Dexak

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Dexak (Tador)
25 mg, coated tablets
Dexketoprofen
Dexak and Tador are different trade names for the same medicine.
Please read this leaflet carefully before taking 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, 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 after 3–4 days, or if you feel worse, consult your doctor.

Table of contents:

1. What Dexak is and what it is used for
2. What you need to know before taking Dexak
3. How to take Dexak
4. Possible side effects
5. How to store Dexak
6. 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 after 3–4 days, or if you feel worse, 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 (a short-term inflammatory condition 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 a combination of 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) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has gastric or duodenal ulcer disease and/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 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 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 is breastfeeding.

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

• If the patient has any 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 have occurred in the past;
• In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. excessive urination, diarrhoea, or vomiting);
• If the patient has heart problems, a history of stroke, or suspicion 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 fertility problems or undergoing fertility investigations (this medicine may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility 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 or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult your doctor before taking this medicine, who may decide to prescribe an additional protective medicine (e.g. misoprostol or medicines 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. Administration of 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 infection and 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. The safety and efficacy have not been established, and therefore this medicine should not be used in children and adolescents.

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

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

• Not recommended for concomitant use:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines

• Warfarin, heparin, or other anticoagulant medicines

• Lithium used in the treatment of certain mood disorders

• Methotrexate (an anticancer or immunosuppressive medicine) used in high doses of 15 mg per week

• Hydantoin derivatives and phenytoin used in epilepsy treatment

• Sulfamethoxazole used in bacterial infection treatment.

• Concomitant use requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists used in the treatment of high blood pressure and heart diseases

• Pentoxifylline and oxpentifylline used in the treatment of ulcers in chronic venous insufficiency

• Zidovudine used in viral infection treatment

• Aminoglycoside antibiotics used in bacterial infection treatment

• Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide) used in diabetes treatment

• Methotrexate used in low doses, below 15 mg per week.

• Concomitant use requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used in bacterial infection treatment

• Cyclosporine and tacrolimus used in immune system disorders and transplantations

• Streptokinase and other thrombolytic or fibrinolytic medicines (medicines used to dissolve blood clots)

• Probenecid used in gout treatment

• Digoxin used in chronic heart failure treatment

• Mifepristone used as an abortion-inducing agent (pregnancy termination)

• Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants

• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation

• Beta-adrenergic blocking agents (beta-blockers) used in high blood pressure and heart disease treatment

• Tenofovir, deferasirox, pemetrexed.

If you have any doubts regarding the use of 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 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
If the patient is pregnant, 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 duration.
From the 20th week 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 volume surrounding the child (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the child's heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
Dexak is not recommended for women planning pregnancy or undergoing fertility investigations.
Information on the potential effect on fertility can be found in section 2, "Warnings and precautions".

Driving and operating machinery
This medicine may cause dizziness and fatigue and therefore may have a minor or moderate effect on the ability to drive vehicles and 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 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 in doubt, consult a 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, medical advice should be sought immediately (see section 2).
The tablets may be divided into equal doses by breaking along the score line.
The usual recommended daily dose is generally 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, a doctor should be consulted. The doctor will inform the patient how many tablets should be taken 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 medicine well, this initial dose may subsequently be increased to the dose recommended for the general population (75 mg).
In cases 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 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 Dexak than recommended
If an overdose is suspected, a doctor or pharmacist should be contacted immediately or the nearest hospital emergency department should be visited. 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. The next dose should be taken according to the prescribed dosing schedule (see section 3 "How to take Dexak").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. The possible adverse reactions are listed below, classified according to their likelihood of occurrence.

Common adverse reactions (may affect up to 1 in 10 people):
Nausea and (or) vomiting, abdominal pain, mainly in the upper quadrants, diarrhoea, indigestion (dyspepsia).

Uncommon adverse reactions (may affect up to 1 in 100 people):
Vertigo (of labyrinthine origin), drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, gastric mucosal inflammation (gastritis), constipation, dryness of the oral mucosa, bloating with gas release, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare adverse reactions (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 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 disorders, prostate gland disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal failure.

Very rare adverse reactions (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), breathlessness due to respiratory muscle spasm (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).

Inform your doctor if you notice any adverse reactions 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 reactions due to long-term use of anti-inflammatory medicines, 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 (NSAIDs), fluid retention and oedema (particularly 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 medicines may rarely cause fever, headache and neck stiffness.

The most frequently observed adverse reactions involved gastrointestinal disorders. 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, indigestion, lower abdominal pain, tarry stools, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease.

Gastric mucosal inflammation has been observed less frequently.

As with other medicines in the NSAID class, haematological reactions may occur (thrombocytopenia, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow hypoplasia).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions 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

Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.

Reporting adverse reactions 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.
Store below 30°C. Keep 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 ingredients are:
  Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate.
  Coating: hypromellose, titanium dioxide (E 171), macrogol 6000, propylene glycol.

What Dexak looks like and contents of the pack
White, round, biconvex coated tablets with a central break line.
The medicine is available in packs containing 10, 20 or 30 coated tablets.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

Marketing Authorisation 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
and
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Poland

Marketing Authorisation Numbers in Romania, the country of export:
1044/2008/01
1044/2008/02
1044/2008/03

Parallel Import Licence Number: 126/23

This medicinal product is authorised for sale in the European Economic Area and 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