Name
Neo Borocillina Inflammation and Pain 400 mg granules for oral solution
Ibuprofen


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

Neo Borocillina Inflammation and Pain is used to treat:
- pains of various origins and natures:
• sore throat during pharyngitis, pharyngotonsillitis and post tonsillectomy (surgical operation to remove the tonsils);
• heachache;
• toothache;
• neuralgia;
• pain in bones, joints and muscles (osteoarticular pain);
• menstrual cramps;
- symptoms of fever and flu.

Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment, if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.


What you need to know before taking the medicine
Do not take Neo Borocillina Inflammation and Pain:
• 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 medicines used to reduce pain (analgesics), 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 ongoing stomach and/or intestinal ulcer (gastroduodenal ulcer) or if you have other stomach diseases (gastropathies);
• if you have had bleeding in the stomach and/or intestine (gastrointestinal haemorrhage) or perforation after previous treatments with other medicines;
• if you have had repeated stomach bleeding or lesions (peptic haemorrhage/ulcer) (two or more distinct episodes of proven ulceration or bleeding);
• if you suffer from severe liver or kidney problems (severe liver or kidney failure);
• 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 for people with phenylketonuria (see section "Warnings and precautions");
• if you have lost a lot of fluids (severe dehydration) due to vomiting, diarrhoea or insufficient fluid intake.


Warnings and precautions
Undesirable effects may be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks).
Talk to your doctor or pharmacist before taking Neo Borocillina Inflammation and Pain:
• if you are elderly because it may increase the risk of developing adverse reactions to NSAIDs, bleeding (haemorrhages) and perforations of the stomach and/or intestine which can be fatal;
• if you have high blood pressure and/or heart failure since fluid accumulation, hypertension and oedema have occurred in association with treatment with NSAIDs;
• if you are using other medicines such as anti-inflammatories given by mouth (oral corticosteroids), medicines that delay blood clotting such as warfarin, medicines that prevent platelets from aggregating (anti-platelet drugs) such as acetylsalicylic acid, antidepressants (serotonin reuptake inhibitors) because they may increase the risk of bleeding or ulceration;
• if you are taking other NSAIDs including cyclooxygenase-2 selective inhibitors;
• if you have heart problems including heart attack, angina (chest pain) or if you have had a 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 'TIA', transient ischaemic 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, a runny nose (chronic rhinitis), the presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you may experience difficulty breathing (bronchospasm), redness of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used to treat joint or muscle pain, fever or to treat inflammation (NSAIDs);
• if you have an infection – see section “infections” below.

Take this medicine with caution:
• if you are a woman planning to become pregnant (see section "Pregnancy, breast-feeding 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 Inflammation and Pain;
• if you have had an ulcer, especially if complicated by bleeding or perforation, you should start with the lowest dose of Neo Borocillina Inflammation and Pain (see section "Do not take Neo Borocillina Inflammation and Pain"). As a precaution, your doctor may prescribe medicines that act by protecting 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 significant amount of fluid, or if you develop swelling, heart problems or high blood pressure;
• if you have impaired kidney function, heart or liver function, or if you are elderly or are taking medicines for high blood pressure, as you may be more susceptible to kidney problems. In addition, the habitual concomitant use of several painkillers may further increase this risk;
• if you suffer from a bleeding disorder or are taking medicines to thin the blood (anticoagulants) (see section "Other medicines and Neo Borocillina Inflammation and Pain");
• if you suffer from a disease that can affect several organs and tissues of the body (diffuse or systemic lupus erythematosus) or a connective tissue disease, which is present in many parts of the body, such as bones and cartilage, because on rare occasions symptoms of "aseptic meningitis" have been observed in patients treated with ibuprofen. 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 without concomitant chronic diseases;
• if you are taking medicines to treat pain, heart disease or high blood pressure (see section "Other medicines and Neo Borocillina Inflammation and Pain").

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken 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 Inflammation and Pain the following occur:
• gastrointestinal bleeding or ulceration. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, may occur during treatment with NSAIDs, including ibuprofen and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
If you have any unusual stomach or intestinal symptoms, gastrointestinal bleeding, especially at the beginning of treatment, stop treatment and contact your doctor.

Signs of an allergic reaction to ibuprofen, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop treatment with Neo Borocillina Inflammation and Pain immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Infections
Neo Borocillina Inflammation and Pain may hide the symptoms of infections such as fever and pain. It is therefore possible that Neo Borocillina Inflammation and Pain 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 chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact 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 may occur especially within the first month. Stop using Neo Borocillina Inflammation and Pain 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 Inflammation and Pain can:
• be associated with the onset of even serious kidney disease (such as renal papillary necrosis, analgesic nephropathy and renal failure), therefore the doctor will monitor the functionality of your kidneys in case of prolonged use and in particular in case of diffuse lupus erythematosus;
• cause eye disorders, therefore it is recommended in case of prolonged treatments, to carry out periodic eye checks. If vision disorders occur, discontinue treatment with Neo Borocillina Inflammation and Pain.

Children and adolescents
Neo Borocillina Inflammation and Pain should 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 usually more severe and can be fatal.
If you are elderly you should take the lowest dosage of Neo Borocillina Inflammation and Pain.
As a precaution, your doctor may prescribe medicines that work by protecting the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Tell your doctor about any unusual stomach and intestinal symptoms, especially when you first start taking 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 bleeding from the stomach and/or intestine, or lesions of the skin and/or mucous membranes, you must stop treatment with Neo Borocillina Inflammation and Pain and contact your doctor. These side effects are usually more frequent in the elderly.

The use of Neo Borocillina Inflammation and Pain can cause side effects that are generally mild or moderate or more serious, allergic-type reactions, although rarely.
If you experience any of the following symptoms, STOP using Neo Borocillina Inflammation and Pain immediately and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
• skin rashes or lesions;
• mucosal lesions;
• signs of allergic reaction, even severe (erythema, itching, hives, blisters on the skin, asthma, difficulty breathing, fast heartbeat, swelling of the skin and mucous membranes, anaphylactic shock);
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, 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 skin rash, high body temperature, swollen lymph nodes, and increased eosinophils, a type of white blood cell (DRESS syndrome);
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• vision disorders;
• yellowish skin (jaundice);
• bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, particularly in the elderly;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience any of the allergic reactions listed above, go to the hospital as it is necessary to have the equipment, drugs and personnel suitable for emergency treatment immediately available, as in rare cases serious side effects, sometimes with fatal outcomes, have been reported following the use of ibuprofen, even in the absence of a known allergy.
The risk of manifesting 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 additional side effects that have also been reported with other medicines similar to Neo Borocillina Inflammation and Pain and which are listed below according to frequency:

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

uncommon (may affect up to 1 in 100 people)
• inflammation of the stomach (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, dyspnea)
• temporary interruption of breathing (apnea)
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney disease (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
• allergic reactions such as skin rash of various forms, hives, 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 low blood pressure
• the skin becomes sensitive to light
• vision disorders

rare (may affect up to 1 in 1,000 people)
• intestinal perforation
• reduction in the number of blood cells: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia), inhibition of platelet aggregation
• depression, confusion, 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 section 2 "Warnings and precautions" with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation
• eye disorders resulting in impaired vision, inflammation of the optic nerve (toxic optic neuropathy)
• increased concentration of non-protein nitrogen in the blood (hyperazotemia)
• swelling due to fluid accumulation in the tissues (edema)
• disease that can affect various organs and tissues of the body (lupus erythematosus)
• liver function tests abnormal: increased transaminases, increased alkaline phosphatase
• abnormal blood tests: decreased hemoglobin, decreased hematocrit, 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 your heart beating (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• increased fluid around the lungs (acute pulmonary edema)
• liver disease (liver failure)
• increased blood pressure (hypertension)
• serious allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making it difficult to breathe, fast heartbeat, severe allergic reaction that occurs quickly and can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• in exceptional cases, serious skin infections and soft tissue diseases (necrotizing fasciitis) may occur during chickenpox infection

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.