Name
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 a blocked nose) and triprolidine hydrochloride (an antihistamine which reduces nasal secretion and dilates the bronchi).
Actigrip is used to treat 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.
Contact 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:
• are allergic to paracetamol, pseudoephedrine hydrochloride, triprolidine hydrochloride, other antihistamines, or any of the other ingredients of this medicine (listed in section 6);
• have high blood pressure (hypertension) or have pre-existing cardiovascular disease or have had a stroke;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• are taking or have taken in the last two weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs) since in these cases the concomitant use of Actigrip may cause an increase in blood pressure or hypertensive crisis (see "Other medicines and Actigrip");
• is taking, orally and/or nasally, vasoconstrictor sympathomimetic drugs (see "Other medicines and Actigrip");
• suffers from epilepsy;
• have glaucoma (increased pressure inside the eye which may cause vision to worsen);
• suffer from severe hemolytic anemia (a disease that destroys red blood cells);
• have had symptoms due to a disease known as favism or fava bean disease, which causes a decrease in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• have a narrowing (stenosis) of the stomach or intestine, bladder, urethra or ureters (urogenital system);
• has breathing problems or suffers from asthma;
• has diabetes;
• have serious liver or kidney problems;
• has thyroid disease;
• has an enlarged prostate (which causes problems such as difficulty urinating or needing to urinate frequently);
• is pregnant or breast-feeding.

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


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

During treatment with Actigrip, tell your doctor immediately if:
If you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a long period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

Severe skin reactions
In patients treated with paracetamol, serious skin reactions such as acute generalised 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 very rarely. Talk to your doctor or pharmacist before taking Actigrip to know the signs of serious skin reactions and stop use at the first signs of skin rash or any other sign of hypersensitivity (see section "4. Possible side effects"). Patients appear to be at higher 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 on the skin folds, trunk and upper limbs. If signs and symptoms such as formation of numerous small pustules with or without pyrexia or erythema are observed, administration of ACTIGRIP should be discontinued and a doctor should be consulted (see section "4. Possible undesirable effects").

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

• 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, both for adults and children you should contact your 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 at the same time as other medicines containing paracetamol (see "Other medicines and Actigrip");
• Due to its paracetamol content, Actigrip may influence the results of some laboratory tests, such as tests for measuring uric acid (uricemia) and glucose (glycemia) in the blood;
• May cause drowsiness;
• Due to the pseudoephedrine content, Actigrip should be discontinued if, for example, high blood pressure, rapid heartbeat, feeling unwell, nausea, headache or increased headache occur;
• Due to the 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 drinking alcoholic beverages during treatment with Actigrip and you should consult your doctor before taking Actigrip in conjunction with medicines that depress the central nervous system;
• If you experience sudden abdominal pain, rectal bleeding or other signs of ischaemic colitis (see section "4. Possible side effects"), stop using ACTIGRIP and contact your doctor;
• With Actigrip, a reduction in blood flow to the optic nerve may occur. If you experience sudden loss of vision, stop taking Actigrip and contact your doctor or healthcare facility immediately. See section 4.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of pseudoephedrine-containing medicines. 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 of Actigrip, pseudoephedrine, can be abused and high doses of pseudoephedrine can be toxic. Continued use may result in taking more Actigrip than the recommended dose to achieve the desired effect, with a consequent increase in the 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 medicines.

For those who practice sports : the use of the drug without therapeutic need constitutes doping and may still result in a positive result in anti-doping tests.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Not known (frequency cannot be estimated from the available data):
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• hallucinations, including visual ones, anxiety, nervousness, restlessness;
• alterations in sensitivity (paraesthesia), psychomotor hyperactivity, stroke (cerebrovascular accident);
• alterations in heart rhythm (arrhythmia), feeling of heart in the throat (palpitations), myocardial infarction;
• nosebleeds (epistaxis);
• itchy skin rash, urticaria, pruritus, photosensitization;
• skin reactions due to drug intake (fixed eruption);
• severe skin rash characterised by the formation of pustules (acute generalised 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 suspension of paracetamol therapy);
• increased blood pressure;
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Tell your doctor if other side effects occur during treatment with ACTIGRIP:
• more or less sudden appearance of skin lesions, for example spotty or widespread changes in colour (skin rash);
• stomach or intestinal reactions such as abdominal discomfort, constipation, nausea, vomiting, diarrhoea (which may be reduced by taking the medicine after meals), dry mouth;
• alteration of liver function, inflammation of the liver (hepatitis);
• drowsiness, feeling of tiredness (asthenia), sweating, dizziness;
• increased density of bronchial secretions;
• headache, lowering of blood pressure, increased heart rate (tachycardia) especially in the elderly;
• blood changes such as a decrease in platelets (thrombocytopenia) or white blood cells (leukopenia, neutropenia, agranulocytosis) or red blood cells (anemia);
• changes in the kidney, such as unusual changes in the amount of urine produced, inability to empty the bladder (urinary retention), blood in the urine (haematuria), inflammation of the kidney (interstitial nephritis) or changes in kidney function (acute renal failure);
• increased pressure inside the eye with possible worsening of vision (acute glaucoma attack), blurred vision, dilation of the pupils (mydriasis).

In isolated cases, haemorrhagic strokes have occurred in patients who have used drugs containing a vasoconstrictor (such as pseudoephedrine). In particular, these cerebrovascular accidents have 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.