NUROFEN 200 mg Film-Coated Tablets

Зміст інструкції

1. NUROFEN 200 mg coated tablets, 400 mg coated tablets

NUROFEN 200 mg coated tablets, 400 mg coated tablets

Ibuprofen

Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after:
• 3 days in adolescents over 12 years of age
• a short period of treatment in adults.

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

1What is Nurofen and what it is used for
Nurofen contains ibuprofen which belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs) whose action allows to reduce pain and swelling
caused by inflammation and fever.
Nurofen is indicated in adultsand adolescentsover 12 years of agefor the treatment
of various types of pain: headache, toothache, neuralgia, muscle, bone and
joint pain, menstrual pain.
Nurofen is also indicated as an adjunct to the symptomatic treatment of febrile and
flu-like states.

2What you need to know before you take Nurofen
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 immediately and contact your doctor or emergency health service immediately if you notice any of these signs.

Do not take Nurofen if:

• you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• you have experienced allergic reactions in the past such as difficulty breathing (bronchospasm,

asthma), rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria
after taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

• you have severe kidney or liver disease (renal or hepatic insufficiency);
• you have severe heart disease (severe heart failure);
• you have suffered from bleeding or perforation of the stomach following previous treatments with NSAIDs;
• you suffer from or have suffered from gastric/duodenal ulcers (peptic ulcers) or ongoing or recurrent bleeding (at least two distinct episodes of demonstrated ulceration or bleeding);
• you are in the last trimester of pregnancy;
• you are to be or have been operated on the heart.

Do not administer 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”);
• you are elderly and/or have suffered from stomach and 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 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). This should also be considered if you are taking low doses of aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section “Other medicines and Nurofen”). During treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, bleeding, ulceration and perforation of the stomach or intestine may occur, which may be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the early stages of treatment. If you experience bleeding or gastrointestinal ulceration, stop taking 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 some diseases of the immune system (oral corticosteroids), anticoagulants such as warfarin, medicines that may have an antiplatelet effect such as aspirin, medicines to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Nurofen”);
• you suffer from high blood pressure and/or severe heart disease (severe heart failure) as, in association with NSAID therapy, fluid retention, high blood pressure and swelling have been reported;
• you suffer from reduced liver and/or kidney function, as regular use of pain relievers such as Nurofen may lead to serious permanent kidney problems (with possible onset of renal failure). Your doctor may advise you to undergo periodic tests during treatment;
• you suffer from or have suffered from asthma (difficulty breathing) or allergic reactions as you may experience shortness of breath;
• you have problems with blood clotting;
• you suffer from a chronic autoimmune disease that causes disorders in various parts of the body, especially the skin (systemic lupus erythematosus) or mixed connective tissue disease, as this increases the risk of aseptic meningitis; you experience the first signs of a hypersensitivity reaction after taking Nurofen. If this occurs or is suspected, you should stop taking Nurofen and consult a doctor. Medically assisted measures must be initiated by specialized medical personnel, in accordance with the symptomatology; Anti-inflammatory/pain-relieving drugs based on ibuprofen may cause a prolongation of bleeding time by reversibly inhibiting platelet aggregation;
• you have an infection - see section “Infections” below.

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a
modest increase in the risk of heart attack or stroke, especially if administered in high
doses. Do not exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Nurofen if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery 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);
• 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 generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen. 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 can mask 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 in
skin infections related to varicella. If you are taking this medicine while you have
an infection and the symptoms of the infection persist or worsen, contact your
doctor immediately.

Children and adolescents
Donot give this medicine to children under 12 years of age.
Caution is required in adolescents (12-18 years) who are dehydrated as there is a risk of
impaired renal function.

Other medicines and Nurofen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Nurofen can influence or be influenced by other medicines, in particular tell your
doctor 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 or acetylsalicylic acid), as they increase the risk of possible side effects.
• medicines used to treat inflammation and some diseases of the immune system (corticosteroids);
• medicines used to treat infections caused by bacteria (quinolone antibiotics);
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine 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 illnesses (lithium);
• a medicine for termination of pregnancy (mifepristone): do not take NSAIDs for 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 disease (cardiac glycosides);
• alcohol, medicines used in the treatment of diseases associated with bone resorption (bisphosphonates), medicines called “Peripheral vasodilators” (pentoxifylline), as they can potentiate the gastrointestinal and risk of bleeding and ulcer side effects;
• a medicine known as a “central muscle relaxant” to relax muscles (baclofen), as it may cause high toxicity.

Some other medicines may also influence or be influenced 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.
You should not drink alcohol during treatment with Nurofen. Some side effects, such as
those affecting the gastrointestinal tract or the nervous system, may be more likely
if you drink alcohol together with Nurofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Do not take Nurofen in the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth.
It may cause problems with the kidneys and heart of the fetus. It may affect the tendency of the mother and
child to bleed and delay or prolong labor more than expected. You should not take Nurofen in the first 6 months of pregnancy, unless absolutely necessary
and under the advice of a doctor. If treatment is necessary during this period or during
attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Nurofen may cause kidney problems in the fetus, if
taken for more than a few days, thus reducing the levels of amniotic fluid surrounding the
child (oligohydramnios) or causing 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 advise additional monitoring.
Breastfeeding
This medicine passes in small amounts into breast milk. It can be used during
breastfeeding if taken at the recommended doses and for short periods of time.
Fertility

Avoidtaking the medicine if you are trying to conceive as it may have an effect
on ovulation. This effect disappears with discontinuation of treatment.

