Ketoprofen lysinate Pensà: detailed information

Package leaflet: Information for the user

KETOPROFEN LYSINE SALT PENSA 80 mg powder for oral solution

Ketoprofen Lysine Salt
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What KETOPROFEN LYSINE SALT PENSA is and what it is used for
What you need to know before taking KETOPROFEN LYSINE SALT PENSA
How to take KETOPROFEN LYSINE SALT PENSA
Possible side effects
How to store KETOPROFEN LYSINE SALT PENSA
Contents of the pack and other information

1. What KETOPROFENE SALE DI LISINA PENSA is and what it is used for

KETOPROFENE SALE DI LISINA PENSA contains as its active substance ketoprofene lysine salt, which belongs to a group of medicines used against pain and inflammation called "Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)".
KETOPROFENE SALE DI LISINA PENSA is indicated in adults for the symptomatic treatment of inflammatory conditions associated with pain, such as:

rheumatoid arthritis (an autoimmune disease causing joint pain and stiffness),
ankylosing spondylitis (a chronic inflammatory disease mainly affecting the spine and joints),
painful osteoarthritis (a disease affecting the joints),
extra-articular rheumatism (rheumatic diseases affecting structures outside the joints),
post-traumatic inflammation (inflammatory condition following trauma),
painful inflammatory conditions in dentistry, otorhinolaryngology, urology and pneumology;

2. What you need to know before taking KETOPROFENE LISINATE SALT PENSA

Do not take KETOPROFENE LISINATE SALT PENSA

if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (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, asthma attacks, acute rhinitis, urticaria, nasal polyps, angioedema (swelling of the deep dermis and subcutaneous tissue that may also affect mucous membranes), or other allergic-type reactions to ketoprofen or substances with a similar mechanism of action (e.g., acetylsalicylic acid or NSAIDs). Severe anaphylactic reactions, rarely fatal, have been observed in these patients (see section 4 “Possible side effects”);
if you currently suffer from or have previously suffered from bronchial asthma;
if you have severe heart failure (inability of the heart to pump sufficient blood to meet the body’s needs);
if you currently have a peptic ulcer (in the stomach) or gastrointestinal bleeding, or if you have previously experienced recurrent peptic ulcer or bleeding (two or more distinct, documented episodes of bleeding or ulceration);
if you have previously experienced gastrointestinal bleeding, ulceration, or perforation, or chronic dyspepsia;
if you have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
if you have leukopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets in the blood);
if you suffer from Crohn’s disease or ulcerative colitis;
if you suffer from gastritis;
if you have severe hepatic (liver cirrhosis, severe hepatitis, reduced liver function) or renal (reduced kidney function) insufficiency;
if you have hemorrhagic diathesis (predisposition to bleeding) or other blood coagulation disorders or hemostatic disorders;
if you are undergoing intensive diuretic therapy;
if you are in the last three months of pregnancy;
if the person taking the medicine is a child under 14 years of age.

Warnings and precautions

Warnings
Side effects can be minimized by using the shortest duration of treatment necessary to control symptoms (see subsection “How to take KETOPROFENE LISINATE SALT PENSA” and the sections below on gastrointestinal and cardiovascular risks).

Concomitant use of KETOPROFENE LISINATE SALT PENSA with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
During treatment with all NSAIDs, including KETOPROFENE LISINATE SALT PENSA, 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.
Your doctor may recommend concomitant use of gastroprotective agents (e.g., misoprostol or proton pump inhibitors), especially if you are elderly, have a history of ulcers, or are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events (see subsection “Other medicines and KETOPROFENE LISINATE SALT PENSA”).
Report any unusual abdominal signs or symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment.
Use caution if you are taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), selective serotonin reuptake inhibitors (e.g., medicines used to treat depression), anticoagulants (blood-thinning medicines such as warfarin), or antiplatelet agents such as acetylsalicilic acid (see subsection “Other medicines and KETOPROFENE LISINATE SALT PENSA”).
Elderly patients are at higher risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3 “How to take KETOPROFENE LISINATE SALT PENSA”). Elderly patients are more prone to reduced kidney, heart, and liver function.
You should be closely monitored if you have or have previously had gastrointestinal disease, for the onset of digestive disturbances, especially gastrointestinal bleeding.
Immediately discontinue treatment with KETOPROFENE LISINATE SALT PENSA at the first signs of gastrointestinal bleeding or ulceration.

