DEXAK 25 mg Granulate

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Dexak SL
3. 25 mg, granules for oral solution
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Dexak SL and what is it used for
5. Important information before taking Dexak SL
   1. When not to take Dexak SL:
   2. Warnings and precautions:
   3. Infections
   4. Children and adolescents
   5. Dexak SL and other medicines
   6. Dexak SL with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Dexak SL contains sucrose
6. How to take Dexak SL
   1. How to take Dexak SL
   2. Overdose of Dexak SL
   3. Missed dose of Dexak SL
7. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1,000 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Reporting side effects
8. How to store Dexak SL
9. Package contents and other information
   1. What Dexak SL contains
   2. What Dexak SL looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Dexak SL

25 mg, granules for oral solution

Dexketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section
• 4.
• If after 3 to 4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dexak SL and what is it used for
• 2. Important information before taking Dexak SL
• 3. How to take Dexak SL
• 4. Possible side effects
• 5. How to store Dexak SL
• 6. Package contents and other information

1. What is Dexak SL and what is it used for

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

2. Important information before taking Dexak SL

When not to take Dexak SL:

• 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, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nasal passages caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress);
• 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 gastrointestinal problems (e.g., indigestion, heartburn);
• If the patient has had bleeding or perforation of the stomach or intestines due to previous use of NSAIDs used to treat pain;
• 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 SL, 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 (high blood pressure 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 of 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 SL. Taking such medications as Dexak SL may be associated with a slight increase in the risk of heart attack 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 or undergoing infertility tests (Dexak SL may affect female fertility and should not be used in women planning pregnancy or undergoing fertility treatment);
• 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, section titled "Infections";
• If the patient is taking other medications that increase the risk of stomach ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulants such as warfarin, or antiplatelet agents. In such cases, the patient should consult their doctor before taking the medicine, as the doctor may decide to prescribe an additional protective medication (e.g., misoprostol or medications 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.

Infections

Dexak SL may mask the symptoms of an infection, such as fever and pain. Therefore, Dexak SL may delay the use of appropriate infection treatment, which can lead 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 symptoms of the infection persist or worsen, they should immediately consult their doctor. The patient should avoid taking this medicine during 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 SL and 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. Some medicines should not be taken at the same time as Dexak SL, and in the case of other medicines, the dose may need to be changed when taken with Dexak SL. The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak SL:

• Acetylsalicylic acid (aspirin), 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 and tacrolimus used to treat immune system diseases and in transplants
• Streptokinase and other thrombolytic or fibrinolytic agents, i.e., medicines used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as an abortifacient (to induce abortion)
• Antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs)
• Antiplatelet agents used to reduce blood clot formation
• Beta-adrenergic blockers used to treat high blood pressure and heart disease
• Tenofovir, deferiprone, pemetrexed.

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

Dexak SL with food and drink

In case of acute pain, it is recommended to take the medicine on an empty stomach, e.g., at least 15 minutes before a meal, which will allow the medicine to start working faster.

Pregnancy, breastfeeding, and fertility

Dexak SL 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 the use of Dexak SL may be inappropriate in this situation. Women who are pregnant or planning to become pregnant should avoid taking this medicine. The use of Dexak SL during pregnancy should only be done under the doctor's recommendation. Dexak SL is not recommended for women planning pregnancy or undergoing fertility treatment. Information on the potential impact on fertility can be found in section 2, "Warnings and precautions".

Driving and using machines

Dexak SL may have a minor impact on the ability to drive vehicles and operate machinery, as it may cause dizziness and vision disturbances. If such symptoms are observed, the patient should not drive vehicles or operate machinery in motion until the symptoms resolve. In case of doubts, the patient should consult their doctor.

Dexak SL contains sucrose

If the doctor has informed the patient that they have an intolerance to some sugars, they should consult their doctor before taking the medicine. Each dose contains 2.418 g of sucrose. This should also be taken into account in patients with diabetes.

3. How to take Dexak SL

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2). Adults over 18 yearsThe recommended daily dose is 1 sachet (25 mg) every 8 hours, but no more than 3 sachets per day (75 mg). If after 3 to 4 days there is no improvement or the patient feels worse, they should contact their doctor. The doctor will inform the patient how many sachets to take per day and for how long. The dose of Dexak SL will depend on the type, severity, and duration of the pain in the patient. In elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose, not exceeding 2 sachets (50 mg). In elderly patients with good tolerance, this initial dose can be increased to the recommended dose for the general population (75 mg of dexketoprofen). In case of acute pain, when faster relief is needed, it is recommended to take the medicine on an empty stomach (at least 15 minutes before a meal), which will cause faster absorption of the medicine (see section 2, "Dexak SL with food and drink"). Children and adolescentsThis medicine should not be used in children and adolescents (under 18 years).

How to take Dexak SL

The contents of the sachet should be dissolved in a glass of water and well mixed to facilitate dissolution. The resulting solution should be taken immediately after preparation.

Overdose of Dexak SL

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.

Missed dose of Dexak SL

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

4. Possible side effects

Like all medicines, Dexak SL can cause side effects, although not everybody gets them. Possible side effects are listed below and are grouped according to the frequency of their occurrence. The information provided is partly based on data on side effects for Dexak tablets, and since Dexak SL granules are absorbed faster than tablets, the frequency of side effects related to the gastrointestinal system may be higher.

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

Nausea and/or vomiting, abdominal 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 disturbances, nervousness, headaches, palpitations, facial flushing, gastritis (gastric 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):

Gastric ulcer, bleeding, or perforation of the digestive tract, which may manifest as bloody vomiting or black stools, fainting, high blood pressure, slowed breathing rate, fluid retention and peripheral edema (e.g., swollen ankles), laryngeal 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 hypersensitivity reactions that can lead to anaphylactic shock), skin ulcers, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial edema or lip and throat edema (angioedema), shortness of breath due to bronchial constriction (bronchospasm), shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus (ringing in the ears), 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 beginning 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 symptoms of allergy occur, the patient should stop treatment with Dexak SL immediately. During the administration of non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure. Taking such medications as Dexak SL may be associated with a slight increase in the risk of heart attack or stroke. In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration of anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness. The most commonly observed side effects were related to the stomach and intestines. Especially in elderly patients, gastric ulcers, perforation, or bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes. After the use of the medicine, the following were observed: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, mouth ulcers, exacerbation of colitis, and Crohn's disease. Less frequently, gastritis was 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell 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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 collected on the safety of the medicine.

5. How to store Dexak SL

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of the month. There are no special precautions for storage of the medicinal product. 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. Package contents and other information

What Dexak SL contains

• The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• Other ingredients are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon flavor, sucrose (see section 2, Dexak SL contains sucrose).

What Dexak SL looks like and contents of the pack

Sachets containing yellowish granules. Dexak SL is available in packs of 10, 20, or 30 sachets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

LABORATORIOS MENARINI S.A., C/ Alfons XII 587, 08918-Badalona (Barcelona), Spain This medicinal product is authorized in the Member States of the European Economic Area under the following names: Austria, Belgium, France, Italy, Luxembourg, Portugal, Spain: Ketesse Cyprus, Greece: Nosatel Czech Republic: Dexoket Estonia, Latvia, Lithuania: Dolmen Germany: Sympal Hungary: Ketodex Ireland, Malta, United Kingdom (Northern Ireland): Keral Netherlands: Stadium Poland: Dexak SL Slovakia: Dexadol Slovenia: Menadex For more 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: 12/2021