Ketoprofen lysinate Dompè

Package leaflet: Information for the user

KETOPROFENE LISINE SALT DOMPÉ 40 mg orodispersible tablets

Ketoprofene lysine salt
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What Ketoprofene lysine salt E-Pharma is and what it is used for
2. What you need to know before taking Ketoprofene lysine salt E-Pharma Trento
3. How to take Ketoprofene lysine salt E-Pharma Trento
4. Possible side effects
5. How to store Ketoprofene lysine salt Dompé
6. Contents of the pack and other information

1. What Ketoprofene Lysine Salt Dompé is and what it is used for

The name of your medicine is Ketoprofene Lysine Salt E-Pharma Trento. Ketoprofene Lysine Salt Dompé contains the active substance ketoprofene lysine salt, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Ketoprofen works by blocking the chemical substances that normally cause inflammation in our body.
This medicine is used for pain of various origin and nature, and in particular: headache, toothache, neuralgia (nerve pain), menstrual pain, and musculoskeletal pain (pain in bones and joints).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Ketoprofen lysine salt Dompé

Do not take Ketoprofen lysine salt E-Pharma Trento

• if you are allergic to ketoprofen or to substances with a similar mechanism of action (e.g. acetylsalicylic acid or other NSAIDs), or to any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information");
• if you have a history of hypersensitivity reactions (allergy) such as bronchospasm (narrowing of the airways causing breathing difficulties), asthma attacks, acute rhinitis, urticaria, or skin rashes. Severe anaphylactic reactions, rarely fatal, have been observed in patients with a history of hypersensitivity (see section 4 "Possible side effects");
• if you have gastric or duodenal ulcer, active peptic ulcer/hemorrhage, or a history of recurrent peptic ulcer bleeding or ulceration (two or more distinct, documented episodes of bleeding or ulceration);
• if you have gastritis or chronic digestive disorders (dyspepsia);
• if you have a history of gastrointestinal bleeding, ulceration, or perforation related to previous NSAID therapy;
• if you have active bleeding or hemorrhagic diathesis (a tendency to bleed);
• if you suffer from leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you are taking anticoagulants (medicines that thin the blood), other NSAIDs, or acetylsalicylic acid (see subsection "Other medicines and Ketoprofen lysine salt E-Pharma Trento");
• if you have severe renal (reduced kidney function), hepatic (reduced liver function), or cardiac insufficiency (the heart's inability to pump sufficient blood to meet the body's needs);
• if you are already taking other anti-inflammatory drugs or acetylsalicylic acid;
• if you are in the third trimester of pregnancy (the last three months of pregnancy) or if you are breastfeeding (see subsection "Pregnancy, breastfeeding and fertility");
• if you are undergoing major surgical procedures; Do not give this medicine to children and adolescents under 15 years of age (see subsection "Children and adolescents").

Warnings and precautions
During treatment with all NSAIDs, including Ketoprofen lysine salt E-Pharma Trento, gastrointestinal bleeding, ulceration, and perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events.
Elderly patients are at greater risk of developing adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal (see section 3 "How to take Ketoprofen lysine salt E-Pharma Trento").
Ketoprofen may be associated with a high risk of severe gastrointestinal toxicity compared to other NSAIDs, especially at high doses.
Severe skin reactions, some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with the use of NSAIDs (see section 4 "Possible side effects"). These reactions usually occur during the initial stages of treatment. Discontinue use of Ketoprofen lysine salt Dompé immediately if a skin rash, mucosal lesions, or any other sign of hypersensitivity occurs.
Medicines such as Ketoprofen lysine salt Dompé may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. The use of some NSAIDs (particularly at high doses and for long-term treatment) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke); such risk cannot be ruled out for ketoprofen lysine salt.

Ask your doctor or pharmacist before taking Ketoprofen lysine salt E-Pharma Trento:

• If you suffer from asthma, chronic obstructive bronchopulmonary disease (chronic inflammation and obstruction of the airways), allergic or chronic rhinitis.
• If you have heart problems, a history of stroke (cerebrovascular accident), or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
• If you have a history (even familial) of hypertension (high blood pressure) and/or mild to moderate congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate cardiac pumping function), as careful monitoring and appropriate instructions are required. Fluid retention and edema (swelling) have been observed during NSAID treatment.
• If you are taking concomitantly medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), selective serotonin reuptake inhibitors (e.g. antidepressants), anticoagulants (medicines that thin the blood) such as warfarin, or

antiplatelet agents such as acetylsalicylic acid (aspirin) (see subsection "Other medicines and Ketoprofen lysine salt E-Pharma Trento").

