Dexak

Patient Information Leaflet

Dexak, 25 mg, oral solution in sachet
Dexketoprofenum
Please read all of this leaflet carefully before taking this medicine, because 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 4 days, or if you feel worse, you should contact your doctor.

Table of contents:

1. What Dexak is and what it is used for
2. Important information before taking Dexak
3. How to take Dexak
4. Possible side effects
5. How to store Dexak
6. Contents of the pack and other information

1. What Dexak is and what it is used for

This medicine is an analgesic belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Dexak 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. This medicine is intended for use in adults.

2. Important information before using Dexak

When not to use Dexak:

• If the patient is allergic to tromethamine dexketoprofen or 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 (short-term inflammation of the nasal mucosa), nasal polyps (nodules inside the nose caused by allergy), urticaria (rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of breathing difficulties), or wheezing after taking acetylsalicylic acid or other NSAIDs;
• If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (a type of redness and/or blistering 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 and/or duodenal ulcer disease or gastrointestinal bleeding, or if there has been a history of gastrointestinal bleeding, ulceration or perforation;
• If the patient has chronic digestive disorders (e.g. indigestion, heartburn);
• If the patient has previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs taken for pain relief;
• If the patient has inflammatory bowel diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney function disorders, or severe liver function disorders;
• If the patient has a tendency to excessive bleeding or coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhoea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:
Before starting treatment with Dexak, 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 function disorders (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 your doctor or pharmacist before using Dexak. Use of medicines such as Dexak 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 reactions (see section 4). If adverse reactions occur, contact your doctor immediately;
• In women experiencing fertility problems or undergoing fertility investigations (this medicine may impair female fertility and should not be used in women planning pregnancy or being treated for infertility);
• 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 previously 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 and/or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI group, e.g. serotonin reuptake inhibitors), anticoagulant medicines such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult your doctor before taking this medicine. The doctor may decide to prescribe an additional medicine to protect the stomach (e.g. misoprostol or medicines that inhibit gastric acid production).
• In patients with asthma combined with 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
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, this medicine 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 existing infection and infection symptoms persist or worsen, consult a doctor immediately.
During treatment with dexketoprofen, allergic reactions to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, stop using Dexak immediately and contact your doctor or emergency services without delay.

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

Dexak with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take.
Some medicines should not be used at the same time as Dexak, while others may require dose adjustments when taken together with Dexak.
Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines together with this medicine:

Not recommended for concomitant use:

• Acetylsalicylic acid, 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 conditions
• 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, less than 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 (terminating pregnancy)
• Selective serotonin reuptake inhibitors (SSRI) antidepressants
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart conditions
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts regarding the use of Dexak, consult your doctor or pharmacist.

Dexak with food, drink and alcohol
It is recommended to take this medicine with food to reduce the possibility of gastrointestinal discomfort (see also section 3 "Method of administration").
Do not consume alcohol while taking this medicine. The occurrence of certain adverse effects, especially those affecting the gastrointestinal tract or central nervous system, is more likely when Dexak is taken together with alcohol.

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 this medicine during the third trimester of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Dexak should not be used during the first 6 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, Dexak, if taken for longer than a few days, may cause: kidney function disorders in the unborn child – this may lead to reduced amniotic fluid surrounding the baby (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility diagnosis.
Information on potential effects on fertility can also be found in section 2 "Warnings and precautions".

Driving and operating machinery
This medicine may have a minor influence on the ability to drive motor vehicles and operate machinery due to possible adverse effects such as dizziness, drowsiness and visual disturbances. If such symptoms occur, do not drive motor vehicles or operate mechanical equipment until symptoms resolve. If in doubt, consult your doctor.

Dexak contains methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed reactions) as it contains methyl parahydroxybenzoate.

Dexak 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 2.0 g of sucrose. This should also be taken into account in patients with diabetes.

Dexak contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use Dexak

This medicine should always be taken exactly as described in this patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If, during an infection, symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

Adults over 18 years of age
The recommended daily dose is 1 sachet (25 mg of dexketoprofen) 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 will depend on the type, severity, and duration of the patient's pain.
For elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose corresponding to no more than 2 sachets (50 mg of dexketoprofen).
If dexketoprofen is well tolerated in elderly patients, this initial dose may subsequently be increased to the dose recommended for the general population (75 mg).

Children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).

Method of administration
The oral solution may be taken directly from the sachet or after mixing the contents of the sachet with a glass of water. After opening the sachet, the entire contents should be used.
The contents of the sachets should be taken with food, which may reduce the possibility of gastrointestinal discomfort (see also section 2 of this leaflet). In cases of acute pain, when faster relief is needed, it is recommended to take the medicine on an empty stomach, at least 15 minutes before any meal, which will result in slightly faster absorption of the medicine.

Use of a higher than recommended dose of Dexak
In case of suspected overdose, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or this patient leaflet with you.

Missed dose of Dexak
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").
If you have any further doubts regarding the use of this medicine, 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 maximum plasma concentration of dexketoprofen after administration of the oral solution is higher than that observed after tablet administration; therefore, a potential increase in the risk of adverse effects (gastrointestinal system) cannot be excluded.

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, bloating, 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, high blood pressure, slowed 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 (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 of the mouth, eyes and genital areas (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, ringing in the ears (tinnitus), skin hypersensitivity reactions, photosensitivity, itching, kidney function problems, reduced white blood cell count (neutropia), reduced platelet count (thrombocytopenia).

Frequency not known: cannot be estimated from available data
Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Fixed drug eruption
An allergic skin reaction known as fixed drug eruption, which may involve circular or oval areas of redness and swelling of the skin, blister formation and itching. Skin darkening 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 drug.

If, at the beginning of treatment, the patient experiences any gastrointestinal adverse effects (e.g. stomach pain, heartburn or bleeding), they should immediately inform their doctor, especially if the patient has previously experienced similar adverse effects due to long-term use of anti-inflammatory drugs, particularly in elderly patients.

If a skin rash or any mucosal damage inside the mouth or on the genital organs occurs, or if any allergic symptoms appear, treatment with this medicine 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 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 (immunological disorders affecting connective tissue), administration of anti-inflammatory drugs may rarely cause fever, headache and neck stiffness.

The most commonly 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 observed: nausea, vomiting, diarrhoea, bloating, constipation, indigestion, lower abdominal pain, tarry stools, bloody vomit, 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, aseptic meningitis may occur, particularly in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow suppression) may also occur.

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 of 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

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dexak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the sachet
after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dexak contains
The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen in the form of dexketoprofen trometamol.
Other ingredients: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate, sodium saccharin, sucrose, macrogol 400, lemon flavour, povidone K-90, disodium phosphate anhydrous, sodium dihydrogen phosphate dihydrate, purified water (see section 2, Dexak contains sucrose).

What Dexak looks like and contents of the pack
A lightly coloured solution with a lemon odour and a sweet lemon-citrus taste.
Packs contain 2, 4, 10 or 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin,
Germany

Manufacturer
Laboratorios Menarini S.A.
Alfons XII, 587 Badalona
08918 Barcelona
Spain

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Finland, France, Italy, Luxembourg, Portugal, Spain: Ketesse
Cyprus, Greece: Nosatel
Estonia, Latvia, Lithuania: Dolmen
Germany: Sympal
Hungary: Ketodex
Ireland, Malta, United Kingdom (Northern Ireland): Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex