KETESSE 25 mg Tablet

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Ketesse 25 25 mg coated tablets
   1. Read the leaflet carefully before taking the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Ketesse 25 and what is it used for
4. Important information before taking Ketesse 25
   1. When not to take Ketesse 25:
   2. Warnings and precautions
   3. Infections
   4. Children and adolescents
   5. Ketesse 25 and other medicines
   6. Using the medicine with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Ketesse 25 contains sodium
5. How to take Ketesse 25
   1. Use in children and adolescents
   2. Overdose of Ketesse 25
   3. Missed dose of Ketesse 25
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1,000 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Reporting side effects
7. How to store Ketesse 25
8. Contents of the pack and other information
   1. What Ketesse 25 contains
   2. What Ketesse 25 looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Ketesse 25 25 mg coated tablets

Dexketoprofen

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

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

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

Table of contents of the leaflet:

• 1. What is Ketesse 25 and what is it used for
• 2. Important information before taking Ketesse 25
• 3. How to take Ketesse 25
• 4. Possible side effects
• 5. How to store Ketesse 25
• 6. Contents of the pack and other information

1. What is Ketesse 25 and what is it used for

Ketesse 25 is a pain reliever belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation, toothache.
If after 3 to 4 days there is no improvement or the patient feels worse, the doctor should be contacted.

2. Important information before taking Ketesse 25

When not to take Ketesse 25:

• If the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If the patient is allergic to acetylsalicylic acid or other non-steroidal 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 lining), nasal polyps (growths in the nose caused by allergy), hives (blistering rash), angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) or wheezing after taking acetylsalicylic acid or other NSAIDs;
• If the patient has had reactions to sunlight in the past: photoallergic or phototoxic reactions (in particular, redness and/or blisters on the skin exposed to the sun) when taking ketoprofen (non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if gastrointestinal bleeding, ulceration, or perforation has occurred in the past;
• If the patient has chronic gastrointestinal problems (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 intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney failure, or severe liver failure;
• If the patient has a tendency to bleed excessively 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 to take Ketesse 25, the doctor or pharmacist should be consulted:

• If the patient has an allergy or has had allergy problems in the past;
• If the patient has kidney, liver, or heart problems (hypertension and/or heart failure) as well as fluid retention or if any of these problems have occurred in the patient 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 problems, has had a stroke, or is suspected to be at risk of these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the doctor should be consulted before taking Ketesse 25. Taking such medicines as Ketesse 25 may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or longer treatment than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such a case, the doctor should be contacted immediately;
• In women with fertility problems or undergoing infertility tests (this medicine may affect female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
• If the patient has blood disorders or blood cell disorders;
• 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 diseases (ulcerative colitis, Crohn's disease) in the past;
• If the patient has other stomach or intestinal diseases;
• If the patient has an infection - see below, section titled "Infections";
• If the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or gastrointestinal bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulant medicines such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, the doctor should be consulted before taking this medicine, who may decide to administer an additional protective medicine (e.g., misoprostol or medicines that reduce stomach acid production).
• If the patient has asthma and 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 medicine 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. Therefore, this medicine may delay the use of appropriate infection treatment, which may lead 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 medicine during an infection, and the symptoms of the infection persist or worsen, the doctor should be consulted immediately.
It is recommended to avoid taking this medicine during chickenpox.

Children and adolescents

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

Ketesse 25 and other medicines

The doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines should not be taken at the same time as Ketesse 25, and in the case of other medicines, the dose may need to be changed due to concurrent use of Ketesse 25.
The doctor, dentist, or pharmacist should always be informed if the patient is taking any of the following medicines together with this medicine:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• Methotrexate (anticancer or immunosuppressive medicine) 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 insufficiency ulcers
• Zidovudine used to treat viral infections
• Aminoglycoside antibiotics used to treat bacterial infections.
• Sulfonylurea derivatives (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 diseases and transplants
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e., medicines used to dissolve clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as an abortifacient (to terminate pregnancy)
• Antidepressant medicines from the SSRI group (selective serotonin reuptake inhibitors)
• Antiplatelet medicines used to reduce platelet aggregation and 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 25, the doctor or pharmacist should be consulted.

Using the medicine with food and drink

Ketesse 25 tablets should be swallowed with a sufficient amount of water. Taking the tablets with food allows for a reduction in the risk of gastrointestinal side effects.
However, in the case of acute pain, it is recommended to take the medicine on an empty stomach, e.g., at least 30 minutes before a meal, which will allow for faster onset of the medicine's action (see section 2 "Using the medicine with food and drink").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult the doctor or pharmacist before taking this medicine.
This medicine should not be taken during the last three months of pregnancy or during breastfeeding.
It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, this medicine should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Ketesse 25, if taken for more than a few days, may cause: kidney problems in the unborn child - this may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility testing. Information on potential fertility effects can be found in section 2 "Warnings and precautions".

