NUROFEN FLU AND COLD*12TABS

NUROFEN COLD AND FLU 200 mg + 30 mg film-coated tablets
Ibuprofen + Pseudoephedrine hydrochloride

What it is and what it is used for
Nurofen Cold and Flu 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 serves to relieve nasal congestion.

Nurofen Cold and Flu 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 Cold and Flu:
• 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 difficult 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 a severe liver disease (hepatic insufficiency);
• if you suffer from a severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you suffer from a severe heart disease (severe heart failure);
• if you suffer from severe heart or circulation problems such as increased heart rate (tachycardia), very high blood pressure (severe hypertension) or hypertension not controlled by medicines, 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 tumour affecting the kidney (phaeochromocytoma);
• if you suffer from increased intraocular pressure (glaucoma);
• if you suffer from difficulty urinating due 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 Cold and Flu if:
• you are taking other medicines used to treat pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) the concomitant use of these medicines may increase the risk of undesirable effects and should be avoided (see paragraph Other medicines and Nurofen Cold and Flu);
• you have blood clotting problems or are taking blood thinners (oral anticoagulants). Your doctor will carefully assess whether you can take this medicine as it may lead to a reduction in clotting (see paragraph Other medicines and Nurofen Cold and Flu);
• 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 paragraph Other medicines and Nurofen Cold and Flu);
• you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in 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 diarrhoea) due to the risk of impaired kidney function;
• you suffer from a chronic autoimmune disease that causes disorders in various parts of the body, particularly of 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 Cold and Flu) your doctor will carefully evaluate co-administration;
• if you develop a febrile generalized rash associated with pustules, stop taking Nurofen Cold and Flu and contact your doctor or seek immediate medical attention. See paragraph 4;
• sudden abdominal pain or rectal bleeding may occur with Nurofen Cold and Flu, due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Nurofen Cold and Flu and contact your doctor or seek immediate medical attention. See paragraph 4;
• you have an infection. See Infections paragraph below.

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

Anti-inflammatory/pain relief drugs 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 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, stop treatment with Nurofen Cold and Flu and contact your doctor (see paragraph Possible side effects).

If you have a history of gastrointestinal problems (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 Cold and Flu, a reduction in blood flow to the optic nerve may occur. If you experience a sudden loss of vision, stop taking Nurofen Cold and Flu and contact your doctor or a healthcare facility immediately. See paragraph 4.

Skin reactions
Serious skin reactions have been reported in association with Nurofen Cold and Flu treatment. Stop taking Nurofen Cold and Flu 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 paragraph 4.

Infections
Nurofen Cold and Flu can mask the symptoms of infections such as fever and pain. It is therefore possible that Nurofen Cold and Flu may delay adequate 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 infection symptoms persist or worsen, contact your doctor immediately.

Cases of reversible posterior 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 NUROFEN COLD AND FLU 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).

For those involved in sports activities
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 everyone gets them.

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

If you experience any of the following side effects, STOP treatment and contact your doctor:
• ulcers 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 mucosal alterations (rashes, redness, itching, blisters), as they could be signs of serious 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 paragraph 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 Cold and Flu. See paragraph 2.
Stop using Nurofen Cold and Flu 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 manifested by hives and itching*;
• skin rashes*;

Rare (may affect up to 1 in 1,000 people):
• diarrhoea, vomiting, gas from the intestine (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 of blood sometimes fatal especially in the elderly (see paragraph Warnings and precautions);
• lesions with bleeding from the mouth, heartburn (gastritis);
• severe kidney disease (severe renal insufficiency including papillary necrosis). Especially during long treatments, associated with increased blood urea levels and swelling (oedema);
• liver damage;
• reduction in the number of blood cells (anaemia, 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 (haematomas);
• severe allergic reactions (anaphylaxis, angioedema or severe shock). Symptoms can be swelling of the face, tongue and larynx, difficulty breathing (dyspnoea), rapid heartbeat (tachycardia), low blood pressure (hypotension);
• viral central nervous system disease (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 haemoglobin levels (the substance that carries oxygen) in the blood;
• blistering skin reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur.

Not known (frequency cannot be estimated from the available data):
• serious conditions affecting the brain blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• respiratory tract disorders, due to allergic reactions, which include wheezing and/or difficult breathing (asthma), wheezing (bronchospasm) and difficulty breathing (dyspnoea)*;
• high blood pressure (hypertension) (see paragraph Warnings and precautions);
• palpitations, alterations in heart rhythm (tachycardia, arrhythmia);
• swelling (oedema);
• chest pain;
• heart failure (see paragraph Warnings and precautions);
• insomnia;
• anxiety;
• agitation;
• restlessness;
• hallucinations;
• worsening of inflammatory bowel diseases (colitis and Crohn's disease) (see paragraph 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 the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen Cold and Flu if you develop these symptoms and contact your doctor immediately. See also paragraph 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, swelling of lymph nodes and increased 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 dyspnoea or c) various skin conditions such as various rashes, itching, hives, redness of the skin with bleeding (purpura), skin marks and swelling in the eye and lip area (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, bleeding, 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, talk to 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.