ACTIGRIP*12 TABLETS 2.5+60+500MG

ACTIGRIP 2.5 mg/60 mg/500 mg tablets
Paracetamol, Pseudoephedrine hydrochloride, Triprolidine hydrochloride

What it is and what it is used for
Actigrip contains three active ingredients: paracetamol (which relieves pain and lowers fever), pseudoephedrine hydrochloride (a decongestant for nasal congestion), and triprolidine hydrochloride (an antihistamine that reduces nasal secretions and dilates the bronchi).
Actigrip is used for the treatment of cold symptoms characterized by nasal obstruction, watery rhinorrhea, headache and/or fever.
Actigrip should be used by adults and children over 12 years of age.
Consult your doctor if you do not feel better or feel worse after 3-5 days of treatment.

What you need to know before taking the medicine
Do not take Actigrip if:
• you are allergic to paracetamol, pseudoephedrine hydrochloride, triprolidine hydrochloride, other antihistamines, or any of the other ingredients of this medicine (listed in section 6);
• you have high blood pressure (hypertension) or pre-existing cardiovascular disease or have had a stroke;
• you have very high blood pressure (severe hypertension) or uncontrolled hypertension by medication;
• you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• you are taking or have taken in the last two weeks medications for depression known as monoamine oxidase inhibitors (MAOIs) as in these cases, concomitant use of Actigrip can cause an increase in blood pressure or hypertensive crises (see Other medicines and Actigrip);
• you are taking, orally and/or nasally, vasoconstrictor sympathomimetic drugs (see Other medicines and Actigrip);
• you suffer from epilepsy;
• you have glaucoma (increased pressure inside the eye with possible worsening of vision);
• you suffer from severe hemolytic anemia (a disease that destroys red blood cells);
• you have had symptoms due to a disease known as favism or bean disease, which causes a decrease in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• you have a narrowing (stenosis) of the stomach or intestine, bladder, urethra, or ureters (urogenital system);
• you have breathing problems or suffer from asthma;
• you have diabetes;
• you have severe liver or kidney problems;
• you have thyroid diseases;
• you have an enlarged prostate (which causes problems such as difficulty urinating or needing to urinate often);
• you are pregnant or breastfeeding.

Do not use Actigrip in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Actigrip if:
• you have decreased kidney function;
• you suffer from liver disease or have severe hepatocellular insufficiency;
• you have breathing problems such as emphysema and chronic bronchitis;
• if you suffer from migraines and are being treated with ergot alkaloids (such as dihydroergotamine, ergotamine or methylergometrine);
• you suffer from alcoholism.

Serious skin reactions
Very rarely, severe skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (known as DRESS syndrome) have been reported in patients treated with paracetamol. Consult your doctor or pharmacist before taking Actigrip to learn the signs of serious skin reactions and discontinue use at the first signs of skin rash or any other sign of hypersensitivity (see section 4. Possible side effects). In the early stages of therapy, patients appear 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 generalized exanthematous pustulosis (AGEP) have been reported very rarely with products containing pseudoephedrine. This acute pustular eruption can occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules, arising from a very diffuse edematous erythema and located mainly on the skin folds, trunk, and upper limbs. If signs and symptoms such as the formation of numerous small pustules with or without pyrexia or erythema are observed, ACTIGRIP administration should be discontinued and a doctor consulted (see section 4. Possible side effects).

Consult your doctor if the fever persists for more than 3 days or if you do not feel better or feel worse after 5 days of treatment, for example, high fever appears, you notice skin lesions, or you have a persistent cough and a lot of mucus discharge.

• High doses of paracetamol can cause adverse reactions, even serious ones, especially affecting the liver, kidneys, and blood. If you take more than the recommended dose, for both adults and children, you should consult a doctor even if no obvious signs or symptoms appear, for careful supervision. Do not use Actigrip at doses higher than those recommended, or for a long time, or concomitantly with other medicines containing paracetamol (see Other medicines and Actigrip);
• Due to its paracetamol content, Actigrip may affect the results of some laboratory analyses, such as tests for measuring uric acid (uricemia) and glucose (glycemia) in the blood;
• It can cause drowsiness;
• Due to its pseudoephedrine content, Actigrip should be discontinued if, for example, high blood pressure, accelerated heart rate, malaise, nausea, headache, or increased headache occur;
• Due to its triprolidine content, Actigrip may increase the sedative effects of substances that depress the central nervous system such as alcohol, sedatives, tranquilizers (see Other medicines and Actigrip). You should therefore avoid the use of alcoholic beverages during treatment with Actigrip and should consult your doctor before taking Actigrip concomitantly with medicines that depress the central nervous system;
• If you experience sudden abdominal pain, rectal bleeding, or other signs of ischemic colitis (see section 4. Possible side effects), stop using ACTIGRIP and consult your doctor;
• Actigrip may cause a reduction in blood flow to the optic nerve. If you experience sudden vision loss, stop taking Actigrip and immediately consult your doctor or a healthcare facility. See section 4.

Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood supply to the brain. Stop using Actigrip immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 Possible side effects for symptoms).

One of the active ingredients in Actigrip, pseudoephedrine, can be abused, and high doses of pseudoephedrine can be toxic. Continuous use can lead to taking more Actigrip than the recommended dose to achieve the desired effect, with a consequent increased risk of overdose. The maximum recommended dose and duration of treatment should not be exceeded (see section 3).

Avoid taking this medicine if you are being treated with anti-inflammatory drugs.

For athletes: the non-therapeutic use of the drug constitutes doping and can still lead to positive anti-doping tests.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Stop treatment with Actigrip immediately and urgently consult your doctor if you experience any of the following conditions:
• you develop symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
- severe headache with sudden onset;
- nausea;
- vomiting;
- confusion;
- seizures;
- changes in vision.
• allergic reactions, even severe ones, such as swelling (angioedema) of the face, eyes, lips, sudden drop in blood pressure (anaphylactic shock);
• seizures, central nervous system excitation, such as inability to fall asleep (insomnia), excessive happiness (euphoria), and tremors;
• Very rare cases of severe skin reactions have been reported with the use of paracetamol, manifesting, for example, with redness, blistering or pus, and exfoliation (e.g., erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis) (see section 2 Warnings and precautions).

Not known (frequency cannot be estimated from the available data):
• serious conditions affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• hallucinations, including visual hallucinations, anxiety, nervousness, restlessness;
• changes in sensitivity (paresthesia), psychomotor hyperactivity, stroke (cerebrovascular accidents);
• heart rhythm disturbances (arrhythmia), sensation of a racing heart (palpitations), myocardial infarction;
• nosebleed (epistaxis);
• skin rash with itching, urticaria, pruritus, photosensitivity;
• skin reactions due to taking medicines (fixed eruption);
• severe skin rash characterized by pustule formation (acute generalized exanthematous pustulosis) (see section 2 Warnings and precautions);
• difficulty urinating (dysuria);
• ischemic colitis;
• 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 continuation or discontinuation of paracetamol therapy);
• increased blood pressure;
• reduced blood flow to the optic nerve (ischemic optic neuropathy).

Inform your doctor if you experience any other side effects during treatment with ACTIGRIP:
• more or less sudden appearance of skin lesions, for example, patchy or diffuse color changes (skin rash);
• stomach or intestinal reactions such as abdominal discomfort, constipation, nausea, vomiting, diarrhea (possibly reduced by taking the medicine after meals), dry mouth;
• impaired liver function, liver inflammation (hepatitis);
• drowsiness, feeling of tiredness (asthenia), sweating, dizziness;
• increased density of bronchial secretions;
• headache, drop in blood pressure, increased heart rate (tachycardia) especially in the elderly;
• blood alterations such as decreased platelets (thrombocytopenia) or white blood cells (leukopenia, neutropenia, agranulocytosis) or red blood cells (anemia);
• kidney alterations, such as unusual changes in the amount of urine produced, inability to empty the bladder (urinary retention), blood in the urine (hematuria), kidney inflammation (interstitial nephritis), or impaired kidney function (acute renal failure);
• increased pressure inside the eye with possible worsening of vision (acute glaucoma attack), blurred vision, pupil dilation (mydriasis).

In isolated cases, hemorrhagic stroke has occurred in patients who used drugs containing a vasoconstrictor (such as pseudoephedrine). In particular, these cerebrovascular incidents occurred due to overdose, improper use, and/or in patients with vascular risk factors (see section 2. What you need to know before taking Actigrip - Do not take Actigrip if - Warnings and precautions).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.