Vicks Flu Action: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vicks Flu Action 200 mg/30 mg film-coated tablets

Ibuprofen and pseudoephedrine 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.

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.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days in adolescents and 5 days in adults.

Contents of this leaflet

What Vicks Flu Action is and what it is used for
What you need to know before taking Vicks Flu Action
How to take Vicks Flu Action
Possible side effects
How to store Vicks Flu Action
Contents of the pack and other information

This medicine is called Vicks Flu Action 200 mg/30 mg film-coated tablets, but will be referred to as Vicks Flu Action throughout this leaflet.

1. WHAT VICKS FLU ACTION IS AND WHAT IT IS USED FOR

Vicks Flu Action contains the active ingredients ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and
pseudoephedrine, which is a nasal decongestant.

Ibuprofen reduces pain, swelling, and high fever.
Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.

Vicks Flu Action is indicated for the symptomatic relief of nasal congestion associated with headache, fever and/or pain due to cold and flu.
Vicks Flu Action is indicated for adults and adolescents over 15 years of age.
Use this combination product only if you have nasal congestion accompanied by pain or fever. Do not use this
product if you have only one of these symptoms.
Consult a doctor if you do not feel better or feel worse after 3 days in adolescents and 5 days in adults.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VICKS FLU ACTION

DO NOT take Vicks Flu Action if:

you are allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6);
you are under 15 years of age;
you are pregnant or breastfeeding;
you have had an allergic reaction (such as wheezing, bronchospasm, asthma, nasal polyps, itching and runny nose, facial swelling, hives, or skin rashes) when taking aspirin or other painkillers, other fever-reducing medicines, or other anti-inflammatory drugs;
you currently have (or have had recurrent episodes of) a stomach/duodenal ulcer (peptic ulcer) or gastrointestinal bleeding (two or more episodes of diagnosed ulceration or gastric bleeding);
you have previously experienced gastrointestinal perforation or bleeding related to NSAIDs;
you have any other type of bleeding;
you have severe liver failure;
you have severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
you have severe heart failure;
you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
you have serious heart or circulatory problems (such as coronary heart disease, chest pain known as angina, rapid heartbeat), overactive thyroid (hyperthyroidism), diabetes, or pheochromocytoma (a tumor of the adrenal gland);
you have had a heart attack (myocardial infarction);
you have had a stroke or are at risk of stroke;
you have had seizures;
you have any unexplained blood disorder;
you have glaucoma (high pressure in the eye);
you have difficulty urinating and/or an enlarged prostate;
you have systemic lupus erythematosus (SLE) or mixed connective tissue disease (MCTD), conditions affecting the immune system that may cause, for example, joint pain and skin changes;
you are taking:
- aspirin (more than 75 mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs) or other painkillers, other nasal decongestants such as phenylpropanolamine, phenylephrine or ephedrine, or methylphenidate (see section “Other medicines and Vicks Flu Action”);
- non-selective monoamine oxidase inhibitors (known as MAOIs, used to treat Parkinson’s disease or depression), or have taken them within the last 2 weeks (see section “Other medicines and Vicks Flu Action”);
- blood-thinning medicines that prevent clot formation (oral anticoagulants, heparins, antiplatelet agents);
- corticosteroids;
- lithium (used to treat bipolar disorder or depression);
- selective serotonin reuptake inhibitors (SSRIs) (antidepressants);
- methotrexate used at doses exceeding 20 mg per week (an immunosuppressant drug).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vicks Flu Action:

if you suffer from or have previously suffered from asthma or allergic disease;
if you are at risk of an asthma attack;
if your doctor has told you that you have a blood clotting disorder;
if you have mild or moderately controlled hypertension (high blood pressure), heart failure, or heart disease (see also section “DO NOT take Vicks Flu Action if”);
if you suffer from psychosis (a psychiatric illness);
if you have a history of gastrointestinal disease (see also section “DO NOT take Vicks Flu Action if”);
if you have mild or moderate kidney or liver problems;
if you are taking medicines for migraine;
if you have an infection – see section “Infections” below.

