Ibumenol: detailed information

Patient Information Leaflet

IBUMENOL 400 mg film-coated tablets

Ibuprofen
Please read all of 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 to do.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days in adolescents, or in adults, after 4 days for pain or 3 days for fever.

Contents of this leaflet:

What IBUMENOL is and what it is used for
What you need to know before taking IBUMENOL
How to take IBUMENOL
Possible side effects
How to store IBUMENOL
Contents of the pack and other information

1. What IBUMENOL is and what it is 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 medicines used to relieve pain and inflammation.
IBUMENOL is used for the short-term symptomatic treatment of 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).
Consult your doctor if you do not feel better or if you feel worse after 3 days, if you have fever, or after 4 days if you are taking this medicine for pain.
Consult your doctor after 3 days if your child/adolescent child 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 to any of the other ingredients of this medicine (listed in section 6)
if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other painkillers, fever-reducing medicines, or other non-steroidal anti-inflammatory drugs (NSAIDs), particularly if associated with nasal polyps, facial swelling (angioedema), and/or asthma
if you have experienced gastrointestinal bleeding or perforation related to taking medications
if you have a stomach or intestinal ulcer (peptic ulcers) or active or recurrent bleeding in the stomach or duodenum, or if you have had this problem repeatedly (two or more distinct episodes of ulceration or bleeding confirmed) in the past
if you have severe liver or kidney problems
if you suffer from severe heart problems (severe heart failure)
if you have bleeding in the brain (cerebrovascular hemorrhage) or any other active bleeding
if you have a blood formation disorder of unknown origin, for example 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, conditions affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs
you have or have previously had stomach or intestinal diseases (e.g., ulcer, ulcerative colitis, or Crohn's disease), as these may worsen (see section 4 "Possible side effects")
you have reduced kidney function
you have liver problems
you suffer from asthma or chronic respiratory diseases
you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g., prednisolone), blood-thinning medicines (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), since their concurrent use should be avoided
you have heart problems, including heart failure, 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 transient ischemic attack, "TIA")
you have high blood pressure, diabetes, high cholesterol, 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 nasal mucosa swelling, or chronic obstructive respiratory diseases, as you may be at higher risk of allergic reactions
you suffer from asthma or chronic respiratory diseases
you are elderly, as you are more likely to experience adverse events from this medicine, particularly gastrointestinal bleeding and perforations, which can be life-threatening
you have recently undergone major surgery
you have a congenital porphyrin metabolism disorder (e.g., acute intermittent porphyria)
you have blood clotting disorders (thickening)
you have an infection – see section >
you have chickenpox, as pain and anti-inflammatory medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine
if you are a dehydrated adolescent or an elderly person, as you are more likely to develop kidney problems.

Signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Immediately discontinue IBUMENOL and contact your doctor or emergency medical services if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported during treatment with ibuprofen, 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 IBUMENOL and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Side effects may be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Generally, habitual intake of (various types of) analgesics may cause serious and permanent kidney damage. This risk may be increased during physical exertion associated with salt loss and dehydration. Therefore, such use should be avoided.
Regular monitoring of liver function, kidney function, and blood counts is necessary during prolonged use of IBUMENOL.
If you have impaired heart, liver, or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly during long-term treatment, and will prescribe the lowest effective dose for the shortest possible duration needed to control symptoms.
Prolonged use of any type of headache painkiller may worsen headaches. If this occurs, consult your doctor for advice and discontinue treatment with IBUMENOL.
Severe allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur.
Medicines such as Ibumenol may cause eye disorders; therefore, periodic ophthalmological examinations are recommended during prolonged treatment.
Infections
IBUMENOL may mask symptoms of infections such as fever and pain. Therefore, IBUMENOL 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, consult your doctor immediately.
Avoid using IBUMENOL during chickenpox.
The use of anti-inflammatory/analgesic 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 the maximum treatment duration.
Potentially fatal gastrointestinal bleeding, ulceration, and perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, immediately discontinue taking this medicine. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 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 for those requiring concomitant use of low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered. If gastrointestinal bleeding or ulceration occurs during treatment with ibuprofen, treatment must be discontinued and a doctor consulted.
The use of NSAIDs in combination with alcohol may worsen adverse reactions caused by the active ingredient, especially those affecting the gastrointestinal tract or central nervous system. NSAIDs such as ibuprofen may mask 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 related to the stomach and intestines. For further information, see section 4 "Possible side effects".
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (particularly gastrointestinal bleeding) immediately, especially during the initial 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 below 40 kg).
Other medicines and IBUMENOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
IBUMENOL may affect or be affected by other medicines. For example:

