KETESSE 25 mg FILM-COATED TABLETS

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 to treat mild or moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhea), 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 ingredients of this medication (listed in section 6)
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medications
• 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 of the skin exposed to sunlight) during the intake of 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 suffered from bleeding, ulceration, or perforation of the stomach or intestine in the past
• If you have chronic digestive problems (e.g., indigestion, heartburn)
• If you have suffered from stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory medications (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 (hypertension and/or heart failure), or fluid retention or have suffered from 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 stroke, 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 infarction") or stroke. This 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 side effects (see section 4). If these occur, consult your doctor immediately
• If you are a woman with fertility problems (this medication may reduce 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 and blood cell production disorder
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue)
• If you have suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past
• If you have suffered from 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), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking this medication: it may be that your doctor prescribes 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

Dexketoprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 the use of this medication

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 using, have recently used, or may need to use any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and other medications that may need 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 clot formation
• Lithium, used to treat some mood disorders
• Methotrexate (cancer and immunosuppressive medication), used at high doses of 15mg/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 15mg/week

Combinations to be taken into account:

• 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 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 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 and drinks:

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of suffering from adverse effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this facilitates the medication's action a little faster

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 to your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong labor more than expected

Do not take this medication 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, this medication may cause kidney problems to 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 this medication is not recommended while trying to conceive or while studying a fertility problem

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

Driving and using machines

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

3. How to take Ketesse

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

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

The lowest effective dose should be used for the shortest necessary duration 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)

The tablet can be divided into equal doses by breaking it at the score line

Generally, the recommended dose is half a tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg)

If you are an elderly patient or suffer from kidney or liver disease, it is recommended to start therapy with a maximum of 2 tablets 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 the medication has been well tolerated

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before meals) as they will be absorbed more easily (see section 2 "Taking Ketesse with food and drinks")

Use in children and adolescents

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

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. 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 forgotten doses. Take the next dose when scheduled (according to section 3 "How to take Ketesse")

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them

Possible side effects are listed below according to their frequency

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

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling, and chills, general malaise

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

Peptic ulcer, perforation of peptic ulcer, or gastrointestinal 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 the 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 side effects (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling 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, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia)

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or bleeding), if you have previously suffered from these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are elderly

Stop taking this medication immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other sign of allergy

During treatment with non-steroidal anti-inflammatory medications, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported

Medications like this may be associated with a small increased risk of suffering from 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 medications can rarely cause fever, headache, and neck stiffness

The most common side effects observed are of a gastrointestinal nature. 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 NSAIDs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

5. Storage of Ketesse

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

Do not use this medicine after the expiry date which is stated on the packaging and on the blister.

The expiry date is the last day of the month stated.

PVC-Aluminum Blister: Do not store above 30°C. Store the blisters in the original package to protect them from light.

Aclar-Aluminum or Aluminum-Aluminum Blister: This medicine does not require any special storage temperature.

Store in the original package to protect it from light.

Medicines should not be disposed of via wastewater or household waste.

Deposit the packages 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 packages and medicines you no longer need.

This will help protect the environment.

6. Package Contents and Additional Information

Ketesse Composition:

• The active ingredient is dexketoprofen (as dexketoprofen trometamol).
• Each coated tablet contains 25 mg of dexketoprofen.

• The other components are:

Tablet core: corn starch, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol distearate.

Coating: dry lacquer (composed of hypromellose, titanium dioxide, macrogol 6000), propylene glycol.

Appearance of Ketesseand Package Contents:

Coated tablets with film, white, round, with convex sides.

Available in blisters in packages containing 4, 10, 20, 30, 50, and 500 coated tablets.

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:

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

or

• MENARINI MANUFACTURING LOGISTICS AND SERVICES, s.r.l.

Via Campo di Pile s/n – L’AQUILA – Italy

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

Spain (EMR), Austria, Belgium, Finland, France, Italy, Luxembourg, Portugal: Ketesse

Cyprus, Greece: Nosatel

Czech Republic: Dexoket

Germany: Sympal

Estonia, Latvia, Lithuania: Dolmen

Hungary: Ketodex

Ireland, Malta, United Kingdom (Northern Ireland): Keral

Netherlands: Stadium

Poland: Dexak

Slovakia: Dexadol

Slovenia: Menadex

Date of the last revision of this leaflet:August/2023

Other sources of information

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