Actigrip

Package leaflet: Information for the patient

ACTIGRIP 2.5 mg / 60 mg / 300 mg tablets

Paracetamol, Pseudoephedrine hydrochloride, Triprolidine hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3–5 days of treatment.

Contents of this leaflet:

1. What Actigrip is and what it is used for
2. What you need to know before taking Actigrip
3. How to take Actigrip
4. Possible side effects
5. How to store Actigrip
6. Contents of the pack and other information

1. What Actigrip is and what it is used for

Actigrip contains three active substances: paracetamol (which relieves pain and reduces fever),
hydrochloride pseudoephedrine (a nasal decongestant for a stuffy nose), and hydrochloride triprolidine (an
antihistamine that reduces nasal secretions and dilates the bronchi).
Actigrip is used for the treatment of symptoms associated with influenza or congestion of the
upper respiratory tract.
Actigrip is intended for use 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.

2. What you should know before taking Actigrip

Do not take Actigrip if:

• you are allergic to paracetamol, hydrochloride pseudoephedrine, hydrochloride triprolidine, 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 diseases, or have had a stroke;
• you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication;
• you suffer from severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
• you are currently taking, or have taken within the last two weeks, medicines for depression known as monoamine oxidase inhibitors (MAOIs), as concomitant use of Actigrip may cause increased blood pressure or hypertensive crisis (see "Other medicines and Actigrip");
• you are currently taking oral and/or nasal sympathomimetic vasoconstrictor medicines (see "Other medicines and Actigrip");
• you have epilepsy;
• you have glaucoma (increased pressure inside the eye with possible worsening of vision);
• you suffer from severe haemolytic anaemia (a disease that destroys red blood cells);
• you have had symptoms due to a condition known as favism or fava bean disease, which causes a reduction in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• you have narrowing (stenosis) of the stomach, intestine, bladder, urethra, or ureters (urogenital system);
• you have respiratory problems or suffer from asthma;
• you have diabetes;
• you have serious liver or kidney problems;
• you have thyroid diseases;
• you have an enlarged prostate volume (causing problems such as difficulty urinating or frequent need to urinate);
• 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 reduced kidney function;
• you suffer from liver diseases or have severe hepatocellular insufficiency;
• you have respiratory problems such as emphysema and chronic bronchitis;
• you suffer from migraine and are being treated with ergot alkaloids (such as dihydroergotamine, ergotamine or methylergonovine);
• you suffer from alcoholism.

During treatment with Actigrip, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment 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). In patients in these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.
Severe skin reactions
In patients treated with paracetamol, very rare but severe skin reactions have been reported, 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). Consult your doctor or pharmacist before taking Actigrip to learn about the signs of serious skin reactions and discontinue use at the first sign of skin rash or any other sign of hypersensitivity (see section 4 "Possible side effects"). Patients appear to be at higher risk during the initial stages of therapy: onset of the reaction occurs mostly during the early stages of treatment.
Very rare cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with products containing pseudoephedrine. 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, primarily located in skin folds, trunk, and upper limbs. If signs and symptoms such as development of numerous small pustules with or without fever or erythema are observed, administration of ACTIGRIP must be discontinued and a doctor must be consulted (see section "4. Possible side effects").
Consult your doctor if fever persists for more than 3 days or if you do not feel better or feel worse after 5 days of treatment, for example, if high fever develops, skin lesions appear, or you develop persistent cough with abundant mucus production.
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 signs or symptoms are evident, for careful monitoring.
Do not use Actigrip at doses higher than recommended, for prolonged periods, or simultaneously
with other medicines containing paracetamol (see "Other medicines and Actigrip").
Due to its paracetamol content, Actigrip may affect the results of certain laboratory tests, such as blood tests measuring uric acid (uricemia) and glucose (glycemia).

