DEXKETOPROFENE PEN 25 MG FILM-COATED TABLETS 20 TABLETS IN PVC-PVDC/AL BLISTER

Name
DEXKETOPROFENE PENSAVITAL 25 mg film-coated tablets
Dexketoprofen


What it is and what it is used for
DEXKETOPROFENE PENSAVITAL 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 periods (dysmenorrhea), toothache.


What you need to know before taking the medicine
Do not take DEXKETOPROFENE PENSAVITAL:
• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• nonsteroidal anti-inflammatory drugs;
• if you suffer from asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (bumps in the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking aspirin or other nonsteroidal anti-inflammatory medicines;
• if you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or blistering of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower fat levels in the blood);
• if you have or have had in the past peptic ulcer, bleeding in the stomach or intestines or have chronic digestive problems (e.g. indigestion, heartburn);
• if you have suffered in the past from bleeding or perforation of the stomach or intestine, due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• if you have a bowel disease with chronic inflammation (Crohn's disease or ulcerative colitis);
• if you suffer from severe heart failure, moderate or severe kidney problems or severe liver problems;
• if you have a bleeding disorder or a blood clotting disorder;
• if you are severely dehydrated (have lost a lot of body fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• if you are in your third trimester of pregnancy or are breastfeeding.


Warnings and precautions
Talk to your doctor or pharmacist before taking DEXKETOPROFENE PENSAVITAL:
• if you suffer from allergies or have had allergy problems in the past;
• if you have kidney, liver or heart problems (hypertension and/or heart failure) as well as fluid retention, or have suffered from any of these problems in the past;
• if you are taking diuretics or suffer from poor hydration and reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea or vomiting);
• if you have heart problems, have had a stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist; medicines such as DEXKETOPROFENE PENSAVITAL may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• if you are elderly: you may be more likely to suffer from side effects (see section 4). If any of these occur, consult your doctor immediately;
• if you are a woman with fertility problems (DEXKETOPROFENE PENSAVITAL may compromise your fertility, therefore you must not take it if you are planning a pregnancy or if you are undergoing fertility tests);
• if you suffer from a disorder in the formation of blood and blood cells;
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting the connective tissue);
• if you have suffered in the past from a chronic inflammatory disease of the intestine (ulcerative colitis, Crohn's disease);
• if you have or have suffered in the past from other stomach or intestinal problems;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, certain antidepressants (those of the SSRI type, i.e. selective serotonin reuptake inhibitors), agents that prevent blood clots such as aspirin or anticoagulants such as warfarin. In such cases, consult your doctor before taking DEXKETOPROFENE PENSAVITAL: he or she may prescribe another medicine to protect your stomach (e.g. misoprostol or medicines that block the production of stomach acid);
• if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
DEXKETOPROFENE PENSAVITAL has not been studied in children and adolescents.
Therefore, safety and efficacy have not been established and the product 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.

Possible side effects are listed below according to how likely they are to occur.

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

Uncommon side effects (may affect up to 1 in 100 people):
Feeling dizzy (vertigo), dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and chills, general feeling of being unwell (malaise).

Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, perforation or bleeding of the peptic ulcer, which may manifest as blood in the vomit or black stools, fainting, high blood pressure, breathing too slowly, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy skin rash, acne, increased sweating, back pain, frequent passage of water, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), damage to liver cells (hepatitis), acute kidney failure.

Very rare (may affect up to 1 in 10,000 people):
Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), open sores on the skin, mouth, eyes and genital areas (Stevens Johnson and Lyell syndromes), swelling of the face or swelling of the lips and throat (angioedema), shortness of breath due to narrowing of 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 number of white blood cells (neutropenia), reduced number of platelets in the blood (thrombocytopenia).

Tell your doctor immediately if you notice any stomach/intestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding) and especially if you are elderly.

Stop using DEXKETOPROFENE PENSAVITAL as soon as you notice the appearance of a skin rash, or any lesions inside the mouth or on the genitals, or any sign of allergy.

Fluid retention and swelling (especially of the ankles and legs), increased blood pressure, and heart failure have been reported during treatment with nonsteroidal anti-inflammatory drugs.

Medicines such as DEXKETOPROFENE PENSAVITAL may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

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

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.