Dexak

Leaflet attached to the packaging: patient information

Dexak

25 mg, granules in a sachet

Dexketoprofen

It is essential to carefully read the contents of the leaflet 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 advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dexak and what is it used for
• 2. Important information 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 is Dexak and what is it used for

Dexak is a pain-relieving medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Dexak is used for the short-term, symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (e.g., back pain, sprains, and acute injuries), painful menstruation, or toothache.

2. Important information before taking Dexak

When not to take 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 had asthma attacks in the past, severe allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nose caused by allergy), hives (blistering rash), or angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has had hypersensitivity reactions to light or phototoxic reactions (a type of redness and/or peeling of the skin after sun exposure) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
• If the patient has stomach or duodenal ulcers or bleeding from the stomach or intestines, or if they have had stomach or intestinal bleeding, ulcers, or perforation in the past;
• If the patient has chronic digestive problems (e.g., indigestion, heartburn);
• If the patient has had stomach or intestinal bleeding or perforation due to previous use of NSAIDs 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 bleed excessively or has bleeding disorders;
• If the patient is severely dehydrated (has lost a lot of fluids) due to vomiting, diarrhea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:

Before starting treatment with Dexak, the patient should discuss it with their doctor or pharmacist.

• If the patient has an allergy or has had allergy problems in the past;
• If the patient has kidney, liver, or heart problems (hypertension and/or heart failure), as well as fluid retention or if any of these problems have occurred in the past;
• In patients taking diuretics or in patients with decreased hydration and reduced blood volume due to excessive fluid loss (e.g., frequent urination, diarrhea, or vomiting);
• If the patient has heart disease, has had a stroke, or is suspected to be at risk for these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor before taking Dexak. Taking such medicines as Dexak may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. The patient should not take higher doses or use the medicine for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, the patient should contact their doctor immediately;
• In women with fertility problems (see section 2: "Pregnancy, breastfeeding, and fertility");
• If the patient has blood disorders or blood cell problems;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• If the patient has other stomach or intestinal diseases;
• If the patient has an infection - see below, the section titled "Infections";
• If the patient is taking other medicines that increase the risk of stomach ulcers or intestinal bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulants like warfarin, or antiplatelet agents. In such cases, the patient should consult their doctor before taking Dexak, as the doctor may decide to prescribe an additional protective medicine (e.g., misoprostol or medicines that reduce stomach acid production);
• In patients with 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 rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections

Dexketoprofen may mask the symptoms of infection, such as fever and pain. Therefore, Dexak may delay the use of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should immediately consult their doctor. The patient should avoid taking Dexak if they have chickenpox.

Children and adolescents

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

Dexak with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Some medicines should not be taken at the same time as Dexak, and for others, the dose may need to be changed when taken with Dexak. The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant 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

Concomitant use that requires caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart disease
• Pentoxifylline and oxypentifylline 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 that requires special consideration:

• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine or tacrolimus used to treat immune system disorders and transplants
• 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 for pharmacological termination of pregnancy (abortion)
• Antidepressant medicines from the SSRI group (selective serotonin reuptake inhibitors)
• Antiplatelet medicines used to reduce blood platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed

In case of any doubts about taking Dexak, the patient should consult their doctor or pharmacist.

Dexak with food, drink, and alcohol

Generally, it is recommended to take the medicine with food to reduce the possibility of stomach upset (see also section 3 "Method of administration"). Taking NSAIDs with alcohol may increase the risk of side effects caused by the active substance.

Pregnancy, breastfeeding, and fertility

Dexak should not be taken during the last three months of pregnancy or during breastfeeding. If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine, as taking Dexak may be inappropriate in this situation. Women who are pregnant or planning to become pregnant should avoid taking this medicine. The use of Dexak during any stage of pregnancy must only be done under the recommendation of a doctor. Taking Dexak may reduce fertility, so it is not recommended for women planning a pregnancy or during infertility diagnosis.

Driving and using machines

Dexak may have a minor influence on the ability to drive vehicles and operate machinery, as it may cause dizziness and drowsiness. If such symptoms are observed, the patient should not drive vehicles or operate moving machinery until the symptoms have resolved. The patient should consult their doctor.

Dexak contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to take Dexak

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The dose of Dexak will depend on the type, severity, and duration of the pain. The patient should take the smallest effective dose for the shortest duration necessary to relieve symptoms. If the infection symptoms (such as fever and pain) persist or worsen after 3 to 4 days, the patient should immediately consult their doctor (see section 2).

Adults over 18 years

The recommended daily dose is 1 sachet (25 mg) every 8 hours, but no more than 3 sachets per day (75 mg).

Use in elderly patients, patients with kidney and liver diseases

In elderly patients or those with mild kidney or mild to moderate liver problems, it is recommended to start treatment with a lower total daily dose, equivalent to no more than 2 sachets (50 mg). If the patient tolerates Dexak well, the initial dose can be increased to the recommended dose for the general population (75 mg). Dexak should not be taken by patients with moderate or severe kidney or severe liver problems. In case of doubts, the patient should consult their doctor or pharmacist.

Use in children and adolescents

This medicine should not be taken by children and adolescents (under 18 years of age).

Method of administration

The entire dose of granules should be placed on the tongue and swallowed immediately as they dissolve in the mouth or with a glass of water. The medicine can be taken with or without food. Taking the medicine with food may reduce the risk of stomach upset; however, 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 any meal or food), which will result in faster absorption of the medicine (see section 2 "Dexak with food, drink, and alcohol").

Treatment duration

If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor.

Overdose of Dexak

In case of suspected overdose, the patient should inform their doctor or pharmacist or go to the nearest hospital emergency department. The patient should remember to take the medicine packaging or patient leaflet with them.

Missing a dose of Dexak

The patient should not take a double dose to make up for a missed dose. The next dose should be taken according to the dosing schedule (see section 3 "How to take Dexak"). In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexak can cause side effects, although not everybody gets them. Possible side effects are listed below and are grouped according to their frequency of occurrence.

Common side effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, stomach pain, mainly in the upper quadrants, diarrhea, indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):

Vertigo of labyrinthine origin, dizziness, drowsiness, sleep disorders, nervousness, headaches, palpitations, flushing, gastritis (stomach inflammation), constipation, dry mouth, bloating, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare side effects (may affect up to 1 in 1,000 people):

Stomach ulcers, bleeding, or perforation of the digestive tract (which may be manifested by bloody vomiting or black stools), fainting, high blood pressure, slowed breathing rate, fluid retention and peripheral edema (e.g., swollen ankles), throat edema, loss of appetite (anorexia), abnormal sensation, pruritic 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 side effects (may affect up to 1 in 10,000 people):

Anaphylactic reactions (acute allergic reactions that can lead to anaphylactic shock), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or lip and throat edema (angioedema), shortness of breath caused by bronchial constriction (bronchospasm), shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity reactions, skin hypersensitivity to light, itching, kidney problems, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia). The patient should immediately inform their doctor if they notice any side effects related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding) at the start of treatment, especially if they have had similar side effects in the past due to long-term use of anti-inflammatory medicines, particularly in elderly patients. If a skin rash or any damage to the mucous membranes inside the mouth or on the genitals or any signs of allergy occur, the patient should stop taking Dexak immediately. When taking NSAIDs, fluid retention and edema (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure. Taking such medicines as Dexak may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), taking anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness. The most commonly observed side effects were related to stomach and intestinal disorders. Especially in elderly patients, stomach ulcers, perforation, or bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes. After taking the medicine, the following have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, mouth ulcers, exacerbation of colitis, and Crohn's disease. Less frequently, stomach inflammation has been observed. As with other NSAIDs, hematologic reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, rarely agranulocytosis, and bone marrow hypoplasia) may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Dexak

The medicine should be stored out of sight and reach of children. The medicine should not be taken after the expiration date stated on the carton and sachet after "EXP". The expiration date refers to the last day of the month stated. This medicine does not require special storage conditions. The medicine should be kept in its original packaging to protect it from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This 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 sachet contains 25 mg of dexketoprofen.
• The other ingredients are: butyl methacrylate copolymer, anhydrous colloidal silica, mannitol (E 421), lemon flavor (containing natural lemon flavor, gum arabic, medium-chain triglycerides), sucralose.

What Dexak looks like and contents of the pack

Light yellow to white granules packaged in single-dose sachets. Dexak is available in packs containing 4 or 10 sachets of PET/Aluminum/PE foil in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany

Manufacturer

LOSAN PHARMA GmbH, Otto-Hahn-Strasse 13, 15, 79395 Neuenburg, Baden-Wuerttemberg, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain, Italy: Ketesse Czech Republic: Dexoket Neo Estonia, Lithuania, Latvia: Dolmen Hungary: Ketodex Ireland, United Kingdom: Keral Austria, Belgium, Luxembourg, Portugal: Ketesse Netherlands: Stadium Greece: Nosatel Poland: Dexak Slovakia: Dexadol For more detailed information, the patient should contact their local representative of the marketing authorization holder: Berlin-Chemie/Menarini Polska Sp. z o.o., Tel. (22) 566 21 00, Fax. (22) 566 21 01 Date of last revision of the leaflet: