Dexak

Leaflet accompanying the packaging: information for the user

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

Dexak (Tador)

25 mg, coated tablets

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

You should 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.
• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3-4 days there is no improvement or if you feel worse, you should contact your doctor.

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. Contents of the packaging 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, such as muscle pain, painful menstruation, toothache.
If after 3-4 days there is no improvement or if you feel worse, you should contact your doctor.

2. Important information before taking Dexak

When not to take Dexak:

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• If you have asthma or have had asthma attacks, severe allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nasal passages 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 you have had hypersensitivity reactions to sunlight: photoallergic or phototoxic reactions (especially redness and/or blisters on the skin exposed to the sun) while taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If you have stomach or duodenal ulcers or bleeding from the stomach or intestines, or if you have had bleeding from the stomach or intestines, ulcers, or perforation;
• If you have chronic gastrointestinal problems (e.g., indigestion, heartburn);
• If you have had gastrointestinal bleeding or perforation due to previous use of NSAIDs for pain relief;
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate or severe kidney failure, or severe liver failure;
• If you have a tendency to bleed excessively or have bleeding disorders;
• If you are severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before taking Dexak, you should discuss it with your doctor or pharmacist:

• If you have an allergy or have had allergy problems;
• If you have kidney, liver, or heart problems (high blood pressure and/or heart failure), as well as fluid retention or if you have had any of these problems in the past;
• For patients taking diuretics or patients who have low blood volume and dehydration (e.g., frequent urination, diarrhea, or vomiting);
• If you have heart problems, have had a stroke, or are at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking). In these cases, you should consult your 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. You should not take higher doses or use the medicine for longer than recommended;
• If you are elderly: there is an increased risk of side effects (see section 4). In this case, you should contact your doctor immediately;
• If you are a woman having trouble getting pregnant or undergoing fertility tests (this medicine may affect female fertility and is not recommended for women planning to become pregnant or undergoing fertility treatment);
• If you have blood disorders or blood cell disorders;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have other stomach or intestinal problems;
• If you have an infection - see below, section titled "Infections";
• If you are taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulant medicines such as warfarin, or antiplatelet agents. In these cases, you should consult your doctor before taking this medicine, who may decide to prescribe an additional protective medicine (e.g., misoprostol or medicines that reduce stomach acid production);

if you have 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.

• If you are taking other medicines that may increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulant medicines such as warfarin, or antiplatelet agents.

Infections

Dexketoprofen may mask the symptoms of an infection, such as fever and pain. Therefore, this medicine may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should immediately consult your doctor.
You should 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines should not be taken with Dexak, and for others, the dose may need to be changed when taken with Dexak.
You should always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines, including Dexak:

• It is not recommended to take:
• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• Methotrexate (an 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 that requires 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 (e.g., chlorpropamide and glibenclamide) used to treat diabetes
• Methotrexate used in low doses below 15 mg per week.
• Concomitant use that requires special consideration:
• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system disorders and transplants
• Streptokinase and other thrombolytic or fibrinolytic agents, 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 (selective serotonin reuptake inhibitors)
• Antiplatelet agents used to reduce blood clotting
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferiprone, pemetrexed.

In case of any doubts about taking Dexak, you should consult your 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 stomach or intestinal side effects. However, in case of acute pain, 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 "Taking the medicine with food and drink").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine if you are in the last 3 months of pregnancy or breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in you and your child and prolong or delay labor.
During the first 6 months of pregnancy, you should not take this medicine unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the lowest possible dose 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 child - 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, your 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

This medicine may cause dizziness and drowsiness, and therefore, it may have a minor or moderate effect on the ability to drive vehicles and operate machinery. If you experience such symptoms, you should not drive vehicles or operate moving machinery until the symptoms have resolved. In case of doubts, you should consult your doctor.

Dexak 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 Dexak

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should ask your doctor or pharmacist.
You should use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should immediately consult your doctor (see section 2).
The tablets can be divided into two equal parts (by breaking them along the score line).
The recommended daily dose is usually ½ 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 if you feel worse, you should contact your doctor. Your doctor will inform you 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 your pain.
In elderly patients or patients with kidney or liver disease, it is recommended to start treatment with a lower total daily dose not exceeding 2 tablets (50 mg).
In elderly patients with good tolerance, the initial dose can 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 "Taking the medicine with food and drink").

Use in children and adolescents

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

Overdose of Dexak

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

Missing a dose of Dexak

You 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 about taking this medicine, you should consult your doctor or pharmacist.

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 their frequency:

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, stomach inflammation (gastritis), constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling of fever and chills, malaise.

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

Stomach ulcers, bleeding, or perforation of the digestive tract (which may manifest as bloody vomiting or black stools), fainting, high blood pressure, slowed breathing rate, fluid retention and swelling (especially of the ankles and feet), 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 allergic reactions that can lead to anaphylactic shock), skin, lip, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or lip and throat swelling (angioedema), shortness of breath caused by bronchospasm, shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity, itching, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
You should inform your doctor if you notice any side effects, especially those related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding), if you have had similar side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
If you experience a skin rash or any mucosal ulceration (e.g., in the mouth) or any signs of allergy, you should stop taking this medicine immediately.
During the administration of nonsteroidal anti-inflammatory drugs, fluid retention and swelling (especially of the ankles and feet) and increased blood pressure and heart failure may occur.
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 bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes.
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, stomach inflammation 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 you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Dexak

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store in a temperature below 30°C, in the original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dexak contains

• The active substance of the medicine is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
• Other ingredients are: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol distearate, hypromellose, titanium dioxide (E 171), propylene glycol, macrogol 6000.

What Dexak looks like and contents of the packaging

White, convex, coated tablets with a score line on both sides. The tablet can be divided into two equal parts.
The medicine is available in packages containing 10, 20, or 30 coated tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
1, Avenue De la Gare, 1611, Luxembourg
Luxembourg

Manufacturer:

LABORATORIOS MENARINI S.A.
c/Alfons XII, 587, E-08918 Badalona, Barcelona
Spain

• A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL

Via 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
Marketing authorization number in Romania, the country of export:1044/2008/01
1044/2008/02
1044/2008/03
Parallel import authorization number:141/20

This medicine is authorized for marketing in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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: 03.06.2025

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