PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Dexak (Enantyum)
25 mg, coated tablets
Dexketoprofen
Dexak and Enantyum are different trade names for the same medicinal product.
Please read the entire 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 physician or pharmacist.
Please keep this leaflet, as you may need to read it again.
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 or pharmacist. See section 4.
If there is no improvement or if you feel worse after 3–4 days, consult your doctor.

Table of contents of the leaflet:

What Dexak is and what it is used for
What you need to know 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 suffers from asthma or has previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nasal growths caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of breathing difficulties), or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly 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 a peptic ulcer of the stomach and/or duodenum or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
If the patient suffers from 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 relief;
If the patient suffers from 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 excessive bleeding or coagulation disorders;
If the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake;
If the patient is in the third trimester of pregnancy or breastfeeding;

Warnings and precautions
Before starting to take 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 problems (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. frequent urination, diarrhoea, or vomiting);
If the patient has heart problems, has had a 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. Taking 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 fertility problems or undergoing fertility testing (Dexak may impair female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
If the patient has blood formation 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 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 or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or antithrombotic agents such as warfarin. In such cases, consult a doctor before taking the medicine. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs that inhibit gastric acid production);
If the patient has asthma, 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. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicy游戏副本

3. How to use Dexak

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The tablets may be divided into equal doses by breaking them along the division line.
The recommended daily dose is usually half a tablet (12.5 mg) every 4 to 6 hours or one 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 in the patient.
In elderly patients or in patients 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, the dose may subsequently be increased to that recommended for the general population (75 mg).
In cases of 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 this 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 than the recommended dose of Dexak
If an overdose is suspected, inform a doctor or pharmacist immediately or go to the emergency department of the nearest hospital. 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 you have any further questions about the use of this medicine, consult your 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 listed below are categorized according to the likelihood of their occurrence.
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 disease, gastrointestinal bleeding or perforation (which may present as bloody vomit or black stools), fainting, hypertension, reduced respiratory rate, fluid retention in the extremities and peripheral oedema (e.g. swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate gland disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal 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 ulceration of lips, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), breathlessness caused by constriction of respiratory muscles (bronchospasm), shortness of breath, rapid heart rate, 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).
You should inform your doctor if you notice any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you 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 (especially of ankles and legs), increased blood pressure and heart failure may occur.
Use of medicines 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 (immune system disorders affecting connective tissue), administration of anti-inflammatory drugs may rarely cause fever, headache and neck stiffness.
The most commonly observed adverse effects involved gastrointestinal disturbances. Particularly in elderly patients, gastric ulcer disease, 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, bloody vomit, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Gastric mucosal inflammation has been observed less frequently.
As with other NSAIDs, 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, you should inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
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 outer carton and on the blister. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store blisters in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the package 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 ingredients are: corn starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

What Dexak looks like and contents of the pack
White, round, coated tablets with a dividing score line.
Dexak is available in packs containing 10 or 30 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Laboratorios Menarini, S.A.
Alfons XII, 587
08918-Badalona (Barcelona)
Spain
Manufacturer:
Laboratorios Menarini, S.A.
Alfons XII, 587
08918-Badalona (Barcelona)
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Spain, the country of export: 681957.9
Parallel import authorisation number: 169/20
This medicinal product is authorised for marketing 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