KETESSE 25 mg GRANULES FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Ketesse 25 mg Granules in Sachet

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 doubts, 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 adverse 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
6. Package contents and additional 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 in adults for the short-term symptomatic treatment of acute pain of mild to moderate intensity, such as muscle or joint pain (e.g., back pain, sprains, and acute trauma), menstrual pain, and 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 from photoallergic or phototoxic reactions (a special form of redness or sunburn on exposed skin) 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 or severe renal impairment, or severe hepatic impairment;
• 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 (hypertension 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, suffer from diabetes, have 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 infarctions") or stroke. Any 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 an elderly patient, you may experience a higher incidence of adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (see section 2, "Pregnancy, Breastfeeding, and Fertility");
• If you have a blood disorder or blood cell disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system diseases that affect connective tissue);
• If you have had or currently have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or currently have stomach or intestinal disorders;
• 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 anticoagulant medications like aspirin or warfarin. 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 gastric acid production).
  • If you have asthma combined with chronic rhinitis or sinusitis and/or nasal polyps, you have a 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

This medication may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay the proper 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.

Avoid using this medication if you have chickenpox.

Children and Adolescents

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

Using Ketesse with Other Medications

Inform your doctor or pharmacist if you are taking, 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 others may require a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to this medication, you are taking any of the following medications:

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and other medications used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (cancer medication and immunosuppressant), 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 considered:

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

Taking Ketesse with Food, Drinks, and Alcohol

Generally, it is recommended to take the medication with meals to reduce the possibility of causing stomach disorders (see also section 3, "Method of Administration").

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

Pregnancy, Breastfeeding, and Fertility

Do not take this medication 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 directed 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 checks.

The use of Ketesse may impair fertility, so it is not recommended to use this medication while trying to conceive or while investigating a fertility problem.

Driving and Using Machines

This medication may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

Ketesse Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially "sodium-free".

3. How to Take Ketesse

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

Your doctor will indicate how many sachets you should take per day and for how long.

The lowest effective dose should be used for the shortest time necessary to alleviate 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

Generally, the recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg).

Elderly Patients or Patients with Hepatic or Renal Impairment

If you are an elderly patient or have mild or moderate liver or kidney problems, it is recommended to start treatment with a maximum of 2 sachets per day (50 mg of dexketoprofen).

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

Do not use this medication if you have moderate or severe kidney problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in Children and Adolescents

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

Method of Administration

Place the complete dose of granules directly on the tongue and swallow as soon as it dissolves in the mouth, or drink a glass of water.

It can be taken with or without food. Taking this medication with food helps reduce the risk of stomach disorders; however, if your pain is intense and you need faster relief, take the granules on an empty stomach (at least 30 minutes before any meal or food intake) because they will be absorbed more easily (see section 2, "Ketesse with Food, Drinks, and Alcohol").

If You Take More Ketesse Than You Should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital or call the Toxicology Information Service, phone: 91.562.04.20. Please remember to always carry the medication packaging or this package leaflet with you.

If You Forget to Take Ketesse

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

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

4. Possible Adverse Effects

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

Possible adverse effects are detailed below according to their likelihood of occurrence.

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, peptic ulcer perforation 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), liver cell damage (hepatitis), 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, 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 an elderly patient.

Stop taking this medicine 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), anti-inflammatory drugs can rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, may occur.

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, gastritis (inflammation of the stomach wall) has been observed.

As with other NSAIDs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may appear.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. 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. Storage 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 blister pack after CAD;. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines 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 you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Ketesse Composition

• The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• The other components are: Butyl methacrylate basic copolymer, anhydrous colloidal silica, mannitol (E 421), lime flavor (containing natural lime flavor, gum arabic, and medium-chain triglycerides), and sucralose.

Appearance of Ketesse and Package Contents

Granulate of a color between slightly yellow and white in single-dose sachets.

It is available in packages containing 2, 4, 10, 20, 30, 50, or 100 sachets and a multi-pack with 5 packages of 100 sachets.

Only some 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:

LOSAN PHARMA GmbH

Otto-Hahn-Strasse 13

79395 Neuenburg, Baden-Wuerttemberg

Germany

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

Spain, Italy: Enantyum/Ketesse

Czech Republic: Dexoket

Estonia, Lithuania, Latvia: Dolmen

Hungary: Ketodex

Ireland, United Kingdom (Northern Ireland): Keral

Austria, Belgium, Luxembourg, Portugal: Ketesse

Netherlands: Stadium

Greece: Viaxal/Nosatel

Poland: Dexak

Slovakia: Dexadol

Date of the last revision of this leaflet: 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.gob.es/