VEGETALLUMINA DOLORE FEB 400 MG GRANULES FOR ORAL SOLUTION IN SACHET 12 SACHETS IN PAPER/PE/AL/SURLYN

Name
VEGETALLUMINA PAIN AND FEVER 400 mg granules for oral solution in sachet
Ibuprofen sodium
Equivalent medicine


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

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

Talk to 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 PAIN AND FEVER
• if you are allergic to ibuprofen, other similar medicines or any of the other ingredients of this medicine (listed in section 6);
• if you have suffered in the past from stomach and intestinal disorders associated with bleeding (gastrointestinal bleeding or perforation related to previous treatment with anti-inflammatory drugs (NSAIDs) or history of recurrent peptic ulcer/haemorrhage, with two or more distinct episodes of proven ulceration or bleeding);
• if you suffer from stomach and intestinal problems associated with the presence of lesions and bleeding (active and recurrent peptic ulcer);
• if you suffer from bleeding in your stomach or intestines (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 bleeding (haemorrhagic diathesis);
• if you suffer from severe heart problems (severe heart failure);
• if in the past, after taking acetylsalicylic acid or other anti-inflammatory medicines (NSAIDs), you have experienced swelling of the face due to accumulation of fluid, especially around the mouth and eyes (angioedema), severe difficulty breathing (bronchospasm), breathing problems (asthma), skin irritation (urticaria), inflammation of the nasal mucosa (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 section "Pregnancy, breast-feeding 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 PAIN AND FEVER.

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

Infections
VEGETALLUMINA PAIN AND FEVER may hide the symptoms of infections such as fever and pain. It is therefore possible that VEGETALLUMINA PAIN AND FEVER 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.

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 VEGETALLUMINA PAIN AND FEVER immediately and contact your doctor or emergency services 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 section "Other medicines and VEGETALLUMINA PAIN AND FEVER");
• are taking other medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (See section "Other medicines and VEGETALLUMINA PAIN AND FEVER");
• has suffered from high blood pressure (hypertension) since, in association with NSAID therapy, you may have problems in eliminating fluids (water retention) and experience swelling due to accumulation of fluids (oedema);
• have suffered from intestinal disorders in the past (ulcerative colitis, Crohn's disease);
• suffer from heart problems (mild to moderate congestive heart failure);
• 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 may worsen. In these cases, especially for prolonged treatments, your doctor may suggest that you undergo periodic tests;
• suffer from coagulation disorders or a decrease in the functioning of the heart, liver or kidneys; in these cases, especially for prolonged treatments, periodic tests may be necessary. Hypersensitivity to VEGETALLUMINA PAIN AND FEVER can cause liver problems (hepatotoxic reactions);
• suffer from lupus erythematosus, a chronic autoimmune disease that can affect various organs and tissues and causes facial lesions and pain, or suffer from other skin diseases (collagen diseases) you must consult your doctor before taking VEGETALLUMINA PAIN AND FEVER;
• intends to start a pregnancy, as the use of VEGETALLUMINA DOLORE E FEBBRE may compromise female fertility; the use of VEGETALLUMINA DOLORE E FEBBRE must be suspended in women who have fertility problems or who are undergoing fertility investigations.

Risks of Stroke and Heart Attack
Anti-inflammatory/pain-relieving drugs may be associated with a small increase in the risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking VEGETALLUMINA PAIN AND FEVER 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);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Gastrointestinal risks
Bleeding into the stomach and intestines (gastrointestinal haemorrhage), formation of serious lesions (ulceration and perforation), which can be fatal, have been reported at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
If you have had an ulcer in the past, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. Your doctor will suggest that you take specific drugs to protect your stomach such as misoprostol or proton pump inhibitors, especially if you take other medicines (for example, 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 may experience (especially bleeding). At doses higher than 1000 mg per day, a prolongation of bleeding time may occur.
If you experience gastrointestinal bleeding or ulceration, stop treatment with VEGETALLUMINA PAIN AND FEVER and contact your doctor or the nearest hospital.

