LEVIADEX*20 TABLETS 25MG

LEVIADEX 25 mg film-coated tablets
Dexketoprofen
Generic medicine

What it is and what it is used for
LEVIADEX is a painkiller belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), and toothache.

What you need to know before taking this medicine
Do not take LEVIADEX
• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if you suffer from asthma or have had asthma attacks, acute allergic rhinitis (short periods of nasal lining inflammation), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties) or wheezing in the chest, after taking aspirin or other non-steroidal anti-inflammatory drugs;
• if you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or irritation of the skin exposed to sunlight) in conjunction with taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• if you suffer from peptic ulcer/bleeding of the stomach or intestine or if you have previously suffered from bleeding, ulceration or perforation of the stomach or intestine;
• if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have previously suffered from bleeding or perforation of the stomach or intestine due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;
• if you suffer from chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• if you suffer from severe heart failure, moderate or severe kidney failure, severe liver failure;
• if you have bleeding problems or coagulation disorders;
• if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• if you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking LEVIADEX:
• if you suffer from allergies, or have had allergy problems in the past;
• if you have kidney, liver or heart conditions (hypertension and/or heart failure) and fluid retention, or if you have suffered from any of these conditions in the past;
• if you are on diuretic therapy or are poorly hydrated and have a reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
• if you suffer from heart conditions, have had a stroke or if you think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or if you are a smoker), discuss therapy with your doctor or pharmacist; medicines like LEVIADEX may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. These risks are more likely with high doses of the drug and with prolonged therapy. Do not exceed the recommended dose or duration of treatment;
• if you are elderly, the risk of side effects is higher (see point 4); if they occur, consult your doctor immediately;
• if you are a woman with fertility problems (LEVIADEX can reduce female fertility, so you should not take the medicine if you are planning a pregnancy or if you are undergoing fertility investigations);
• if you suffer from a disorder of blood and blood cell formation;
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you suffer or have suffered in the past from other stomach or intestinal disorders;
• if you have chickenpox, because, in exceptional cases, NSAIDs can worsen the infection;
• if you have an infection - see the Infections section below;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral steroids, some antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents like aspirin or anticoagulants like warfarin. In these cases, consult your doctor before taking LEVIADEX: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that reduce stomach acid production);
• if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a greater risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of LEVIADEX has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the medicine should not be used in children and adolescents.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, ordered according to their likelihood of occurrence.

Common side effects: may affect up to 1 in 10 patients
Nausea and/or vomiting, stomach pain, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 patients
Dizziness, lightheadedness, drowsiness, insomnia, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general feeling of being unwell (malaise).

Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, bleeding or perforated peptic ulcer, which manifests as haematemesis, i.e., vomiting blood, or black stools, fainting, hypertension, slowed breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensitivity, itchy skin rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function test (blood analysis), hepatocellular damage (hepatitis), acute kidney failure.

Very rare side effects: may affect up to 1 in 10,000 patients
Anaphylactic reactions (hypersensitivity reactions that may also lead to collapse), open wounds on the skin, mouth, eyes and genital area (Stevens-Johnson and Lyell syndromes), facial oedema or swelling of the lips and throat (angioedema), shortness of breath due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Reduced white blood cell count (neutropenia), decreased platelets in the blood (thrombocytopenia).

Tell your doctor immediately if you notice any side effects in your stomach or intestines at the start of treatment (e.g. stomach pain, heartburn or bleeding), if you have previously suffered from these side effects due to prolonged use of anti-inflammatory drugs and especially if you are elderly.

Stop using LEVIADEX as soon as you notice the appearance of a skin rash or any lesion inside the mouth or genitals, or any sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (particularly of the ankles and legs), increased blood pressure and heart failure have been reported.

Medicines like LEVIADEX may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may, in rare cases, cause fever, headache and neck stiffness.

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.