Nurofenimmedia

Package leaflet: Information for the patient

NUROFENIMMEDIA 200 mg coated tablets

Ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after:
  • 3 days in adolescents over 12 years of age;
  • a short period of treatment in adults.

Contents of this leaflet:
1 What Nurofenimmedia is and what it is used for
2 What you need to know before taking Nurofenimmedia
3 How to take Nurofenimmedia
4 Possible side effects
5 How to store Nurofenimmedia
6 Contents of the pack and other information

1 What Nurofenimmedia is and what it is used for
Nurofenimmedia contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This medicine works by reducing pain and swelling caused by inflammation and by lowering fever.
Nurofenimmedia is indicated in adults and adolescents over 12 years of age for the treatment of various types of pain: headache (migraine and tension headache), toothache, neuralgia, lower back pain, muscle, bone and joint pain (including pain due to accidental or sports-related injuries), and menstrual pain.
Nurofenimmedia is also indicated as an adjunctive treatment for the symptomatic relief of colds and influenza-like conditions.

2 What you need to know before taking Nurofenimmedia
Allergic reactions to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Immediately stop taking Nurofenimmedia and contact your doctor or emergency medical services if you experience any of these symptoms.

Do not take Nurofenimmedia if:

• you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• you have previously experienced allergic reactions such as breathing difficulties (bronchospasm, asthma), rhinitis (runny nose), swelling of the face, lips or throat (angioedema), or hives after taking ibuprofen, acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• you suffer from severe kidney or liver disease (renal or hepatic failure);
• you have had gastrointestinal bleeding or perforation in the past due to previous NSAID treatment;
• you currently have or have had stomach or duodenal ulcers (peptic ulcers), active or recurrent bleeding (at least two distinct episodes of confirmed ulceration or bleeding), or other stomach disorders;
• you suffer from severe heart disease (severe heart failure);
• you are in the last trimester of pregnancy;
• you are breastfeeding.
  Do not administer Nurofenimmedia to children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofenimmedia if:

• you are taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors) (see section “Other medicines and Nurofenimmedia”);
• you are elderly and/or have a history of stomach or intestinal disorders (history of ulcers), especially if complicated by bleeding or perforation, as this may increase the risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medications that protect the stomach (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 disorders (see section “Other medicines and Nurofenimmedia”). During treatment with any NSAID, at any time and with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, and perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Nurofen and contact your doctor;
• you suffer from or have suffered from inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• you are taking medicines that may increase the risk of ulceration or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects such as aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Nurofenimmedia”);
• you suffer from high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling have been reported with NSAID therapy;
• you have impaired liver and/or kidney function, as regular use of analgesic medicines such as Nurofenimmedia may worsen kidney problems. Your doctor may recommend periodic blood tests during treatment;
• you suffer from or have suffered from asthma (difficulty breathing) or allergic reactions, as you may experience breathing difficulties;
• you have had a condition involving displacement of part of the stomach from the abdomen into the chest through the diaphragm (hiatal hernia);
• you have blood clotting disorders;
• you suffer from a chronic autoimmune disease that affects various parts of the body, especially the skin (systemic lupus erythematosus) or mixed connective tissue disease, as this may increase the risk of aseptic meningitis;
• you have an infection – see the “Infections” section below.

Pain-relieving/anti-inflammatory medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken at high doses. Do not exceed the recommended dose or duration of treatment.
Discuss treatment with your doctor or pharmacist before taking Nurofenimmedia if you have:

• heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

If you are undergoing prolonged treatment with Nurofenimmedia, you should have periodic eye examinations.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, 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). Stop using Nurofenimmedia and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Infections
Nurofenimmedia may mask symptoms of infection such as fever and pain. Therefore, Nurofenimmedia may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.

Children and adolescents
Do not give this medicine to children under 12 years of age.
Caution is required in dehydrated adolescents (12–18 years) as there is a risk of impaired kidney function.

Other medicines and Nurofenimmedia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Nurofenimmedia may affect or be affected by other medicines, particularly if you are taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid), as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• medicines used to treat bacterial infections (quinolone antibiotics);
• medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) and diuretics;
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat AIDS (zidovudine);
• medicines used to treat diabetes (high blood sugar levels);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used to treat cancer and rheumatism (methotrexate);
• a medicine used for mental disorders (lithium);
• a medicine used for medical termination of pregnancy (mifepristone): do not take NSAIDs in the 8–12 days following mifepristone intake;
• medicines used to treat heart conditions (cardiac glycosides).