Take special care with VEGETALLUMINA PAIN AND FEVER:
Severe 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. Stop using VEGETALLUMINA PAIN AND FEVER and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Stop taking VEGETALLUMINA PAIN AND FEVER and consult your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Vision problems
If you experience any visual disturbances, stop taking this medicine and contact your eye doctor.

Elderly patients
If you are elderly, the risk of side effects is higher, especially bleeding and perforation of the stomach and intestines (gastrointestinal events) which can be fatal. The risk of gastrointestinal bleeding, 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 time possible to control your symptoms. Your doctor may prescribe medicines that have a protective effect on the stomach (misoprostol or proton pump inhibitors), especially if you take other medicines (for example, 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 higher than 1000 mg per day, a prolongation of bleeding time may occur. If you experience gastrointestinal bleeding or ulceration, stop treatment with VEGETALLUMINA DOLORE E FEBBRE and contact your doctor or the nearest hospital.

Children and adolescents
This medicine should be given with caution to dehydrated adolescents because there is an increased risk of kidney problems (see section 3 "Use in adolescents aged 12 to 18 years"). Use caution when starting treatment with ibuprofen if you suffer from severe dehydration.
Ibuprofen may mask objective and subjective signs of infection. Therefore, in case of infection, use ibuprofen therapy with caution.
NSAIDs may cause an increase in liver function test results.
Pay particular attention in the above cases keeping 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 PAIN AND FEVER if you develop these symptoms and contact your doctor immediately. See also section 2:
• reddish, non-raised, target-shaped or circular patches 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 and swollen lymph nodes (DRESS syndrome);
• widespread, extensive, 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).

The following side effects may occur:

Very common (may affect more than 1 in 10 people)
• difficulty in digestion (dyspepsia);
• diarrhea.

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

Uncommon (may affect up to 1 in 100 people)
• formation of lesions in the stomach or intestine (peptic ulcers or haemorrhages) which are sometimes fatal, especially in the elderly;
• vomit;
• presence of blood in the stool (melena);
• inflammation of the stomach (gastritis);
• inflammation of the mouth (stomatitis);
• confusion;
• drowsiness;
• itching, skin irritation (hives, rash), serious skin problem associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing (angioedema);
• allergic reactions;
• difficulty breathing (asthma, worsening of asthma, bronchospasm, dyspnoea).

Rare (may affect up to 1 in 1,000 people)
• formation of lesions in the stomach or intestine (gastrointestinal perforation);
• constipation;
• presence of blood in vomit (hematemesis);
• inflammation of the mouth 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 anemia, haemolytic anemia, granulocytopenia);
• presence of blood in the urine (hematuria);
• difficulty passing urine (dysuria);
• liver problems;
• alteration of liver function tests (elevated transaminases);
• disturbances in distinguishing colors;
• severe allergic reaction (anaphylaxis).

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

Not known (the frequency of which cannot be estimated from the available data)
• decreased appetite and body weight (anorexia);
• swelling of a part of the body due to fluid accumulation (edema);
• fever;
• heart problems (heart failure);
• increased blood pressure (hypertension);
• blood circulation problems (thrombosis);
• decrease in blood pressure (hypotension);
• depression and mental problems (psychotic reaction);
• infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
• a swelling affecting the connection point between the optic nerve and the eye (papilloedema);
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome): A serious 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, 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);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• unexpected and exaggerated skin reactions to sun exposure (photosensitivity reaction);
• anemia;
• muscle stiffness;
• increased levels of uric acid in the blood (uricemia);
• poor elimination of sodium and fluids which manifests itself with swelling (edema);
• menstrual cycle disorders;
• inflammation of the liver (hepatitis), liver damage, jaundice;
• alteration of kidney function tests;
• serious clinical reaction that occurs in a subject sensitized to contact with a specific allergen (anaphylactic shock);
• burning and sore throat (throat irritation).

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.