Patients with active or past peptic ulcer:
Use caution if you have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these conditions may recur with NSAID use (see section 4 “Possible side effects”).
Ketoprofen, especially at high doses, may be associated with a higher risk of severe gastrointestinal toxicity compared to other NSAIDs.

Skin reactions:
Serious skin reactions (of the skin), some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with NSAID use (see section 4 “Possible side effects”). In the initial stages of therapy, patients appear to be at higher risk: the reaction usually occurs within the first month of treatment. Discontinue use of KETOPROFENE LISINATE SALT PENSA at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity.

If you have celiac disease (gluten intolerance), you may take KETOPROFENE LISINATE SALT PENSA as it does not contain gluten.
If you have phenylketonuria (a rare disease characterized by the inability to metabolize the amino acid phenylalanine), you may take KETOPROFENE LISINATE SALT PENSA as it does not contain aspartame.

Talk to your doctor or pharmacist before taking KETOPROFENE LISINATE SALT PENSA:

If you have impaired kidney function, KETOPROFENE LISINATE SALT PENSA should be administered with caution.
If you have heart failure (a condition in which the heart is weakened), liver function abnormalities such as cirrhosis (severe liver impairment), kidney function abnormalities such as nephrosis (degenerative kidney disease), or chronic renal insufficiency (impaired kidney function), if you are on diuretic therapy (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.
As with all NSAIDs, the medicine may increase the values of certain laboratory tests, such as blood urea nitrogen and creatinine.
If you have liver disease or abnormal liver function tests, as liver transaminase levels (liver enzymes) should be periodically evaluated, especially during long-term therapy.
As with other NSAIDs, the medicine may cause small transient increases in some liver parameters and also significant increases in GPT/ALT and GOT/AST transaminases (liver enzymes) (see section 4 “Possible side effects”). If a marked increase in these parameters occurs, treatment must be discontinued. Rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported with ketoprofen use. During long-term therapy, liver and kidney function tests and blood counts should be performed.
If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pumping function), established ischemic heart disease (heart disease occurring due to reduced blood flow caused by narrowing of the coronary arteries), peripheral artery disease, and/or cerebrovascular disease (blood vessels of the brain), as you should only be treated with lysine ketoprofen salt, like all NSAIDs, after careful evaluation.
If you have cardiac problems or 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 smoke).
If you have a history (even familial) of mild to moderate hypertension (high blood pressure) and/or congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pumping function), as adequate monitoring and appropriate instructions are required. Fluid retention and edema (swelling) have been observed during NSAID treatment.
Medicines such as KETOPROFENE LISINATE SALT PENSA may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). Any risk is more likely with high doses and prolonged treatment.
An increased risk of atrial fibrillation (heart rhythm disorder) has been reported with NSAID use.
Hyperkalemia may occur, especially if you have diabetes, renal insufficiency, and/or are on treatment with agents promoting hyperkalemia (see subsection “Other medicines and KETOPROFENE LISINATE SALT PENSA”). In these circumstances, potassium levels should be monitored.
If you have an infection. KETOPROFENE LISINATE SALT PENSA may mask symptoms of infection such as fever and pain. Therefore, KETOPROFENE LISINATE SALT PENSA may 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 chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
If you have allergic manifestations or have previously suffered from allergies, as the medicine should be administered with caution.
Like all non-steroidal drugs, the use of ketoprofen in patients with bronchial asthma or allergic diathesis (predisposition to allergy) may trigger an asthma attack. If you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, you are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may cause asthma attacks or bronchospasm, shock, and other allergic phenomena, especially in individuals allergic to acetylsalicylic acid and/or NSAIDs (see subsection “Do not take KETOPROFENE LISINATE SALT PENSA”).
Consult your doctor if you experience visual disturbances (such as blurred vision).
If you have hematopoietic disorders (affecting blood cell formation and maturation), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as KETOPROFENE LISINATE SALT PENSA should be administered with caution.