• If you have active or previous peptic ulcer, or inflammatory bowel disease (ulcerative colitis, Crohn's disease), or a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may recur with NSAID use (see section "Possible side effects").
• If you are using other NSAIDs, including selective cyclooxygenase-2 inhibitors, because concomitant use of Ketoprofen lysine salt Dompé with other NSAIDs should be avoided (see subsection "Other medicines and Ketoprofen lysine salt E-Pharma Trento").
• If you have hepatic porphyria (a rare blood disorder characterized by altered activity of a liver enzyme), as the medicine could trigger an attack.
• If you have liver disease or abnormal liver function tests, as transaminase levels (liver enzymes) should be periodically evaluated, especially during long-term therapy. Rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported with ketoprofen use.
• If you experience visual disturbances, such as blurred vision.
• If you have heart failure (a condition in which the heart is weakened), liver function disorders such as cirrhosis (severe liver impairment), kidney function disorders such as nephrosis (degenerative kidney disease), or chronic renal failure (impaired kidney function), if you are taking diuretics (medicines used to increase urine production), or if you may have low blood volume (hypovolemia), especially if you are elderly at the start of treatment, as kidney function must be closely monitored. Elderly patients are more prone to reduced kidney, heart, or liver function.
• If you are elderly or have had a peptic ulcer, especially if complicated by bleeding or perforation (see subsection "Do not take Ketoprofen lysine salt E-Pharma Trento"), because the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased NSAID doses. In this case, treatment should be started with the lowest available dose. Concomitant use of stomach-protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered if you are elderly, have had a peptic ulcer, or are taking low-dose aspirin or other medicines that may increase the risk of gastrointestinal events (see subsection "Other medicines and Ketoprofen lysine salt E-Pharma Trento").
• If you have a history of gastrointestinal toxicity (damage to the stomach or intestines), particularly if you are elderly. Report any abdominal signs or symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. Discontinue treatment with Ketoprofen lysine salt Dompé immediately at the first signs of gastrointestinal bleeding or ulceration.
• If you have an infection – see section "Infections" below.

Do not use this medicine for prolonged treatment. If there is no noticeable improvement after a short period of treatment, consult your doctor.
Infections
Ketoprofen lysine salt Dompé may mask symptoms of infections such as fever and pain. Therefore, Ketoprofen lysine salt Dompé could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to varicella. If you take this medicine while having an infection and the symptoms of infection persist or worsen, contact your doctor immediately.
Children and adolescents
Ketoprofen lysine salt Dompé must not be taken by children and adolescents under 15 years of age (see subsection "Do not take Ketoprofen lysine salt E-Pharma Trento").
Other medicines and Ketoprofen lysine salt Dompé
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention if you are taking the following medicines:

