VEGETALLUMINA PAIN FEVER*12TB

VEGETALLUMINA DOLORE E FEBBRE 400 mg granules for oral solution in sachet
Ibuprofen sodium
Equivalent medicinal product

What it is and what it is used for
This medicine contains the active ingredient ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which act by relieving pain (analgesic action) and reducing the symptoms of inflammation (anti-inflammatory action).

VEGETALLUMINA DOLORE E FEBBRE is indicated for the treatment of pain or inflammatory conditions in the following cases:
• pain treatment: headache, toothache, menstrual pain, neuralgia, osteoarticular (bone) and muscle pain;
• treatment of feverish and flu-like states, in addition to other medicines.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not take VEGETALLUMINA DOLORE E FEBBRE
• if you are allergic to ibuprofen, other similar medicines or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have suffered in the past from stomach and intestinal disorders associated with bleeding (gastrointestinal haemorrhage or perforation related to previous treatments with anti-inflammatory drugs (NSAIDs) or a history of recurrent haemorrhage/peptic ulcer, with two or more distinct episodes of demonstrated ulceration or bleeding);
• if you suffer from stomach and intestinal disorders associated with the presence of lesions and bleeding (active and recurrent peptic ulcer);
• if you suffer from stomach or intestinal bleeding (gastrointestinal bleeding);
• if you have other bleeding, such as cerebrovascular bleeding;
• if you suffer from ulcerative colitis or Crohn's disease;
• if you suffer from severe liver or kidney problems (severe liver and kidney failure);
• if you suffer from haemorrhages (haemorrhagic diathesis);
• if you suffer from severe heart problems (severe heart failure);
• if in the past, after taking acetylsalicylic acid or other anti-inflammatory drugs (NSAIDs), you have experienced swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulties (bronchospasm), breathing problems (asthma), skin irritation (urticaria), inflammation of the nasal mucous membranes (rhinitis) or nasal polyposis;
• if you suffer from systemic lupus erythematosus or other skin diseases (collagen diseases);
• if you are in the third trimester of pregnancy (See paragraph Pregnancy, breastfeeding and fertility);
• if you suffer from phenylketonuria, a condition in which the levels of certain substances in the urine and blood are altered.

Warnings and precautions
Talk to your doctor or pharmacist before taking VEGETALLUMINA DOLORE E FEBBRE.

Talk to your pharmacist or nurse if you have an infection - see section Infections below.

Infections
VEGETALLUMINA DOLORE E FEBBRE may mask the symptoms of infections such as fever and pain. It is therefore possible that VEGETALLUMINA DOLORE E FEBBRE 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 worsen, consult your doctor immediately.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema) and chest pain, have been reported with ibuprofen.
Stop VEGETALLUMINA DOLORE E FEBBRE immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Take this medicine with caution if:
• you are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see the paragraph Other medicines and VEGETALLUMINA DOLORE E FEBBRE);
• you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (See the paragraph Other medicines and VEGETALLUMINA DOLORE E FEBBRE);
• you have suffered from high blood pressure (hypertension) because, in association with NSAID therapy, you may have problems eliminating fluids (fluid retention) and experience swelling due to fluid accumulation (oedema);
• you have suffered in the past from intestinal disorders (ulcerative colitis, Crohn's disease);
• you suffer from heart disorders (mild to moderate congestive heart failure);
• you have suffered from breathing problems (bronchospasm) especially if following the use of medicines. In patients who suffer or have suffered from bronchial asthma or allergic diseases, bronchospasm could worsen. In these cases, especially for prolonged treatments, your doctor may suggest you undergo periodic tests;
• you suffer from coagulation disorders or a decrease in heart, liver or kidney function; in these cases, especially for prolonged treatments, periodic tests may be necessary. Hypersensitivity to VEGETALLUMINA DOLORE E FEBBRE can cause liver problems (hepatotoxic reactions);
• you suffer from lupus erythematosus, a chronic autoimmune disease that can affect various organs and tissues and causes facial lesions and pain, or you suffer from other skin diseases (collagen diseases) you should consult your doctor before taking VEGETALLUMINA DOLORE E FEBBRE;
• you intend to start a pregnancy, as the use of VEGETALLUMINA DOLORE E FEBBRE can compromise female fertility; the use of VEGETALLUMINA DOLORE E FEBBRE should be suspended in women who have fertility problems or who are undergoing fertility investigations.

Risk of Stroke and Heart Attack
Anti-inflammatory/pain relief medicines 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.
You should discuss your therapy with your doctor or pharmacist before taking VEGETALLUMINA DOLORE E FEBBRE 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 to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Gastrointestinal risks
At any time, with or without warning symptoms or a previous history of serious gastrointestinal events, stomach and intestinal bleeding (gastrointestinal haemorrhage), the formation of serious lesions (ulceration and perforation) have been reported, which can be fatal.
If you have suffered from ulcer in the past, the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. Your doctor will suggest you take specific medicines to protect your stomach such as misoprostol or proton pump inhibitors, especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems).

If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with VEGETALLUMINA DOLORE E FEBBRE, tell your doctor about any gastrointestinal symptoms you experience (especially bleeding). At doses exceeding 1000 mg per day, a prolongation of bleeding time may occur.
If you experience bleeding or gastrointestinal ulceration, stop treatment with VEGETALLUMINA DOLORE E FEBBRE and consult your doctor or the nearest hospital.