Anti-inflammatory/pain-relieving medicines such as Vicks Flu Action may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke, especially when used at high doses. Any risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or the recommended duration of treatment.
Vicks Flu Action should be discontinued if you experience increased blood pressure, rapid or irregular heartbeat, nausea, or any neurological event such as the onset or worsening of headache.
Cases of Posterior Reversible 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 flow to the brain. Stop using Vicks Flu Action immediately and seek immediate medical help if you develop symptoms that could indicate PRES or RCVS (see section 4 “Possible side effects” for symptoms).
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), or chest pain, have been reported with ibuprofen. Stop taking Vicks Flu Action immediately and contact your doctor or emergency services right away if you notice any of these signs.
With Vicks Flu Action, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, stop taking Vicks Flu Action and consult your doctor or a healthcare facility immediately. See section 4.
Sudden abdominal pain or rectal bleeding may occur with Vicks Flu Action due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Vicks Flu Action and contact your doctor or seek immediate medical help. See section 4.

Infections
Vicks Flu Action may mask signs of infection such as fever and pain. Therefore, Vicks Flu Action could delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Talk to your doctor or pharmacist before taking Vicks Flu Action if:

you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or have had any type of stroke (including “mini-strokes” or transient ischemic attacks “TIA”) (see also section “DO NOT take Vicks Flu Action if”);
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke (see also section “DO NOT take Vicks Flu Action if”).

During treatment, avoid drinking alcohol.
Ibuprofen may cause severe allergic reactions, especially in patients allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock.
Serious skin reactions have been reported, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), in association with treatment with Vicks Flu Action. Discontinue use of Vicks Flu Action and consult your doctor immediately if a skin rash, mucosal lesions, blisters, or other signs of allergy appear, as they may be early signs of a serious skin reaction. See section 4.
In dehydrated adolescents, there is a risk of kidney problems.
If symptoms persist or worsen, consult your doctor.

Children and adolescents
Vicks Flu Action must not be administered to children under 15 years of age.

Other medicines and Vicks Flu Action
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Vicks Flu Action must not be used if you are taking:

aspirin;
other non-steroidal anti-inflammatory drugs (NSAIDs);
other painkillers or fever-reducing medicines;
or if you have taken monoamine oxidase inhibitors (MAOIs, used to treat Parkinson’s disease or depression) within the last 2 weeks;
other vasoconstrictors used as nasal decongestants (e.g., phenylpropanolamine, phenylephrine, ephedrine, methylphenidate) administered orally or nasally;
medicines that prevent blood clotting such as anticoagulants or antiplatelet agents (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines that may increase the risk of stomach ulcers or bleeding, for example, steroids, antidepressants belonging to the SSRI class (e.g., fluoxetine, paroxetine) or NSAIDs, including aspirin;
lithium;
high-dose methotrexate (more than 20 mg per week).

Vicks Flu Action may affect or be affected by certain other medicines. For example:

anticoagulant medicines (i.e., blood thinners/prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines for high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan, guanethidine, reserpine, and methyldopa);
medicines that may increase the risk of stomach ulcers or bleeding, e.g., steroids, antidepressants of the SSRI class (e.g., fluoxetine, paroxetine) or other NSAIDs, including aspirin and selective cyclooxygenase (COX-2) inhibitors;
medicines for heart rhythm disorders, angina, heart failure, or fluid retention (e.g., cardiac glycosides, quinidine), because Vicks Flu Action may reduce their effectiveness or increase the risk of heart rhythm abnormalities, high blood pressure, or impaired kidney function;
cyclosporine (an immunosuppressant), as there may be an increased risk of impaired kidney function;
medicines for depression (lithium, tricyclic antidepressants) may increase the risk of side effects; concomitant use with phenytoin (an anticonvulsant) may increase serum levels of these medicines. With proper use (maximum of 5 days), serum phenytoin levels usually do not require monitoring;
other decongestants or appetite suppressants, as they may increase the risk of side effects;
reversible inhibitors of monoamine oxidase A (RIMAs, used to treat depression), linezolid (an antibiotic), and ergot alkaloids (used to treat Parkinson’s disease) may increase the risk of high blood pressure;
probenecid or sulfinpyrazone may delay the excretion of ibuprofen;
sulfonylureas (antidiabetic agents), although interactions with ibuprofen have not been widely reported, glucose levels should be monitored as a precaution during concomitant use;
medicines to increase urine production (diuretics);
high-dose methotrexate (over 20 mg per week), which may enhance the effect of methotrexate;
quinolone antibiotics, due to an increased risk of developing seizures;
tacrolimus, trimethoprim, corticosteroids;
medicines for migraine;
zidovudine (for HIV treatment), terpene derivatives, clobutinol, atropine-like substances, and local anesthetics, which may increase the risk of seizures;
injectable heparin and preparations containing Gingko biloba, due to an increased risk of bleeding.

