Dexak Sl

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Dexak SL(Enantyum)

25 mg, granules for oral solution

Dexketoprofen
Dexak SL and Enantyum are different trade names for the same drug.

You should 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 the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should 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. Contents of the pack and other information

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

Dexak SL is a pain reliever belonging to the group of nonsteroidal 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, 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 nonsteroidal 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) or wheezing after taking acetylsalicylic acid or other nonsteroidal 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) while taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
• If the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if they have had gastrointestinal bleeding or ulcers in the past;
• If the patient has chronic gastrointestinal problems (e.g., indigestion, heartburn);
• If the patient has had gastrointestinal bleeding or perforation due to previous use of NSAIDs for pain relief;
• If the patient has inflammatory bowel diseases (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 in a state of severe dehydration (excessive fluid loss) 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, you should discuss it with your 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 the above problems have occurred in the patient 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, before taking Dexak SL, you should consult a doctor. Taking such medications as Dexak SL 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 medication. You should not take higher doses or use the medication for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, you should contact your doctor immediately;
• In women with fertility problems or undergoing fertility tests (Dexak SL may affect female fertility and should not be used in women planning to become pregnant or undergoing fertility treatment);
• If the patient has blood disorders or blood cell disorders;
• 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 gastrointestinal bleeding, such as oral steroids, certain antidepressants

(drugs from the SSRI group, e.g., serotonin reuptake inhibitors), anticoagulant medications such as acetylsalicylic acid or anticoagulant medications such as warfarin. In such cases, before taking the medication, you should consult a doctor, who may decide to administer 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 medication 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. As a result, Dexak SL 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 medication during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor. You should avoid taking this medication during chickenpox.

Children and adolescents

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

Dexak SL and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Some medications should not be taken at the same time as Dexak SL, and in the case of other medications, the dosage may need to be adjusted due to concurrent use of Dexak SL.
You should always inform your doctor, dentist, or pharmacist if you are taking any of the following medications with Dexak SL.
Concomitant use is not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory medications
• Warfarin, heparin, or other anticoagulant medications
• Lithium used to treat certain mood disorders
• Methotrexate (anticancer or immunosuppressive medication) 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 oxypentifylline used to treat chronic venous insufficiency ulcers
• 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 transplants
• Streptokinase and other thrombolytic or fibrinolytic medications, i.e., medications 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)
• Antidepressant medications from the SSRI group
• Antiplatelet medications used to reduce blood clot formation
• Beta-adrenergic blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed.

In case of any doubts related to taking Dexak SL, you should consult a doctor or pharmacist.

Dexak SL with food and drink

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

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, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication, 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 medication. The use of Dexak SL during pregnancy must be done only under the guidance of a doctor.
It is not recommended to take Dexak SL in women planning to become pregnant or during fertility testing. 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, you should not drive vehicles or operate machinery until the symptoms have resolved. In case of doubts, you should consult a doctor.

Dexak SL contains sucrose

If the doctor has informed the patient that they have an intolerance to some sugars, they should consult a doctor before taking the medication.
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 medication should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.
You 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, you should immediately consult a 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).
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 patients 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, the 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 medication on an empty stomach (at least 15 minutes before a meal), which will result in faster absorption of the medication (see section 2, "Dexak SL with food and drink").
Children and adolescents
This medication should not be taken by children and adolescents (under 18 years of age).

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, you should inform a doctor or pharmacist or go to the nearest hospital emergency department. You should remember to take the medication packaging or patient leaflet with you.

Missed dose of Dexak SL

You 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 related to taking Dexak SL, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medications, this medication 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 in granule form is absorbed faster than in tablet form, 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, dryness of the oral mucosa, bloating, rash, fatigue, pain, feeling of heat and chills, malaise.

Rare side effects (may affect up to 1 in 1000 people):

Gastric ulcer disease, gastrointestinal bleeding, or perforation, which may manifest as bloody vomiting or black stools, fainting, hypertension, 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 caused by 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).
You should immediately inform your doctor if you observe any side effects related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding) at the beginning of treatment, especially if you have had similar side effects in the past due to long-term use of anti-inflammatory medications, 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, you should immediately stop treatment with Dexak SL.
During the administration of nonsteroidal 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 (myocardial infarction) or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration of anti-inflammatory medications 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, stomach ulcers, perforation, or gastrointestinal bleeding may occur, in some cases with fatal outcomes.
After taking the medication, the following have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral ulcerative stomatitis, exacerbation of colitis, and Crohn's disease. Less frequently, gastritis 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your 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 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
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Dexak SL

The medication should be stored out of sight and reach of children.
You should not take this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
There are no special storage precautions.
Medications should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 containing 10 or 20 sachets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Laboratorios Menarini, S.A.
Alfonso XII, 587

• 08918 - Badalona (Barcelona) Spain

Manufacturer:

Laboratorios Menarini, S.A.
Alfonso XII, 587

• 08918 - Badalona (Barcelona) Spain

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in Spain, the country of export: 651368.2
Parallel import authorization number: 277/22
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
Date of leaflet approval: 06.07.2022
[Information about the trademark]