Dexak

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 medicine.
Please read the following information carefully before using 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 3–4 days, or if you feel worse, you should consult your doctor.

Table of contents of the leaflet:

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, 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 previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nodules inside the nose 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 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 bleeding from the stomach or intestines, 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 earlier use of NSAIDs used 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 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 woman is in the third trimester of pregnancy or 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 kidney, liver, or heart function disorders (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;
• In patients receiving diuretic therapy or in patients with reduced hydration and blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
• If the patient has heart problems, history of stroke, or suspicion of being in a high-risk group for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult a doctor before using Dexak. 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 conceiving 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 gastric or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI class drugs, e.g. selective serotonin reuptake inhibitors), antithrombotic drugs such as acetylsalicylic acid, or anticoagulants such as warfarin. In such cases, consult a 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. Taking this medicine may trigger asthma attacks or bronchospasm, especially 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. Safety and efficacy have not been established, and therefore this medicine should not be used in children and adolescents.
Dexak and other medicines
Inform your doctor about all medicines currently 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 concurrently with Dexak.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with this medicine:

• Not recommended to use together:
  • Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
  • Warfarin, heparin, or other antithrombotic 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.
• 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 organ transplantation
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines 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)
• Antidepressants from the selective serotonin reuptake inhibitors (SSRI) group
• Antiplatelet medicines 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 using Dexak, consult your doctor or pharmacist.
Taking with food and drink
Dexak tablets should be swallowed with sufficient water. Taking 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 effect on fertility
If the woman 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 woman is in the last 3 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 6 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 the 20th week of pregnancy, Dexak, if taken for longer than a few days, may cause:
renal function disorders in the unborn child – this may lead to reduced amniotic fluid surrounding the child (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 diagnosis.
Information on potential effects 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 motor vehicles and operate machinery. If such symptoms occur, do not drive 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 take 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.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (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 half a tablet (12.5 mg) every 4 to 6 hours or 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. Your doctor will inform you 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.
For 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 food), 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 should 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 or go to the emergency department of the nearest hospital immediately. 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 as scheduled (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 listed below are categorized 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, 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 reactions (may affect up to 1 in 1000 people):
Peptic ulcer disease, gastrointestinal bleeding or perforation (which may present as vomiting blood 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 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 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), 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 reactions 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 (particularly of the ankles and legs), increased blood pressure and heart failure may occur.
Use of such medicines as this one 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 connective tissue disorders), administration of anti-inflammatory drugs may rarely cause fever, headache and neck stiffness.
The most commonly observed adverse reactions 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 were observed: nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, lower abdominal pain, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Gastritis was 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 reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their 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
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.
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines should 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 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: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glyceryl distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

What Dexak looks like and contents of the pack
White, round, biconvex coated tablets with a dividing score line.
The medicine is available in blister packs containing 10, 20 or 30 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Spain, the country of export:
Laboratorios Menarini, S.A.
Alfons XII, 587 - Badalona (Barcelona), Spain
Manufacturer:
Laboratorios Menarini, S.A.
Alfons XII, 587 - Badalona (Barcelona), Spain
A. Menarini Manufacturing Logistics and Services, s.r.l.
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
Marketing authorization number in Spain, the country of export: 681957.9
Parallel import authorization number: 17/16
This medicine is authorized for marketing in the European Economic Area countries 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