Dexak

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. 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.

It is necessary to carefully read the contents of the leaflet before using 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 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 this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 3-4 days there is no improvement or if the patient feels worse, they should contact their 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-relieving medicine 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 3-4 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 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 another NSAID;
• If the patient has had 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 (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcers or bleeding from the stomach or intestines, or if they have had stomach or intestinal bleeding, ulcers, 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 for pain relief;
• 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-related 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 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., 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 slight increase in the 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;
• In women with fertility problems or undergoing infertility tests (Dexak 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, the section titled "Infections";
• If the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, such as oral steroid medicines, certain antidepressants (SSRI medicines, 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, as the doctor may decide to prescribe an additional protective medicine (e.g., misoprostol or medicines that reduce stomach acid production);

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

• 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

Dexak 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 infection symptoms persist or worsen, they should immediately consult their doctor.
It is recommended to avoid taking this medicine during chickenpox.

Children and adolescents

The use of this medicine in children and adolescents has not been studied. 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. Some 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 when taken with Dexak.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak:

• It is not recommended to take the following medicines at the same time:
• 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 ulcers in chronic venous insufficiency
• 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 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 blood clotting
• Beta-adrenergic 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.

Using 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 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 the medicine to start working faster.

Pregnancy, breastfeeding, and fertility

Dexak should not be taken during the last three months 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, as the use of Dexak may be inappropriate in this situation.
Pregnant or breastfeeding women should avoid taking this medicine. The use of Dexak during any stage of pregnancy must only be done under the doctor's recommendation.
Dexak is not recommended for women planning pregnancy or undergoing fertility tests. Information on the potential impact on fertility can be found in section 2, "Warnings and precautions".

Driving and using machines

Dexak may cause dizziness and fatigue, and therefore, it may have a minor or moderate impact on the ability to drive vehicles and operate machinery. If such symptoms are observed, the patient should not drive vehicles or operate 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 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 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 the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
The recommended daily dose is usually 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 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 those 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 faster absorption of the medicine (see section 2, "Using Dexak with food and drink").

Use in children and adolescents

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

Overdose of Dexak

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 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 vestibular 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, 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 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 ulcers, ulcers of the lips, eyes, and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath caused by bronchospasm, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and hypersensitivity to sunlight, 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 in elderly patients.
If a skin rash or any mucosal ulceration (e.g., in the mouth) or any symptoms of allergy occur, the patient should immediately stop taking Dexak and consult their doctor.
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 Dexak may be associated with a slight increase in the 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 a fatal outcome.
After taking the medicine, the following side effects have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral ulceration, 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 this leaflet, they should tell their doctor, 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Dexak

The medicine should be stored out of sight and reach of children.
The medicine should not be used 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. The patient should ask their 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, propylene glycol, macrogol
• 6000.

What Dexak looks like and what the packaging contains

Dexak tablets are white, round, coated tablets with a dividing line.
Packaging contents: 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 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Romania, the country of export:
1044/2008/01
1044/2008/02
1044/2008/03

Parallel import authorization number: 387/21

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain (RMS), Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
Date of leaflet approval: 21.07.2022
[Information about the trademark]