IBUMENOL 400 mg Tabletki Powlekane

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1. IBUMENOL 400 mg film-coated tablets
   1. What is IBUMENOL and what is it used for
   2. What you need to know before taking IBUMENOL
2. IBUMENOL may mask the symptoms of infections such as fever and pain. It is therefore possible
   1. How to take IBUMENOL
3. IBUMENOL must be taken orally (for oral use) with plenty of water. Take the
   1. Possible side effects
   2. How to store IBUMENOL
   3. Contents of the pack and other information

IBUMENOL 400 mg film-coated tablets

Ibuprofen

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 3 days in adolescents or, in the case of adults, after 4 days for pain or 3 days for fever.

Contents of this leaflet:

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

1. What is IBUMENOL and what is it used for

IBUMENOL contains the active substance ibuprofen, which belongs to a group of medicines
known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). NSAIDs are drugs against
pain and inflammation.
IBUMENOL is used for the symptomatic treatment of short-term mild to moderate pain, such as
headache, toothache, menstrual pain, and/or fever.
IBUMENOL 400 mg is recommended for adults and adolescents with a body weight of
40 kg or more (aged 12 years or older).
See a doctor if you do not feel better or if you feel worse after 3 days, if you have a fever,
or 4 days if you are taking this medicine for pain.
See a doctor after 3 days if your child/adolescent does not feel better or
worsens after 3 days.

2. What you need to know before taking IBUMENOL

Do not take IBUMENOL

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other pain relievers, fever reducers, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma.
• if you have had bleeding or perforation of the stomach or intestines related to taking medications
• if you have an active or recurrent ulcer (peptic ulcers) or bleeding in the stomach or duodenum or if you have had this problem repeatedly (two or more distinct episodes of ulceration or bleeding) in the past
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have bleeding in the brain (cerebrovascular hemorrhage) or another ongoing bleeding
• if you suffer from a blood formation disorder of unknown origin, e.g. thrombocytopenia
• if you have any disease that increases the risk of bleeding;
• if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake)
• after the sixth month of pregnancy (see “Pregnancy and breastfeeding”).

Do not use IBUMENOL in children under 12 years of age.

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

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs
• you suffer from or have suffered from diseases of the stomach and intestines (e.g. ulcer, ulcerative colitis or Crohn's disease), as they may worsen (see section 4 “Possible side effects”)
• you have reduced kidney function
• you have liver problems
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• you are taking other medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) or antiplatelet agents (e.g. acetylsalicylic acid)
• you are taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as their concurrent use should be avoided
• you have heart problems, including heart failure, angina (chest pain), or have a history of 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 transient ischemic attack, “TIA”)
• you have high blood pressure, diabetes, high cholesterol or a family history of heart disease or stroke or if you are a smoker
• you suffer from allergies (e.g. skin reactions to other substances, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive respiratory diseases, as in that case you are at greater risk of allergic reactions
• you suffer from asthma or long-lasting (chronic) respiratory diseases
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforations of the stomach and intestines which can be life-threatening
• you have just undergone major surgery
• you have a congenital defect in porphyrin metabolism (e.g. acute intermittent porphyria).
• you have problems with blood coagulation (thickening)
• you have an infection - see paragraph >
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise against using this medicine
• if you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems.

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 IBUMENOL immediately and contact your doctor or emergency health service immediately if you notice any of these signs.
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 IBUMENOL and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in paragraph 4.
Side effects can be limited by using the minimum effective dose for the shortest duration necessary to control symptoms.
In general, regular intake of (various types of) pain relievers can cause serious and permanent kidney problems. This risk may be increased under physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
Regular monitoring of liver values, kidney function, and blood count is necessary with prolonged use of IBUMENOL.
If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, especially in the case of prolonged treatments, and will prescribe the most effective lowest dose and for the shortest duration of treatment necessary to control symptoms.
Prolonged use of any type of pain reliever for headaches can worsen these values. If this situation occurs, consult your doctor for advice and stop treatment with IBUMENOL.
Serious allergic reactions (aphylactoid reactions, up to anaphylactic shock) can occur
Medicines such as Ibumenol can cause eye disorders, therefore it is recommended in case of prolonged treatments, to undergo periodic eye examinations.
Infections

IBUMENOL may mask the symptoms of infections such as fever and pain. It is therefore possible

that IBUMENOL 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 bacterial skin infections related to varicella. If you take this medicine
while you have an infection and the symptoms of the infection persist or worsen, consult
your doctor immediately.
Avoid the use of IBUMENOL during varicella.
The use of anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a
modest increase in the risk of heart attack or stroke, especially if taken in high
doses. Do not exceed the recommended dose or the maximum duration of treatment
Gastrointestinal bleeding (bleeding in the stomach or intestines),
ulcerations and perforations potentially fatal have been reported with all NSAIDs in
any time during treatment, with or without warning symptoms or a previous history of
serious gastrointestinal events. If you experience gastrointestinal bleeding or ulceration
stop taking this medicine immediately. The risk of
gastrointestinal bleeding, ulceration or perforation is greater with increasing
doses of NSAIDs, in patients with a history of ulcer, especially if complicated by
bleeding or perforation (see paragraph 2 "Do not take IBUMENOL"), and in the elderly.
These patients should start treatment with the lowest available dose. For these
patients, as well as patients requiring concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal, a
combined therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be evaluated.
When gastrointestinal bleeding or ulcerations occur during treatment with ibuprofen
treatment should be discontinued and a doctor should be consulted.
The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by
the active ingredient, especially those affecting the gastrointestinal tract or the central nervous
system. NSAIDs such as ibuprofen can mask the symptoms of infection and fever. If
any of the above conditions apply to you, consult your doctor before using IBUMENOL.

Elderly
Elderly patients taking NSAIDs are at higher risk of adverse effects, particularly those
relating to the stomach and intestines. For more information, see paragraph 4
“Possible side effects”.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any
unusual abdominal symptoms (especially bleeding in the stomach or intestines), in
particular in the early stages of treatment.

Children and adolescents
There is a risk of kidney impairment in dehydrated adolescents.
IBUMENOL 400 mg is not suitable for children under 12 years of age (with body weight
less than 40 kg).

Other medicines and IBUMENOL
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.
IBUMENOL can affect or be affected by other medicines. For example:

• corticosteroids (such as prednisolone), as their intake may increase the risk of ulceration or gastrointestinal bleeding
• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib) as these may increase the risk of gastrointestinal bleeding and ulcers
• cardiac glycosides (example digoxin), drugs used for heart disease;
• anticoagulant drugs (i.e. that thin the blood/prevent coagulation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (drugs used for depression), as their intake may increase the risk of bleeding in the stomach or intestines
• potassium-sparing diuretics: as this may lead to hyperkalemia
• drugs that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-based drugs, angiotensin II receptor antagonists such as losartan) and diuretics (drugs that promote the elimination of fluids), as NSAIDs may decrease the effects of these medicines and there may be an increased risk of kidney impairment. In this case, make sure to drink enough water during the day
• methotrexate (drug used for cancer or rheumatism), as the effect of methotrexate may be potentiated
• tacrolimus (drug used to suppress the immune response), due to the increased risk of kidney toxicity
• cyclosporine (drug used to suppress the immune response), as kidney damage may occur
• zidovudine and ritonavir (drugs for the treatment of AIDS), as the use of IBUMENOL may increase the risk of joint bleeding or bleeding causing swelling in HIV-positive hemophiliacs
• sulfonylureas (antidiabetic drugs): NSAIDs may increase the hypoglycemic effect of sulfonylureas. As a precaution, during the concomitant use of these medicines, it is recommended to monitor blood sugar levels
• probenecid and sulfinpyrazone: as the excretion of ibuprofen may be delayed. Ibuprofen may reduce the effect of these drugs.
• aminoglycosides (antibiotics), as NSAIDs may increase the concentration of aminoglycosides in plasma
• lithium (used for the treatment of certain psychiatric disorders): ibuprofen may increase its concentration in plasma
• quinolone antibiotics, as their intake together with NSAIDs may increase the risk of seizures
• cholestyramine, as taking ibuprofen together with cholestyramine may delay and reduce the absorption of ibuprofen. These drugs should be administered several hours apart
• CYP2C9 inhibitors such as voriconazole and fluconazole, as taking these drugs may increase ibuprofen concentrations in plasma. A dose reduction of ibuprofen should be particularly considered when high doses are administered with voriconazole and fluconazole
• mifepristone, as NSAIDs may reduce the effect of mifepristone
• phenytoin, a drug used for epilepsy
• bisphosphonates and pentoxifylline, as their intake may increase the undesirable effects related to the stomach and intestines and the risk of bleeding or ulceration
• herbal extracts: ginkgo biloba may increase the risk of bleeding.
• oxpentifylline, a drug used for problems with blood vessels;
• baclofen, a drug used to relax muscles;
• moclobemide, a drug used for the treatment of depression.

