Name
Vegedol 400 mg film-coated tablets
Ibuprofen as ibuprofen lysine


What it is and what it is used for
The active substance is ibuprofen which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling and high temperature.
Vegedol is used for the short-term symptomatic treatment of:
• mild to moderate pain such as headache, migraine, toothache, dysmenorrhea (period pain), muscle pain, back pain, rheumatic pain;
• fever;
• feverish state and cold and flu symptoms.

For rheumatic pain, the medicine should be used only on the advice of a doctor.

Vegedol is indicated for use in adults and adolescents over 12 years of age and weighing at least 40 kg.


What you need to know before taking the medicine
Do not take Vegedol
- If you are allergic to ibuprofen, aspirin (acetylsalicylic acid) or other painkillers, or any of the other ingredients of this medicine (listed in section 6);
- If you have had shortness of breath, asthma, runny nose, swelling or hives after using aspirin (acetylsalicylic acid) or similar painkillers (NSAIDs);
- If you have (or have had two or more episodes of) gastric/duodenal ulcer, or bleeding;
- If you have had gastrointestinal bleeding or perforation related to previous NSAID use;
- If you have severe heart, liver, or kidney failure;
- If you have unclear blood formation disorders, if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
- If you are in the last 3 months of pregnancy;
- If you are a teenager weighing less than 40 kg or under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking Vegedol if you:
- have or have had asthma or an allergic disease as it may cause shortness of breath, - suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria;
- have kidney, heart, liver or intestinal problems;
- has a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease);
- has certain hereditary diseases related to blood formation (e.g., acute intermittent porphyria);
- have systemic lupus erythematosus (SLE) or mixed connective tissue disease, immune system conditions that cause joint pain, skin changes, and disorders of other organs;
- you have chickenpox, it is advisable not to take Vegedol as your condition may worsen;
- have an infection – see section “Infections” below;
- recently had major surgery;
- has a dehydration problem;
- is taking other NSAIDs. Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided;
- is in the first 6 months of pregnancy.


Other warnings
• Anti-inflammatory/pain-relieving medicines 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.
• You should discuss your treatment with your doctor or pharmacist before taking Vegedol if:
- 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);
- have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.
• 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 taking Vegedol immediately and contact your doctor or emergency services immediately if you notice any of these signs.

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 Vegedol and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Side effects can be minimized by using the lowest effective dose for the shortest possible period of time. Elderly people are at increased risk of developing side effects.

Ibuprofen may temporarily inhibit the function of blood platelets (platelet aggregation). Therefore, patients with blood clotting disorders should be carefully monitored. Ask your doctor or dentist or inform them if Vegedol is administered before surgical procedures.

The habitual use of different types of painkillers can cause permanent kidney damage and a risk of kidney failure. This risk can be increased during physical exertion associated with salt loss and dehydration. The habitual use of painkillers should therefore be avoided.

Long-term use of any type of painkiller for headaches can make your headaches worse. If you notice or suspect this, talk to your doctor and stop taking it. The diagnosis of medication-induced headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

During prolonged administration of Vegedol, it is necessary to regularly monitor liver and kidney function values, as well as blood count.

NSAIDs may mask the symptoms of infection and fever.

Infections
Vegedol may hide the symptoms of infections such as fever and pain. It is therefore possible that Vegedol may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and 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.

Children and adolescents
Do not give this medicine to adolescents weighing less than 40 kg or children under 12 years of age.
There is a risk of impaired renal function in dehydrated adolescents.


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

Some side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Older people using this medicine are at greater risk of developing problems associated with side effects.

Medicines such as Vegedol may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke (see section 2, Other warnings).

Stop taking the medicine and see a doctor immediately if you develop:
- stomach pain, bright red stools, passing very dark stools, vomiting blood or dark particles that look like coffee grounds [signs of intestinal bleeding] (uncommon);
- swelling of the face, tongue or throat, difficulty breathing, fast heart rate, drop in blood pressure resulting in shock. This may also happen when you first start using this medicine [signs of a serious allergic reaction] (very rare);
- asthma attacks (with possible low blood pressure), worsening of asthma, wheezing of unknown cause or shortness of breath [signs of serious allergic reaction] (uncommon);
- reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, 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] (very rare);
- extensive skin rash, high body temperature and swollen lymph nodes and increased eosinophils (a type of white blood cell) [DRESS syndrome] (frequency cannot be estimated from the available data);
- a large, 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) (frequency cannot be estimated from the available data);
- severe pain in the upper stomach, often with nausea and vomiting (inflammation of the pancreas) (very rare) 1 in 10,000 people);
- fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme tiredness, nose and skin bleeding (problems with the production of blood cells) (very rare);
- inflammation of the lining of the brain with symptoms including stiff neck, headache, nausea, feeling sick, fever or mental clouding (aseptic meningitis). Patients with autoimmune diseases (SLE, mixed connective tissue disease) are more likely to be affected (very rare);
- chest pain, which may be a sign of a potentially serious allergic reaction called;
- Kounis syndrome (frequency cannot be estimated from the available data).

Tell your doctor if you notice any of the following side effects:

Common (may affect up to 1 in 10 people):
- Gastrointestinal disorders, such as heartburn, abdominal pain, feeling of being unwell, malaise, flatulence, diarrhoea, constipation and slight gastric and/or intestinal blood loss which may cause anaemia in exceptional cases.

Uncommon (may affect up to 1 in 100 people):
- Gastric or intestinal ulcers, sometimes with bleeding and perforation;
- Inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;
- Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness;
- Vision disturbances;
- Allergic reactions, such as skin rashes and itching;
- Various types of skin rashes.

Rare (may affect up to 1 in 1,000 people):
- Ringing in the ears (tinnitus);
- Kidney damage (papillary necrosis) and high concentrations of uric acid in the blood.

Very rare (may affect up to 1 in 10,000 people):
- Inflammation of the esophagus, intestinal stenosis;
- Serious skin infections and soft tissue complications may occur in chickenpox;
- Accumulation of fluid in body tissues, especially in patients with high blood pressure or kidney problems, swelling and foamy urine (nephrotic syndrome), inflammatory disease of the kidneys (interstitial nephritis) with possible acute kidney failure;
- Psychotic reactions, depression;
- With the use of some painkillers (NSAIDs), worsening of inflammation of infectious origin (e.g. necrotizing fasciitis) has been described. If signs of infection appear or if these worsen during the use of ibuprofen, see a doctor immediately. It should be investigated whether there is an indication for anti-infective/antibiotic therapy;
- Hypertension, inflammation of blood vessels, palpitations, heart failure, heart attack;
- Liver dysfunction, liver damage (especially with long-term use), liver failure, acute inflammation of the liver (hepatitis);
- Hair loss.

Frequency not known:
- the skin becomes sensitive to light.

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.