KETESSE 25 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ketesse 25 mg Granules for Oral Solution

dexketoprofen

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

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

Contents of the Package Leaflet:

1. What is Ketesse and what is it used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. Storage of Ketesse

1. Contents of the pack and further information

1. What is Ketesse and what is it used for

Ketesse is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of acute pain of mild or moderate intensity, such as acute muscle or joint pain, menstrual pain (dysmenorrhea), or toothache.

2. What you need to know before taking Ketesse

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 non-steroidal anti-inflammatory medication;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing), or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory medications;
• If you have suffered photoallergic or phototoxic reactions (a special type of skin redness or burn when exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications used to reduce blood fat levels)
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had a history of stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory medications (NSAIDs) for pain;

• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient 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 allergy problems in the past;
• If you have kidney, liver, or heart disease (high blood pressure and/or heart failure), or fluid retention, or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment. Medications like Ketesse may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment;
• If you are elderly, you may experience a higher incidence of side 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 you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a blood disorder or a disorder affecting blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If you have had stomach or intestinal disorders in the past;
• If you have an infection; see the "Infections" section below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), 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 (e.g., misoprostol or other medications that block the production of stomach acid).
• If you have asthma combined with chronic rhinitis or sinusitis and/or nasal polyps, as you are at higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the rest of the population. The 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. Consequently, Ketesse may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection 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 recently taken 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 may require a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory medications;
• Warfarin or acenocoumarol (Sintrom), heparin, or other medications used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (a medication for cancer and immunosuppression), used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week.

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; i.e., medications used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
• Beta blockers, used for high blood pressure and heart disorders.
  • 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 sachets on an empty stomach; i.e., at least 15 minutes before meals, as this will facilitate the medication's action.

Pregnancy, breastfeeding, and fertility

Do not take Ketesse during the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor 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 the 20th week of pregnancy, Ketesse may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid 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.

The use of Ketesse is not recommended while trying to conceive or while undergoing fertility studies.

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

Driving and using machines

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

Ketesse contains sucrose

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

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

3. How to take Ketesse

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

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults over 18 years

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

The recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets 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 sachets 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 sachets on an empty stomach (at least 15 minutes before meals), 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).

Instructions for proper use

Dissolve the entire contents of a sachet in a glass of water; stir to help dissolve. The resulting solution should be taken immediately after reconstitution.

If you take more Ketesse than you should

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

If you forget to take Ketesse

Do not take a double dose to make up for forgotten doses. Take the next dose when scheduled (according to section 3, "How to take Ketesse").

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The possible adverse effects are detailed below according to their frequency. Since the list is based in part on the adverse effects observed with the use of Ketesse tablets, and given that Ketesse granules are absorbed more quickly than tablets, it is possible that the real frequency of adverse effects (gastrointestinal) may be higher with Ketesse granules.

Frequent Adverse Effects: may affect up to 1 in 10 people

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

Uncommon Adverse Effects: may affect up to 1 in 100 people

Rotatory sensation (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, febrile sensation, and chills, general malaise.

Rare Adverse 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 edema (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 kidney failure.

Very Rare Adverse Effects: may affect up to 1 in 10,000 people

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

Inform your doctor immediately if you notice any adverse effect of a gastrointestinal type at the start of treatment (e.g., stomach pain or burning, or bleeding), if you have previously suffered from any of these adverse effects due to prolonged treatment with non-steroidal 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 non-steroidal 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 increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("stroke").

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

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, 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, inflammation of the stomach wall (gastritis) has been observed.

As with other non-steroidal anti-inflammatory drugs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of Adverse Effects

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

5. Conservation of Ketesse

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the envelope. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ketesse

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

Appearance of the Product and Package Contents

Envelopes containing a lemon-yellow granulate.

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

Not all package 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

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

Date of the last revision of this prospectus: November 2022

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.