KETESSE 25 mg ORAL SOLUTION IN SACHET

Introduction

Package Leaflet: Information for the User

Ketesse 25 mg Oral Solution in Sachet

dexketoprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and other information

1. What is Ketesse and what is it used for

This medicine is a pain reliever belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of acute pain of mild to moderate intensity, such as acute muscle or joint pain, menstrual pain (dysmenorrhea), toothache.

This medicine is indicated for adult patients.

2. What you need to know before you take Ketesse

Do not take Ketesse

• If you are allergic (hypersensitive) to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• 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 in the nasal passages 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 medicines;
• If you have suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory medicine) or fibrates (medicines 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 medicines (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 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, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medicines like Ketesse may be associated with a small increased risk of heart attacks ("myocardial infarctions") or strokes. Any 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 an elderly patient, 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 (This medicine may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a blood disorder or blood cell disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system 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 section on "Infections" below;
• If you are taking other medicines 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 medicines like aspirin or warfarin. In these cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block the production of stomach acid).
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask the signs of an infection, such as fever and pain. Consequently, this medicine 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 medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Children and adolescents

Dexketoprofen 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.

Using Ketesse with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. There are some medicines that should not be taken together and others that may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory medicines;
• Warfarin, heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, (a medicine for cancer and immunosuppressant), used at high doses of 15mg/week;

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 15mg/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 medicines; i.e., medicines 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 medicines with Ketesse, consult your doctor or pharmacist.

Taking Ketesse with food, drinks, and alcohol

It is recommended to take the medicine with meals to reduce the possibility of causing stomach disorders (see also section 3, "Method of administration").

Do not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or central nervous system, are more likely when alcohol is taken at the same time as Ketesse.

Pregnancy, breastfeeding, and fertility

Do not take this medicine 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 ability 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 cause 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 this medicine is not recommended 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 using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause dizziness or drowsiness and visual disturbances as side 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 medicine contains less than 23 mg of sodium (1mmol) per sachet; it is essentially "sodium-free".

Ketesse contains methyl parahydroxybenzoate (E 218)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

Ketesse contains sucrose

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

It contains 2 g of sucrose per dose, which should be taken into account in patients with diabetes mellitus.

3. How to take Ketesse

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

Adults from 18 years of age

It is generally recommended to take 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg).

If you are an elderly patient or have kidney or liver problems, it is recommended to start treatment 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) if dexketoprofen has been well tolerated.

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years of age).

Method of administration

The oral solution can be taken directly from the sachet or after pouring the contents of the sachet into a glass of water. Once the sachet is opened, consume its entire contents.

Take the sachets with food, as it helps to reduce the risk of stomach or intestinal side effects (see also section 2). If the pain is intense and you need faster relief, take the sachets on an empty stomach, i.e., at least 15 minutes before meals, as this helps the medicine start working a little faster.

If you take more Ketesse than you should

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

If you forget to take Ketesse

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

If you have any doubts about the use of this medicine, 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.

Because the plasma concentration levels of dexketoprofen achieved with the oral solution pharmaceutical form are higher than those obtained with tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

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).

Infrequent Adverse Effects (may affect up to 1 in 100 people):

Dizzy sensation (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (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 swelling (e.g., ankle swelling), 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), facial swelling or lip and throat swelling (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 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 an allergic reaction.

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 stroke ("cerebrovascular accident").

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, stomach wall inflammation (gastritis) has been observed.

As with other NSAIDs, aseptic meningitis, which can occur predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and 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 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 after CAD. 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 sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 of oral solution contains 25 mg of dexketoprofen as dexketoprofen trometamol.

The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol 400, lemon flavor, povidone K-90, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water (see section 2, Ketesse contains sucrose).

Appearance of Ketesse and Package Contents

Clear-colored solution with a lemon odor and lemon-citrus flavor.

It is presented in packages containing 2, 4, 10, or 20 sachets.

Not all package sizes may be marketed.

Marketing Authorization Holder

MENARINI INTERNATIONAL O.L., S.A.

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

Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

GUIDOTTI FARMA, S.L.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

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

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

Cyprus, Greece: Nosatel

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.gob.es/