Other medicines and KETOPROFENE LISINATE SALT PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
It is not recommended that you take KETOPROFENE LISINATE SALT PENSA in combination with:

other NSAIDs and high-dose salicylates (including selective cyclooxygenase-2 inhibitors) exceeding 3 g per day, as they may increase the risk of gastrointestinal ulcers and bleeding.
medicines that thin the blood (anticoagulants such as heparin and warfarin, and platelet aggregation inhibitors such as ticlopidine and clopidogrel). NSAIDs may enhance the effects of these medicines (see subsection “Warnings and precautions”), thereby increasing the risk of bleeding. If co-administration cannot be avoided, you must be closely monitored.
Lithium (a medicine used to treat manic-depressive psychosis). NSAIDs may increase lithium blood levels to toxic values.
Methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and some cancers), used at doses exceeding 15 mg per week: there may be an increased risk of methotrexate hematological toxicity. Allow at least 12 hours between discontinuation or initiation of ketoprofen treatment and methotrexate administration.
Hydantoins (such as phenytoin) and sulfonamides (such as certain antibiotics and other medicines): the toxic effects of these substances may be increased.

Caution is required if you take KETOPROFENE LISINATE SALT PENSA in combination with:

Medicines that may promote hyperkalemia, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim.
Tenofovir (a medicine used in the treatment of certain viral infections): may increase the risk of renal failure.
Medicines used to treat high blood pressure, such as beta-blockers, diuretics, ACE inhibitors, and angiotensin II antagonists. You should be adequately hydrated before starting concomitant therapy, and renal function should be monitored after starting concomitant therapy (see subsection “Warnings and Precautions”). NSAIDs may reduce the effect of diuretics.
Methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and some cancers), used at doses below 15 mg/week: there may be an increase in methotrexate hematological toxicity. During the first weeks of combination use, weekly complete blood count monitoring should be performed. If you are elderly or have impaired renal function, monitoring should be more frequent.
Corticosteroids (medicines used to treat inflammatory conditions): there may be an increased risk of gastrointestinal ulceration or bleeding (see subsection “Warnings and Precautions”).
Pentoxifylline (a medicine used to improve blood circulation in the limbs): there may be an increased risk of bleeding. More frequent clinical monitoring may be necessary.
Zidovudine (a medicine used to treat HIV): there may be an increase in hematological toxicity with possible severe anemia. Blood tests should be performed after starting NSAID treatment.
Sulfonylureas (diabetes medicines, such as gliclazide): NSAIDs may enhance the hypoglycemic effect of sulfonylureas.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels; however, a pharmacokinetic interaction between ketoprofen and cardiac glycosides has not been demonstrated.

Combinations with other medicines to consider:

Antihypertensive medicines (beta-blockers, ACE inhibitors, diuretics): NSAIDs may reduce the effect of antihypertensive medicines.
Mifepristone (a medicine used for medical termination of pregnancy): the effectiveness of the contraceptive method may theoretically be reduced due to the properties of NSAIDs.
Intrauterine contraceptive devices: the effectiveness of the device may be reduced, leading to pregnancy.
Cyclosporine, tacrolimus (medicines used after transplantation or for the treatment of immune system disorders): risk of additional nephrotoxic effects, especially in the elderly.
Thrombolytics (medicines that facilitate the dissolution of blood clots): increased risk of bleeding.
Antiplatelet agents (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs, such as certain antidepressants): increased risk of gastrointestinal bleeding.
Probenecid (a medicine used to treat gout): co-administration of probenecid may increase ketoprofen blood concentrations.
Quinolone antibiotics: possible increased risk of seizures.
Diphenylhydantoin and sulfamides: dosage reduction may be necessary.
Gemeprost (a medicine used in gynecological procedures): reduced effectiveness.
Avoid alcohol consumption.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of KETOPROFENE LISINATE SALT PENSA during the first and second trimesters of pregnancy should be avoided.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological study results suggest an increased risk of miscarriage and cardiac malformation and gastroschisis (fetal abdominal wall defect) after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is considered to increase with dose and duration of therapy.
During the first and second trimesters of pregnancy, take this medicine only if strictly necessary and on medical advice.
If ketoprofen is used by a woman trying to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors 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 (amniotic fluid volume below normal);