• Phenytoin (a medicine used to treat epilepsy) or sulfonamides (antibacterial medicines): since ketoprofen has high protein binding, it may be necessary to reduce the dosage of phenytoin or sulfonamides if they are administered concurrently.
• Lithium (a medicine used to treat manic-depressive psychosis): concomitant administration of NSAIDs causes increased lithium blood levels.
• Probenecid (a medicine used to treat gout): may increase ketoprofen blood concentrations.
• Corticosteroids (medicines used to treat inflammatory conditions): an increased risk of gastrointestinal ulceration or bleeding may occur (see subsection "Warnings and Precautions").
• Pentoxifylline (a medicine used to improve blood circulation in the limbs), thrombolytics (medicines that help dissolve blood clots), antiplatelet agents (such as aspirin, ticlopidine, or clopidogrel), and other NSAIDs (including selective cyclooxygenase-2 inhibitors): may increase the risk of bleeding.
• Selective serotonin reuptake inhibitors (SSRIs) (antidepressant medicines): may increase the risk of gastrointestinal bleeding (see subsection "Warnings and precautions").
• Anticoagulant medicines (that thin the blood) such as warfarin or heparin: NSAIDs may enhance the effects of anticoagulant medicines (see subsection "Warnings and precautions").
• Diuretics (medicines used to increase urine production): if you are taking diuretics and are particularly dehydrated, you are at higher risk of developing renal failure (reduced kidney function). You should be rehydrated before starting concomitant therapy, and kidney function should be closely monitored after treatment initiation (see subsection "Warnings and precautions"). NSAIDs may reduce the effect of diuretics.
• Other NSAIDs (including selective cyclooxygenase-2 inhibitors) and high doses of salicylates: concurrent administration of multiple NSAIDs may increase the risk of gastrointestinal ulcers.
• Antihypertensive medicines (used to treat high blood pressure): NSAIDs may reduce the effectiveness of antihypertensive medicines.
• ACE inhibitors and angiotensin II antagonists: if you have impaired kidney function (particularly if dehydrated and elderly), co-administration of an ACE inhibitor or angiotensin II antagonist with NSAIDs may lead to further deterioration of kidney function, including possible acute renal failure (sudden reduction in kidney function). This combination should be used with caution, especially in the elderly. You should be adequately hydrated, and kidney function should be monitored after starting concomitant therapy.
• Methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and some cancers) at doses exceeding 15 mg/week: there may be an increased risk of hematological toxicity from methotrexate.
• Hypoglycemic medicines: be aware of potential interactions between Ketoprofen lysine salt Dompé and these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Scientific studies suggest an increased risk of miscarriage and cardiac and gastrointestinal malformations in early pregnancy following use of medicines that inhibit prostaglandin synthesis.
Do not use Ketoprofen lysine salt Dompé during the first and second trimesters of pregnancy unless strictly necessary. If Ketoprofen lysine salt Dompé is used in women who are trying to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
Do not use Ketoprofen lysine salt Dompé during the third trimester of pregnancy.
During the third trimester of pregnancy, all medicines in the class of Ketoprofen lysine salt Dompé may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension, i.e. increased pressure in the pulmonary circulation);
• renal dysfunction, which may progress to renal failure with oligohydramnios (reduced amniotic fluid volume); and the mother and newborn, at the end of pregnancy, to:
• possible prolonged bleeding time and antiplatelet effects, which may occur even at very low doses;
• inhibition of uterine contractions, resulting in delayed or prolonged labor.

Breastfeeding
Do not use Ketoprofen lysine salt Dompé during breastfeeding.
Fertility
Do not use Ketoprofen lysine salt Dompé if you are planning to become pregnant.
Discontinue administration of Ketoprofen lysine salt Dompé if you have fertility problems or are undergoing fertility investigations.
Driving and use of machines
If drowsiness, dizziness, or convulsions occur after taking Ketoprofen lysine salt Dompé, avoid driving, operating machinery, or performing activities requiring full alertness (see section 4 "Possible side effects").
Ketoprofen lysine salt Dompé contains sucrose, sorbitol, and aspartame
This medicine contains:

• Sucrose and sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
• Aspartame, a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
  Sodium content
  This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Ketoprofene lysine salt E-Pharma Trento

Take this medicine exactly as stated in this leaflet or as directed by your pharmacist. If you have any doubts, consult your pharmacist.
Recommended doses are:
Adults and adolescents over 15 years of age: 1 tablet per dose; if necessary, the dose may be repeated 2–3 times daily in cases of more intense pain.
Take the medicine preferably with food, after meals.
Use in patients with asthma, history of peptic ulcer, heart, liver or kidney disease: the dose must be carefully determined by the physician, who will evaluate whether a reduction of the above-mentioned doses is necessary (see “Warnings and precautions”).
Do not use this medicine for prolonged periods without medical advice and do not exceed the recommended doses: in particular, elderly patients should adhere to the lowest doses indicated above.
Limit the duration of treatment to the time needed to overcome the painful episode.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
Method of administration
Dissolve the tablet in the mouth and swallow. Water is not required for taking this medicine.
If you take more Ketoprofene lysine salt Dompé than you should
Cases of overdose with doses up to 2.5 g of ketoprofene have been reported. In most cases, only mild symptoms have been observed, limited to lethargy, drowsiness, headache, dizziness, confusion, loss of consciousness, pain, nausea, vomiting, and epigastric pain (in the upper abdomen).
Gastrointestinal bleeding, hypotension (low blood pressure), respiratory depression, and cyanosis (bluish discoloration of the skin and mucous membranes) may also occur.
There are no specific antidotes in case of ketoprofene overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In case of renal impairment, haemodialysis (blood dialysis) may be useful in removing the circulating medicine.
In case of accidental ingestion/overdose of Ketoprofene lysine salt Dompé, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforations or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see subsection “Warnings and precautions”).
The frequency and severity of these effects are significantly reduced when the medicine is taken after a meal.