Some medicines may also affect or be affected by treatment with Vicks Flu Action. Therefore, always consult your doctor or pharmacist before using Vicks Flu Action with other medicines, even those available without a prescription.
In the perioperative period, acute hypertensive response may develop due to pseudoephedrine administration. Therefore, treatment with Vicks Flu Action should be discontinued several days before surgery, and the anesthetist should be informed.

Vicks Flu Action with food and drinks
Swallow tablets with water, preferably with food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Vicks Flu Action must not be taken during pregnancy. The active ingredients, ibuprofen and pseudoephedrine, may cause serious problems for the fetus.
NSAIDs may cause kidney and heart problems in the fetus. They may affect the tendency of the mother and baby to bleed and may delay or prolong labor beyond the expected time.
From the 20th week of pregnancy, NSAIDs may cause kidney problems in the fetus, reducing amniotic fluid levels surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart.

Breastfeeding
The active ingredients, ibuprofen and pseudoephedrine, have been detected in breastfed infants whose mothers took these substances. Therefore, Vicks Flu Action must not be taken during breastfeeding.

Fertility
Vicks Flu Action contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of therapy.

Driving and using machines
Vicks Flu Action has no known effects on the ability to drive vehicles or operate machinery. However, dizziness or hallucinations may occur, and this possibility should be considered.

Vicks Flu Action contains:

Sodium – this medicine contains 1.65 mg of sodium per tablet. This should be taken into account by patients on a low-sodium diet.

For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. HOW TO TAKE VICKS FLU ACTION

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Vicks Flu Action is for oral use only.
Recommended dose:
Adults and adolescents aged 15 years and older: 1 tablet every 4–6 hours as needed. For more severe symptoms, 2 tablets every 6–8 hours as needed.
Do not exceed the maximum daily dose of 6 tablets.
Swallow the tablets with water, preferably with food. Do not break or crush the tablets.
Vicks Flu Action should only be used if you have both nasal congestion and headache and/or fever. If you have only one of these symptoms (nasal congestion or headache and/or fever), ask your doctor or pharmacist for an alternative medicine.
In patients over 60 years of age, treatment should start with the lowest possible dose due to an increased risk of gastrointestinal bleeding, ulceration, or perforation. If you belong to this age group, your doctor may advise you to take gastroprotective medicines alongside Vicks Flu Action.
If you have mild to moderate kidney or liver problems, consult your doctor before using this medicine, as dosage adjustment may be necessary depending on your condition.
The lowest effective dose for the shortest duration needed to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Use in children and adolescents
Do not administer to children under 15 years of age.
Duration of treatment
This medicinal product is intended for short-term use only. Use the lowest possible dose for the shortest time necessary to relieve symptoms.
Do not exceed 5 days of treatment in adults.
Do not exceed 3 days of treatment in adolescents (15–18 years).
If symptoms persist or worsen, consult your doctor.
If you take more Vicks Flu Action than you should
If you have taken more ibuprofen and pseudoephedrine hydrochloride than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood traces), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
If you forget to take Vicks Flu Action
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
STOP TAKING this medicine immediately and consult your doctor immediately if:

you develop any of the symptoms listed below, which could be signs of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS):
- severe headache with sudden onset;
- nausea;
- vomiting;
- confusion;
- seizures;
changes in vision.
- if you experience any of the following signs, which could indicate a serious allergic reaction:
difficulty breathing or swallowing;
swelling of the face, lips, tongue, or throat;
severe itching of the skin with rash (hives);
severe skin reaction with blisters under the skin;
rapid heartbeat with low blood pressure.
- if you have signs of intestinal bleeding such as:
bright red stools, feeling faint, bloody or black tarry stools, stomach pain that does not improve, vomiting blood or dark particles resembling coffee grounds.

