Dexak sl

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 brand names for the same medicine.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as prescribed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 to 4 days, you should contact your doctor.

Table of contents of the leaflet:

1. What Dexak SL is and what it is 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 packaging and other information

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

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

2. Important information before using Dexak SL

When not to use Dexak SL:

• If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• If the patient is allergic to acetylsalicylic acid or to 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 throat, or respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions or phototoxic reactions (a type of redness and/or peeling of the skin after exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has peptic ulcer disease of the stomach and/or duodenum 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 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 bleed excessively or has coagulation disorders;
• If the patient is in a state of severe dehydration (significant fluid loss) due to vomiting, diarrhoea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or is breastfeeding.

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

• If the patient has allergies or has previously experienced allergic problems;

• If the patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;

• In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);

• If the patient has heart disease, has had a stroke, or is suspected of being at risk for these conditions (e.g. due to high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult a doctor before using Dexak SL. Medicines such as Dexak SL 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;

• In elderly patients: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;

• In women experiencing fertility problems or undergoing fertility investigations (Dexak SL may impair female fertility and should not be used in 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 diseases;

• If the patient has an infection – see below, section titled "Infections";

• If the patient is taking other medicines that increase the risk of peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulants such as warfarin. In such cases, consult a doctor before taking the medicine. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or medicines that inhibit gastric acid production).

• In patients with 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
Dexak SL may mask symptoms of infection such as fever and pain. Therefore, Dexak SL may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately. Avoid using this medicine during chickenpox.

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

Dexak SL and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Some medicines should not be used simultaneously with Dexak SL, and in the case of others, dosage adjustments may be necessary when used concomitantly with Dexak SL.

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

Not recommended for concomitant use:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs
• 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 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

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 transplant patients
• 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)
• Selective serotonin reuptake inhibitor (SSRI) antidepressants
• 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 you have any doubts regarding the use of Dexak SL, consult your doctor or pharmacist.

Dexak SL with food and drink
For acute pain, it is recommended to take the medicine on an empty stomach, e.g. at least 15 minutes before a meal, to allow faster onset of action.

Pregnancy, breastfeeding, and effect on fertility
Do not use Dexak SL during the last three months of pregnancy or while breastfeeding.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine, as its use may be inappropriate in such circumstances.
Women who are pregnant or planning to become pregnant should avoid using this medicine. Use during any stage of pregnancy must be strictly under medical supervision.
Use of Dexak SL is not recommended in women planning pregnancy or undergoing infertility diagnosis. Information on potential effects on fertility is provided in section 2, "Warnings and precautions".

Driving and operating machinery
Dexak SL may have a minor influence on the ability to drive motor vehicles and operate machinery, as it may cause dizziness and visual disturbances. If such symptoms occur, do not drive motor vehicles or operate mechanical equipment until symptoms resolve. In case of doubt, consult a doctor.

Dexak SL contains sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Each dose contains 2.418 g of sucrose. This should also be taken into account in patients with diabetes.

3. How to use Dexak SL

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, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Adults over 18 years
The recommended daily dose is 1 sachet (25 mg) every 8 hours, but not more than 3 sachets per day (75 mg).
If there is no improvement after 3 to 4 days, or if the patient feels worse, medical advice should be sought. The doctor will inform the patient how many sachets should be taken per day and for how long. The dose of Dexak SL will depend on the type, severity, and duration of the pain experienced by the patient.
In elderly patients or in those with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 sachets (50 mg).
In elderly patients who tolerate the medicine well, this initial dose may subsequently be increased to the recommended dose for the general population (75 mg of dexketoprofen).
In cases of acute pain when faster relief is required, the medicine should be taken on an empty stomach (at least 15 minutes before a meal), which will result in faster absorption of the medicine (see section 2 "Dexak SL with food and drink").
Children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
How to use Dexak SL
The contents of the sachet should be dissolved in a glass of water and stirred well to facilitate dissolution. The resulting solution should be taken immediately after preparation.
Taking more Dexak SL than recommended
In case of suspected overdose, 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 a dose of Dexak SL is missed
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 use Dexak SL").
If there are any further questions regarding the use of Dexak SL, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects listed below are categorized according to the likelihood of their occurrence.
The information provided below is partly based on data regarding adverse effects of Dexak tablets. Since
Dexak SL granules are absorbed more rapidly than tablets, gastrointestinal adverse effects may occur
more frequently.

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

Uncommon adverse effects (may affect up to 1 in 100 people):
Vestibular dizziness, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, facial flushing,
gastric mucosal inflammation (gastritis), constipation, dryness of the oral mucosa, flatulence, rash, fatigue, pain,
feeling of fever and chills, malaise.

Rare adverse effects (may affect up to 1 in 1,000 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),
laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain,
increased urination, menstrual disorders, prostate gland disorders, abnormal liver function tests, liver cell damage
(hepatitis), acute renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin ulceration,
ulcers of the mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or
swelling of lips and throat (angioedema), shortness of breath due to airway constriction (bronchospasm), shortness of
breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity
reactions, photosensitivity, itching, kidney function problems, reduced number of white blood cells (neutropia),
reduced platelet count (thrombocytopenia).

Patients should immediately 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 effects due to long-term use of anti-inflammatory medicines, particularly elderly patients.

If a skin rash or any mucosal damage inside the mouth or on the genital organs, or any allergic symptoms occur,
treatment with Dexak SL should be stopped immediately.

During administration of non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and oedema (especially of
ankles and legs), increased blood pressure and heart failure may occur.

Use of medicines such as Dexak SL may be associated with a small increased risk of myocardial infarction ("heart
attack") or 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 effects 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 have been reported: nausea, vomiting, diarrhoea, flatulence,
constipation, dyspepsia, lower abdominal pain, tarry stools, haematemesis, ulcerative inflammation of the oral mucosa,
exacerbation of colitis and Crohn's disease. Gastric mucosal inflammation has been 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 effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist, or
nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store Dexak SL

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.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 with trometamol). Each sachet contains 25 mg of dexketoprofen.
• Other ingredients: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E 104), lemon flavour, sucrose (see section 2, “Dexak SL contains sucrose”).

What Dexak SL looks like and contents of the pack
Yellow-lemon coloured granules in sachets. Dexak SL is available in packs containing 10 or 20 sachets.

For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation number in Spain, the country of export: 651368.2
Parallel import authorisation number: 277/22
This medicinal product is authorised for marketing in the European Economic Area under the following trade 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