Pay particular attention with VEGETALLUMINA DOLORE E FEBBRE:
Severe skin reactions
Severe 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. Stop using VEGETALLUMINA DOLORE E FEBBRE and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Stop taking VEGETALLUMINA DOLORE E FEBBRE and consult your doctor immediately if a rash, mucous membrane lesions, blisters or other signs of allergy appear, as these may be the first signs of a very severe skin reaction. See paragraph 4.

Vision problems
If you experience vision problems, stop treatment with this medicine and consult an ophthalmologist.

Elderly patients
If you are an elderly person, the risk of undesirable effects is higher, especially stomach and intestinal bleeding and perforations (gastrointestinal events) which can be fatal. The risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. Therefore, start treatment with the lowest available dose and take VEGETALLUMINA DOLORE E FEBBRE for the shortest possible period useful to control symptoms. Your doctor may indicate medicines that have a protective action on the stomach (misoprostol or proton pump inhibitors), especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems). If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with VEGETALLUMINA DOLORE E FEBBRE, tell your doctor about any gastrointestinal symptoms you experience (especially bleeding). At doses exceeding 1000 mg per day, a prolongation of bleeding time may occur. If you experience haemorrhage or gastrointestinal ulceration, stop treatment with VEGETALLUMINA DOLORE E FEBBRE and consult your doctor or the nearest hospital.

Children and adolescents
This medicine should be administered with caution in dehydrated adolescents because there is an increased risk of kidney problems (see paragraph 3 Use in adolescents aged 12 to 18 years). Use caution when starting ibuprofen treatment if you suffer from severe dehydration.
Ibuprofen can mask objective and subjective signs of infection. Therefore, in case of infection, use ibuprofen therapy with caution.
NSAIDs can cause an increase in liver function test results.
Pay particular attention in the above cases, bearing in mind that any risk is more likely when using this medicine at high doses and in prolonged therapies.

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

Stop using VEGETALLUMINA DOLORE E FEBBRE if you develop these symptoms and contact your doctor immediately. See also paragraph 2:
• non-raised reddish, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome);
• widespread, extensive, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following side effects may occur:

Very common (may affect more than 1 in 10 people)
• indigestion (dyspepsia);
• diarrhoea.

Common (may affect up to 1 in 10 people)
• abdominal pain or discomfort, burning sensation in the stomach (heartburn);
• nausea, flatulence;
• headache, dizziness;
• skin disease, rash.

Uncommon (may affect up to 1 in 100 people)
• formation of stomach or intestinal lesions (peptic ulcers or haemorrhages) sometimes fatal, particularly in the elderly;
• vomiting;
• presence of blood in the faeces (melena);
• stomach inflammation (gastritis);
• mouth inflammation (stomatitis);
• confusion;
• drowsiness;
• itching, skin irritation (urticaria, exanthema), severe skin problem associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema);
• allergic reactions;
• breathing difficulties (asthma, worsening of asthma, bronchospasm, dyspnoea).

Rare (may affect up to 1 in 1,000 people)
• formation of stomach or intestinal lesions (gastrointestinal perforation);
• constipation;
• presence of blood in vomit (haematemesis);
• mouth inflammation associated with the presence of lesions (ulcerative stomatitis);
• worsening of some chronic inflammatory bowel diseases (colitis and Crohn's disease);
• hearing disorders, perception of ringing in the ear (tinnitus);
• vision disorders (blurred vision and amblyopia);
• alteration of platelet, white blood cell and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, granulocytopenia);
• presence of blood in the urine (haematuria);
• difficult urination (dysuria);
• liver problems;
• alteration of liver function tests (elevated transaminases);
• difficulty distinguishing colours;
• severe allergic reaction (anaphylaxis).

Very rare (may affect up to 1 in 10,000 people)
• weakening of sensory and orientation functions (clouding of consciousness);
• severe skin disorders (exfoliative dermatitis, reactions including Stevens-Johnson syndrome and erythema multiforme, toxic epidermal necrolysis, allergic vasculitis);
• kidney problems (interstitial nephritis, papillary necrosis, kidney failure, including the acute form).

Not known (frequency cannot be estimated from the available data)
• decreased appetite and body weight (anorexia);
• swelling of a body part due to fluid accumulation (oedema);
• fever;
• heart problems (heart failure);
• increased blood pressure (hypertension);
• blood circulation problems (thrombosis);
• decreased blood pressure (hypotension);
• depression and mental problems (psychotic reaction);
• infection of the membranes covering the brain without bacterial growth in culture (aseptic meningitis);
• swelling affecting the connection point between the optic nerve and the eye (papilloedema);
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red and scaly rash, with the formation of 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);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• unexpected and exaggerated skin manifestations on sun exposure (photosensitivity reaction);
• anaemia;
• muscle stiffness;
• increased uric acid levels in the blood (hyperuricemia);
• poor sodium and fluid elimination manifesting as swelling (oedema);
• menstrual cycle disorders;
• liver inflammation (hepatitis), liver damage, jaundice;
• alteration of kidney function test;
• severe clinical reaction triggered in a sensitized subject on contact with a specific allergen (anaphylactic shock);
• burning and sore throat (throat irritation).


Reporting of 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.