Package leaflet: Information for the user

Warning! Keep this 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 medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.
Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement or if you feel worse after 3–4 days, consult your doctor.

List of contents of the leaflet:

What Dexak is and what it is used for
Important information before taking Dexak
How to take Dexak
Possible side effects
How to store Dexak
Contents of the pack and other information

1. What Dexak is and what it is used for

Dexak is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), or toothache.
If there is no improvement or if you feel worse after 3–4 days, consult your doctor.

2. Important information before using Dexak

When not to use 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 previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nodules inside the nose caused by allergy), urticaria (blister-like rash), angioedema (swelling of the face, eyes, lips, tongue or throat, or respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly manifesting as redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
If the patient has gastric and/or duodenal ulcer disease or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
If the patient has chronic digestive problems (e.g. indigestion, heartburn);
If the patient has previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs used for pain treatment;
If the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe renal failure, or severe hepatic failure;
If the patient has a tendency to bleed excessively or has coagulation disorders;
If the patient is severely dehydrated (excessive loss of body fluids) 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 treatment with Dexak, consult a doctor or pharmacist:

If the patient has allergies or has previously experienced allergy-related problems;
If the patient has kidney, liver, or heart disorders (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;
In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. excessive urination, diarrhea, or vomiting);
If the patient has heart problems, history of stroke, or is suspected of being at risk for these conditions (e.g. due to high blood pressure, diabetes, high cholesterol levels, or smoking). In such cases, consult a doctor before using Dexak. Use of medicines such 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. Do not use higher doses or longer treatment duration than recommended;
If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
In women experiencing difficulty becoming pregnant or undergoing fertility testing (Dexak may impair female fertility and is not recommended in women planning pregnancy or undergoing fertility treatment);
If the patient has blood or blood cell formation disorders;
If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If the patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
If the patient has or has previously had other stomach or intestinal disorders;
If the patient has an infection – see below, section titled "Infections";
If the patient is taking other medicines that increase the risk of gastric and/or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI drugs, e.g. selective serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult a doctor before taking the medicine, who may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs inhibiting gastric 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 general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexak may mask signs of infection such as fever and pain. Therefore, Dexak may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore the medicine should not be used in children and adolescents.

Dexak and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Some medicines should not be used together with Dexak, while others may require dose adjustments when used concomitantly with Dexak.
Always inform the doctor, dentist, or pharmacist if taking any of the following medicines together with Dexak:

Not recommended to use concurrently:
- Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
- Warfarin, heparin, or other anticoagulant drugs
- Lithium used to treat certain mood disorders
- Methotrexate (an anticancer or immunosuppressive drug) 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 diseases
- Pentoxifylline and oxpentifylline 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
Concurrent use requiring special consideration:
- Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
- Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve blood clots
Probenecid used to treat gout
Digoxin used to treat chronic heart failure
Mifepristone used as an abortion-inducing agent (terminates pregnancy)
Selective serotonin reuptake inhibitors (SSRIs) antidepressants
Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
Beta-adrenergic blocking agents (beta-blockers) used to treat high blood pressure and heart diseases
Tenofovir, deferasirox, pemetrexed

If in doubt about taking Dexak, consult a doctor or pharmacist.

Taking the medicine with food and drink
Dexak tablets should be swallowed with sufficient water. Taking the tablets with food may reduce the risk of gastrointestinal adverse effects.
However, in case of acute pain, it is recommended to take the medicine on an empty stomach, e.g. at least 30 minutes before a meal, to allow faster onset of action.

Pregnancy, breastfeeding, and effects on fertility
Do not use Dexak during the last three months of pregnancy or during breastfeeding.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor, as using Dexak in this situation may be inappropriate.
Women who are pregnant or planning pregnancy should avoid using this medicine. Use of the medicine at any stage of pregnancy must be strictly under medical supervision.
Dexak is not recommended for women planning pregnancy or undergoing fertility diagnosis.
Information on potential effects on fertility is provided in section 2, "Warnings and precautions".

Driving and operating machinery
Dexak may cause dizziness and fatigue and therefore may have a minor or moderate effect on the ability to drive motor vehicles and operate machinery. If such symptoms occur, do not drive motor vehicles or operate mechanical equipment until symptoms resolve. If in doubt, consult a doctor.

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

3. How to use Dexak

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended daily dose is usually 1 tablet (25 mg) every 8 hours, but not more than 3 tablets per day (75 mg).
If there is no improvement after 3 to 4 days, or if the patient feels worse, contact a doctor. The doctor will inform the patient how many tablets should be taken per day and for how long.
The dose of Dexak will depend on the type, severity, and duration of pain experienced by the patient.
In elderly patients or those with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
In elderly patients who tolerate the initial dose well, it may subsequently be increased to the recommended dose for the general population (75 mg).
For acute pain requiring faster relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine (see section 2 "Taking the medicine with food and drink").

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

Taking more Dexak than recommended
If an overdose is suspected, inform a doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.

Missed dose of Dexak
Do not take a double dose to make up for a missed dose. The next dose should be taken according to the prescribed dosing schedule (see section 3 "How to use Dexak").
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects are listed below and grouped according to how likely they are to occur.
Common adverse effects (may affect up to 1 in 10 people):
Nausea and (or) vomiting, abdominal pain, mainly in the upper quadrants, diarrhoea, indigestion (dyspepsia).
Uncommon adverse effects (may affect up to 1 in 100 people):
Vertigo (of labyrinthine origin), drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the gastric mucosa (gastritis), constipation, dryness of the oral mucosa, bloating with flatulence, rash, fatigue, pain, feeling of fever and chills, malaise.
Rare adverse effects (may affect up to 1 in 1000 people):
Peptic ulcer, gastrointestinal bleeding or perforation (which may present as bloody vomit or black stools), fainting, hypertension, reduced respiratory rate, fluid retention in the limbs and peripheral oedema (e.g. swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensations, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disturbances, prostate gland disorders, abnormal liver function tests, liver cell damage (hepatitis), acute kidney failure.
Very rare adverse effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin, lip, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to bronchial muscle spasm (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity, itching, kidney damage, reduced white blood cell count (neutropia), reduced platelet count (thrombocytopenia).
Patients should inform their doctor if they experience any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if they have previously experienced similar adverse effects due to long-term use of anti-inflammatory drugs, particularly in elderly patients.
If a skin rash or any mucosal lesion (e.g. inside the mouth) or any allergic symptoms occur, treatment with Dexak should be stopped immediately.
During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure may occur.
Use of drugs such 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 (immunological disorders affecting connective tissue), administration of anti-inflammatory drugs may rarely cause fever, headache and neck stiffness.
The most frequently observed adverse effects involved gastrointestinal disturbances. Particularly in elderly patients, gastric ulceration, perforation or bleeding from the stomach and (or) duodenum may occur, in some cases with fatal outcome.
After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, bloating, constipation, dyspepsia, lower abdominal pain, tarry stools, haematemesis, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Gastritis has been observed less frequently.
As with other drugs in the NSAID class, haematological reactions may occur (purpura, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow hypoplasia).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Dexak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 30°C in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Dexak contains

The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
Other components are: maize starch, microcrystalline cellulose, sodium carboxymethylstarch, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

What Dexak looks like and contents of the pack
Dexak tablets are white, round, film-coated tablets with a central break line.
Pack contents: 10, 20 or 30 film-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity in Romania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, country of export: 1044/2008/01
1044/2008/02
1044/2008/03
Parallel import authorization number: 387/21
This medicinal product is authorized for sale in 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