VEGEDOL 400 MG FILM-COATED TABLETS 20 TABLETS IN PVC/PVDC/AL BLISTER

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


What is it and what is it for?
The active ingredient is ibuprofen, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by altering 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 (menstrual cramps), muscle pain, back pain, rheumatic pain;
• fever;
• fever and cold and flu symptoms.

For rheumatic pain, the medicine should be used only as directed by 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 to 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 pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema, or hives;
- 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 recommended not to take Vegedol as your condition may worsen;
- have an infection – see section “Infections” below;
- recently had major surgery;
- has a dehydration problem;
- are 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 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.
• 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 a "mini-stroke" or "TIA" - transient ischemic 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 have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Vegedol immediately and contact your doctor or emergency medical 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), and 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. Consult your doctor or dentist or inform them if Vegedol is being administered before surgical procedures.

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

Prolonged use of any type of painkiller for headaches can worsen symptoms. If you observe or suspect this, consult your doctor and discontinue treatment. Medication-overuse headache (MOH) should be suspected in patients who experience 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 counts.

NSAIDs can mask the symptoms of infection and fever.

Infections
Vegedol may mask the symptoms of infections, such as fever and pain. Therefore, Vegedol may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, 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. Elderly 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 this 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, rapid heartbeat, drop in blood pressure resulting in shock. This can also happen the first time you use 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 a serious allergic reaction] (uncommon);
- flat, target-shaped or circular reddish 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] (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 vesicles 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 blood cell production) (very rare);
- inflammation of the lining of the brain with symptoms including neck stiffness, headache, nausea, feeling unwell, 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 unwell, malaise, flatulence, diarrhoea, constipation and slight bleeding in the stomach and/or intestine which may cause anemia 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 can occur with chickenpox;
- Accumulation of fluid in body tissues, especially in patients with high blood pressure or kidney problems, swelling and foamy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) with possible acute kidney failure;
- Psychotic reactions, depression;
- Worsening of infectious inflammation (e.g., necrotizing fasciitis) has been reported with the use of some painkillers (NSAIDs). If signs of infection appear or worsen while taking ibuprofen, see a doctor immediately. Anti-infective/antibiotic therapy should be investigated.
- 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 experience any side effects, including any not listed in this leaflet, talk to 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.