corticosteroids (such as prednisolone), as their use may increase the risk of gastrointestinal ulceration or 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 (e.g., digoxin), medicines used for heart conditions
anticoagulant medicines (i.e., those that thin the blood/prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine)
antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (medicines used for depression), as their use may increase the risk of gastrointestinal bleeding
potassium-sparing diuretics: as this may lead to hyperkalemia
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-based medicines, angiotensin-II receptor antagonists such as losartan) and diuretics (medicines promoting fluid elimination), as NSAIDs may reduce the effectiveness of these medicines and may increase the risk of kidney impairment. In this case, ensure adequate daily water intake
methotrexate (a medicine used for cancer or rheumatism), as the effect of methotrexate may be enhanced
tacrolimus (a medicine used to suppress immune response), due to increased risk of kidney toxicity
cyclosporine (a medicine used to suppress immune response), as kidney damage may occur
zidovudine and ritonavir (medicines for treating AIDS), as the use of IBUMENOL may increase the risk of joint bleeding or swelling-related bleeding in HIV-positive hemophiliacs
sulfonylureas (antidiabetic medicines): NSAIDs may enhance the hypoglycemic effect of sulfonylureas. As a precaution, blood sugar monitoring is recommended during concomitant use of these medicines
probenecid and sulfinpyrazone: as ibuprofen excretion may be delayed. Ibuprofen may reduce the effect of these medicines
aminoglycosides (antibiotics): as NSAIDs may increase aminoglycoside plasma concentrations
lithium (used to treat certain psychiatric disorders): ibuprofen may increase its plasma concentration
quinolone antibiotics: as their concomitant use with NSAIDs may increase the risk of seizures
colestyramine: as taking ibuprofen together with colestyramine may delay and reduce ibuprofen absorption. These medicines should be administered several hours apart
CYP2C9 inhibitors such as voriconazole and fluconazole: as taking these medicines may increase ibuprofen plasma concentrations. A reduction in ibuprofen dose should be particularly considered when high doses are administered with voriconazole and fluconazole
mifepristone: as NSAIDs may reduce its effect
phenytoin, a medicine used for epilepsy
bisphosphonates and pentoxifylline: as their use may increase stomach- and intestine-related side effects and the risk of bleeding or ulceration
herbal extracts: Ginkgo biloba may increase the risk of bleeding
oxpentifylline, a medicine used for blood vessel problems
baclofen, a medicine used to relax muscles
moclobemide, a medicine used to treat depression

Other medicines may also affect or be affected by treatment with IBUMENOL.
Therefore, always consult your doctor or pharmacist before taking IBUMENOL with other medicines.
IBUMENOL with alcohol
Alcohol consumption should be avoided during treatment with ibuprofen.
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
Inform your doctor if you become pregnant while taking IBUMENOL. During the first and second trimesters 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 treatment duration as short as possible.
Do not take IBUMENOL during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor beyond normal. You should not take IBUMENOL during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy onwards, IBUMENOL may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels 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
Only minimal amounts of ibuprofen and its breakdown products are excreted in breast milk. Since no harmful effects on infants have been reported to date, breastfeeding usually does not need to be interrupted during short-term use of ibuprofen at recommended doses.
Fertility
If you are planning a pregnancy 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 upon discontinuation of the medicine.
Driving and using machines
Since side effects such as fatigue, dizziness, and visual disturbances may occur with ibuprofen use, your ability to react and actively participate in road traffic or operate machinery may be impaired in isolated cases. This effect is greater when combined with alcohol.
IBUMENOL contains:
Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for short-term use only.
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 (such as fever and pain) persist or worsen (see section 2).

Method of administration
If you have a sensitive stomach, it is especially recommended to take IBUMENOL during meals.

Recommended dose
Adults and adolescents weighing 40 kg or more (aged 12 years and older)
The initial dose is 1 tablet of IBUMENOL. If necessary, an additional tablet may be taken. The interval between doses should be based on 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 weighing less than 40 kg
IBUMENOL 400 mg is not indicated for children under 12 years of age and adolescents weighing 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, possibly reducing the dosages indicated above. If you have severe kidney or liver problems, you must not take this medicine.

Duration of treatment
Adults: Consult your doctor or pharmacist if your symptoms worsen or if you need to take this medicine for more than 4 days for pain or more than 3 days for fever, or if new symptoms occur.
Adolescents (from 12 years of age): Consult your doctor if symptoms worsen or if use of this medicine is needed for more than 3 days.

Method of administration
IBUMENOL must be taken orally with plenty of water. Swallow 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 accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and actions to take.

Symptoms
Most patients who ingest significant amounts of ibuprofen will develop symptoms within 4–6 hours.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with blood traces), abdominal or chest pain, headache, tinnitus, confusion, and uncontrolled eye movements, decreased blood pH (metabolic acidosis). At higher doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing problems have been reported.
Hypothermia (lowered body temperature), kidney effects, gastrointestinal bleeding, loss of consciousness, deep sleep (lethargy), coma, apnea (lack of breathing), diarrhea, and central nervous system (CNS) and respiratory depression have also been reported rarely. If you are an asthmatic patient, worsening of asthma may occur.
Disorientation, excited state, fainting, and cardiovascular toxicity including hypotension (low blood pressure), bradycardia (slowed heart rate), and tachycardia (increased heart rate) have also been reported. In cases of significant overdose, renal failure and liver damage are possible.
Children may also develop cramps due to severe and involuntary muscle contractions.

