Dexak sl

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Dexak SL (Enantyum)
25 mg, oral solution granules
Dexketoprofen
Dexak SL and Enantyum are different brand names for the same medicine.
Please read this leaflet carefully before taking 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 directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, 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 your condition worsens after 3 to 4 days, contact your doctor.

Table of contents:

1. What Dexak SL is and what it is used for
2. What you need to know 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 Dexak SL is and what it is used for

Dexak SL is an analgesic medicine from 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 has previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths inside the nose caused by allergy), urticaria (blister-like 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 or phototoxic reactions (a type of redness and/or peeling of the skin following 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 they have previously experienced 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 treatment;
• If the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal insufficiency, or severe hepatic insufficiency;
• If the patient has a high tendency to bleeding or 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 woman 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 kidney, liver, or heart dysfunction (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred in the past;
• In patients receiving diuretic therapy 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 your doctor before using Dexak SL. Taking 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;
• If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately;
• In women experiencing difficulty becoming pregnant or undergoing fertility testing (Dexak SL may impair female fertility and should not be used in women planning pregnancy or undergoing fertility treatment);
• If the patient has blood or blood cell formation disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has previously experienced chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• If the patient has current or previous gastrointestinal 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 bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. selective serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult your doctor before taking the medicine. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs inhibiting 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, especially 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 takes this medicine during an ongoing infection and infection symptoms persist or worsen, they should 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. The safety and efficacy have not been established, and therefore Dexak SL 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 you plan to take. Some medicines should not be used together with Dexak SL, while others may require dosage adjustments 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 drugs
• Lithium used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive drug) 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 drugs, i.e. drugs 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 inhibitors (SSRIs)
• Antiplatelet drugs 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
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, to allow faster onset of action.

Pregnancy, breastfeeding, and effects on fertility
Do not use Dexak SL during the last three months of pregnancy or during breastfeeding.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine, as Dexak SL may be inappropriate in such cases.
Pregnant women or women planning pregnancy should avoid using this medicine. Use of the medicine at any stage of pregnancy must only occur under medical advice.
Use of Dexak SL is not recommended in women planning pregnancy or undergoing fertility 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 your 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 this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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, consult your doctor 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, contact your doctor. 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 pain experienced by the patient.
In elderly patients or 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 dose recommended for the general population (75 mg of dexketoprofen).
For acute pain, when faster relief is required, it is recommended to take the medicine 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 must not be used in children and adolescents (under 18 years of age).
How to use Dexak SL
Dissolve the contents of the sachet in a glass of water and stir well to facilitate dissolution.
The resulting solution should be drunk immediately after preparation.
Use of a higher than recommended dose of Dexak SL
If an overdose is suspected, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.
Missed dose of Dexak SL
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 you have any further doubts regarding the use of Dexak SL, consult your 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, the frequency of gastrointestinal adverse
effects may be higher.

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 vertigo, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, facial
flushing, inflammation of the gastric mucosa (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 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 the 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 (blood tests), liver cell damage (hepatitis), acute kidney 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 in the mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell's syndrome),
facial swelling or swelling of lips and throat (angioedema), breathlessness due to airway constriction
(bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision,
tinnitus (ringing in the ears), skin hypersensitivity reactions, photosensitivity, itching, kidney function
impairment, reduced white blood cell count (neutropia), reduced platelet count (thrombocytopenia).

Immediately inform the doctor if the patient observes any adverse effects affecting the stomach or intestines
at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if the patient has previously
experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly
patients.

If a skin rash, 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
in 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 commonly observed adverse effects involved gastrointestinal disturbances. Particularly in elderly
patients, gastric or duodenal ulcer disease, perforation, or bleeding may occur, in some cases with fatal
outcome.

After administration of the medicine, the following have been reported: 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 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, inform a doctor or pharmacist. Adverse
effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects helps to provide more information on the safety of the medicine.

5. How to store Dexak SL

Keep this medicine out of the 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 required.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dexak SL contains

• The active substance is dexketoprofen (as dexketoprofen 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 granules in sachets.
Dexak SL is available in packs containing 10, 20 or 30 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, the country of export: 651368.2
Parallel import authorisation number: 469/15
This medicinal product is authorised for sale in the European Economic Area countries 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