ACTIGRIP 500 mg/60 mg Tablets

Зміст інструкції

1. ACTIGRIP GIORNO & NOTTE tablets
   1. What is ACTIGRIP DAY AND NIGHT and what it is used for
   2. What you need to know before you take ACTIGRIP DAY AND NIGHT
   3. How to take ACTIGRIP GIORNO E NOTTE
   4. Possible side effects
   5. How to store ACTIGRIP GIORNO E NOTTE
   6. Contents of the pack and other information

ACTIGRIP GIORNO & NOTTE tablets

Paracetamol, Pseudoephedrine hydrochloride, Diphenhydramine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What is ACTIGRIP DAY AND NIGHT and what it is used for

ACTIGRIP DAY AND NIGHT is a medicine used for the treatment of cold and flu symptoms.
and the flu.

2. What you need to know before you take ACTIGRIP DAY AND NIGHT

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 section 6);
• you have high blood pressure (hypertension) or heart disease (cardiovascular disease);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension with medication;
• if 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 smoke);
• you are taking or have taken in the last two weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs);
• you suffer or have suffered from convulsions 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 fava 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 tract), bladder, urethra or ureters (urogenital tract);
• you suffer from asthma;
• you suffer from diabetes;
• you have an increased thyroid function (hyperthyroidism);
• you have an enlarged prostate volume causing problems such as difficulty urinating or needing to urinate frequently (prostatic hypertrophy);
• you are pregnant or think you may be or are breastfeeding with breast milk.

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

Warnings and precautions
Consult 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, take medicines that alter its function or abuse 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 taking analgesics, antipyretics, anticoagulants or antiplatelet agents concurrently.

During treatment with ACTIGRIP DAY & NIGHT, immediately inform your doctor if:

• If you suffer from serious illnesses, including severe kidney 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). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

Stop using ACTIGRIP DAY AND NIGHT and consult your doctor if you do not notice any improvement or
if you notice a worsening of symptoms or if new symptoms appear.
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 flow to the brain.
Stop using Actigrip day and night immediately and seek immediate medical attention if
you develop symptoms that may be signs of PRES or RCVS (see section 4 “Possible side effects” for symptoms).
With ACTIGRIP DAY AND NIGHT, sudden abdominal pain or
rectal bleeding may occur due to inflammation of the colon (ischemic colitis). 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”).
With ACTIGRIP DAY AND NIGHT, a reduction in blood flow to the optic nerve may occur.
If you experience sudden vision loss, stop taking ACTIGRIP DAY
AND NIGHT and immediately consult your doctor or a healthcare facility. 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 a
quantity of ACTIGRIP DAY AND NIGHT greater than the recommended dose to obtain the
desired effect, resulting in an increased risk of overdose. The maximum recommended dose and
duration of treatment must not be exceeded (see section 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 to the liver, kidneys and blood. PAY ATTENTION: the total daily dose of paracetamol should not exceed 4 grams per day.

Do not use ACTIGRIP DAY AND NIGHT 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 DAY AND NIGHT”).
Serious skin reactions
During treatment with paracetamol, even very rarely, serious skin reactions have been reported
that manifest with redness, formation of blisters or pus and exfoliation (for example
acute generalized 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”). Patients
seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases
in the early stages of treatment.
Serious skin reactions such as acute and generalized 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 pustules, mostly non-follicular, originating from a
very widespread edematous erythema and located mainly on the skin folds, trunk and
upper limbs. If you develop a generalized febrile erythema 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 the treatment with ACTIGRIP DAY AND NIGHT and contact your doctorif you notice any
skin reaction or other signs of allergy(see section 4).

• Due to the paracetamol content, ACTIGRIP DAY AND NIGHT may affect the results of some laboratory tests, such as tests for measuring uric acid (uricemia) and glucose (glycemia) in the blood.

For those who play sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Other medicines and ACTIGRIP DAY AND NIGHT
Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Do not take ACTIGRIP DAY AND NIGHT with:

• other medicines that contain paracetamol or that reduce fever (antipyretics) and pain (analgesics: NSAIDs, selective COX-2 inhibitors, corticosteroids);
• other medicines that contain diphenhydramine, even for topical use (for example creams).

PAY ATTENTION: some of the following medicines may interact with ACTIGRIP DAY AND NIGHT:

• anticholinergic drugs, for example medicines used to treat mood disorders such as antidepressants (tricyclics and MAOIs), atropine and other psychotropic drugs;
• hypnotics, sedatives and tranquilizers;
• antihistamines;
• sympathomimetic drugs, such as medicines that reduce nasal congestion (decongestants) or appetite suppressants (anorectics, amphetamine-like);
• antihypertensives such as methyldopa, alpha and beta-blockers, debrisoquine, guanethidine, betanidine and bretylium (drugs for high blood pressure);
• cholestyramine (used to lower blood cholesterol);
• metoclopramide or domperidone (used to treat nausea and vomiting);
• medicines that delay blood clotting (anticoagulants), such as warfarin or other coumarins;
• anticonvulsants or antiepileptics (medicines used to treat epilepsy) such as glutethimide, phenobarbital, carbamazepine;
• rifampicin (drug used for the treatment of tuberculosis);
• cimetidine (drug used for peptic ulcer);
• probenecid (drug used in gout);
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).
• ACTIGRIP DAY AND NIGHT with alcoholDo not drink alcohol while using ACTIGRIP DAY AND NIGHT as this may interfere with your treatment and/or increase the risk of side effects, especially to the liver.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
The active ingredients of ACTIGRIP DAY AND NIGHT cross the placenta and are secreted into the
breast milk: the use of ACTIGRIP DAY AND NIGHT is contraindicated during pregnancy and
breastfeeding.

Driving and operating machinery
The blue tablets of ACTIGRIP DAY AND NIGHT can cause drowsiness. Make sure you
do not suffer from this side effect before driving vehicles or using machinery.

3. How to take ACTIGRIP GIORNO E NOTTE

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Check the table below to verify the correct dose to take.

• Take the tablets by mouth (orally) and without chewing.
• Do not exceed the recommended doses. If you have any doubts, consult your doctor or pharmacist. Follow the doses reported carefully.
• ACTIGRIP GIORNO E NOTTE contains 2 types of tablets of different colors, which must be taken at different times of the day.

Children under 12 years of age
Do not use ACTIGRIP GIORNO E NOTTE in children under 12 years of age.

Adults and children over 12 years of age
AgeDose
Adults and children over 12 years of age
During the day
1 white tablet, 3 times a day: 1 in the morning, 1 at
midday and 1 in the afternoon.

During the evening
1 blue tablet, in the evening before bedtime.

• Do not take more than 3 white tablets a day.
• If you do not feel better, if high fever or other undesirable effects occur after 3 days of continuous use, stop treatment.

If you take more ACTIGRIP GIORNO E NOTTE than you should,you may experience serious side effects,
especially affecting the liver, blood and heart. Seek immediate medical attention or
go to the nearest hospital even if you feel well, as these effects may manifest even
several hours after taking it.
Keep this medicine out of the reach of children. In case of overdose, seek help from
your doctor or contact a poison control center immediately.

If you forget to take ACTIGRIP GIORNO E NOTTE
Do not take a double dose to make up for a missed dose.
Be careful: always wait 4-6 hours between one dose and the next.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ACTIGRIP GIORNO E NOTTE immediately and urgently contact your doctor if you develop 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
• vomiting
• confusion
• convulsions
• changes in vision

Very common side effects (may affect more than 1 in 10 people):

• Abdominal and stomach pains
• Difficult digestion (dyspepsia)
• Diarrhea
• Vomiting, dryness of the throat
• Headache
• Drowsiness
• Sedation
• Excitation
• Increased sweating
• Sleep disorders
• Blurred vision
• Skin rash
• 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 buzzing in the ears (tinnitus)
• Problems with coordination of movements (ataxia)
• Euphoria
• Tremors
• Reduced blood pressure (hypotension)
• Decreased mucous secretions
• Double vision (diplopia)
• Blurred vision
• Increased pressure in the eye with vision disturbances (glaucoma, angle-closure glaucoma)
• Abdominal discomfort (epigastric discomfort)
• Difficulty breathing (dyspnea)
• Urinary retention
• Increased levels of certain values in the blood (hyperamylasemia)
• Fatigue
• Weakness (asthenia)
• Liver function disorders
• 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 rash (exanthems)
• Decreased kidney function (acute renal failure)
• Kidney inflammation (interstitial nephritis)
• Presence of blood in the urine (hematuria)
• Failure to produce urine (anuria)
• Constipation
• Sneezing
• Dryness of the throat and bronchi
• Skin sensitivity to light (photosensitivity)
• Nervous system disorders (central depression)
• Mental confusion
• Cognitive dysfunction

Rare side effects (may affect up to 1 in 10,000 people):

• Increased thyroid function (hyperthyroidism)
• Kidney damage (renal papillary necrosis)
• Hallucinations
• Nightmares
• Manias
• Anxiety
• Psychiatric disorders
• Severe headaches
• Reduced memory or concentration
• Convulsions
• 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 can cause difficulty swallowing and breathing (laryngeal edema)
• Inflammation of the liver (hepatitis)
• Inflammation of the pancreas (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)
• Changes in the electrocardiogram (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 sensitivity (paresthesia)
• Psychomotor hyperactivity
• Stroke (cerebrovascular accidents)
• Feeling nervous
• Headache, confusion, convulsions, visual disturbances (See section 2 “Warnings and precautions”)
• Alteration of some values in the blood (increased transaminases), increased blood pressure
• Widespread skin rashes (pruritic exanthems)
• Severe skin reactions (see section 2 “Warnings and precautions”)
• Difficulty urinating (dysuria)
• Chest discomfort
• Perception of heartbeat (palpitations)
• Allergic reactions (hypersensitivity)
• Visual hallucination
• Inflammation of the colon due to insufficient blood flow (ischemic colitis) (See section “2 Warnings and precautions”).
• The sudden onset of fever, redness of the skin or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first two days of treatment with ACTIGRIP GIORNO E NOTTE (See section “2 Warnings and precautions”). Stop using ACTIGRIP GIORNO E NOTTE if you develop these symptoms and contact your doctor or seek immediate medical attention.
• Reduced blood flow to the optic nerve (ischemic optic neuropathy)
• Severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 GIORNO E NOTTE

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C and in the original package to protect the medicine
from light and humidity.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACTIGRIP GIORNO E NOTTE contains
The active ingredients are: paracetamol, pseudoephedrine hydrochloride and diphenhydramine hydrochloride.

• 1 white tablet contains: 500 mg of paracetamol and 60 mg of pseudoephedrine hydrochloride;
• 1 blue tablet contains: 500 mg of paracetamol and 25 mg of diphenhydramine hydrochloride.

The other ingredients are:

• 1 white tablet contains: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, povidone, crospovidone, stearic acid;
• 1 blue tablet contains: microcrystalline cellulose, corn starch, sodium glycolate starch, hydroxypropylcellulose, pregelatinized corn starch, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose, Opadry blue 02H205000 (containing propylene glycol).

Description of the appearance of ACTIGRIP GIORNO E NOTTE and contents of the pack
ACTIGRIP GIORNO E NOTTE is available in a pack containing 12 white tablets and 4
blue tablets.

Marketing Authorisation 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 27100 Val de Reuil France.