Other medicines may also affect or be affected by treatment with Nurofenimmedia. Therefore, always consult your doctor or pharmacist before using Nurofenimmedia with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Nurofenimmedia during the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery.
It may cause kidney and heart problems in the fetus. It may affect bleeding tendencies in both mother and baby and delay or prolong labour more than expected. You should not take Nurofenimmedia during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, Nurofenimmedia may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Do not take this medicine while breastfeeding.

Fertility
Avoid taking this medicine if you are trying to become pregnant, as it may affect ovulation. This effect is reversible upon discontinuation of treatment.

Driving and using machines
Nurofenimmedia does not affect or affects negligibly the ability to drive or use machinery, when taken for short-term treatment.

Nurofenimmedia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3 How to take Nurofenimmedia
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Use in children and adolescents:
Nurofenimmedia must not be taken by children under 12 years of age.

Use in elderly patients:
If you are elderly, you should follow the lowest recommended doses.

Swallow the Nurofenimmedia tablets whole with a little water.
Nurofenimmedia should be taken only for short-term treatment.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Consult your doctor if you do not notice improvement or if symptoms worsen after:

• 3 days in adolescents over 12 years of age,
• a short period of treatment in adults.

If you take more Nurofenimmedia than you should
If you have taken more Nurofenimmedia than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice regarding the risk and necessary actions.

Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with traces of blood), abdominal pain, deep sleep with reduced response to normal stimuli (lethargy), headache, ringing in the ears (tinnitus), confusion, and uncontrolled eye movements (nystagmus). At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low potassium levels in the blood, feeling cold, and breathing problems may occur.

Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.

You may also experience: increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney-related effects, bleeding of the stomach and intestines, deep loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the central nervous system and respiratory depression, disorientation, excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia). In addition, reduced blood coagulation (prolonged prothrombin time) may occur.

If you take significantly high doses of ibuprofen, severe kidney and liver damage may occur. In patients with asthma, the condition may worsen.

If you forget to take Nurofenimmedia
Do not take a double dose to make up for the missed tablet.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

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

STOP treatment immediately and consult your doctor if you experience any of the following side effects:

• Allergic reactions, even severe ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), altered heart rate (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• Reddish, flat spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• Widespread 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 beginning of treatment (generalized pustular exanthema). Stop using Nurofenimmedia if you develop these symptoms and contact your doctor immediately. See also section 2.

Other side effects include:

Uncommon (may affect up to 1 in 100 people):

• Stomach disturbances such as heartburn, stomach pain, and nausea
• Headache
• Dizziness
• Skin rash

Rare (may affect up to 1 in 1,000 people):

• Diarrhoea, vomiting, flatulence, 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 blood
• Bleeding lesions in the mouth, heartburn (gastritis)
• Severe kidney disorders (renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration, reduced urea excretion in urine, and swelling (oedema)
• Liver damage, especially after long-term treatment
• Reduction in blood cells (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, skin bruising (haematomas)
• Aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever, or disorientation (more frequent if you have systemic lupus erythematosus or mixed connective tissue disease)
• Decreased haemoglobin levels in the blood

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
• Visual disturbances, eye discomfort
• Severe heart disease (heart failure), swelling (oedema), and high blood pressure (hypertension)
• Respiratory disorders including asthma, worsening of asthma, laboured breathing (bronchospasm), and difficulty breathing (dyspnoea)
• Worsening of inflammatory bowel diseases (colitis and Crohn's disease)
• Reduced normal daily urine output
• Increased liver enzymes in the blood (transaminases)
• A widespread, red, scaly rash with pustules under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Stop using Nurofenimmedia if you develop these symptoms and contact your doctor immediately. See also section 2.
• Skin becomes sensitive to light

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Nurofenimmedia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6 Contents of the pack and other information

What Nurofenimmedia tablets contain

• The active substance is ibuprofen lysine salt. Each tablet contains 342 mg ibuprofen lysine salt, equivalent to 200 mg ibuprofen.
• Other components are: povidone, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Nurofenimmedia and pack contents
Nurofenimmedia is available as film-coated tablets.
Pack contents: 12 or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A. – via G. Spadolini 7 – 20141 Milano

Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands