 years of age. It is recommended to take a white tablet three times a day, in the morning, at noon and in the afternoon, and a blue tablet in the evening before going to sleep.

Contraindications

It is not recommended to take Actigrip Day and Night:

• in case of hypersensitivity to the active substances or to any of the excipients;
• for children under the age of 12;
• in case of pregnancy, even presumed or during breastfeeding;
• in case of severe heart failure, cardiovascular diseases, hypertension, glaucoma;
• in case of patients with a history of stroke or predisposing risk factors;
• in case of patients with a history of gastrointestinal haemorrhage 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);
• in case of hyperthyroidism and diabetes;
• in case of prostatic hypertrophy, stenosis of the urogenital system;
• if you suffer from asthma;
• in the case of patients who are undergoing treatment with monoamine oxidase inhibitors (MAOIs) and in the two weeks following such treatment;
• in case of patients with a history of seizures and epilepsy;
• in the case of patients with glucose-6-phosphate dehydrogenase insufficiency.

Special warnings

Avoid using Actigrip Day and Night 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 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, concomitantly treated with drugs that impair liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic 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 during treatment with all NSAIDs, at any time, 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 (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, in the case of simultaneous treatment with anticoagulant or antiplatelet drugs, the doses of the drug must be reduced. When gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Administer 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. 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. Discontinue treatment at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. 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. Treatment should be discontinued if the following symptoms associated with the pseudoephedrine content occur: arterial hypertension, tachycardia, heart palpitations or arrhythmia, nausea or any neurological signs (onset or exacerbation of headache). In the rare cases of occurrence of allergic reactions, the administration must be suspended. Paracetamol should be used with caution in subjects with renal and hepatocellular insufficiency. Due to the paracetamol content, the administration of the drug can interfere with the determination of uric acid (by the phosphotungstic acid method) and with that of glycaemia (by the glucose-oxidase-peroxidase method). The product contains substances prohibited for doping.

Pregnancy and breastfeeding

• Pregnancy

The product is contraindicated in case of confirmed and presumed pregnancy, and during lactation. Inhibition of prostaglandin synthesis can affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and 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 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) and renal dysfunction, which can progress to renal failure with oligo-hydroamines; the mother and the newborn, at the end of pregnancy, to a possible prolongation of the bleeding time, and an antiplatelet effect that can occur even at very low doses and to an inhibition of uterine contractions resulting in delay or prolongation of labor.

• Feeding time

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

Expiry and correct storage

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, properly stored, the product must be stored in a cool place away from sources of heat and humidity; absolutely keep out of the reach of children.

Warning: do not use the medicine after the expiry date indicated on the package.

Contained elements

Actigrip Day & Night contains the following ingredients:
Active ingredient: paracetamol 500 mg, pseudoephedrine hydrochloride mg; paracetamol 500 mg, diphenhydramine hydrochloride 25 mg.
Excipients: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate, povidone, crospovidone, stearic acid; microcrystalline cellulose, maize starch, sodium starch glycolate, 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 adnexa: 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: disorders of liver function. Uncommon side effects. Skin and skin adnexa disorders: 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. Rare side effects. Endocrine disorders: hyperthyroidism. Disorders of the urinary system: renal papillary necrosis. CNS disorders: hallucinations and nightmares, secondary mania, anxiety, psychiatric disorders, severe headaches. 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 increase, myocardial infarction, hypertension, angioedema, edema, Hepatobiliary disorders: hepatotoxicity. Skin and skin disorders: Bullous reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis. Hypersensitivity reactions': toxic shock syndrome.

Format

Actigrip is sold in packs of 12 day tablets + 4 night tablets for a total of 16 ready-to-use tablets.