Nurofen

Patient Information Leaflet

NUROFEN 200 mg coated tablets, 400 mg coated tablets

Ibuprofen
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, please consult your pharmacist.
• If you experience any side effect, 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 course of treatment in adults.

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

1 What Nurofen is and what it is used for
Nurofen contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These act to reduce pain and swelling caused by inflammation, as well as 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, and menstrual pain.
Nurofen is also indicated as an adjunctive treatment for the symptomatic relief of feverish and flu-like conditions.

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

Do not take Nurofen if:

• you are allergic (hypersensitive) 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, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• you suffer from severe kidney or liver disease (renal or hepatic insufficiency);
• you suffer from severe heart disease (severe heart failure);
• you have previously experienced stomach or intestinal bleeding or perforation following treatment with NSAIDs;
• you currently have or have had gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• you are in the last trimester of pregnancy;
• you are undergoing or have undergone heart surgery.

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

Warnings and precautions
Consult your doctor or pharmacist before taking Nurofen 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 Nurofen”);
• you are elderly and/or have previously suffered from stomach or intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly combining it with medicines 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 Nurofen”). During treatment with any NSAID, at any time and regardless of warning symptoms or prior history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early 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 like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Nurofen”);
• 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 suffer from impaired liver and/or kidney function, as habitual use of analgesic medicines such as Nurofen may lead to serious, permanent kidney problems (possibly leading to renal failure). 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 suffer from coagulation disorders;
• you suffer from a chronic autoimmune disease affecting various parts of the body, particularly the skin (systemic lupus erythematosus) or mixed connective tissue disease, as this increases the risk of aseptic meningitis;
• you experience early signs of hypersensitivity reaction after taking Nurofen. If this occurs or is suspected, stop taking Nurofen and consult your doctor. Medically supervised measures should be initiated by specialized medical personnel, according to the symptoms presented. Anti-inflammatory/analgesic medicines containing ibuprofen may cause prolonged bleeding time by reversibly inhibiting platelet aggregation;
• you have an infection – see section “Infections” below.

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

Discuss treatment with your doctor or pharmacist before taking Nurofen 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, family history of heart disease or stroke, or if you are a smoker.

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 Nurofen and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Infections
Nurofen may mask symptoms of infections such as fever and pain. Therefore, Nurofen could 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) due to the risk of impaired kidney function.

Other medicines and Nurofen
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Nurofen may affect or be affected by other medicines, particularly inform your doctor 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 used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat AIDS (zidovudine);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in the treatment of cancer and rheumatism (methotrexate);
• a medicine used for mental disorders (lithium);
• a medicine used for medical termination of pregnancy (mifepristone): do not take NSAIDs within 8–12 days after taking mifepristone;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan) and diuretics;
• medicines used to treat heart conditions (cardiac glycosides);
• alcohol, medicines used to treat bone resorption disorders (bisphosphonates), or medicines known as “peripheral vasodilators” (pentoxifylline), as they may increase gastrointestinal side effects and the risk of bleeding and ulceration;
• a medicine known as a “central muscle relaxant” to relax muscles (baclofen), as it may cause increased toxicity.

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

Nurofen with food, drinks and alcohol
If you suffer from stomach problems, take Nurofen preferably with food.
Do not consume alcohol during treatment with Nurofen. Some side effects, particularly those affecting the gastrointestinal tract or nervous system, may be more likely if alcohol is consumed together with Nurofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Nurofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery.
It may cause kidney and heart problems in the fetus. It may affect the bleeding tendency in both mother and child and delay or prolong labour beyond the expected duration. You should not take Nurofen 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, Nurofen may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
This medicine passes into breast milk in small amounts. It may be used during breastfeeding if taken at the recommended doses and for short periods.

Fertility
Avoid taking this medicine if you are trying to conceive, as it may affect ovulation. This effect reverses upon discontinuation of treatment.

Driving and using machines
Nurofen does not affect or has a negligible effect on the ability to drive or use machines when taken for short-term treatment.

Nurofen 200 mg and 400 mg coated tablets contain:

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Nurofen 200 mg coated tablets contain:
sodium:
This medicine contains less than 1 mmol (23 mg) of sodium (the main component of table salt) per tablet (17.34 mg), i.e., essentially ‘sodium-free’, and slightly more than 1 mmol (23 mg) of sodium per 2 tablets (34.68 mg). This corresponds to 1.73% of the maximum recommended daily dietary intake for an adult.

Nurofen 400 mg coated tablets contain:
sodium:
This medicine contains 34.69 mg of sodium (the main component of table salt) per tablet. This corresponds to 1.73% of the maximum recommended daily dietary intake for an adult.

3 How to take Nurofen
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Nurofen 200 mg coated tablets

Nurofen
400 mg coated tablets

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

Use in elderly:
No dose adjustment is required.
If you suffer from stomach problems, take Nurofen preferably with food.
Nurofen should be used only for short-term treatment.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
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 Nurofen than you should
If you have taken more Nurofen than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and actions to be taken.
Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Other possible symptoms include: increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney effects, stomach and intestinal bleeding, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the central nervous system and respiratory function, 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 asthmatic patients, the disease may worsen.

If you forget to take Nurofen
Do not take a double dose to make up for a forgotten 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, including severe ones, which may include: hives, itching, purpura, swelling of the face, mouth, and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma.
• Red, flat, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and 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 occur at the beginning of treatment (generalized exanthematous pustulosis).

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):

• Diarrhea, vomiting, flatulence, constipation
• Increased transaminases, increased alkaline phosphatase, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased uric acid
• Stroke or cerebrovascular accident
• Liver damage (hepatotoxicity)

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
• Bleeding lesions in the mouth, stomach burning (gastritis)
• Severe heart disease (heart failure), edema, and high blood pressure (hypertension)
• Severe kidney diseases (renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration (early signs: urinating less than normal, general malaise). Blood in the urine (hematuria), kidney inflammation (nephritis), a group of signs and symptoms such as protein loss in urine, reduced blood protein levels, fluid accumulation in the body leading to swelling, increased blood lipid or fat levels, blood hypercoagulability, related to kidney diseases (nephrotic syndrome)
• Liver damage, especially after long-term treatment, hepatitis, jaundice
• Reduction in blood cell count (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, bruising (hematomas)
• Aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever, or disorientation (more frequent in patients with systemic lupus erythematosus or mixed connective tissue disease)
• Decreased 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, labored breathing (bronchospasm), and difficulty breathing (dyspnea)
• Worsening of inflammatory bowel diseases (colitis and Crohn's disease)
• 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 cells)
• Inflammation of the pancreas (pancreatitis)
• A widespread, red, scaly rash with pustules under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized exanthematous pustulosis). Stop using Nurofen if you develop these symptoms and contact your doctor immediately. See also section 2.
• Skin becomes sensitive to light

The 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 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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nurofen
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.
Nurofen 200 mg film-coated tablets: no special storage conditions required.
Nurofen 400 mg film-coated tablets: store at a temperature not exceeding 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information
What Nurofen 200 mg film-coated tablets contain

• The active substance is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other components are: sucrose, croscarmellose sodium, sodium lauryl sulfate, sodium citrate, carmellose sodium, stearic acid, anhydrous colloidal silica, talc, dried nebulized gum arabic, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520).

What Nurofen 400 mg film-coated tablets contain

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are: sucrose, croscarmellose sodium, sodium lauryl sulfate, sodium citrate, carmellose sodium, stearic acid, anhydrous colloidal silica, talc, dried nebulized gum arabic, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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