• It may cause drowsiness.
• Due to its pseudoephedrine content, Actigrip should be discontinued if, for example, high blood pressure, rapid heartbeat, feeling unwell, nausea, headache, or worsening of 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, and tranquillizers (see "Other medicines and Actigrip"). Therefore, you must avoid consuming alcoholic beverages during treatment with Actigrip and consult your doctor before taking Actigrip together 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 reduced blood flow to the optic nerve. If sudden vision loss occurs, stop taking Actigrip and contact your doctor or a healthcare facility immediately. 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 may lead to reduced blood supply to the brain. Stop using Actigrip immediately and seek immediate medical assistance if you develop symptoms that could indicate PRES or RCVS (see section 4 "Possible side effects" for symptoms).
One of the active ingredients of Actigrip, pseudoephedrine, may cause abuse, and high doses of pseudoephedrine can be toxic. Continuous use may lead to taking more Actigrip than the recommended dose to achieve the desired effect, increasing the risk of overdose. The maximum recommended dose and treatment duration must not be exceeded (see section 3).
Avoid taking this medicine if you are being treated with anti-inflammatory drugs.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Actigrip
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Actigrip with:

• other medicines containing paracetamol or those that reduce fever and pain;
• tricyclic antidepressants (medicines used to treat mood disorders), antipsychotics, or other medicines acting on the brain such as barbiturates, sedatives, tranquillizers, hypnotics;
• medicines used for depression known as monoamine oxidase inhibitors (MAOIs), or if you have taken them within the last 2 weeks, as this may cause an increase, even sudden, in blood pressure (see "Do not take ACTIGRIP");
• furazolidone, an antibiotic;
• sympathomimetic medicines used to reduce nasal swelling (decongestants);
• medicines that reduce appetite (anorectics, amphetamine-like substances).

BE CAREFUL if you are taking the following medicines, as they may interact with Actigrip:

• antihypertensives (medicines for high blood pressure) such as methyldopa, alpha and beta-blockers, debrisochine, guanethidine, betanidine, and bretylium: their effect may be partially counteracted by Actigrip;
• ergot alkaloids (such as dihydroergotamine, ergotamine or methylergonovine) used to treat headaches, as they may induce vasoconstriction with sudden increase in blood pressure;
• oral hypoglycaemics, medicines that lower blood sugar;
• metoclopramide (used to treat nausea and vomiting);
• other substances with anticholinergic action;
• blood-thinning medicines (anticoagulants, such as warfarin and coumarin derivatives); anticonvulsants or antiepileptics (medicines used to treat epilepsy) such as glutethimide, phenobarbital, carbamazepine;
• oral contraceptives;
• rifampicin (medicines used to treat tuberculosis);
• cimetidine (medicines used for peptic ulcer);
• antibiotics causing ear damage (ototoxic), such as neomycin;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2). If you are scheduled
  for surgery, your doctor may advise you to stop taking ACTIGRIP a few days beforehand.

Actigrip and alcohol
Do not drink alcohol while using Actigrip, as this may interfere with your treatment and/or increase the risk of adverse events, especially affecting the liver.
Pregnancy and breastfeeding
Do not take Actigrip if you are pregnant or breastfeeding.
Driving and using machines
Actigrip may cause drowsiness. Make sure you do not experience this side effect before driving or operating machinery.
Actigrip contains: methyl para-hydroxybenzoate. It may cause allergic reactions (including delayed ones).

3. How to take Actigrip

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 tablet, 2–3 times a day, for a maximum of 5 days of treatment.

• Take the tablets by mouth (oral use) with a glass of water and with food.
• Do not exceed the recommended doses. If you have any doubts, consult your doctor or pharmacist.

Paediatric population (adolescents over 12 years up to 18 years of age): 1 tablet 2–3 times a day, for a maximum of 3 days of treatment.
Children under 12 years of age
Do not use Actigrip in children under 12 years of age.
Elderly
Elderly individuals may be more sensitive to this medicine. If you are elderly, adhere to the lowest recommended dosage.

If you take more Actigrip than you should, you may experience the following adverse effects:

• nausea, vomiting, insomnia, tremors, pupil dilation (mydriasis), anxiety, agitation, hallucinations, palpitations, increased or decreased heart rate (tachycardia and bradycardia), drowsiness even to profound lethargy, irritability, seizures, increased blood pressure (hypertension and hypertensive crisis), breathing difficulties, heart rhythm disturbances (arrhythmia), intracerebral haemorrhage, myocardial infarction, psychosis, muscle breakdown (rhabdomyolysis), low potassium levels in the blood (hypokalaemia), and intestinal infarction;
• in children: inability to fall asleep (insomnia), drowsiness, hyperactivity, seizures, and tremors;
• pallor, loss of appetite (anorexia), nausea, vomiting, and severe liver problems caused by high doses of paracetamol.

