Package Insert: Information for the User

Ketesse 25 mg Powder for Oral Solution

dexketoprofen

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Ketesse is an analgesic belonging to thegroup ofmedicaments known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the symptomatic treatment of short-term acute pain of mild or moderate intensity, such as acute muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

Do not take Ketesse

-If you are allergic to dexketoprofen or any of the other components of this medication (listed in section 6);

-If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;

-If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing), or chest wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;

-If you have had photoallergic or phototoxic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels)

• If you have a stomach ulcer, stomach or intestinal bleeding, or have had stomach or intestinal bleeding, ulceration, or perforation in the past;
• If you have chronic digestive problems (for example, indigestion, stomach burning);
• If you have had stomach or intestinal bleeding or perforation due to previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) used for pain;

-If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);

-If you have severe heart failure, moderate to severe renal insufficiency, or severe liver insufficiency;

-If you have bleeding disorders or blood clotting disorders;

-If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate fluid intake;

-If you are in the third trimester of pregnancy or breastfeeding;

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ketesse:

-If you are allergic or have had allergic reactions in the past;

-If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had these conditions in the past;

-If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);

-If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist. Medications like Ketesse may be associated with a small increase in the risk of heart attacks or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;

-If you are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;

-If you are a woman with fertility problems (Ketesse may reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);

-If you have a disorder in blood production and cell formation;

-If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);

-If you have had or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

-If you have had or have had gastrointestinal or intestinal disorders;

-If you have an infection; see the "Infections" heading below;

-If you are taking other medications that increase the risk of stomach ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood clotting agents such as acetylsalicylic acid (aspirin), or anticoagulants like warfarin or acenocoumarol (Sintrom). In these cases, consult your doctor before taking Ketesse: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).

-If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Ketesse may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ketesse may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

During chickenpox, it is recommended to avoid using this medication.

Children and adolescents

Ketesse has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children or adolescents.

Taking Ketesse with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and other medications that may require a dose change if taken together.

Inform your doctor, dentist, or pharmacist if, in addition to Ketesse, you are using or being administered any of the following medications:

Non-recommended associations:

-Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;

-Warfarin or acenocoumarol (Sintrom), heparin, or other medications used to prevent blood clotting;

-Lithium, used to treat mood disorders;

-Metotrexate (cancer medication and immunosuppressant), used at high doses of 15mg/week;

-Hidantoins and phenytoin, used for epilepsy;

-Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

-Inhibitors of the ECA, diuretics, and angiotensin II antagonists, used to control high blood pressure and heart conditions;

-Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;

-Zidovudine, used to treat viral infections;

- Aminoglycoside antibiotics, used for bacterial infections;

-Sulfonilureas (e.g., chlorpropamide and glibenclamide), used for diabetes;

-Metotrexate, used at low doses, less than 15mg/week.

Associations to be considered:

-Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;

-Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;

-Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to break down blood clots;

-Probenecid, used for gout;

-Digoxin, used in the treatment of chronic heart failure;

-Mifepristone, used as an abortifacient (to interrupt pregnancy);

-SSRI antidepressants;

-Antiplatelet agents used to reduce platelet aggregation and blood clot formation;

-Beta-blockers, used for high blood pressure and heart conditions.

• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medications with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drinks

In case of acute pain, take the packets on an empty stomach; that is, at least 15 minutes before meals, as this will facilitate the medication's action a little faster.

Pregnancy, breastfeeding, and fertility

Do not take Ketesse during the last three months of pregnancy or while breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected.

Do not take Ketesse during the first six months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

From week 20 of pregnancy, Ketesse may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Ketesse is not recommended for use while trying to conceive or while studying a fertility problem.

Regarding potential effects on female fertility, see also section 2, "Warnings and precautions".

Driving and operating machinery

Ketesse may slightly affect your ability to drive and operate machinery, as it may cause drowsiness, dizziness, and blurred vision as adverse effects of treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

Ketesse contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

It contains 2.418 g of saccharose per dose, which should be taken into account in patients with diabetes mellitus.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults aged 18 years and older

The dose of Ketesse you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many packets to take per day and for how long.

The recommended dose is 1 packet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 packets per day (75 mg).

If you are elderly or have kidney or liver disease, it is recommended to start therapy with a maximum of 2 packets per day (50 mg).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if Ketesse has been well tolerated.

If your pain is intense and you need quick relief, take the packets on an empty stomach (at least 15 minutes before eating) as they will be absorbed more easily (see section 2 “Ketesse with food and drinks”).

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years old).

Instructions for proper use

Dissolve the entire content of a packet in a glass of water; agitate/shake to help dissolve. The obtained solution should be taken immediately after reconstitution.

If you take more Ketesse than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Ketesse

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to Take Ketesse”).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency. Since the list is based in part on the side effects observed with the use of Ketesse tablets, and since Ketesse granules are absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with Ketesse granules.

Frequent side effects: may affect up to 1 in 10 people

Nausea and/or vomiting, mainly upper abdominal pain, diarrhea, digestive disorders (dyspepsia).

Less frequent side effects: may affect up to 1 in 100 people

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects: may affect up to 1 in 1,000 people

Peptic ulcer, perforation of peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), acute renal failure.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), difficulty breathing due to narrowing of airways (bronchospasm), lack of air, tachycardia, low blood pressure, pancreatitis inflammation, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g. stomach pain or burning or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are elderly.

Stop taking Ketesse immediately if you notice the appearance of a skin rash or any lesion inside the mouth or on the genitals, or any other sign of allergy.

During treatment with nonsteroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Ketesse may be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or a stroke (“stroke”).

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

The most commonly observed side effects are of gastrointestinal type. They may cause peptic ulcers, perforation or bleeding, sometimes fatal, especially in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported. Less frequently, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia) may appear.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter the expiration date that appearson the packaging and on the label. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unusedmedicines at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Composition of Ketesse

• The active principle is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• The other components are: ammonium glycyrrhizate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon aroma, and sucrose (see section 2, Ketesse contains sucrose).

Appearance of the product and contents of the packaging

Sachets containing a yellow lemon granulate.

Ketesse 25 mg is available in packaging of 2, 4, 10, 20, 30, 40, 50, 100, and 500 sachets.

Not all packaging sizes may be marketed.

Marketing authorization holder

MENARINI INTERNATIONAL O.L., S.A.

1, Avenue de la Gare, L-1611, Luxembourg

Local representative

GUIDOTTI FARMA, S.L.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

Responsible manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria, Belgium, France, Italy, Luxembourg, Portugal, Spain: Ketesse

Cyprus, Greece: Nosatel

Czech Republic: Dexoket

Estonia, Latvia, Lithuania: Dolmen

Germany: Sympal

Hungary: Ketodex

Ireland, Malta, United Kingdom (Northern Ireland): Keral

Netherlands: Stadium

Poland: Dexak

Slovak Republic: Dexadol

Slovenia: Menadex

Last review date of this leaflet: November 2022

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/ .