Dexak sl

Patient Information Leaflet

Caution! Keep this leaflet. 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 this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, 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, you should contact your doctor.

Table of Contents:

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 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 (nasal growths caused by allergy), urticaria (blister-like 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 fat levels);
• If the patient has gastric and/or duodenal ulcer disease 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 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 impairment, or severe hepatic impairment;
• 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 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 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 to be at risk for these conditions (e.g. due to high blood pressure, diabetes, high cholesterol levels or smoking). In such cases, consult your 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 your doctor immediately;
• In women experiencing fertility problems or undergoing infertility investigations (Dexak SL may impair female fertility and should not be used in women planning pregnancy or undergoing infertility treatment);
• If the patient has blood cell formation 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 or has 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 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 your 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 provoke 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 increase the 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, consult a doctor immediately.
Avoid using this medicine during chickenpox.
Allergic reactions to dexketoprofen have been reported during treatment, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, stop using Dexak SL immediately and contact your doctor or emergency services without delay.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. The safety and efficacy of this medicine 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 dose adjustment when used concomitantly.
Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines together with Dexak SL:

Concomitant use not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory medicines
• Warfarin, heparin or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• High-dose methotrexate (an anticancer or immunosuppressive medicine) at 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
• Low-dose methotrexate, 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 (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 medicines 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 regarding the use of Dexak SL, consult your doctor or pharmacist.

Dexak SL with food and drink
In cases 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 effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Dexak SL during the last three months of pregnancy or during breastfeeding.
Dexketoprofen may cause kidney and heart problems in the unborn child. This medicine may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
Dexak SL should not be used during the first six months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
From week 20 of pregnancy, dexketoprofen may cause: impaired kidney function in the unborn child – this may lead to reduced amniotic fluid volume (oligohydramnios); narrowing of a blood vessel (ductus arteriosus) in the baby’s heart has also been observed. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Dexak SL is not recommended for use in women planning pregnancy or undergoing infertility diagnosis.
Information on potential effects on fertility can be found 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 or operate machinery until symptoms resolve. If in 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 diabetic patients.

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 the patient's pain.
In elderly patients or in patients 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 initial dose well, the dose may subsequently be increased to that recommended for the general population (75 mg of dexketoprofen).
In cases of 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 consumed immediately after preparation.

Taking more Dexak SL than recommended
In case of suspected overdose, inform a doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.

Missing 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 dosing schedule (see section 3 "How to use Dexak SL").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Uncommon side effects (may affect up to 1 in 100 people):
Vestibular dizziness, 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 side effects (may affect up to 1 in 1000 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 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, 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 which may lead to anaphylactic shock), skin, mouth, eye or genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), breathlessness due to airway narrowing (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).

Frequency unknown: cannot be estimated from available data
Chest pain, which may be a symptom of a potentially severe allergic reaction known as Kounis syndrome.
Fixed drug eruption.
An allergic skin reaction known as fixed drug eruption, which may include round or oval areas of redness and swelling of the skin, blister formation and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Fixed drug eruptions typically recur in the same location(s) upon re-exposure to the medicine.

If, at the beginning of treatment, the patient observes any gastrointestinal side effects (e.g. stomach pain, heartburn or bleeding), particularly if the patient has previously experienced similar side effects due to long-term use of anti-inflammatory medicines, especially in elderly patients, a doctor should be informed immediately.

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

When taking non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially 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 heart attack ("myocardial infarction") 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 and intestinal disturbances. Particularly in elderly patients, gastric or duodenal ulcer disease, perforation or bleeding may occur, in some cases with fatal outcome.

Following administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, bloody vomit, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease.

Gastritis (inflammation of the gastric mucosa) 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.

Side 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 side 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 cardboard box and on the sachet. The expiry date refers to the last day of the specified 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. These measures will help protect the environment.

6. Contents of the packaging 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 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Spain, the country of export: 651368.2
602958.9
Parallel Import Licence number: 16/16
This medicinal product is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) 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