Driving and operating machinery
Nurofen does not impair or impairs negligibly the ability to drive vehicles or operate
machinery, if taken for short periods of treatment.

Nurofen 200 mg and 400 mg coated tablets contains:

• sucrose: if you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

Nurofen 200 mg coated tablets contains:
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 is equivalent
to 1.73% of the recommended maximum daily intake of salt with the diet of an adult.

Nurofen 400 mg coated tablets contains:
sodium:
This medicine contains 34.69 mg of sodium(the main component of table
salt) per tablet. This is equivalent to 1.73% of the maximum recommended daily
intake with the diet of an adult.

3How to take Nurofen
Take this medicine following exactly what is reported in this leaflet or the
instructions of the doctor, or pharmacist. If you have doubts, 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 should not be taken by children under 12 years of age.
Use in the elderly:
No dose adjustments are required.
If you suffer from stomach problems, take Nurofen preferably on a full stomach.
Nurofen should be taken for short-term treatments.
The lowest effective dose should be used for the shortest period necessary to relieve
symptoms. If you have an infection, consult your doctor immediately if the symptoms (for
example fever and pain) persist or worsen (see paragraph 2).
Undesirable effects can be minimized by using the minimum effective dose for the
shortest possible duration necessary to control the symptoms.
Consult your doctor if you do not notice any improvement or if you notice a worsening of the symptoms
after:

• 3 days in adolescents over 12 years
• 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 taken this medicine by
mistake, always contact a doctor or the nearest hospital in order to receive advice on
the risk and advice on the actions to be taken.
Symptoms of overdose may include: nausea, stomach pain, vomiting (with
possible traces of blood), headache, ringing in the ears, confusion and
uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of
consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine,
low levels of potassium in the blood, feeling cold to the body and breathing problems have been reported.
Symptoms of an overdose may appear within 4 – 6 hours of taking

ibuprofen.
You may also experience: increased acids in the blood (metabolic acidosis), lowering
of body temperature (hypothermia), effects on the kidney, bleeding from the
stomach and intestines, severe loss of consciousness (coma), temporary interruption of
breathing (apnea), diarrhea, reduced activity of the nervous system and respiratory activity,
disorientation, excited state, fainting, lowering of blood pressure
(hypotension), decrease or increase in heart rate (bradycardia or tachycardia). In addition,
a reduction in coagulation (prolongation of prothrombin time) may also occur.
If you take significantly high doses of ibuprofen, you may experience serious damage to
the kidneys and liver. In asthmatic subjects, the disease may worsen

If you forget to take Nurofen
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
If you experience any of the following side effects STOPtreatment and consult
the doctor:

• allergic reactions, even severe, which may include: hives, itching, purpura, swelling of face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), altered heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma.
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Diffuse skin rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Diffuse skin rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Further side effects include:

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

• stomach problems, such as heartburn, stomach pain and nausea
• headache
• dizziness
• skin rashes

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 ictus
• 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 of blood
• lesions with bleeding of the mouth, heartburn (gastritis)
• severe heart disease (heart failure), edema and high blood pressure (hypertension)
• severe kidney disease (renal failure, papillary necrosis) particularly following long-term treatments, associated with an increase in the concentration of urea in the blood (the first signs are: urinating in a smaller quantity than usual, general malaise). Presence of blood in the urine (hematuria), inflammation of the kidney (nephritis), a set of signs and symptoms such as loss of proteins in the urine, decreased levels of proteins in the blood, accumulation of fluids in the body with consequent swelling, increased levels of lipids or fats in the blood, hypercoagulability of the blood, correlated to kidney diseases (nephrotic syndrome)
• liver damage especially following long-term treatments, hepatitis, jaundice
• reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial ulcers of the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin, bruises on the skin (hematomas)
• 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)
• decrease in hemoglobin levels in the blood
• visual disturbances

Not known( frequency cannot be estimated on the basis of 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 (dyspnea)
• worsening of inflammatory bowel diseases (colitis and Crohn's disease)
• it is possible to develop a serious skin reaction known as DRESS syndrome. 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 and scaly skin rash, with pustules under the skin and blisters located mainly on the skin folds, on the trunk and on the upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen if you develop these symptoms and contact your doctor immediately. See also paragraph 2.
• the skin becomes sensitive to light

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through 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.

5How 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 Scad..
The expiry date refers to the last day of that month.
Nurofen 200 mg coated tablets: no particular storage conditions.
Nurofen 400 mg coated tablets: store at a temperature not exceeding 30°C.
Do not dispose of any medicine in the water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6 Content of the pack and other information
What Nurofen 200 mg coated tablets contains

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

What Nurofen 400 mg coated tablets contains

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

Description of the appearance of Nurofen and contents of the pack
Nurofen comes in the form of coated tablets.
The content of the pack is 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 Milan

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