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

IBUMENOL with alcohol
The intake of alcohol should be avoided during treatment with ibuprofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Tell your doctor if you become pregnant while taking IBUMENOL. During
the first and second trimester of pregnancy, your doctor will prescribe ibuprofen only if
absolutely necessary. In this case, the dose should be kept as low as
possible and the duration of treatment should be as short as possible.
Do not take IBUMENOL if you are in the last 3 months of pregnancy, as it may harm
the fetus or cause problems during childbirth. This medicine may cause problems with the kidneys and
heart of the fetus. It may affect your and your baby's tendency to bleed and
delay or prolong labor more than expected. You should not take IBUMENOL in
the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If you need treatment in this period or during attempts to conceive,
the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy onwards, IBUMENOL 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 a narrowing of a blood vessel (ductus arteriosus) in
the baby's heart. If you need treatment for more than a few days, your doctor
may recommend additional monitoring.
Breastfeeding
Only minimal amounts of ibuprofen and its degradation products are
excreted in breast milk. As no adverse effects on infants have been known to date,
it is usually not necessary to discontinue breastfeeding during short-term use
of ibuprofen at recommended doses.
Fertility
If you want to become pregnant or have difficulty conceiving, consult your doctor,
as IBUMENOL belongs to a group of medicines (NSAIDs) that may impair
fertility in women. This effect is reversible by discontinuing the
medicine.

Driving and operating machinery
As side effects such as fatigue, dizziness and visual disturbances may occur
with the use of ibuprofen, the ability to react and actively participate in road
traffic and operate machinery may be impaired in isolated cases. This is more true in
combination with alcohol.
IBUMENOL contains:
Lactose: if you have been diagnosed with intolerance to some sugars, contact your
doctor before taking this medicine.
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e.
essentially ‘sodium-free’.

3. How to take IBUMENOL

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
This medicine is for short-term use only.
The lowest effective dose should be used for the shortest period necessary to relieve the
symptoms. If you have an infection, consult your doctor immediately if the symptoms (e.g.
fever and pain) persist or worsen (see section 2).
Method of administration
If you have a sensitive stomach, it is particularly recommended to take IBUMENOL during
meals.
The recommended dose is:

Adults and adolescents with a body weight of 40 kg or more (aged 12 years or
older)
The initial dose is 1 tablet of IBUMENOL. If necessary, you can take an additional
tablet. The interval between doses should be chosen based on the symptoms and the maximum
daily dose. However, the interval between doses must not be less than six hours. Do not take
more than 3 tablets of IBUMENOL in 24 hours.

Children under 12 years of age and adolescents with a body weight of less than 40 kg
IBUMENOL 400 mg is not indicated for children under 12 years of age and adolescents with
a body weight of less than 40 kg.

Elderly
Consult your doctor who will determine the appropriate dose for you by reducing the recommended
dose, especially if you suffer from kidney and/or liver disorders.

Patients with impaired renal or hepatic function
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, even
reducing the dosages indicated above. If you have severe kidney or liver problems, you should not
take this medicine.

Duration of treatment
Adults: consult your doctor or pharmacist if your symptoms worsen or if taking
this medicine is necessary for more than 4 days in case of pain or 3 days in case of
fever, or if new symptoms appear.
Adolescents (from 12 years of age): consult your doctor if symptoms worsen or if the use
of this medicine is necessary for more than 3 days.
Method of administration

IBUMENOL must be taken orally (for oral use) with plenty of water. Take the

tablets whole, without chewing, breaking, crushing or sucking them.

If you take more IBUMENOL than you should
If you have taken more IBUMENOL than you should or if your child has taken this medicine
by mistake, always contact a doctor or the nearest hospital to obtain advice
on the risk and recommendations regarding the actions to be taken.
Symptoms
Most patients who ingest significant quantities of ibuprofen
will manifest symptoms within 4-6 hours.
Symptoms of overdose may include nausea, stomach pain, vomiting (with
possible traces of blood), pain in the abdomen or chest, headache, ringing in the
ears, confusion and uncontrolled eye movements, decreased blood pH
(metabolic acidosis). At high doses, drowsiness, chest pain,
palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness,
blood in the urine, low potassium levels in the blood, feeling cold to the touch and breathing problems have been reported.
Rarely, hypothermia (lowering of body temperature), kidney effects, gastrointestinal bleeding, loss of consciousness, deep sleep (lethargy), coma, apnea (cessation of breathing), diarrhea, and depression of the central nervous system (CNS) and respiratory system have also been reported. If you are an asthmatic patient, you may
experience a worsening of asthma.
Disorientation, a state of excitement, fainting and cardiovascular toxicity including hypotension (lowering of blood pressure), bradycardia
(slowing of the heart rate) and tachycardia (increased heart rate) have been reported. In cases of significant overdose, renal failure and liver damage are possible.
Children may also develop cramps due to significant and involuntary
muscle contraction.
Treatment
There is no specific substance capable of reversing the effects of an ibuprofen overdose. Therefore, symptomatic and
supportive treatment is indicated in case of overdose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects can be limited by using the minimum dose for the minimum time
necessary to relieve symptoms. You may experience one of the known side effects of
NSAIDs. If this occurs, or if you have any doubts, stop taking
this medicine and consult your doctor as soon as possible.
Elderly people who use this medicine are at greater risk of developing
problems associated with side effects.