Other adverse reactions may include:
Uncommon (may affect up to 1 in 100 people):

headache, dizziness, sleep disturbances, restlessness, irritability, or fatigue;
visual disturbances;
dry mouth, thirst;
gastrointestinal discomfort (stomach or intestine), nausea, vomiting, diarrhea, loss of appetite, dyspepsia (indigestion).

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

tinnitus (ringing in the ears);
nervousness, tremors, anxiety, agitation, restlessness, insomnia;
worsening of asthma, wheezing;
allergic reaction with bronchospasm (shortness of breath);
abdominal pain, flatulence (gas in the stomach), constipation;
edema (swelling), hypertension (high blood pressure), palpitations, heart failure, irregular heartbeat, rapid heartbeat, chest pain, heart attack;
kidney tissue damage, elevated uric acid levels in the blood;
skin rashes, hives, itching, redness, excessive sweating.

Very rare (may affect up to 1 in 10,000 people):

gastric/duodenal ulcer (peptic ulcer), in some cases with bleeding and perforation (blood in vomit or stools), gastritis, mouth ulcers, worsening of colitis and Crohn's disease;
liver disorders, particularly with long-term therapy, liver failure, acute hepatitis;
infectious inflammation, symptoms of aseptic meningitis (headache, fever, neck stiffness, nausea, vomiting, or disorientation), especially in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease), blood disorders (anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained nosebleeds, and bruising;
severe allergic reactions (signs may include facial swelling, angioedema, shortness of breath, bronchospasm, rapid heartbeat, drop in blood pressure, anaphylactic shock);
psychotic reactions, depression;
kidney failure or other kidney disorders, increased serum creatinine;
esophagitis (heartburn), pancreatitis, diaphragm-like intestinal stricture;
flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
hair loss, severe skin infections, soft tissue complications during chickenpox.

Frequency not known (frequency cannot be estimated from available data):

severe conditions affecting the blood vessels in the brain, known as Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS);
reduced blood flow to the optic nerve which may cause vision loss or focusing problems (ischemic optic neuropathy);
dilated pupils (mydriasis);
increased blood sugar levels;
drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell). Stop using this medicine if you develop these symptoms and seek immediate medical advice;
a widespread, red, scaly rash with pustules under the skin and blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). Stop using Vicks Flu Action if you develop these symptoms and contact your doctor immediately. See also section 2;
inflammation of the colon due to insufficient blood supply (ischemic colitis);
stroke;
intestinal problems that may cause sudden pain or rectal bleeding;
seizures;
difficulty passing urine in men with prostate enlargement;
hallucinations, abnormal behavior;
skin becomes sensitive to light (photosensitivity reaction);
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines like Vicks Flu Action may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VICKS FLU ACTION

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack/box 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. PACK CONTENTS AND OTHER INFORMATION

What Vicks Flu Action contains

The active substances are ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine base).
The other components are microcrystalline cellulose, pregelatinized starch (maize), povidone K-30, anhydrous colloidal silica, stearic acid 95, sodium croscarmellose, sodium lauryl sulfate, polyvinyl alcohol - partially hydrolyzed, talc (E553b), macrogol 3350, pearly pigment based on MICA (mixture of potassium aluminium silicate (E555) - [mica], titanium dioxide (E171)), polysorbate 80, hypromellose,

titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172),
black iron oxide (E172).
(For further information on sodium, see end of section 2).

Description of the appearance of Vicks Flu Action and pack contents
Vicks Flu Action tablets are yellow, film-coated, oval-shaped tablets
(size: approximately 15.6 mm x 7.7 mm).
Tablets are available in blisters of 12, 20 or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Procter & Gamble S.r.l., Viale Giorgio Ribotta, 11 – 00144 Rome, Italy.
Manufacturer
P&G Health Austria GmbH & Co. OG, Hösslgasse 20, 9800 Spittal an der Drau, Austria