Overdose may cause hepatic cytolysis (liver cell destruction) which may progress to massive and irreversible necrosis, caused by high doses of paracetamol.
If you take more Actigrip than you should, inform your doctor immediately or go to the nearest hospital, even if you feel well, because some adverse effects may appear several hours after ingestion.
Keep this medicine out of the reach of children. In case of overdose, seek medical help or contact a poison control centre immediately.
If you forget to take Actigrip
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with Actigrip immediately and contact your doctor urgently if you experience any of the following conditions:

• symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including: severe headache with sudden onset, nausea, vomiting, confusion, seizures, or changes in vision;
• allergic reactions, even severe ones, such as swelling (angioedema) of the face, eyes, lips, or throat (laryngeal edema) with breathing difficulties, or sudden drop in blood pressure (anaphylactic shock);
• seizures, excitation of the central nervous system, such as inability to fall asleep (insomnia), excessive happiness (euphoria), and tremors.

Very rare cases of serious skin reactions have been reported with the use of paracetamol, manifesting, for example, as redness, blistering, pus formation, or skin peeling (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) (see section 2 “Warnings and precautions”).

Not known (frequency cannot be estimated from available data):

• serious conditions affecting the brain's blood vessels, known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• hallucinations (including visual), anxiety, nervousness, restlessness;
• changes in sensation (paraesthesia), psychomotor hyperactivity, stroke (cerebrovascular accidents);
• changes in heart rhythm (arrhythmia), sensation of pounding heartbeat (palpitations), myocardial infarction;
• nosebleeds (epistaxis);
• skin rash with itching, urticaria, pruritus;
• skin reactions due to drug intake (fixed drug eruption);
• severe skin eruption characterized by pustule formation (acute generalized exanthematous pustulosis) (see section 2 “Warnings and precautions”);
• difficulty urinating (dysuria);
• feeling of nervousness;
• ischemic colitis;
• increased transaminase levels (a slight increase in transaminase levels may occur in some patients taking recommended doses of paracetamol. These cases are not associated with liver failure and usually resolve with continuation or discontinuation of paracetamol therapy);
• increased blood pressure;
• reduced blood flow to the optic nerve (ischemic optic neuropathy);
• serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Inform your doctor if any other side effects occur during treatment with ACTIGRIP:

• sudden or less sudden appearance of skin lesions, for example, discolored spots or widespread skin changes (rash), skin reactions after exposure to sunlight (photosensitization);
• stomach or intestinal reactions such as constipation, nausea, diarrhea, vomiting (which may be reduced by taking the medicine after meals), dry mouth;
• altered liver function, liver inflammation (hepatitis);
• drowsiness, feeling of fatigue (asthenia), sweating, dizziness;
• increased density of bronchial secretions;
• headache, low blood pressure, changes or increased heartbeats (extrasystoles, tachycardia), especially in elderly patients;
• blood disorders such as reduced platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia), or red blood cells (anaemia), reduced granulocyte count (agranulocytosis);
• kidney-related disorders, such as unusual changes in urine output, for example, lack of urine production (anuria), inability to empty the bladder (urinary retention), presence of blood in urine (haematuria), kidney inflammation (interstitial nephritis), or altered kidney function (acute kidney failure);
• increased pressure inside the eye with possible worsening of vision (acute attack of glaucoma), blurred vision, dilated pupils (mydriasis).

In isolated cases, haemorrhagic stroke has occurred in patients who used medications containing a vasoconstrictor (such as pseudoephedrine). In particular, these cerebrovascular events occurred following overdose, misuse, 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Actigrip

Keep this medicine out of the sight and reach of children.
Store in a dry place at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Actigrip contains
The active substances are: paracetamol, hydrochloride pseudoephedrine and triprolidine hydrochloride.
Each tablet contains: 300 mg paracetamol, 60 mg pseudoephedrine hydrochloride and 2.5 mg triprolidine hydrochloride.
The other components are: microcrystalline cellulose, maize starch, stearic acid, pregelatinized starch, methyl p-hydroxybenzoate.

Description of the appearance of Actigrip and contents of the pack
Actigrip is available in a pack containing one 12-tablet blister.

Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23.500 - 00071 Santa Palomba – Pomezia - Roma

Manufacturer
Istituto Biochimico Nazionale Savio S.r.l. - Via del Mare, 36 – 00040 Pomezia (Roma)

Patient Information Leaflet

ACTIGRIP 2.5 mg/60 mg/500 mg tablets

Paracetamol, Pseudoephedrine hydrochloride, Triprolidine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–5 days of treatment.

Contents of this leaflet:

1. What Actigrip is and what it is used for
2. What you need to know before taking Actigrip
3. How to take Actigrip
4. Possible side effects
5. How to store Actigrip
6. Contents of the pack and other information

1. What Actigrip is and what it is used for

Actigrip contains three active substances: paracetamol (which relieves pain and reduces fever),
pseudoephedrine hydrochloride (a nasal decongestant for a blocked nose), 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 congestion, watery rhinorrhea, headache and/or fever.
Actigrip is intended for use 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.

2. What you need to know before taking Actigrip

Do not take Actigrip if:

• you are allergic to paracetamol, hydrochloride pseudoephedrine, hydrochloride triprolidine, 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 diseases, 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 renal failure;
• you are currently taking or have taken within the last two weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs), as the concomitant use of Actigrip
  may 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 haemolytic anaemia (a disease that destroys red blood cells);
• you have had symptoms due to a disease known as favism or fava bean disease, which causes a reduction in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• you have a narrowing (stenosis) of the stomach or intestine, bladder, urethra or ureters (urinary tract);
• you have breathing problems or suffer from asthma;
• you have diabetes;
• you have serious liver or kidney problems;
• you have thyroid diseases;
• you have an enlarged prostate volume (causing problems such as difficulty urinating or frequent need to urinate);
• you are pregnant or breastfeeding.

Do not use Actigrip in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Actigrip if:

• you have reduced kidney function;
• you suffer from liver disease or have severe hepatic insufficiency;
• you have respiratory problems such as emphysema and chronic bronchitis;
• you suffer from migraine and are being treated with ergot alkaloids (such as dihydroergotamine, ergotamine or methylergometrine);
• you suffer from alcoholism.

During treatment with Actigrip, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients in these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods 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.
Serious skin reactions
Very rarely, serious skin reactions have been reported in patients treated with paracetamol, 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). Talk to your doctor or pharmacist before taking Actigrip to learn about the signs of serious skin reactions and stop using it at the first sign of a skin rash or any other sign of hypersensitivity (see section "4. Possible side effects"). During the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases during the initial phase of treatment.
Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been very rarely reported with products containing pseudoephedrine. 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 very widespread oedematous erythema, mainly located in skin folds, trunk, and upper limbs. If signs and symptoms such as development of numerous small pustules with or without fever or erythema are observed, administration of ACTIGRIP must be stopped and a doctor must be consulted (see section "4. Possible side effects").
Consult your doctor if fever persists for more than 3 days or if you do not feel better or feel worse after 5 days of treatment, for example, if you develop high fever, notice skin lesions, or have a persistent cough with abundant mucus production.

• 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 must contact your doctor even if no signs or symptoms are evident, for careful monitoring. Do not use Actigrip at doses higher than recommended, for long periods, or simultaneously with other medicines containing paracetamol (see "Other medicines and Actigrip").
• Due to its paracetamol content, Actigrip may affect the results of certain laboratory tests, such as blood tests measuring uric acid (uricemia) and glucose (glycemia).
• It may cause drowsiness.
• Due to its pseudoephedrine content, Actigrip should be discontinued if, for example, high blood pressure, rapid heartbeat, feeling unwell, nausea, headache, or worsening of headache occur.
• Due to its triprolidine content, Actigrip may enhance the sedative effects of substances that depress the central nervous system, such as alcohol, sedatives, tranquillizers (see "Other medicines and Actigrip"). Therefore, you must avoid consuming alcoholic beverages during treatment with Actigrip and consult your doctor before taking Actigrip together 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;
• With Actigrip, a reduction in blood flow to the optic nerve may occur. If sudden vision loss occurs, stop taking Actigrip and consult your doctor or a healthcare facility immediately;
• 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 may lead to reduced blood supply to the brain. Stop using Actigrip immediately and seek immediate medical assistance 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, may cause abuse, and high doses of pseudoephedrine may be toxic. Continuous use may lead to taking more Actigrip than the recommended dose to achieve the desired effect, thereby increasing the risk of overdose. The maximum recommended dose and treatment duration must not be exceeded (see section 3).
• Avoid taking this medicine if you are being treated with anti-inflammatory drugs.
• For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Actigrip
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Actigrip with:

