NUROFEN FLU COLD*24TAB

NUROFEN INFLUENZA AND COLD 200 mg + 30 mg film-coated tablets
Ibuprofen + pseudoephedrine hydrochloride

What it is and what it is used for
Nurofen Influenza and Cold contains two active ingredients:
- Ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action reduces pain and swelling caused by inflammation and lowers fever;
- Pseudoephedrine hydrochloride, belongs to a group of medicines called vasoconstrictors whose action on blood vessels inside the nose helps relieve nasal congestion.

Nurofen Influenza and Cold is indicated for adults and adolescents over 12 years of age for the treatment of cold and flu symptoms such as blocked nose (nasal and sinus congestion), aches, headaches, fever and sore throat.
Consult your doctor if you do not feel better or feel worse after 3 days in adolescents over 12 years of age and after 5 days in adults.

What you need to know before taking the medicine
Do not take Nurofen Influenza and Cold:
• if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), other medicines to treat fever or pain, you have experienced allergic reactions such as nasal polyps, wheezing and/or difficulty breathing (asthma), rhinitis, swelling of the face, lips and throat (angioedema) or hives;
• if you suffer or have suffered from recurrent gastric/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct episodes of diagnosed ulcers or bleeding);
• if you suffer from severe kidney or liver disease (kidney or liver failure);
• suffer from severe heart disease (severe heart failure);
• if you suffer from severe heart or circulatory problems such as increased heart rate (tachycardia), high blood pressure, chest pain that occurs when the heart does not receive enough oxygen (angina pectoris);
• if you suffer from an overactive thyroid (hyperthyroidism);
• if you suffer from a disease characterized by a high concentration of glucose in the blood (diabetes);
• if you suffer from a tumor affecting the kidney (pheochromocytoma);
• if you suffer from increased intraocular pressure (glaucoma);
• if you suffer from difficulty urinating related to prostate problems;
• if you are under 12 years of age;
• if you are pregnant or breastfeeding;
• if you are taking antidepressants, such as non-selective monoamine oxidase inhibitors (known as MAOIs) or have taken them in the last 14 days.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofen Influenza and Cold if:
• you are taking other medicines used to treat pain, lower fever and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors); concomitant use of these medicines may increase the risk of side effects and should be avoided (see section "Other medicines and Nurofen Influenza and Cold")
• you suffer from coagulation problems or are taking blood thinners (oral anticoagulants). Your doctor will carefully assess whether you can take this medicine as it can lead to a reduction in coagulation (see section "Other medicines and Nurofen Influenza and Cold");
• you are elderly and/or have suffered from stomach and intestinal disorders (history of ulcer), especially with bleeding or perforation or if you are taking medicines that may increase the risk of gastrointestinal events. In these cases, your doctor will advise you to start treatment with the lowest available dose and possibly the concomitant use of medicines that protect the stomach (misoprostol or proton pump inhibitors);
• you suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• you are taking medicines that could increase the risk of ulceration or bleeding, medicines used to treat inflammation (oral corticosteroids), blood thinners (such as warfarin), antiplatelet drugs (aspirin) and medicines to treat depression (selective serotonin reuptake inhibitors) (see section "Other medicines and Nurofen Influenza and Cold");
• you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including 'mini-stroke' or TIA, transient ischemic attack);
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• you suffer from reduced kidney function;
• you suffer or have suffered from allergic reactions or asthma episodes (difficulty breathing) as you may experience shortness of breath;
• you suffer from liver disorders;
• in dehydrated adolescents (i.e. who have lost a lot of fluids with fever, vomiting or diarrhea) due to the risk of impaired kidney function;
• you suffer from a chronic autoimmune disease that causes disorders in various parts of the body, in particular the skin (systemic lupus erythematosus) or mixed connective tissue disease, as it increases the risk of aseptic meningitis;
• if you suffer from hyperexcitability;
• if you take medicines that mimic the effects of sympathetic nervous system stimulation on various tissues such as nasal decongestants, appetite suppressants and amphetamine stimulants (see Other medicines and Nurofen Influenza and Cold), your doctor will carefully evaluate co-administration;
• if you develop a widespread feverish rash associated with pustules, stop taking Nurofen Influenza and Cold and contact your doctor or seek immediate medical attention. See section 4;
• sudden abdominal pain or rectal bleeding may occur with Nurofen Influenza and Cold, due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Nurofen Influenza and Cold and contact your doctor or seek immediate medical attention. See section 4;
• you have an infection. See section "Infections" below

Anti-inflammatory/painkiller medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.

During treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, bleeding, ulceration and perforation of the stomach or intestine have been reported, which can be fatal. If bleeding or ulceration occurs, discontinue treatment with Nurofen Influenza and Cold and contact your doctor (see section "Possible side effects").

If you have suffered from gastrointestinal problems in the past (gastrointestinal toxicity), especially if you are elderly, inform your doctor of any unusual symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

With Nurofen Influenza and Cold, a reduction in blood flow to the optic nerve may occur. If sudden loss of vision occurs, stop taking Nurofen Influenza and Cold and contact your doctor or a healthcare facility immediately. See section 4.

Skin reactions
Serious skin reactions have been reported in association with Nurofen Influenza and Cold treatment. Stop taking Nurofen Influenza and Cold and consult your doctor immediately if you experience 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.

Infections
Nurofen Influenza and Cold can mask the symptoms of infections such as fever and pain. It is therefore possible that Nurofen Influenza and Cold may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and can in any case lead to positive anti-doping tests.

Children and adolescents
Do not give this medicine to children under 12 years of age.
In dehydrated adolescents, there is a risk of impaired kidney function.

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

If you experience any of the following side effects, STOP treatment and consult your doctor:
• ulceration or bleeding of the stomach and intestine, not necessarily preceded by warning symptoms or a previous history of serious stomach and intestinal diseases;
• skin and mucous membrane alterations (rashes, redness, itching, blisters), as these could be signs of severe allergic reactions (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The onset of reactions occurs in most cases in the early stages of treatment;
• difficulty breathing (bronchospasm);
• hallucinations, restlessness or sleep disturbances (see section "Warnings and precautions").

The sudden onset of fever, reddening of the skin or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis) may occur within the first 2 days of treatment with Nurofen Influenza and Cold. See section 2.
Stop using Nurofen Influenza and Cold if you develop these symptoms and contact your doctor or seek immediate medical attention.

Additional side effects include:

Uncommon (may affect up to 1 in 100 people): • digestive disorders (dyspepsia), abdominal pain and nausea
• headache, tremors
• allergic reactions manifesting as hives and itching.*
• skin rashes*

Rare (may affect up to 1 in 1,000 people):
• diarrhea, vomiting, flatulence and difficulty passing stools (constipation)

Very rare (may affect up to 1 in 10,000 people):
• peptic ulcers, perforation and bleeding of the stomach and intestine, black stools and vomiting blood, sometimes fatal, particularly in the elderly (see section "Warnings and precautions")
• bleeding lesions of the mouth, heartburn (gastritis)
• severe kidney disease (severe kidney failure including papillary necrosis). Especially during long treatments, associated with increased blood urea levels and swelling (edema).
• liver damage
• reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruises on the skin (hematomas)
• severe allergic reactions (anaphylaxis, angioedema or severe shock). Symptoms may include swelling of the face, tongue and larynx, difficulty breathing (dyspnea), fast heart rate (tachycardia), low blood pressure (hypotension)
• central nervous system disease of viral origin (aseptic meningitis), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (more frequent if you suffer from systemic lupus erythematosus or mixed connective tissue disease)
• decreased levels of hemoglobin (the substance that carries oxygen) in the blood
• skin reactions with blisters may occur including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis

Not known (frequency cannot be estimated from the available data):
• respiratory tract disorders, due to allergic reactions, which include wheezing and/or difficulty breathing (asthma), wheezing (bronchospasm) and difficulty breathing (dyspnea)*
• high blood pressure (hypertension) (see section "Warnings and precautions")
• palpitations, changes in heart rhythm (tachycardia, arrhythmia)
• swelling (edema)
• chest pain
• heart failure (see section "Warnings and precautions")
• insomnia
• anxiety
• agitation
• restlessness
• hallucinations
• worsening of inflammatory bowel diseases (colitis and Crohn's disease) (see section "Warnings and precautions")
• dry mouth
• excessive sweating
• muscle weakness
• reduction in the normal amount of urine over the course of the day
• irritability
• thirst
• a widespread, red and scaly rash, with pustules forming under the skin and blisters localized mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen Influenza and Cold 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)
• reduced blood flow to the optic nerve (ischemic optic neuropathy)
• skin becomes sensitive to light

A severe 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).

*allergic reactions include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea or c) various skin conditions such as various rashes, itching, hives, redness of the skin with bleeding (purpura), skin marks and swelling in the area of the eyes and lips (angioedema) and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme) allergic reactions due to pseudoephedrine or similar compounds (cross-reactivity reactions with pseudoephedrine).

The following side effects have also been observed: gastrointestinal intolerance, hemorrhages, sweating, dizziness, chest pain (precordial pain), difficulty urinating and insomnia.

Reporting of 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.