NUROFEN INFLUENZA COOL 200 MG + 30 MG COATED TABLETS 24 COATED TABLETS

Name
NUROFEN FLU AND COLD 200 mg + 30 mg 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 allows to reduce the pain and swelling caused by inflammation and to lower fever;
• pseudoephedrine hydrochloride, belongs to a group of medicines called vasoconstrictors which act on the blood vessels inside the nose to relieve nasal congestion.

Nurofen Cold and Flu is indicated in 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, headache, fever and sore throat.
Contact your doctor if you do not feel better or feel worse after 3 days in adolescents over 12 years 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 polyps in the nose, 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 ulcers or bleeding diagnosed);
• if you suffer from severe liver disease (liver failure);
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you suffer from severe heart disease (severe heart failure);
• if you suffer from serious heart or circulation problems such as increased heart rate (tachycardia), very high blood pressure (severe hypertension) or high blood pressure not controlled by medicines, chest pain that occurs when the heart does not receive enough oxygen (angina pectoris);
• if you suffer from overactive thyroid (hyperthyroidism);
• if you suffer from a disease characterised 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 a pregnant or breastfeeding woman;
• if you are taking medicines for depression, such as non-selective monoamine oxidase inhibitors (known as MAOIs) or if you have taken them in the last 14 days.


Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofen Cold & 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 side effects and should be avoided (see section "Other medicines and Nurofen Cold and Flu");
• suffer from clotting problems or are taking medicines to thin the blood (oral anticoagulants). Your doctor will carefully assess whether you can take this medicine as it may lead to a reduction in clotting (see section "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);
• suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• are taking medicines that could increase the risk of ulceration or bleeding, medicines used to treat inflammation (oral corticosteroids), medicines used to thin the blood (such as warfarin), antiplatelet drugs (aspirin) and medicines to treat depression (selective serotonin reuptake inhibitors) (see section "Other medicines and Nurofen Cold and Flu");
• have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
• have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker;
• suffer from reduced kidney function;
• suffer or have suffered from allergic reactions or episodes of asthma (difficulty breathing) as you may experience shortness of breath;
• suffers from liver disorders;
• in dehydrated adolescents (i.e. those who have lost a lot of fluids through fever, vomiting or diarrhoea) due to the risk of altered kidney function;
• suffers from a chronic autoimmune disease that causes disorders in various parts of the body, particularly the skin (systemic lupus erythematosus) or mixed connective tissue disease, as it increases the risk of aseptic meningitis;
• if you suffer from hyperexcitement;
• 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 generalised feverish rash associated with pustules, stop taking Nurofen Cold and Flu and contact your doctor or seek medical advice immediately.
See paragraph 4;
• sudden abdominal pain or rectal bleeding may occur with Nurofen Cold & Flu, due to inflammation of the colon (ischaemic colitis). If you develop these gastrointestinal symptoms, stop taking Nurofen Cold & Flu and contact your doctor or seek medical help immediately. See section 4;
• have an infection. See section "Infections" below.

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 Nurofen Cold & Flu immediately and contact your doctor or emergency department immediately if you notice any of these signs.

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.

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

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

With Nurofen Cold and Flu, there may be a reduction in blood flow to the optic nerve. If you experience sudden loss of vision, stop taking Nurofen Cold and Flu and contact your doctor or healthcare provider immediately. See section 4.

Skin reactions
Serious skin reactions have been reported in association with treatment with Nurofen Cold and Flu. Stop taking Nurofen Cold and Flu and consult your doctor immediately if you experience a skin 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 Cold & Flu may hide the symptoms of infections such as fever and pain. It is therefore possible that Nurofen Cold & 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 bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicinal products containing pseudoephedrine.
PRES and RCVS are rare conditions that can result in reduced blood supply to the brain.
Stop using NUROFEN COLD & FLU 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).

For those who do sports activities
The use of the drug without therapeutic need constitutes doping and may still result in 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 renal function.


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

Stop taking NUROFEN COLD & FLU immediately and see a doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include: sudden onset of severe headache, nausea, vomiting, confusion, convulsions, changes in vision.

If you experience any of the following side effects STOP treatment and contact your doctor:
• ulcerations or bleeding of the stomach and intestines, not necessarily preceded by warning symptoms or a previous history of serious stomach and intestinal diseases;
• changes in the skin and mucous membranes (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 section "Warnings and precautions").

The sudden onset of fever, redness of the skin or numerous small pustules (possible symptoms of Acute Generalised Exanthematous Pustulosis) may occur within the first 2 days of treatment with Nurofen Cold and Flu. See section 2.
Stop using Nurofen Cold & Flu if you develop these symptoms and contact your doctor or seek medical help immediately.
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):
• diarrhea, vomiting, passing gas from the intestines (flatulence) and difficulty in going to the toilet (constipation).

Very rare (may affect up to 1 in 10,000 people):
• peptic ulcers, perforation and bleeding of the stomach and intestines, black stools and vomiting of blood sometimes fatal particularly in the elderly (see section "Warnings and precautions");
• lesions with bleeding from the mouth, heartburn (gastritis);
• severe kidney disease (severe renal failure including papillary necrosis). Especially during long-term treatment, associated with increased levels of urea in the blood 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 tiredness, unexplained bleeding, bruising on the skin (hematomas);
• severe allergic reactions (anaphylaxis, angioedema or severe shock). Symptoms may include swelling of the face, tongue and larynx, difficulty breathing (dyspnoea), rapid heartbeat (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;
• 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 blood vessels in the brain known as posterior reversible 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, including shortness of breath and/or difficulty breathing (asthma), wheezing (bronchospasm) and difficulty breathing (dyspnoea)*;
• high blood pressure (hypertension) (see section "Warnings and precautions");
• palpitations, alterations 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 during the day;
• irritability;
• thirst;
• 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 generalised exanthematous pustulosis). Stop using Nurofen Cold & 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);
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• the skin becomes sensitive to light.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen 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), marks on the skin 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 reported: gastrointestinal intolerance, bleeding, sweating, dizziness, chest pain (precordial pain), difficulty urinating, and insomnia.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.