• other medicines containing paracetamol or those that reduce fever and pain;
• tricyclic antidepressants (medicines used to treat mood disorders), antipsychotics, or other medicines acting on the brain such as barbiturates, sedatives, tranquillizers, hypnotics;
• medicines used for depression known as monoamine oxidase inhibitors (MAOIs) or have taken them within the last 2 weeks, as this may cause an increase, even sudden, in blood pressure (see "Do not take ACTIGRIP");
• furazolidone, an antibiotic;
• sympathomimetic drugs used to reduce nasal swelling (decongestants);
• medicines that reduce appetite (anorexiants, amphetamine-like drugs).

BE CAREFUL if you are taking the following medicines, as they may interact with Actigrip:

• antihypertensives (medicines for high blood pressure) such as methyldopa, alpha and beta-blockers, debrisochin, guanethidine, betanidine, and bretylium: their effect may be partially counteracted by Actigrip;
• ergot alkaloids (such as dihydroergotamine, ergotamine or methylergometrine) used to treat headache, as they may induce vasoconstriction with sudden increase in blood pressure;
• oral hypoglycaemics, medicines that lower blood sugar;
• metoclopramide (used to treat nausea and vomiting);
• other substances with anticholinergic action;
• medicines that thin the blood (anticoagulants, such as warfarin and coumarin derivatives); anticonvulsants or antiepileptics (medicines used to treat epilepsy) such as glutethimide, phenobarbital, carbamazepine;
• oral contraceptives;
• rifampicin (medicines used to treat tuberculosis);
• cimetidine (medicines used for peptic ulcer);
• antibiotics that cause ear damage (ototoxic), such as neomycin;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2);
• if you are scheduled for surgery, your doctor may advise you to stop taking ACTIGRIP a few days beforehand.

Actigrip and alcohol
Do not drink alcohol while using Actigrip, as this may interfere with your treatment and/or increase the risk of adverse events, especially affecting the liver.
Pregnancy and breastfeeding
Do not take Actigrip if you are pregnant or breastfeeding.
Driving and using machines
Actigrip may cause drowsiness. Make sure you do not experience this side effect before driving or operating machinery.

3. How to take Actigrip

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 tablet, 2–3 times daily, for a maximum of 5 days of treatment.

• Take the tablets by mouth (oral use) with a glass of water and with food.
• Swallow the tablet whole.
• Do not exceed the recommended doses. If you have any doubts, consult your doctor or pharmacist.

Paediatric population (adolescents over 12 years up to 18 years of age): 1 tablet 2–3 times daily, for a maximum of 3 days of treatment.
Children under 12 years of age
Do not use Actigrip in children under 12 years of age.
Elderly
Elderly individuals are more sensitive to this medicine. If you are elderly, adhere to the lowest recommended dosage.

If you take more Actigrip than you should, you may experience the following adverse effects:

• nausea, vomiting, insomnia, tremors, pupil dilation (mydriasis), anxiety, agitation, hallucinations, palpitations, increased or decreased heart rate (tachycardia and bradycardia), drowsiness even to the point of profound lethargy, irritability, seizures, increased blood pressure (hypertension and hypertensive crisis), breathing difficulties, heart rhythm disturbances (arrhythmia), intracerebral haemorrhage, myocardial infarction, psychosis, muscle breakdown (rhabdomyolysis), decreased potassium levels in the blood (hypokalaemia), and intestinal infarction;
• in children: inability to fall asleep (insomnia), drowsiness, hyperactivity, seizures, and tremors;
• pallor, loss of appetite (anorexia), nausea, vomiting, and severe liver problems caused by high doses of paracetamol.

Overdose may cause hepatic cytolysis (liver cell destruction) and may progress to massive and irreversible necrosis (widespread cell death), caused by high doses of paracetamol.
If you take more Actigrip than you should, contact your doctor immediately or go to the nearest hospital, even if you feel well, because some adverse effects may appear several hours after ingestion.
Keep this medicine out of the reach of children. In case of overdose, seek medical help or contact a poison control centre immediately.
If you forget to take Actigrip
Do not take a double dose to make up for the missed tablet.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Actigrip immediately and contact your doctor urgently if you experience any of the following:

• symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:
  • sudden, severe headache
  • nausea
  • vomiting
  • confusion
  • seizures
  • changes in vision
• allergic reactions, even severe ones, such as swelling (angioedema) of the face, eyes, or lips, or a sudden drop in blood pressure (anaphylactic shock);
• seizures, central nervous system stimulation, such as inability to sleep (insomnia), excessive happiness (euphoria), and tremors;
• with the use of paracetamol, very rare cases of serious skin reactions have been reported, which may present as redness, blistering, pus formation, or skin peeling (e.g. erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) (see section 2 “Warnings and precautions”).

Not known (frequency cannot be estimated from available data):

• serious conditions affecting the brain's blood vessels, known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• hallucinations (including visual), anxiety, nervousness, restlessness;
• altered sensation (paraesthesia), psychomotor hyperactivity, stroke (cerebrovascular accidents);
• changes in heart rhythm (arrhythmia), sensation of pounding heartbeat (palpitations), myocardial infarction;
• nosebleeds (epistaxis);
• skin rash with itching, urticaria, pruritus, photosensitivity;
• skin reactions due to drug intake (fixed drug eruption);
• severe skin eruption characterized by pustule formation (acute generalized exanthematous pustulosis) (see section 2 “Warnings and precautions”);
• difficulty urinating (dysuria);
• ischemic colitis;
• increased transaminase levels (a slight increase in transaminase levels may occur in some patients taking recommended doses of paracetamol. These cases are not associated with liver failure and usually resolve either with continuation or discontinuation of paracetamol therapy);
• increased blood pressure;
• reduced blood flow to the optic nerve (ischaemic optic neuropathy);
• serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Tell your doctor if you experience any of the following side effects during treatment with ACTIGRIP:

• sudden or gradual onset of skin lesions, such as discoloured spots or widespread 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;
• altered liver function, liver inflammation (hepatitis);
• drowsiness, feeling of fatigue (asthenia), sweating, dizziness;
• increased thickness of bronchial secretions;
• headache, low blood pressure, increased heart rate (tachycardia), especially in the elderly;
• blood disorders such as reduced platelets (thrombocytopenia), reduced white blood cells (leucopenia, neutropenia, agranulocytosis), or reduced red blood cells (anaemia);
• kidney-related disorders such as unusual changes in urine output, inability to empty the bladder (urinary retention), presence of blood in urine (haematuria), kidney inflammation (interstitial nephritis), or impaired kidney function (acute renal failure);
• increased pressure inside the eye, possibly worsening vision (acute attack of glaucoma), blurred vision, dilated pupils (mydriasis).

In isolated cases, haemorrhagic stroke has occurred in patients using medicines containing a vasoconstrictor (such as pseudoephedrine). In particular, these cerebrovascular events have occurred with overdose, misuse, 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Actigrip

Keep this medicine out of the sight and reach of children.
Store in a dry place at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Actigrip contains
The active substances are: paracetamol, hydrochloride pseudoephedrine and triprolidine hydrochloride.
Each tablet contains: 500 mg paracetamol, 60 mg pseudoephedrine hydrochloride
(pseudoephedrine 49.154 mg) and 2.5 mg triprolidine hydrochloride (triprolidine 2.091 mg).
The other components are: pregelatinized maize starch, povidone, crospovidone, stearic acid,
microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Actigrip and package contents
Actigrip 2.5 mg/60 mg/500 mg tablets are white, round tablets with bevelled edges and flat faces; the tablets have a partial score line and are marked with the code "X9B" on one side.
Actigrip is available in a pack containing one Al/PVC/PVDC blister with 12 tablets.

Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23.500 - 00071 Santa Palomba – Pomezia - Rome

Manufacturer
JNTL Consumer Health (France) SAS - Domaine de Maigremont F27100 Val de Reuil, France