and the mother and newborn, at the end of pregnancy, to:

possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses;
inhibition of uterine contractions resulting in delayed or prolonged labor.

Use of the drug near delivery may cause alterations in hemodynamics of the newborn’s small circulation with serious consequences for respiration.
Therefore, DO NOT use KETOPROFENE LISINATE SALT PENSA during the third trimester of pregnancy (see subsection “Do not take KETOPROFENE LISINATE SALT PENSA”).

Breastfeeding
There is no available information on the excretion of ketoprofen in breast milk. Ketoprofen is not recommended during breastfeeding.

Fertility
The use of NSAIDs, including KETOPROFENE LISINATE SALT PENSA, may reduce female fertility and is not recommended in women attempting to conceive. Administration of NSAIDs, including KETOPROFENE LISINATE SALT PENSA, should be suspended in women with fertility problems or undergoing fertility investigations.

Driving and using machines
If dizziness, drowsiness, or seizures occur after taking ketoprofen, avoid driving, using machines, or performing activities requiring special alertness.

KETOPROFENE LISINATE SALT PENSA contains sorbitol and sodium

This medicine contains 1.3 mg of sorbitol per sachet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially “sodium-free”.

3. How to take KETOPROFENE LISINE SALT PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet of 80 mg (full dose) three times daily, during meals.
The maximum daily dose is 320 mg of ketoprofen lysine salt. Higher doses are not recommended
(see section “Warnings and precautions”).
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).

Special populations:
Use in elderly patients
The dose must be carefully determined by the doctor, who should consider reducing the above-mentioned dosages (see section “Warnings and precautions”).

Use in patients with hepatic impairment
It is advisable to start treatment at the lowest daily dosage (see section “Warnings and precautions”).

Use in patients with mild or moderate renal impairment
It is advisable to reduce the initial dose and maintain therapy with the lowest effective dose. Individual dose adjustments may be considered only after good tolerability of the drug has been established. Monitor urine output and kidney function (see section “Warnings and precautions”).

KETOPROFENE LISINE SALT PENSA must not be used in patients with severe hepatic or renal dysfunction (see section “Do not take KETOPROFENE LISINE SALT PENSA”).

Method of administration
Empty the contents of one sachet into half a glass of water and stir.

If you take more KETOPROFENE LISINE SALT PENSA than you should
In case of accidental ingestion or overdose of KETOPROFENE LISINE SALT PENSA, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms have been mild and limited to lethargy, drowsiness, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, headache, dizziness and diarrhoea.
In cases of severe overdose, hypotension, respiratory depression and gastrointestinal bleeding have been observed. The patient should be immediately transferred to a specialist centre to initiate symptomatic treatment.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In case of renal failure, haemodialysis may be useful to remove the drug from the body.

If you forget to take KETOPROFENE LISINE SALT PENSA
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.
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.
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, vertigo, somnolence
Constipation, diarrhoea, flatulence (intestinal gas), gastritis, abdominal discomfort
Rash, pruritus (itching)
Oedema (fluid retention causing swelling), fatigue, peripheral oedema (swelling in extremities), chills

Rare (may affect up to 1 in 1,000 people)

Haemorrhagic anaemia (anaemia due to blood loss)
Paraesthesia (abnormal skin sensation, tingling)
Blurred vision (see section “Warnings and precautions”)
Tinnitus (ringing in the ears)
Asthma
Stomatitis (mouth ulcer), peptic ulcer (gastric or duodenal ulcer), colitis
Hepatitis, increased transaminases (liver enzymes), increased blood bilirubin (elevated serum bilirubin levels due to liver disorders), jaundice
Weight gain

