Dexak

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dexak(Keral)

25 mg, coated tablets

Dexketoprofen
Dexak and Keral are different trade names for the same medicine.

Table of contents of the leaflet:

• 1. What is Dexak and what is it used for
• 2. Important information before taking Dexak
• 3. How to take Dexak
• 4. Possible side effects
• 5. How to store Dexak
• 6. Package contents and other information

1. What is Dexak and what is it used for

Dexak is a pain reliever belonging to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of mild to moderate pain, e.g. muscle pain, painful menstruation, toothache.
If after 3-4 days there is no improvement or if the patient feels worse, they should consult a doctor.

2. Important information before taking Dexak

When not to take Dexak:

• 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 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 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;

It is necessary to carefully read the contents of the leaflet 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 a doctor or pharmacist.
• The 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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3-4 days there is no improvement or if the patient feels worse, they should contact their doctor.
• If the patient has a history of hypersensitivity reactions to sunlight: photoallergic or phototoxic reactions (especially in the form of redness and/or blisters on the skin exposed to the sun) while taking ketoprofen (nonsteroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if they have had gastrointestinal bleeding, ulceration, or perforation 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 has 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 Dexak, the patient should discuss it with their doctor or pharmacist:

• If the patient has an allergy or has had allergy problems;
• 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 reduced hydration and decreased 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 for these conditions (e.g. in cases of high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor before taking Dexak. Taking such medicines as Dexak 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. The patient should not take higher doses or use the medicine for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, the patient should contact their doctor immediately;
• If the patient is a woman with fertility problems or undergoing infertility tests (Dexak may affect female fertility and is not recommended for women planning to become pregnant 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, e.g. oral steroid medicines, certain antidepressants (SSRI, e.g. selective serotonin reuptake inhibitors), anticoagulant medicines such as acetylsalicylic acid or warfarin. In such cases, the patient should consult their doctor before taking Dexak, who may decide to prescribe 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 an infection, such as fever and pain. Therefore, Dexak may delay the use of appropriate infection treatment, which may lead to an 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, they should consult their doctor 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.

Dexak and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Certain medicines should not be taken at the same time as Dexak, and in the case of other medicines, the dose may need to be changed due to concurrent use of Dexak.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak:

• Not recommended for concurrent use:
• 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.
• Concurrent 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.
• Concurrent 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
• Antidepressant medicines from the SSRI group
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferiprone, pemetrexed.

In case of any doubts related to taking Dexak, the patient should consult their doctor or pharmacist.

Taking Dexak with food and drink

Dexak tablets should be swallowed with a sufficient amount of water. Taking the tablets with food can reduce the risk of gastrointestinal side effects.
However, in the case of acute pain, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will cause the medicine to be absorbed faster (see section 2 "Taking the medicine with food and drink").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken if the patient is in the last 3 months of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.
During the first 6 months of pregnancy, this medicine should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Dexak, if taken for more than a few days, may cause:
kidney problems in the unborn baby - this may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning to become pregnant or undergoing fertility treatment. Information on potential fertility effects can be found in section 2 "Warnings and precautions".

Driving and using machines

Dexak may cause dizziness and fatigue, and therefore may have a minor or moderate effect on the ability to drive vehicles and operate machinery. If such symptoms are observed, the patient should not drive vehicles or operate moving machinery until the symptoms have resolved. In case of doubts, the patient should consult their doctor.

Dexak contains sodium

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

3. How to take Dexak

This medicine should always be taken exactly as described in the patient leaflet or as directed 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 necessary period to alleviate the 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).
The tablets can be divided into equal doses by breaking them at the score line.
The recommended daily dose is usually half a tablet (12.5 mg) every 4 to 6 hours or 1 tablet (25 mg) every 8 hours, but no more than 3 tablets per day (75 mg).
If after 3-4 days there is no improvement or the patient feels worse, they should contact their doctor. The doctor will inform the patient how many tablets to take per day and for how long.
The dose of Dexak will depend on the type, severity, and duration of the pain in the patient.
In elderly patients or patients with kidney or liver disease, it is recommended to start treatment with a lower total daily dose equivalent to no more than 2 coated tablets (50 mg).
In the case of good tolerance in elderly patients, this initial dose can be increased to the recommended dose for the general population (75 mg).
In the case of acute pain, when faster relief is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will cause the medicine to be absorbed faster (see section 2 "Taking the medicine with food and drink").

Use in children and adolescents

This medicine should not be used in children and adolescents under the age of 18.

Taking a higher dose of Dexak than recommended

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

Missing a dose of Dexak

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 Dexak").
In case of any further doubts related to taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexak can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to their frequency of 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 disturbances, nervousness, headaches, palpitations, facial flushing, gastritis (gastric inflammation), constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare side effects (may affect up to 1 in 1000 people):

Stomach ulcers, 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, or genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or lip and throat swelling (angioedema), shortness of breath caused by bronchospasm, wheezing, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions, sun hypersensitivity, itching, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
The patient should inform their doctor if they notice any side effects, especially those related to the stomach or intestines (e.g. stomach pain, heartburn, or bleeding), if they have had similar side effects in the past due to long-term use of anti-inflammatory medicines, especially if they are elderly.
If a skin rash or any mucosal ulceration (e.g. in the mouth) or any signs of allergy occur, the patient should stop taking Dexak 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 such medicines as Dexak 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, mouth ulcers, exacerbation of colitis, and Crohn's disease. Less frequently, gastritis has been observed.
As with other NSAIDs, hematologic reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, rarely agranulocytosis, and bone marrow hypoplasia) 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. 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dexak

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

6. Package contents and other information

What Dexak contains

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

What Dexak looks like and what the package contains

Dexak tablets are white, round, coated tablets with a score line.
Dexak is available in packages containing 10, 20, or 30 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

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

Manufacturer:

Laboratorios Menarini S.A.
Alfons XII 587
08918 Badalona (Barcelona)
Spain

• A. Menarini Manufacturing Logistics and Services, srl Via Campo di Pile s/n Loc. Campo di Pile, L’Aquila, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Irish marketing authorization number:PA 865/2/2

Parallel import authorization number: 3/25

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain (RMS), 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 leaflet approval: 08.05.2025

[Information about the trademark]