Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Dexak (Ketesse 25 mg), 25 mg, film-coated tablets
Dexketoprofen
Dexak and Ketesse 25 mg are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this 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 or pharmacist. See section 4.
If there is no improvement after 3–4 days, or if you feel worse, consult your doctor.

Table of contents:

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), and toothache.
If there is no improvement after 3–4 days, or if you feel worse, you should 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 has previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths inside the nose caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or associated respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly in the form of 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 currently has peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding, or if they have previously experienced 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 relief;
If the patient has chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
If the patient has a tendency to excessive bleeding or coagulation disorders;
If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhoea, or inadequate fluid intake;
If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting Dexak, discuss with your doctor or pharmacist:

If the patient has allergies or has previously experienced allergy-related problems;
If the patient has impaired kidney, liver, or heart function (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, elevated cholesterol levels, or smoking). In such cases, consult your 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 your doctor immediately;
In women experiencing difficulty becoming pregnant or undergoing fertility investigations (this medicine may impair female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
If the patient has blood cell formation disorders or blood cell abnormalities;
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 peptic ulcer disease of the stomach and/or duodenum or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, such as selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulant drugs such as warfarin. In such cases, consult your doctor before taking this 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 acetylsalicylic acid and/or NSAIDs.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, this medicine 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 takes this medicine during an existing infection and symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

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

Dexak and other medicines
Always inform your doctor, dentist, or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use. Some medicines should not be used simultaneously with Dexak, while others may require dose adjustments when used together.

Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexak:

Concomitant use not recommended:
- 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
Concomitant use requiring caution:
- ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart disease
- 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
Concomitant 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 used to dissolve blood clots
- Probenecid used to treat gout
- Digoxin used to treat chronic heart failure
- Mifepristone used as an abortion-inducing agent (to terminate pregnancy)
- Selective serotonin reuptake inhibitors (SSRIs)
- Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
- Beta-blockers used to treat high blood pressure and heart disease
- Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking Dexak, consult your doctor or pharmacist.

Taking Dexak with food and drink
Dexak tablets should be swallowed with sufficient water. Taking the tablets with food may reduce the risk of gastrointestinal side 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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take this medicine if the patient is in the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
During the first six months of pregnancy, this medicine should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From week 20 of pregnancy, Dexak, if taken for longer than a few days, may cause:
impaired kidney function in the unborn child – this may lead to reduced amniotic fluid (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility investigations.
Information on potential effects on fertility is provided in section 2, "Warnings and precautions".

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

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

3. How to use Dexak

This medicine should always be taken exactly as described in this 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 duration necessary to relieve symptoms should be used.
If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Tablets may be divided into equal doses by breaking them along the division line.
The usual recommended daily dose is generally 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 your doctor. The doctor will inform the patient 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 the patient's pain.
In elderly patients or those with kidney or liver disease, it is recommended to start treatment 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).
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, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.
If you forget to take Dexak
Do not take a double dose to make up for a missed dose. Take the next dose according to the prescribed dosing schedule (see section 3 "How to use Dexak").
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The possible adverse effects listed below are categorized according to their likelihood of 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, flatulence with passage of gas, 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, decreased respiratory rate, fluid retention in the limbs 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 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 caused by constriction of respiratory muscles (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 (neutropenia), 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 this medicine should be stopped immediately.
During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of the ankles and legs), increased blood pressure and heart failure may occur.
Use of medicines such as this one may be associated with a small increased risk of myocardial infarction ("heart attack") 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 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, flatulence, constipation, dyspepsia, lower abdominal pain, tarry stools, bloody vomit, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastritis 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 adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
[PVC/Aluminium blister]:
Do not store above 30°C. Store blisters in the outer packaging to protect from light.
[Aclar/Aluminium blister or Aluminium/Aluminium blister]:
No special storage temperature requirements for this medicinal product.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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:
Tablet core: Corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glycerol distearate.
Coating: Dry coating (composition: hypromellose, titanium dioxide, polyethylene glycol 6000), propylene glycol.

What Dexak looks like and contents of the pack
White, round, biconvex coated tablets with a dividing score line, in blisters packed in a cardboard box.
The medicine is available in packs containing 10, 20 or 30 coated tablets.
For more detailed information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Austria, country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer:
Laboratorios Menarini S.A.
Alfonso XII 587, 08918-Badalona (Barcelona), Spain
A. Menarini Manufacturing Logistics and Services s.r.l.
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, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Austria, country of export: 1-22482
Parallel Import Authorisation Number: 1/25

This medicine is authorised 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