ACTIGRIP DAY&NIGHT*12+4 TABLETS

ACTIGRIP DAY & NIGHT tablets
Paracetamol, Pseudoephedrine hydrochloride, Diphenhydramine hydrochloride

What it is and what it is used for
ACTIGRIP DAY AND NIGHT is a medicine used to treat cold and flu symptoms.

What you need to know before taking the medicine
Do not take ACTIGRIP DAY AND NIGHT if:
• you are allergic to paracetamol, pseudoephedrine hydrochloride, diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in paragraph 6);
• you have high blood pressure (hypertension) or heart disease (cardiovascular disease);
• you have very high blood pressure (severe hypertension) or hypertension not controlled by medication;
• you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• you have had a stroke or think you may be at risk for this condition (for example, if you have high blood pressure, diabetes, or high cholesterol, or if you smoke);
• you are taking or have taken medicines for depression known as monoamine oxidase inhibitors (MAOIs) in the last two weeks;
• you suffer or have suffered from seizures or epilepsy;
• you have glaucoma (increased pressure inside the eye with possible worsening of vision);
• you have had symptoms due to a disease known as favism or broad 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 (gastro-intestinal system), bladder, urethra or ureters (urogenital system);
• you suffer from asthma;
• you suffer from diabetes;
• you have an overactive thyroid (hyperthyroidism);
• you have an enlarged prostate causing problems such as difficulty urinating or needing to urinate often (prostatic hypertrophy);
• you are pregnant or think you may be pregnant or are breastfeeding.

Do not use ACTIGRIP DAY AND NIGHT in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACTIGRIP DAY AND NIGHT if:
• you suffer from severe hemolytic anemia (a disease that destroys red blood cells) or have a blood disorder known as glucose-6-phosphate dehydrogenase deficiency;
• you have liver problems, are taking medications that alter its function or consume large amounts of alcohol (alcoholism);
• you have respiratory problems such as emphysema or chronic bronchitis;
• you have kidney problems (reduced kidney function);
• you have thyroid problems;
• you are concurrently taking analgesics, antipyretics, anticoagulants or antiplatelet agents.

Stop using ACTIGRIP DAY AND NIGHT and consult your doctor if you do not notice improvements or if you notice a worsening of symptoms or if new symptoms appear.

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 Day and Night immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see paragraph 4 Possible side effects for symptoms).

Sudden abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis) may occur with ACTIGRIP DAY AND NIGHT. If you experience these gastrointestinal symptoms, stop using ACTIGRIP DAY AND NIGHT and contact your doctor or seek immediate medical attention. (see section 4 Possible side effects).

A reduction in blood flow to the optic nerve may occur with ACTIGRIP DAY AND NIGHT. If you experience sudden vision loss, stop taking ACTIGRIP DAY AND NIGHT and contact your doctor or healthcare facility immediately. See paragraph 4.

One of the active ingredients of ACTIGRIP DAY AND NIGHT, pseudoephedrine, can cause abuse and high doses of pseudoephedrine can be toxic. Continued use can lead to taking more ACTIGRIP DAY AND NIGHT than the recommended dose to achieve the desired effect, resulting in an increased risk of overdose. The maximum recommended dose and duration of treatment should not be exceeded (see paragraph 3).

ACTIGRIP DAY AND NIGHT should be discontinued if, for example, high blood pressure, rapid heartbeat, feeling unwell, nausea, headache, or increased headache occur.

Important information about paracetamol
• High doses of paracetamol can cause adverse reactions, even serious ones, especially affecting the liver, kidneys and blood. BE CAREFUL: the total daily dose of paracetamol should not exceed 4 grams per day.

Do not use ACTIGRIP DAY AND NIGHT at higher than recommended doses, or for a long time, or concomitantly with other medicines containing paracetamol (see Other medicines and ACTIGRIP DAY AND NIGHT).

Serious skin reactions
During treatment with paracetamol, even if very rarely, serious skin reactions have been reported, which manifest with redness, blistering or pus and exfoliation (e.g. acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (known as DRESS syndrome)) (see paragraph 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.

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products. This acute pustular rash can occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules, resulting from a widespread edematous erythema and located mainly on skin folds, trunk and upper limbs. If you develop a febrile generalized rash associated with pustules, stop taking ACTIGRIP DAY AND NIGHT and contact your doctor or seek immediate medical attention. (see paragraph 4. Possible side effects).

STOP treatment with ACTIGRIP DAY AND NIGHT and contact your doctor if you notice any skin reaction or other signs of allergy (see paragraph 4).
• Due to its paracetamol content, ACTIGRIP DAY AND NIGHT can affect the results of some laboratory analyses, such as tests for measuring uric acid (uricemia) and glucose (glycemia) in the blood.