In rare cases, hypersensitivity reactions may present as severe systemic reactions: laryngeal oedema (swelling of the larynx), glottis oedema (swelling of the glottis), dyspnoea (difficulty breathing), palpitations, and even anaphylactic shock. In such cases, immediate medical assistance is required.

The following adverse reactions have been observed with the use of ketoprofen in adults:
Common (may affect up to 1 in 10 people)

• Dyspepsia (indigestion), nausea, abdominal pain, vomiting.
  Uncommon (may affect up to 1 in 100 people)
• Headache, dizziness, somnolence;
• Constipation, diarrhoea, flatulence (gas in the intestine), gastritis;
• Rash (skin eruption), pruritus (itching);
• Oedema (fluid retention causing swelling), fatigue.
  Rare (may affect up to 1 in 1,000 people):
• Haemorrhagic anaemia (anaemia due to bleeding);
• Paraesthesia (abnormal skin sensation, tingling);
• Blurred vision (see subsection “Warnings and precautions”);
• Tinnitus (ringing in the ears);
• Asthma;
• Stomatitis (inflammation of the mucous membranes in the mouth), peptic ulcer (gastric or duodenal ulcer);
• Hepatitis, increased transaminases (liver enzymes), elevated serum bilirubin levels due to liver disorders;
• Weight gain.
  Frequency not known (frequency cannot be estimated from the available data):
• Thrombocytopenia (reduced number of platelets in the blood), agranulocytosis (severe reduction in white blood cells), bone marrow failure (reduced production of blood cells);
• Anaphylactic reactions (including shock), hypersensitivity (allergy);
• Mood alterations;
• Seizures, dysgeusia (altered taste);
• Heart failure;
• Hypertension (increased blood pressure), vasodilation (dilation of blood vessels);
• Bronchospasm (narrowing of the airways causing breathing difficulties), especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs; rhinitis, dyspnoea (difficulty breathing), laryngeal oedema (swelling of the larynx), glottis oedema (swelling of the glottis);
• Exacerbation of colitis and Crohn's disease, gastrointestinal bleeding and perforation, ulcerative stomatitis (mouth ulcers), melaena (passage of black, tarry stools due to digested blood), haematemesis (vomiting blood), duodenal ulcer and perforation;
• Photosensitivity reactions (reactions to sunlight or UV lamps), alopecia (loss of hair), urticaria, angioedema (swelling of the face and mucous membranes), bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin reactions), oedema (swelling), exanthema (skin rash);
• Acute renal failure, kidney diseases including tubulointerstitial nephritis, nephritic syndrome, altered renal function tests.

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (particularly at high doses and for long-term treatment) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see subsection “Warnings and precautions”). The risk of adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see subsection “Warnings and precautions”). Following the instructions provided in this leaflet reduces the risk of adverse effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketoprofen lysine salt Dompé

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, properly stored.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What Ketoprofene sale di lisina Dompé contains - The active substance is ketoprofene lysine salt. One
tablet contains 40 mg of ketoprofene lysine salt, equivalent to 25 mg of ketoprofene.

• The other components are: mannitol, Xylitab® 200 (xylitol, carboxymethylcellulose), lemon flavour, sorbitol (E420), L-leucine, sugar spheres, methacrylic acid copolymer butylated (Eudragit® E PO), sucrose, aspartame (E951), hydrated colloidal silica, stearic acid, sodium lauryl sulfate, magnesium stearate, polysorbate 20, simethicone.

Description of the appearance of Ketoprofene sale di lisina Dompé and pack contents
Orodispersible tablets for oral use, white to ivory in colour – packs containing 10, 20 or 30
orodispersible tablets.
Marketing Authorization Holder and Manufacturer
DOMPE' FARMACEUTICI S.P.A.
VIA SAN MARTINO, 12 - 12/A, 20122 MILAN