VOLTADEXI*20FC TAB 200MG

VoltaDexi 200 mg film-coated tablets
Dexibuprofen

What it is and what it is used for
Dexibuprofen, the active ingredient in VoltaDexi, belongs to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs such as dexibuprofen are used as painkillers and to control inflammation. They work by reducing the amount of prostaglandins (substances that control inflammation and pain) the body produces.

What VoltaDexi 200 mg is used for
VoltaDexi is used in adults for the short-term symptomatic treatment of acute mild to moderate pain of various origins, such as:
- musculoskeletal pain, such as back pain;
- dental pain, pain after a tooth extraction;
- menstrual pain;
- headache;
- pain during colds and flu (such as headache and limb pain).

Contact your doctor if you do not feel better or if you feel worse after 4 days in case of pain and after 3 days in case of fever.

What you need to know before taking the medicine
Do not take VoltaDexi if:
- you are allergic to dexibuprofen or any of the other ingredients of this medicine (listed in section 6);
- you are allergic to acetylsalicylic acid or other painkillers (your allergy may cause difficulty breathing, asthma, runny nose, rash or facial swelling);
- you have previously experienced bleeding or perforation in the gastrointestinal system caused by NSAIDs;
- you have or have previously experienced recurrent stomach or duodenal ulcers (vomiting blood or black stools or bloody diarrhoea could be a sign of bleeding in the stomach or intestine);
- you suffer from unknown blood formation disorders;
- you have cerebral bleeding (cerebrovascular haemorrhage) or other active bleeding;
- you currently have an exacerbation of an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
- you suffer from severe heart failure or severe liver or kidney disease;
- you are a woman in the third trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking VoltaDexi if:
- you have had a stomach or duodenal ulcer;
- you have suffered from intestinal ulcers, ulcerative colitis or Crohn's disease;
- you suffer from liver or kidney disease or if you are alcohol-dependent;
- you have oedema (fluid accumulation in body tissues);
- you suffer from heart disease or high blood pressure;
- you suffer from systemic lupus erythematosus (a disease that affects joints, muscles and skin) or mixed collagenosis (a collagen disease that affects connective tissues);
- you are having trouble getting pregnant. (In rare cases, medicines like VoltaDexi may affect female fertility. Fertility will return to normal when you stop taking VoltaDexi);
- you suffer or have suffered from asthma or allergic diseases, as you may experience shortness of breath;
- you suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases as there is a greater risk of allergic reactions. Allergic reactions may present as asthmatic attacks (so-called analgesic asthma), Quincke's oedema (swelling mainly in the facial area, lips, eyelids or genitals) or urticaria;
- you have recently undergone major surgery;
- you suffer from certain hereditary blood formation disorders (e.g. acute intermittent porphyria);
- you have an infection - see the Infections section below.

Cases of gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing doses of NSAIDs, in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 2) and in the elderly.
These patients should start treatment with the lowest available dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients as well as for patients requiring concomitant use of low-dose acetylsalicylic acid or other medicines that could increase gastrointestinal risk.

If you have previously experienced gastrointestinal toxicity, especially if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor, especially in the initial stages of treatment.

Anti-inflammatory/painkilling drugs such as dexibuprofen may be associated with a modest increased risk of heart attack or stroke, particularly if used at high doses. Do not exceed the recommended dose or duration of treatment.

Talk to your doctor or pharmacist before taking VoltaDexi if:
- you have heart problems, including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or transient ischaemic attack TIA);
- you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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 dexibuprofen.
Stop VoltaDexi immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

If you take high doses of painkillers for a long time (off-label use), you may get headaches. In this case, ask your doctor for advice; you should not take any more VoltaDexi to treat the headache.
In general, habitual use of analgesics, especially with combinations of several painkillers, can cause permanent kidney damage, including the risk of kidney failure (analgesic nephropathy).

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

Infections
VoltaDexi can hide the symptoms of infections such as fever and pain. It is therefore possible that VoltaDexi may delay appropriate 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, contact your doctor immediately.