Driving and using machines

This medicine may cause dizziness and drowsiness and may have a minor or moderate effect on the ability to drive vehicles and operate machinery.
In case of observing such symptoms, vehicles should not be driven, and machinery should not be operated until the symptoms have resolved.
In case of doubts, the doctor should be consulted.

Ketesse 25 contains sodium

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

3. How to take Ketesse 25

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the doctor should be consulted immediately (see section 2).
The tablets can be divided into equal doses by breaking them at the score line.
The recommended daily dose is half a tablet (12.5 mg) every 4 to 6 hours or 1 coated tablet (25 mg) every 8 hours. The total daily dose should not exceed 3 coated tablets (75 mg).
If after 3 to 4 days there is no improvement or the patient feels worse, the doctor should be contacted. The doctor will inform the patient how many tablets to take per day and for how long.
The dose of this medicine will depend on the type, severity, and duration of the patient's pain.
In elderly patients or those with kidney or liver disease, treatment should be started with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
In case of good tolerance of this medicine in elderly patients, the initial dose can then be increased to the recommended dose for the general population (75 mg).
In case of acute pain, when rapid relief is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will allow for faster absorption of the medicine (see section 2 "Using the medicine with food and drink").

Use in children and adolescents

This medicine should not be used in persons under 18 years of age.

Overdose of Ketesse 25

In case of suspected overdose, the doctor or pharmacist should be informed or the patient should go to the emergency department of the nearest hospital. It should be remembered to take the medicine packaging or patient leaflet along.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

Missed dose of Ketesse 25

A double dose should not be taken 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 25").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to the frequency of their occurrence.

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

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

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

Dizziness (of labyrinthine origin), drowsiness, sleep disorders, nervousness, headaches, palpitations, facial flushing, stomach inflammation (gastritis), constipation, dryness of the mucous membrane of the mouth, bloating with gas passage, rash, fatigue, pain, feeling of fever and chills, malaise.

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

Stomach ulcer, gastrointestinal bleeding, or perforation (which may manifest as bloody vomiting or black stools), fainting, hypertension, slowed breathing rate, fluid retention and peripheral edema (e.g., swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, 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 hypersensitivity reactions that can lead to anaphylactic shock), skin, lip, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), shortness of breath caused by bronchial muscle spasm (bronchospasm), shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions, skin hypersensitivity to sunlight, itching, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
The doctor should be informed if the patient observes any side effects at the beginning of treatment related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding), if the patient has had similar side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
If a skin rash or any mucous membrane damage (e.g., in the mouth) or any symptoms of allergy occur, treatment with this medicine should be stopped immediately.
During the administration of non-steroidal 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 such medicines as this one may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration of anti-inflammatory medicines 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 a fatal outcome.
After taking the medicine, the following 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. Less frequently, gastritis has been observed.
As with other NSAIDs, hematologic reactions (thrombocytopenic purpura, aplastic anemia, and hemolytic anemia, rarely agranulocytosis, and bone marrow hypoplasia) may occur.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
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 medicine.

5. How to store Ketesse 25

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
[PVC/Aluminum blister:]
Do not store above 30°C. Blisters should be stored in the outer packaging to protect from light.
[Aclar/Aluminum blister or Aluminum/Aluminum blister:]
No special storage temperature instructions. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ketesse 25 contains

• The active substance of the medicine is dexketoprofen (in the form of dexketoprofen trometamol). 1 coated tablet contains 25 mg of dexketoprofen.
• Other ingredients are: Tablet core: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol distearate. Coating: dry coating (consisting of hypromellose, titanium dioxide, macrogol 6000), propylene glycol).

What Ketesse 25 looks like and contents of the pack

White, round, convex on both sides, coated tablets with a score line, in blisters.
The medicine is available in packs containing: 10, 20, or 30 coated tablets.
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

• A. Menarini Manufacturing Logistics and Services s.r.l. Campo di Pile, L’Aquila, Italy

or
Laboratorios Menarini S.A.
C/Alfonso XII, 587 E–08918-Badalona (Barcelona), Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain (RMS), Hungary, Italy: Enantyum
Estonia, Latvia, Lithuania, Poland: Ketesse
Greece: Viaxal
In order to obtain more detailed information, the representative of the marketing authorization holder should be contacted:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01
Date of last revision of the leaflet: 08/2023