VICKS FLU ACTION 200 MG + 30 MG FILM-COATED TABLETS 12 TABLETS IN PVC/PCTFE-AL BLISTER

Name
Vicks Flu Action 200 mg/30 mg film-coated tablets
Ibuprofen and pseudoephedrine hydrochloride


What is it and what is it used for?
Vicks Flu Action contains the active ingredients ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which is a nasal decongestant.
• Ibuprofen reduces pain, swelling and high fever.
• Pseudoephedrine works on the capillaries in the nose to relieve nasal congestion.

Vicks Flu Action is indicated for the symptomatic relief of nasal congestion with headache, fever and/or pain associated with colds and flu.
Vicks Flu Action is indicated in adults and adolescents over 15 years of age.

Use this combination product only if you have a stuffy nose with pain or fever. Do not use this product if you have only one of these symptoms.

Talk to your doctor if you do not feel better or feel worse after 3 days in adolescents and 5 days in adults.


What you need to know before taking the medicine
DO NOT take Vicks Flu Action if:
- are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6);
- is under 15 years of age;
- is pregnant or breastfeeding;
- have had an allergic reaction (such as wheezing, bronchospasm, asthma, nasal polyps, itching and runny nose, facial swelling, hives, or skin rash) when using aspirin or other pain relievers, other fever medicines, or other anti-inflammatory medicines;
- have (or have had recurrent episodes of) a stomach/duodenal ulcer (peptic ulcer) or bleeding (two or more episodes of diagnosed ulceration or gastric bleeding);
- have previously had gastrointestinal perforation or bleeding related to NSAIDs;
- has other types of bleeding;
- has severe liver failure;
- have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
- has severe heart failure;
- have very high blood pressure (severe hypertension) or hypertension that is not controlled by medications;
- have serious heart or circulatory problems (such as coronary artery disease, chest pain called angina, rapid heartbeat), overactive thyroid (hyperthyroidism), diabetes, pheochromocytoma (a tumor of the adrenal gland);
- had a heart attack (myocardial infarction);
- have had a stroke or are at risk of stroke;
- he had convulsions;
- has any type of unexplained blood disorder;
- has glaucoma (high pressure in the eye);
- has difficulty urinating and/or an enlarged prostate;
- have systemic lupus erythematosus (SLE) or mixed connective tissue disease (MCTD), a disease that affects the immune system and causes, for example, joint pain and skin changes;
- is 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 and used in the treatment of Parkinson's disease or depression) or have taken them in the last 2 weeks (see section "Other medicines and Vicks Flu Action" );
- drugs that thin the blood and prevent the formation of clots (oral anticoagulants, heparins, antiplatelet agents);
- corticosteroids;
- lithium (used in the treatment of bipolar disorder or depression);
- selective serotonin reuptake inhibitors (SSRIs) (antidepressants);
- methotrexate, used at doses greater than 20 mg per week (immunosuppressant drug).


Warnings and precautions
Talk to your doctor or pharmacist before taking Vicks Flu Action:
- if you suffer or have suffered from asthma or an 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 moderate, well-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 (psychiatric illness);
- if you have a history of gastrointestinal disease (see also the 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 medications 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 high doses and prolonged treatment. Do not exceed the recommended dose or 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 medications containing pseudoephedrine. PRES and RCVS are rare conditions that can result in reduced blood flow to the brain. Stop using Vicks Flu Action immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Vicks Flu Action immediately and contact your doctor or emergency room immediately if you notice any of these signs.

With Vicks Flu Action, a reduction in blood flow to the optic nerve may occur.
If you experience sudden vision loss, stop taking Vicks Flu Action and contact your doctor or healthcare provider 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 attention.
See section 4.

Infections
Vicks Flu Action may mask signs of infection, such as fever and pain. Therefore, Vicks Flu Action may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.

Talk to your doctor or pharmacist about your treatment before taking Vicks Flu Action if:
- have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or have had any type of stroke (including "ministrokes" or "transient ischemic attacks" "TIAs") (see also section "DO NOT take Vicks Flu Action if");
- have high blood pressure, diabetes or high cholesterol, a family history of heart disease or stroke, or if you smoke (see also the section "DO NOT take Vicks Flu Action if").

You should avoid drinking alcohol during treatment.

Ibuprofen can cause serious allergic reactions, especially in patients allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, and shock.
Serious skin reactions, 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), have been reported in association with treatment with Vicks Flu Action. Stop taking Vicks Flu Action and consult your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Dehydrated adolescents are at risk of kidney problems.

If symptoms persist or worsen, contact your doctor.

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


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

STOP TAKING this medicine immediately and consult your doctor immediately:
- if you develop 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
• vomit
• confusion
• convulsions
• vision changes

- if you experience any of the following signs, which could be signs of 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
• acceleration of the heart rate 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 doesn't get better, vomiting blood or dark particles like coffee grounds.

Other side effects may include:

Uncommon (may affect up to 1 in 100 people):
- headache, dizziness, sleep disturbances, agitation, irritability or tiredness;
- visual disturbances;
- dry mouth, thirst;
- gastrointestinal (stomach or intestinal) discomfort, nausea, vomiting, diarrhea, loss of appetite, dyspepsia (heartburn).

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 (stomach ache), flatulence (gas in the stomach), constipation;
- edema (swelling), hypertension (high blood pressure), palpitations, heart failure, irregular heartbeat, rapid heartbeat, chest pain, heart attack;
- damage to kidney tissue, high concentration of uric acid in the blood;
- skin rashes, hives, itching, redness, excessive sweating.

Very rare (may affect up to 1 in 10,000 people):
- stomach/duodenal ulcer (peptic ulcer), in some cases with bleeding and perforation (blood in vomit or stool), gastritis, mouth ulcers, worsening of colitis and Crohn's disease;
- liver disorders, particularly in 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 an existing autoimmune disease (such as lupus erythrohematosus, mixed connective tissue disease), blood disorders (anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained nosebleeds, and bruising;
- severe allergic reactions (signs of which may include facial swelling, angioedema, shortness of breath, bronchospasm, rapid heartbeat, drop in blood pressure, anaphylactic shock);
- psychotic reactions, depression;
- renal failure or other renal disorders, increased serum creatinine;
- esophagitis (heartburn); pancreatitis, diaphragm-like intestinal stenosis (narrowing);
- flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe 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.

Not known (frequency cannot be estimated from the available data): - serious conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
- reduced blood flow to the optic nerve which can cause vision loss or focusing problems (ischemic optic neuropathy);
- dilated pupils (mydriasis);
- increased blood sugar levels;
- Drug reaction with eosinophilia and systemic symptoms: A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell). Stop using this medicine if you develop these symptoms and seek medical advice immediately.
- a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in the skin folds, trunk, and upper limbs, accompanied by fever at the start 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 can cause sudden pain or rectal bleeding;
- convulsions;
- difficulty passing urine in men with prostatic hypertrophy;
- hallucinations, abnormal behavior;
- the skin becomes sensitive to light (photosensitivity reaction);
- chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Drugs such as Vicks Flu Action may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.