In case of varicella zoster infection (chickenpox), you should avoid taking NSAIDs.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms. Elderly people who use this medicine are at higher risk of developing problems associated with side effects.
The following list includes all known possible side effects, even those for long-term treatment with high doses, e.g. for rheumatic diseases. They may occur less frequently when a low dosage is used and only for a short period of time as recommended for VoltaDexi 200 mg.

Stop taking VoltaDexi and contact your doctor immediately:
- if you experience severe stomach pain, especially when you start taking VoltaDexi;
- if you have black stools, bloody diarrhoea or if you vomit blood;
- if you experience chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
- if you have non-raised, target-shaped or circular reddish 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]; if you have a widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome);
- if you have a widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis);
- if you have symptoms such as fever, sore throat and mouth pain, flu-like symptoms, tiredness, nosebleeds and skin bleeding. These may be caused by a reduction in white blood cells in the body (agranulocytosis);
- if you suffer from severe or persistent headache;
- if you have yellowing of the skin and whites of the eyes (jaundice);
- if you have swelling of the face, tongue or pharynx, difficulty swallowing or breathing (angioedema), leading to worsening of asthma.

Common: may affect 1 to 10 out of 100 patients
- gastrointestinal disturbances, such as abdominal pain, feeling unwell and indigestion, diarrhoea, gas (flatulence), constipation, heartburn, vomiting and slight blood loss in the stomach and/or intestine which may cause anaemia in exceptional cases.

Uncommon: may affect 1 to 10 out of 1,000 patients
- stomach 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 fatigue;
- visual disturbances;
- urticaria;
- hypersensitivity reactions, including urticaria (rash with red, raised, itchy bumps) and itching.

Rare: may affect 1 to 10 out of 10,000 patients
- tinnitus (ringing in the ears), hearing problems in case of prolonged treatment;
- kidney damage (papillary necrosis), high blood urea concentrations and high blood uric acid concentrations;
- liver function disorders (usually reversible).

Very rare: may affect less than 1 out of 10,000 patients
- difficulty breathing (mainly in patients with bronchial asthma), worsening of asthma;
- inflammation of the oesophagus or pancreas, formation of a membranous stricture in the small and large intestine (intestinal strictures similar to a diaphragm);
- high blood pressure, inflammation of blood vessels, palpitations, heart failure;
- reduced urine output compared to normal and swelling (especially in patients with hypertension or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which can cause acute kidney failure. If any of the above symptoms occur or if you experience a general feeling of unwellness, stop taking VoltaDexi and consult your doctor immediately, as these could be the first signs of kidney damage or kidney failure;
- psychotic reactions and depression;
- liver damage, especially during long-term treatment, liver function failure, acute liver inflammation (hepatitis) and jaundice;
- problems with blood cell production (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In these cases, you must stop therapy immediately and consult a doctor. You must not treat these symptoms with painkillers or medicines that reduce fever (antipyretic products);
- a worsening of infection-related inflammation (e.g. necrotising fasciitis) has been described in association with the use of certain painkillers (NSAIDs). If signs of infection appear or if they worsen during the use of ibuprofen, consult your doctor immediately to assess the need for anti-infective/antibiotic therapy;
- in exceptional cases, severe skin infections and soft tissue complications during a chickenpox infection;
- symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, malaise, fever or blurred consciousness have been observed when using ibuprofen. Patients with autoimmune diseases (systemic lupus erythematosus [SLE], mixed connective tissue disease) may be more likely to be affected. If you experience these disorders, consult a doctor immediately;
- severe forms of skin reactions such as rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia);
- severe general hypersensitivity reactions (facial, tongue and laryngeal oedema, dyspnoea, tachycardia, hypotension, severe shock, worsening of asthma).

Not known (frequency cannot be estimated from the available data)
- A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
- A widespread, red and scaly rash, with pustules forming under the skin and blisters localised mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
Stop use if you develop these symptoms and contact your doctor immediately. See also section 2.

Medicines such as VoltaDexi may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you get 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.