Treatment
There is no specific antidote to counteract the effects of an ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may be minimized by using the lowest effective dose for the shortest necessary duration 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 patients using this medicine are at higher risk of developing problems associated with side effects.

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

severe stomach problems, burning or abdominal pain due to injury of the stomach or intestinal wall (peptic ulcer), sudden and severe pain in the upper abdomen or stomach (gastrointestinal perforation). These side effects are uncommon;
vomiting blood (haematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal haemorrhage). These conditions are common side effects;
allergic reactions, even severe ones, presenting with more or less sudden onset of skin lesions, such as widespread or patchy redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, or throat edema with possible difficulty breathing or swallowing (angioedema). These conditions occur with uncommon frequency. Rarely, a severe, potentially life-threatening allergic reaction may occur, characterized by increased heart rate and sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
severe skin rashes with redness, peeling and/or blister formation (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, 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 affecting connective tissue causing joint or muscle pain, skin changes and problems in other organs. This condition occurs rarely;
worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in one area of the body due to tissue necrosis (death of tissue cells);
inflammation of the meninges (aseptic meningitis), presenting with: high fever, sudden headache, inability to flex the neck, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely;
a severe 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);
vision disturbances;
chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome;
flat, non-elevated reddish spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, ulcers in 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];
widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

Contact your doctor if you experience any of the following side effects, if they worsen, or if you notice any unlisted effect.

Common (may affect up to 1 in 10 people):

dizziness or tiredness, headache;
stomach ache, indigestion, diarrhoea, heartburn, nausea, vomiting, flatulence, constipation;
various skin rashes.

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

sneezing, blocked or runny nose or nasal itching (rhinitis);
hypersensitivity reactions with skin rash and itching, and asthma attacks (possibly with low blood pressure). In this case, inform your doctor immediately and discontinue ibuprofen;
tingling or prickling sensations, drowsiness, restlessness, irritability;
difficulty falling asleep, feeling anxious;
urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light;
vision disturbances. In this case, inform your doctor immediately and discontinue ibuprofen;
hearing problems, dizziness or vertigo, ringing in the ears (tinnitus);
skin reaction following sun exposure (photosensitivity);
difficulty breathing, wheezing or coughing, asthma or worsening of asthma;
inflammation of the stomach lining, gastrointestinal ulcers, sometimes with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis or Crohn’s disease;
changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
nephrotic syndrome (fluid accumulation in the body (edema) and protein in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation in the body (edema) and general malaise may be signs of kidney disease or even kidney failure. If any of the above symptoms occur, stop taking IBUMENOL and consult your doctor immediately.

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

decreased number of white blood cells (leucopenia) or of certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (haemolytic anaemia) or due to bone marrow problems (aplastic anaemia);
feeling depressed or confused;
during treatment with ibuprofen, symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or mental confusion have been observed. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. If these symptoms occur, contact a doctor immediately;
vision disturbances due, for example, to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
kidney tissue damage (papillary necrosis), particularly with long-term treatment, and increased uric acid and blood urea concentration;
fluid retention (edema).

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

worsening of inflammation related to infection (e.g. necrotizing fasciitis) associated with the use of certain painkillers (NSAIDs) has been reported. If signs of infection occur or worsen during use of IBUMENOL, consult a doctor immediately. It should be assessed whether anti-infective/antibiotic therapy is indicated;
blood count abnormalities;
pancytopenia, anaemia, leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unusual and unexplained bruising. In such cases, treatment must be stopped immediately and a doctor consulted. Do not take any painkillers or fever-reducing medicines (antipyretics));
psychotic reactions – high blood pressure, heart failure, heart attack;
inflammation of blood vessels;
inflammation of the pancreas and oesophagus;
diaphragm-like intestinal stenosis;
liver failure or liver damage, particularly with long-term use, presenting with yellowing of the skin and eyes, pale stools and dark urine;
in exceptional cases, severe skin infections and soft tissue complications have occurred during varicella infection;
hair loss (alopecia);
reduced urine output and increased formation of tissue fluid (edema), particularly in patients with high blood pressure or impaired kidney function.

Not known (frequency cannot be estimated from available data):

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);
a widespread, red, scaly rash, with pustule formation under the skin and blisters, mainly affecting skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute 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 upper stomach, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
worsening of colon inflammation (colitis) or Crohn’s disease (frequency not known: frequency cannot be estimated from available data);
hallucinations, malaise.

Medicines like this one 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, talk to 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 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 carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IBUMENOL contains

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
The other components 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, oval-shaped, biconvex tablets, white in colour, with a break line on both sides.
Each pack contains 20 film-coated tablets.

Marketing Authorization Holder
S.F. Group Srl – Via Tiburtina, 1143 – 00156 Rome, Italy

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