NUROFEN 400 MG COATED TABLETS 12 PVC/ALUMINIUM TABLETS

Name
NUROFEN 200 mg coated tablets
NUROFEN 400 mg coated tablets
Ibuprofen


What it is and what it is used for
Nurofen contains ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which work by reducing pain and swelling caused by inflammation and fever.

Nurofen is indicated in adults and adolescents over 12 years of age for the treatment of various types of pain: headache, toothache, neuralgia, muscle, bone and joint pain, menstrual pain.
Nurofen is also indicated as an adjuvant for the symptomatic treatment of fever and influenza.


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

Do not take Nurofen if:
• are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• have previously experienced allergic reactions such as difficulty breathing (bronchospasm, asthma), rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or hives after taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffer from severe kidney or liver disease (renal or hepatic failure);
• suffer from severe heart disease (severe heart failure);
• have suffered from stomach bleeding or perforation following previous NSAID treatments;
• suffer or have suffered from active or recurrent gastric/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct episodes of proven ulceration or bleeding);
• is in the last trimester of pregnancy;
• is due to have or has had heart surgery.

Do not give Nurofen to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofen 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) (see section "Other medicines and Nurofen");
• are elderly and/or have had stomach and intestinal problems (history of ulcer), especially if complicated by bleeding or perforation as an increase in gastrointestinal bleeding and perforation may occur. In these cases, your doctor will advise you to start treatment with the lowest available dose and possibly the concomitant use of stomach-protective medicines (misoprostol or proton pump inhibitors). This should also be considered if you are taking low dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section "Other medicines and Nurofen"). Bleeding, ulceration and perforation of the stomach or intestine, which may be fatal, may occur at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. Therefore, tell your doctor about any uncommon gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop taking Nurofen and contact your doctor;
• suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• are taking medicines which may increase the risk of ulceration or bleeding, such as medicines used to treat inflammation and certain immune system diseases (oral corticosteroids), anticoagulants such as warfarin, medicines which may have an antiplatelet effect such as aspirin, medicines to treat depression (selective serotonin reuptake inhibitors) (see section "Other medicines and Nurofen");
• suffer from high blood pressure and/or severe heart disease (heart failure) as fluid retention, high blood pressure and swelling have been reported in association with NSAID therapy;
• suffer from reduced liver and/or kidney function, as the habitual use of painkillers such as Nurofen can lead to serious permanent kidney problems (with possible onset of kidney failure). Your doctor will advise you to carry out periodic tests during treatment;
• suffer or have suffered from asthma (difficulty breathing) or allergic reactions as you may experience shortness of breath;
• suffers from clotting problems;
• suffer from a chronic autoimmune disease that causes problems in various parts of the body, especially the skin (systemic lupus erythematosus) or mixed connective tissue disease, as the risk of aseptic meningitis increases; manifests the first signs of a hypersensitivity reaction after taking Nurofen. If this occurs or is suspected, you should stop taking Nurofen and consult your doctor. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms;
Anti-inflammatory/pain-relieving drugs containing ibuprofen may cause a prolongation of bleeding time by reversibly inhibiting platelet aggregation;
• have an infection – see section “Infections” below.

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.

You should discuss your treatment with your doctor or pharmacist before taking Nurofen if you 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);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Nurofen and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections
Nurofen may hide the symptoms of infections such as fever and pain. It is therefore possible that Nurofen 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.

Children and adolescents
Do not give this medicine to children under 12 years of age.
Caution is advised in dehydrated adolescents (12-18 years) as 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.

If you experience any of the following side effects STOP treatment and contact your doctor:
• allergic reactions, including serious ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), altered heart beat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma;
• 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];
• Widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Additional side effects include:

Uncommon (may affect up to 1 in 100 people):
• stomach disturbances, such as heartburn, stomach pain and nausea
• heachache
• dizziness
• skin rashes

Rare (may affect up to 1 in 1,000 people):
• diarrhea, vomiting, flatulence, constipation
• increased transaminases, increased alkaline phosphatase, decreased haematocrit, prolonged bleeding time, decreased blood calcium, increased uric acid
• brain attack or stroke
• liver damage (hepatotoxicity)

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 blood
• lesions with bleeding from the mouth, heartburn (gastritis)
• severe heart disease (heart failure), swelling and high blood pressure (hypertension)
• severe kidney disease (renal failure, papillary necrosis) particularly following long-term treatment, associated with an increase in the concentration of urea in the blood (the first signs are: urinating less than normal, general malaise). Presence of blood in the urine (haematuria), inflammation of the kidney (nephritis), a set of signs and symptoms such as loss of protein in the urine, decreased levels of protein in the blood, accumulation of fluid in the body resulting in swelling, increased levels of lipids or fats in the blood, hypercoagulability of the blood, related to kidney disease (nephrotic syndrome)
• liver damage especially following long-term treatments, hepatitis, jaundice
• 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, nose and skin bleeding, bruising on the skin (hematomas)
• aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (more common if you have systemic lupus erythematosus or mixed connective tissue disease)
• decrease in hemoglobin levels in the blood
• visual disturbances

Not known (frequency cannot be estimated from the available data):
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• respiratory tract disorders including asthma, worsening of asthma, shortness of breath (bronchospasm) and difficulty breathing (dyspnoea)
• worsening of inflammatory bowel diseases (colitis and Crohn's disease)
• 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)
• inflammation of the pancreas (pancreatitis)
• 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 if you develop these symptoms and contact your doctor immediately. See also section 2
• the skin becomes sensitive to light

Use of ibuprofen, especially at high doses (2400 mg/day) may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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.