Stop taking this medicine and seek immediate medical attention if
you experience:

• serious stomach problems, burning or abdominal pain due to injury to the wall of the stomach or intestine (peptic ulcer), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal hemorrhage). These conditions are common side effects;
• allergic reactions, even severe, which manifest with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a severe allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reactions, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blister formation (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma, even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing joint or muscle pain, skin changes and problems with other organs. This condition occurs rarely.
• worsening of infections such as the appearance of necrotizing fasciitis, which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the neck, nausea, vomiting, confusion, lethargy and discomfort to light. This condition occurs rarely.
• a severe skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• visual disturbances
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose,

of the 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 rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis)

See a doctor if you experience any of the following side effects, if they
worsen or if you notice any effect not listed in this leaflet.
Common(may affect up to 1 in 10 people):

• feeling of dizziness or fatigue, headache
• stomach pain, indigestion, diarrhea, heartburn, nausea, vomiting, flatulence, constipation
• various skin rashes

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

• sneezing, stuffy or runny nose or itchy nose (rhinitis)
• hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with low blood pressure). In this case, the doctor must be informed immediately and the intake of ibuprofen must be stopped.
• feeling of tingling or numbness, drowsiness, agitation, irritability
• difficulty falling asleep, feeling of anxiety
• urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitization to light
• visual disturbances. In this case, the doctor must be informed immediately and the intake of ibuprofen must be stopped.
• hearing problems, feeling of dizziness or spinning (vertigo), ringing in the ears (tinnitus)
• skin reaction following exposure to the sun (photosensitivity);
• difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• inflammation of the stomach lining, gastrointestinal ulcers, in some cases with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease
• changes in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• nephrotic syndrome (accumulation of fluid inside the body (edema) and accumulation of protein in the urine); renal inflammation (interstitial nephritis), which may be accompanied by acute renal dysfunction. Reduced urine output, accumulation of fluid inside the body (edema) and generally a feeling of malaise may be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop taking IBUMENOL and consult a doctor immediately.

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

• decrease in the number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decrease in the number of platelets (thrombocytopenia), decrease in the number of red blood cells due to destruction (hemolytic anemia) or due to problems with the bone marrow (aplastic anemia);
• feeling of depression or confusion
• during treatment with ibuprofen, symptoms of aseptic meningitis have been observed with stiff neck, headache, nausea, vomiting, fever or clouded consciousness. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. If such symptoms occur, contact a doctor immediately
• visual impairment due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• damage to kidney tissue (papillary necrosis), in particular with long-term treatment, and increased uric acid and urea concentration in the blood
• fluid retention (edema)

Very rare(may affect up to 1 in 10,000)

• a worsening of infections related to infection (e.g. necrotizing fasciitis) has been described associated with the use of some painkillers (NSAIDs). If signs of an infection occur or worsen during the use of IBUMENOL, consult a doctor immediately. It must be examined if there is an indication for an anti-infective/antibiotic therapy.
• changes in blood count
• pancytopenia, anemia, leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (the first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, bleeding from the nose and skin, unusual and unexplained bruising. In these cases, therapy must be stopped immediately and a doctor must be consulted. No treatment with painkillers or with medicines that reduce fever (antipyretic drugs) should be undertaken
• psychotic reactions - high blood pressure, heart failure, heart attack
• inflammation of blood vessels
• inflammation of the pancreas and esophagus
• diaphragm-like intestinal stenosis
• liver failure or damage, especially with long-term use, which manifests with yellowing of the skin and eyes or pale stools and dark urine.
• in exceptional cases, severe skin and soft tissue infections and complications have occurred during chickenpox infection
• hair loss (alopecia)
• reduction of urine excretion and increased formation of tissue fluid (edema), especially in patients with high blood pressure or impaired renal function

Not known(the frequency cannot be defined on the basis of available data):

• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• A widespread, red and scaly rash, with pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using IBUMENOL if you develop these
  symptoms and contact your doctor immediately. See also section 2.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the oral mucosa with ulcers (ulcerative stomatitis),
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: the frequency cannot be defined on the basis of available data);
• hallucinations, malaise.

Medicines like this 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 . By reporting side effects you can contribute to providing more information on the safety of this
medicine.

5. How to store IBUMENOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What IBUMENOL contains

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica and magnesium stearate Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol (E 1520)

Description of the appearance of IBUMENOL and contents of the pack
IBUMENOL is presented as film-coated oblong, biconvex tablets, of
white color, with a fracture line on both sides.
Each pack contains 20 film-coated tablets.

Marketing authorisation holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Roma

Manufacturer
Rovi Pharma Industrial Services SA
Via Complutense, 140
Alcalá de Henares,
28805 Madrid, Spain
Farmalider S.A
C/Aragoneses, 2
28108 Alcobendas – Madrid, Spain