For those who engage in sports activities: the use of the drug without therapeutic necessity 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 gets them.

Stop treatment with ACTIGRIP DAY AND NIGHT immediately and urgently contact your doctor if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision

Very common side effects (may affect more than 1 in 10 people):
- Abdominal and stomach pain
- Indigestion (dyspepsia)
- Diarrhea
- Vomiting, dry throat
- Headache
- Drowsiness
- Sedation
- Excitement
- Increased sweating
- Sleep disturbances
- Altered vision
- Skin rashes
- Hives
- Dry nose

Common side effects (may affect up to 1 in 10 people):
- Itching
- Contact dermatitis
- Inflammation of the skin or mucous membranes
- Reduced blood pressure including dizziness or lightheadedness when standing up (orthostatic/postural hypotension)
- Irregular heartbeat (arrhythmia)
- Increased heart rate (tachycardia)
- Nervousness
- Insomnia
- Dizziness
- Ringing or whistling in the ears (tinnitus)
- Problems with movement coordination (ataxia)
- Euphoria
- Tremors
- Reduced blood pressure (hypotension)
- Decreased mucous secretions
- Double vision (diplopia)
- Altered vision
- Increased eye pressure with vision disturbances (glaucoma, narrow-angle glaucoma)
- Abdominal discomfort (epigastric discomfort)
- Difficulty breathing (dyspnea)
- Urinary retention
- Increase in some blood values (hyperamylasemia)
- Fatigue
- Weakness (asthenia)
- Liver dysfunction
- Nausea
- Dry mouth

Uncommon side effects (may affect up to 1 in 100 people):
- Skin reaction (fixed drug eruption)
- Severe skin rash (erythema multiforme)
- Widespread skin rash (exanthems)
- Decreased kidney function (acute kidney failure)
- Kidney inflammation (interstitial nephritis)
- Presence of blood in the urine (hematuria)
- Absence of urine production (anuria)
- Constipation
- Sneezing
- Dry throat and bronchi
- Skin sensitivity to light (photosensitivity)
- Central nervous system disorders (central depression)
- Mental confusion
- Cognitive function disorders

Rare side effects (may affect up to 1 in 10,000 people):
- Increased thyroid function (hyperthyroidism)
- Kidney impairment (renal papillary necrosis)
- Hallucinations
- Nightmares
- Mania
- Anxiety
- Psychiatric disorders
- Severe headaches
- Reduced memory or concentration
- Seizures
- Blood disorders (dyscrasias)
- Severe reduction in the number of white blood cells in the blood (agranulocytosis)
- Reduction in the number of red blood cells (anemia, hemolytic anemia)
- Reduction in the number of platelets (thrombocytopenia)
- Severe allergic reaction (anaphylactic shock)
- Swelling of the throat that may cause difficulty in swallowing and breathing (laryngeal edema)
- Liver inflammation (hepatitis)
- Pancreas inflammation (pancreatitis)

Very rare side effects (may affect up to 1 in 10,000 people):
- Reduction in the number of white blood cells (leukopenia)
- Reduction in the number of a type of white blood cells called neutrophils (neutrophilia)
- Reduction in the number of all blood cells (pancytopenia)
- Chest pain (angina)
- Electrocardiogram changes (ST segment elevation)
- Myocardial infarction
- Increased blood pressure (hypertension)
- Swelling due to fluid accumulation, around the mouth and eyes (angioedema)
- Fluid accumulation (edema)
- Liver disorders (hepatotoxicity)
- Severe immune system response (toxic shock syndrome)

Frequency not known (frequency cannot be estimated from the available data)
- serious conditions affecting the cerebral blood vessels known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
- Confusional state
- Irritability
- Agitation
- Abnormal coordination
- Altered sensation (paresthesia)
- Psychomotor hyperactivity
- Stroke (cerebrovascular accidents)
- Feeling nervous
- Headache, confusion, seizures, visual disturbances (See paragraph 2 Warnings and precautions)
- Alteration of some blood values (increased transaminases), increased blood pressure
- Widespread skin rashes (itchy exanthema)
- Serious skin reactions (see paragraph 2 Warnings and precautions)
- Difficulty urinating (dysuria)
- Chest discomfort
- Awareness of heartbeat (palpitations)
- Allergic reactions (hypersensitivity)
- Visual hallucination
- Colon inflammation due to insufficient blood flow (ischemic colitis) (See paragraph 2 Warnings and precautions)
- The sudden onset of fever, skin redness or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first two days of treatment with ACTIGRIP DAY AND NIGHT (See paragraph 2 Warnings and precautions).
Stop using ACTIGRIP DAY AND NIGHT if you develop these symptoms and contact your doctor or seek immediate medical attention.
- Reduced blood flow to the optic nerve (ischemic optic neuropathy).

Reporting 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.