Very rare (may affect up to 1 in 10,000 people)

Dyskinesia (movement disorder), syncope (fainting)
Hypotension (low blood pressure)
Laryngeal oedema (swelling of the larynx)
Haematuria (blood in urine)
Asthenia (physical weakness), facial oedema

Frequency not known (frequency cannot be estimated from the available data)

Thrombocytopenia (reduced number of blood platelets), agranulocytosis (severe reduction in white blood cells), bone marrow failure (reduced production of blood cells), haemolytic anaemia (anaemia due to abnormal destruction of red blood cells), neutropenia (reduced number of neutrophil white blood cells), aplastic anaemia (anaemia due to insufficient production of blood cells in the bone marrow), leukocytosis (increased number of white blood cells), thrombocytopenic purpura, leukopenia (reduced number of white blood cells)
Anaphylactic reactions (including shock), hypersensitivity
Depression, hallucinations, confusion, mood alterations, excitability, insomnia. In a paediatric patient who received a double dose compared to the recommended dose in the SmPC, anxiety and behavioural disorder were also observed
Seizures
Dysgeusia (altered taste)
Tremor, hyperkinesia
Heart failure, atrial fibrillation (irregular heart rhythm), palpitations, tachycardia (increased heart rate)
Hypertension (increased blood pressure), vasodilation (widening of blood vessels), vasculitis (inflammation of blood or lymphatic vessels) (including leukocytoclastic vasculitis)
Bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea (difficulty breathing), laryngospasm, acute respiratory failure (one fatal case has been reported in an asthmatic and aspirin-sensitive patient)
Gastralgia (stomach pain), exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage, gastrointestinal perforation (sometimes fatal, particularly in elderly patients), pyrosis (heartburn), gastric ulcer, duodenal ulcer, oedema (swelling) of the mouth, pancreatitis, erosive gastritis, haematemesis (vomiting blood) or melena (passing of digested blood in stools), hyperchlorhydria (excess hydrochloric acid in gastric juice), gastric pain, tongue oedema
Photosensitisation (reaction to sunlight or UV lamps), alopecia (hair loss), urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (serious skin reactions), erythema (skin redness), exanthema (skin rash), maculopapular exanthema, purpura, acute generalized exanthematous pustulosis (skin eruption with pustule formation), dermatitis
Acute kidney injury, tubulointerstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerulonephritis, fluid and sodium retention with possible oedema, acute tubular necrosis (damage to kidney tubular cells), renal papillary necrosis (damage to renal papillae), oliguria (reduced urine output), abnormal kidney function tests
Periorbital oedema (swelling around the eyes)
Aseptic meningitis (inflammation of the membranes covering the brain not caused by bacteria)
Lymphangitis (inflammation of lymphatic vessels)
Hyperkalaemia (increased blood potassium levels), hyponatraemia (decreased blood sodium levels)

Medicines such as KETOPROFENE LISINATE PENSA may be associated (particularly at high doses and with long-term treatment) with an increased risk of arterial thrombotic events (blood clot formation in blood vessels), such as heart attack (myocardial infarction) or stroke (cerebrovascular accident) (see section 2 “What you need to know before taking KETOPROFENE LISINATE PENSA”).
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOPROFENE LISINATE PENSA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
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 LISINATE SALT PENSA contains
The active substance is ketoprofene lysinate.
Each sachet contains 80 mg of ketoprofene lysinate (equivalent to 50 mg of ketoprofen).
The other components are: sorbitol, sodium chloride, anhydrous colloidal silica, sodium saccharin, mint flavouring.
Description of the appearance of KETOPROFENE LISINATE SALT PENSA and pack contents
Powder for oral solution.
Pack containing 30 sachets.
Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milan
Manufacturer
Mipharm S.p.A., Via Quaranta 12 – 20141 Milan