NEOBOROCILLINA INF DOL*12SACHETS

Neo Borocillina Infiammazione e Dolore 400 mg granules for oral solution
Ibuprofen

What it is and what it is used for
Neo Borocillina Infiammazione e Dolore contains the active ingredient ibuprofen, which belongs to the class of medicines known as non-steroidal anti-inflammatory and anti-rheumatic drugs (NSAIDs) that act by reducing pain (analgesic action) and inflammation (anti-inflammatory action) and lowering body temperature in case of fever (antipyretic action).

Neo Borocillina Infiammazione e Dolore is used to treat:
- pain of various origins and nature:
• sore throat during pharyngitis, pharyngotonsillitis and post-tonsillectomy (surgical removal of the tonsils);
• headache;
• toothache;
• neuralgia;
• bone, joint and muscle pain (osteoarticular pain);
• menstrual pain;
- symptoms of fever and flu.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment, if the problem recurs or if you have noticed any recent change in its characteristics.

What you need to know before taking the medicine
Do not take Neo Borocillina Infiammazione e Dolore:
• if you are allergic to ibuprofen, or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid, other pain relievers (analgesics), fever reducers (antipyretics) and non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have experienced, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), an allergy with narrowing of the bronchi (bronchospasm) or associated with inflammation and constriction of the airways (asthma), nasal congestion (rhinitis) or skin rash (urticaria);
• if you have a severe or active stomach and/or intestinal ulcer (gastroduodenal ulcer) or if you have other stomach diseases (gastropathies);
• if you have had stomach and/or intestinal bleeding (gastrointestinal hemorrhage) or perforation after previous treatments with other medicines;
• if you have had bleeding or stomach lesions (hemorrhage/peptic ulcer) that occurred repeatedly (two or more distinct episodes of confirmed ulceration or bleeding);
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from severe heart problems (severe heart failure);
• if you are in the last 3 months of pregnancy or if you are breastfeeding (see section Pregnancy, breastfeeding and fertility);
• if the patient is a child under 12 years of age;
• if you have phenylketonuria, because this medicine contains aspartame and may be harmful to those suffering from phenylketonuria (see section Warnings and precautions);
• if you have lost a lot of fluids (severe dehydration) due to vomiting, diarrhea or insufficient fluid intake.

Warnings and precautions
Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time needed to control symptoms (see the sections below on gastrointestinal and cardiovascular risks).
Talk to your doctor or pharmacist before taking Neo Borocillina Infiammazione e Dolore:
• if you are elderly because it can increase the risk of adverse reactions to NSAIDs, bleeding (hemorrhage) and perforation of the stomach and/or intestines which can be fatal;
• if you have high blood pressure and/or heart failure as fluid accumulation, hypertension and edema have occurred in association with NSAID treatment;
• if you are using other medicines such as oral anti-inflammatory drugs (oral corticosteroids), medicines that delay blood clotting such as warfarin, medicines that prevent platelet aggregation (antiplatelets) such as acetylsalicylic acid, antidepressants (serotonin reuptake inhibitors) because they can increase the risk of bleeding or ulceration;
• if you are taking other NSAIDs including selective cyclooxygenase-2 inhibitors;
• if you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial 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);
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• if you have had episodes of difficulty breathing (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs;
• if you suffer from asthma, runny nose (chronic rhinitis), presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you could experience difficulty breathing (bronchospasm), skin redness with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used for the treatment of joint or muscle pain, fever or for the treatment of inflammation (NSAIDs);
• if you have an infection - see section Infections below.

Take this medicine with caution:
• if you are a woman planning a pregnancy (see section Pregnancy, breastfeeding and fertility);
• if you are a woman who has fertility problems or if you are undergoing fertility investigations, because you should stop treatment with Neo Borocillina Infiammazione e Dolore;
• if you have had an ulcer, especially if complicated by bleeding or perforation, you should start with the lowest dosage of Neo Borocillina Infiammazione e Dolore (see section Do not take Neo Borocillina Infiammazione e Dolore). As a precaution, your doctor may prescribe medicines that protect the gastrointestinal mucosa such as misoprostol or proton pump inhibitors;
• if you have suffered or suffer from a gastrointestinal disease such as ulcerative colitis or Crohn's disease because these conditions could worsen;
• if you are taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events;
• if you have lost a considerable amount of fluids, or if you experience swelling, heart problems or high blood pressure;
• if you have decreased kidney function, heart or liver malfunction, or if you are elderly or on medication for high blood pressure, as you may be more prone to kidney problems. In addition, the habitual concomitant use of different pain relievers can further increase this risk;
• if you suffer from a clotting disorder or are taking medicines to thin the blood (anticoagulants) (see section Other medicines and Neo Borocillina Infiammazione e Dolore);
• if you suffer from a disease that can affect different organs and tissues of the body (diffuse or systemic lupus erythematosus) or a connective tissue disease, present in many parts of the body, such as bones and cartilage, because in rare occasions in patients treated with ibuprofen, symptoms of aseptic meningitis have been observed. Although aseptic meningitis is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients who did not have concomitant chronic diseases;
• if you are taking medicines to treat pain, heart disease or high blood pressure (see section Other medicines and Neo Borocillina Infiammazione e Dolore).

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.
Stop treatment and inform your doctor if, during treatment with Neo Borocillina Infiammazione e Dolore, you experience:
• gastrointestinal bleeding or ulceration. During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulceration or perforation may occur, which can also cause death, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
If you have unusual stomach or intestinal symptoms, gastrointestinal bleeding, especially at the beginning of treatment, stop treatment and consult your doctor.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema) and chest pain, have been reported with ibuprofen.
Stop treatment with Neo Borocillina Infiammazione e Dolore immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Infections
Neo Borocillina Infiammazione e Dolore can mask the symptoms of infections such as fever and pain. It is therefore possible that Neo Borocillina Infiammazione e Dolore may delay appropriate 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 chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

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 ibuprofen treatment. These reactions can occur especially within the first month. Stop using Neo Borocillina Infiammazione e Dolore and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Medicines such as Neo Borocillina Infiammazione e Dolore can:
• be associated with the appearance of even severe kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), therefore the doctor will monitor your kidney function in case of prolonged use and in particular in case of diffuse lupus erythematosus;
• cause eye disorders, therefore, in case of prolonged treatments, periodic eye check-ups are recommended. If visual disturbances occur, stop treatment with Neo Borocillina Infiammazione e Dolore.

Children and adolescents
Neo Borocillina Infiammazione e Dolore must not be administered to children under 12 years of age.
In dehydrated adolescents, there is a risk of impaired kidney function.

Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or intestinal bleeding and perforation, which are generally more severe and can be fatal.
If you are elderly, you should take the lowest dosage of Neo Borocillina Infiammazione e Dolore.
As a precaution, your doctor may prescribe medicines that protect the gastrointestinal mucosa such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach and intestinal symptoms, especially at the beginning of treatment with this medicine.

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

If you develop an ulcer, or stomach and/or intestinal bleeding, or skin and/or mucous membrane lesions, you must stop treatment with Neo Borocillina Infiammazione e Dolore and consult your doctor. These side effects are usually more common in the elderly.

The use of Neo Borocillina Infiammazione e Dolore can cause generally mild or moderate side effects or more severe allergic reactions, although rarely.
If you experience any of the following symptoms, IMMEDIATELY STOP using Neo Borocillina Infiammazione e Dolore and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
• skin rashes or lesions;
• mucous membrane lesions;
• signs of an allergic reaction, including severe ones (erythema, itching, hives, skin blisters, asthma, shortness of breath, rapid heartbeat, swelling of the skin and mucous membranes, anaphylactic shock);
• reddish, non-raised, target-shaped or circular spots 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 rash, elevated body temperature, enlarged lymph nodes and an increase in eosinophils, a type of white blood cell (DRESS syndrome);
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis);
• vision disturbances;
• yellowish skin (jaundice);
• bleeding, ulceration and perforation of the stomach and intestine, which can be fatal, particularly in the elderly;
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

If you experience any of the above allergic reactions, go to the hospital as immediate access to appropriate equipment, medicines and personnel for emergency treatment is required, as rare cases of severe side effects, sometimes fatal, have been reported following the use of ibuprofen, even in the absence of known allergies.
The risk of experiencing these symptoms is higher in the early stages of therapy: in most cases, the reaction occurs within the first month of treatment.
Furthermore, you may experience other side effects that have also been reported with other medicines similar to Neo Borocillina Infiammazione e Dolore and are listed below by frequency:

common (may affect up to 1 in 10 people)
• dizziness
• malaise
• fatigue

uncommon (may affect up to 1 in 100 people)
• stomach inflammation (gastritis)
• insomnia, anxiety
• numbness of the limbs or other parts of the body (paraesthesia), drowsiness
• nasal congestion (rhinitis) (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease)
• difficulty breathing (bronchospasm, dyspnoea)
• temporary cessation of breathing (apnoea)
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• liver inflammation (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (renal function impairment and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
• allergic reactions such as skin rash of various forms, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea), asthma attacks with lowering of blood pressure
• skin becomes sensitive to light
• vision disturbances

rare (may affect up to 1 in 1,000 people)
• intestinal perforation
• reduction in the number of blood cells: reduction of white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia), inhibition of platelet aggregation
• depression, confusional state, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders, see paragraph 2 Warnings and precautions with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation
• eye disorders with consequent vision disturbances, inflammation of the optic nerve (toxic optic neuropathy)
• increased concentration of non-protein nitrogen in the blood (hyperazotaemia)
• swelling due to accumulation of fluid in the tissues (oedema)
• disease that can affect various organs and tissues of the body (lupus erythematosus)
• altered liver function tests: increased transaminases, increased alkaline phosphatase
• altered blood tests: reduced haemoglobin, reduced haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid

very rare (may affect up to 1 in 10,000 people)
• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• sensation of feeling one's own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• increased fluid around the lungs (acute pulmonary oedema)
• liver disease (liver failure)
• increased blood pressure (hypertension)
• severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making breathing difficult, rapid heartbeat, severe allergic reaction with rapid onset that can cause death (anaphylaxis), severe rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• in exceptional cases, severe skin infections and soft tissue disorders (necrotizing fasciitis) may occur during chickenpox infection

not known (frequency cannot be estimated from the available data)
• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhoea
• gas emission (flatulence)
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory diseases of the colon and intestine (colitis, Crohn's disease)
• a widespread, red and scaly rash, with pustule formation under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Neo Borocillina Infiammazione e Dolore if you develop these symptoms and contact your doctor immediately. See also paragraph 2.

Side effects generally tend to regress with discontinuation of treatment.
Following the instructions in the leaflet reduces the risk of side effects.

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