Dexak sl

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dexak SL (Enantyum)
25 mg, oral solution granules
Dexketoprofen
Dexak SL and Enantyum are different trade names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
recommended by the doctor or pharmacist.

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

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 pack 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 other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or previously experienced asthma attacks, acute allergic rhinitis (a short-term inflammatory condition of the nasal lining), nasal polyps (nasal growths caused by allergy), urticaria (blister-like rash), angioedema (swelling of the face, eyes, lips, tongue or throat, or breathing difficulties) or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient previously experienced photosensitivity reactions or phototoxic reactions (a type of redness and/or skin peeling 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 gastric or duodenal ulcer disease 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 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 excessive bleeding or coagulation disorders;
• If the patient is severely dehydrated (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 a history of allergic reactions;
• If the patient has kidney, liver or heart problems (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. excessive 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. Use of 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 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 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 a history of chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• If the patient has or previously had other stomach or intestinal disorders;
• If the patient has an infection – see below, section titled "Infections";
• If the patient is taking other medicines that increase the risk of gastric or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. selective 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 drugs 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 increase the 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 infection and infection symptoms persist or worsen, 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. Safety and efficacy have not been established, and therefore Dexak SL should not be used in children and adolescents.

Dexak SL and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines should not be used together with Dexak SL, and in other cases dosage adjustments may be necessary when Dexak SL is taken concurrently.

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 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 disease
• 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. 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 (to terminate pregnancy)
• Selective serotonin reuptake inhibitors (SSRIs)
• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking 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 effects 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 a pregnancy, she should consult a doctor or pharmacist before using this medicine, as Dexak SL may be inappropriate in such circumstances.

Pregnant women or women planning pregnancy should avoid using this medicine. Use of the medicine at any stage of pregnancy must only occur under a doctor's recommendation.

Use of Dexak SL is not recommended in women planning pregnancy or during fertility investigations. 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 vehicles and operate machinery, as it may cause dizziness and visual disturbances. If such symptoms occur, do not drive or operate machinery until symptoms resolve. If in 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 using 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.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of an infection (such as fever and pain) persist or worsen, consult a 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 a 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 in the patient.
In elderly patients or those with kidney or liver disease, treatment should begin 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).
For acute pain requiring rapid relief, it is recommended to take the medicine on an empty stomach (at least 15 minutes before a meal), which results 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.

Taking more Dexak SL than recommended
If an overdose is suspected, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.

If you miss a 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 about 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 experiences them.
The possible adverse effects listed below are categorized according to their likelihood of 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):
Vertigo, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the stomach lining (gastritis), constipation, dryness of the oral mucosa, flatulence, rash, fatigue, pain, feeling feverish 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 vomiting blood or black stools, fainting, hypertension, reduced respiratory rate, fluid retention 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 disorders, abnormal liver function tests (blood 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, mouth, eyes and genital areas (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 white blood cell count (neutropia), reduced platelet count (thrombocytopenia).

If the patient observes any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), they should immediately inform their doctor, especially if such adverse effects have occurred previously 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 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 (particularly of the 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 (immune system 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, peptic 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, 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, the patient should inform their doctor, pharmacist or nurse.

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
Adverse effects can also be reported to the marketing authorisation holder or parallel importer.

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 instructions apply.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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: 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
Sachets containing lemon-yellow granules.
Dexak SL is available in packs containing 10, 20 or 30 sachets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona)
Spain
Manufacturer:
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona)
Spain
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Spanish Marketing Authorisation Number (country of export): 651368.2
Parallel Import Authorisation Number: 160/23
This medicinal product is authorised for sale in 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