Ketesse

Leaflet accompanying the packaging: patient information

Ketesse, 25 mg, oral solution in a sachet

Dexketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section
• 4.
• If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ketesse and what is it used for
• 2. Important information before taking Ketesse
• 3. How to take Ketesse
• 4. Possible side effects
• 5. How to store Ketesse
• 6. Contents of the pack and other information

1. What is Ketesse and what is it used for

This medicine is a pain reliever from the group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Ketesse is used for the short-term, symptomatic treatment of mild to moderate acute pain, e.g. acute muscle or joint pain, painful menstruation, toothache. This medicine is intended for use in adults.

2. Important information before taking Ketesse

When not to take Ketesse:

• If the patient is allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in section 6);
• If the patient is allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or has had asthma attacks in the past, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• If the patient has had light-induced allergic reactions: photoallergic or phototoxic reactions (a type of redness and/or blistering after sun exposure) when taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
• If the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if they have had gastrointestinal bleeding or ulcers in the past;
• If the patient has chronic gastrointestinal disorders (e.g. indigestion, heartburn);
• If the patient has had gastrointestinal bleeding or perforation due to previous use of NSAIDs used to treat pain;
• If the patient has chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney or liver impairment;
• If the patient has a tendency to bleed or coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:

Before starting treatment with Ketesse, the patient should discuss it with their doctor or pharmacist.

• If the patient has an allergy or has had allergy problems in the past;
• If the patient has kidney, liver, or heart problems (high blood pressure and/or heart failure) as well as fluid retention or if any of these problems have occurred in the past;
• In patients taking diuretics or in patients with decreased hydration and reduced blood volume due to excessive fluid loss (e.g. frequent urination, diarrhea, or vomiting);
• If the patient has heart disease, has had a stroke, or is at risk of these conditions (e.g. due to high blood pressure, diabetes, high cholesterol, or smoking). In these cases, the patient should consult their doctor or pharmacist before taking Ketesse. Taking such medications as Ketesse may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses of the medication. The patient should not take higher doses or use the medication for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). If side effects occur, the patient should contact their doctor immediately;
• In women with fertility problems or undergoing infertility tests (this medication may affect female fertility and should not be used in women planning to become pregnant or undergoing fertility treatment);
• If the patient has blood disorders or blood cell problems;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If the patient has other stomach or intestinal problems;
• If the patient has an infection - see below, section titled "Infections";
• If the patient is taking other medications that increase the risk of stomach ulcers or gastrointestinal bleeding, such as oral steroid medications, certain antidepressants (SSRI, e.g. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulant medications such as warfarin. In these cases, the patient should consult their doctor before taking this medication, as their doctor may decide to prescribe an additional medication to protect the stomach (e.g. misoprostol or medications that reduce stomach acid production).
• In patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Administration of this medication may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections

Dexketoprofen may mask the symptoms of infection, such as fever and pain. As a result, this medication may delay the use of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medication during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

Children and adolescents

Dexketoprofen has not been studied in children and adolescents. The safety and efficacy of this medication have not been established, and it should not be used in children and adolescents.

Ketesse and other medications

The patient should tell their doctor or pharmacist about all medications they are taking, including those available without a prescription, as well as any medications they plan to take.
Some medications should not be taken at the same time as Ketesse, and others may require a dose adjustment when taken with Ketesse.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medications with Ketesse:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medications
• Warfarin, heparin, or other anticoagulant medications
• Lithium used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive medication) used in high doses of 15 mg per week
• Hydantoin derivatives and phenytoin used to treat epilepsy
• Sulfamethoxazole used to treat bacterial infections

Concomitant use requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart disease
• Pentoxifylline and oxypentifylline used to treat chronic venous ulcers
• Zidovudine used to treat viral infections
• Aminoglycoside antibiotics used to treat bacterial infections
• Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide) used to treat diabetes
• Methotrexate used in low doses, below 15 mg per week

Concomitant use requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system disorders and in transplants
• Streptokinase and other thrombolytic or fibrinolytic medications, i.e. medications used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as an abortifacient
• Antidepressant medications from the SSRI group
• Antiplatelet medications used to reduce blood clot formation
• Beta-adrenergic blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed

In case of any doubts about taking Ketesse, the patient should consult their doctor or pharmacist.

Ketesse with food, drink, and alcohol

It is recommended to take the medication with food to reduce the possibility of gastrointestinal disorders (see also section 3 "Method of administration").
Alcohol should not be consumed while taking this medication. The occurrence of certain side effects, especially those related to the gastrointestinal tract or central nervous system, is more likely when taking Ketesse with alcohol.

Pregnancy, breastfeeding, and fertility

This medication should not be taken during the third trimester of pregnancy or during breastfeeding.
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medication, as the use of Ketesse may be inappropriate in this situation.
Pregnant or breastfeeding women should avoid taking this medication. The use of Ketesse during pregnancy must only be done under medical supervision.
This medication is not recommended for women planning to become pregnant or undergoing fertility testing.
Information on the potential impact on fertility can also be found in section 2, "Warnings and precautions".

Driving and using machines

This medication may have a minor impact on the ability to drive vehicles and operate machinery, due to the possibility of dizziness, drowsiness, and vision disturbances as side effects.
In case of observing such symptoms, the patient should not drive vehicles or operate machinery until the symptoms have resolved.
In case of doubts, the patient should consult their doctor.

Ketesse contains methyl parahydroxybenzoate (E 218)

This medication may cause allergic reactions (also delayed), as it contains methyl parahydroxybenzoate.

Ketesse contains sucrose

If the doctor has informed the patient that they have an intolerance to some sugars, they should contact their doctor before taking the medication.
Each dose contains 2.0 g of sucrose. This should also be considered in patients with diabetes.

Ketesse contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per sachet, which means the medication is considered "sodium-free".

3. How to take Ketesse

This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
Adults over 18 years old
The recommended daily dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, but no more than 3 sachets per day (75 mg).
If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor. The doctor will inform the patient how many sachets to take per day and for how long.
The dose will depend on the type, severity, and duration of the patient's pain.
In elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose, equivalent to no more than 2 sachets (50 mg of dexketoprofen).
In case of good tolerance to dexketoprofen in elderly patients, the initial dose can be increased to the recommended dose for the general population (75 mg).

Children and adolescents

This medication should not be taken by children and adolescents (under 18 years old).

Method of administration

The oral solution can be taken directly from the sachet or after mixing the contents of the sachet with a glass of water. After opening the sachet, the entire contents should be consumed.
The contents of the sachets should be taken with food, which may reduce the possibility of gastrointestinal disorders (see also section 2 of this leaflet). In case of acute pain, when rapid relief is needed, it is recommended to take the medication on an empty stomach, at least 15 minutes before any meal, which will result in slightly faster absorption of the medication.

Overdose of Ketesse

In case of suspected overdose, the patient should immediately contact their doctor or pharmacist or go to the nearest hospital emergency department. The patient should remember to take the medication packaging or patient leaflet with them.

Missed dose of Ketesse

The patient should not take a double dose to make up for a missed dose. The next dose should be taken according to the dosing schedule (see section 3 "How to take Ketesse").
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Ketesse can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to their frequency of occurrence. The maximum concentration of dexketoprofen in plasma after oral administration is higher than that observed after tablet administration, so it cannot be excluded that there may be a potential increase in the risk of side effects (gastrointestinal tract).

Common side effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, abdominal pain, mainly in the upper quadrants, diarrhea, indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):

Vertigo of labyrinthine origin, dizziness, drowsiness, sleep disturbances, nervousness, headaches, palpitations, facial flushing, gastritis (gastric inflammation), constipation, dry mouth, bloating, rash, fatigue, pain, feeling of fever and chills, malaise.

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

Gastric ulcer disease, gastrointestinal bleeding, or perforation (which may manifest as bloody vomiting or black stools), fainting, high blood pressure, slowed breathing rate, fluid retention and peripheral edema (e.g. swollen ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

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

Anaphylactic reactions (acute allergic reactions that can lead to anaphylactic shock), skin ulceration, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or lip and throat edema (angioedema), shortness of breath due to bronchial constriction (bronchospasm), shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus (ringing in the ears), skin allergic reactions, skin sensitivity to light, pruritus, kidney problems, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

The patient should immediately inform their doctor if they observe any side effects related to the stomach or intestines (e.g. stomach pain, heartburn, or bleeding) at the start of treatment, especially if they have had similar side effects in the past due to long-term use of anti-inflammatory medications, particularly in elderly patients.
If a skin rash or any damage to the mucous membranes inside the mouth or on the genitals or any symptoms of allergy occur, the patient should stop taking this medication immediately.
During the administration of nonsteroidal anti-inflammatory drugs, fluid retention and edema (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure.
Taking medications like Ketesse may be associated with a small increased risk of heart attack or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration of anti-inflammatory medications may rarely cause fever, headache, and neck stiffness.
The most commonly observed side effects were related to the stomach and intestines. Especially in elderly patients, stomach ulcers, perforation, or gastrointestinal bleeding may occur, in some cases with fatal outcomes.
After taking the medication, the following side effects have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral ulcerative stomatitis, exacerbation of colitis, and Crohn's disease.
Rarely, gastritis has been observed.
As with other NSAIDs, aseptic meningitis may occur, mainly in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematologic reactions (thrombocytopenic purpura, aplastic anemia, and hemolytic anemia, rarely agranulocytosis and bone marrow failure) may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Ketesse

The medication should be stored out of sight and reach of children.
The medication should not be taken after the expiration date stated on the carton and sachet after EXP. The expiration date refers to the last day of the specified month.
No special storage precautions are required.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ketesse contains

The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen in the form of dexketoprofen trometamol.
Other ingredients are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate, sodium saccharin, sucrose, macrogol 400, lemon flavor, povidone K-90, disodium phosphate anhydrous, sodium dihydrogen phosphate dihydrate, purified water (see section 2, Ketesse contains sucrose).

What Ketesse looks like and contents of the pack

A lightly colored solution with a lemon flavor and sweet lemon-citrus taste.
Packaging contains 2, 4, 10, or 20 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturer

Laboratorios Menarini S.A.
Alfons XII, 587, Badalona
08918 Barcelona
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Hungary, Italy, Spain: Enantyum
Estonia, Latvia, Lithuania: Ketesse
Greece: Viaxal
Poland: Ketesse
Date of last revision of the leaflet: 05/2021