Dexak

Patient Information Leaflet

Dexak
25 mg, granules in sachet
Dexketoprofen
Please read the entire leaflet carefully before using 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 directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 3 to 4 days, consult a 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

Dexak is an analgesic medicine 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 muscle or joint pain (e.g. back pain, sprains and acute injuries), painful menstruation (dysmenorrhoea), or toothache.

2. Important information before using Dexak

When not to use Dexak:

• 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 (a 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 a combination of breathing disorders), 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 a peptic ulcer of the stomach and/or duodenum or gastrointestinal bleeding, or if they have previously experienced stomach or intestinal 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 kidney failure, or severe liver failure;
• If the patient has a tendency to bleed excessively or has 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, 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 have occurred in the past;
• 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, high cholesterol levels, or smoking). In such cases, consult your doctor before using Dexak. 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 effects (see section 4). In such cases, contact your doctor immediately;
• In women experiencing fertility problems (see section 2: "Pregnancy, breastfeeding and effects on fertility");
• If the patient has blood cell or blood 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 or has previously had other stomach or intestinal diseases;
• If the patient has an infection - see the section titled "Infections" below;
• 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), anticoagulants such as acetylsalicylic acid, or anticoagulant drugs such as warfarin. In such cases, consult your doctor before taking Dexak. 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. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, Dexak 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 infection and symptoms persist or worsen, consult a doctor immediately. Avoid using Dexak if the patient has chickenpox.

During treatment with dexketoprofen, allergic reactions to the drug have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, stop using Dexak immediately and contact a 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 should not be used in children and adolescents.

Dexak and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take, including those available without a prescription. Some medicines should not be used together with Dexak, and in other cases, dosage adjustments may be necessary when Dexak is taken concurrently. Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexak:

Not recommended for concomitant use:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other anticoagulant drugs
• Lithium used to treat certain mood disorders
• High-dose methotrexate (an anticancer or immunosuppressive drug) 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 or tacrolimus used to treat immune system disorders and in organ transplantation
• Streptokinase and other thrombolytic or fibrinolytic drugs used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used for medical termination of pregnancy
• Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants
• 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 disease
• Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking Dexak, consult your doctor or pharmacist.

Dexak with food, drink, and alcohol
It is generally recommended to take the medicine with food to reduce the risk of gastrointestinal discomfort (see also section 3 "Directions for use").
Using NSAIDs together with alcohol may worsen adverse effects caused by the active substance.

Pregnancy, breastfeeding, and effects 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 during the last three months of pregnancy or while breastfeeding.
It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, Dexak should not be used unless the doctor considers it 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 the 20th week of pregnancy, if Dexak is taken for longer than a few days, it may cause: impaired kidney function in the unborn child – this may lead to reduced amniotic fluid surrounding the baby (oligohydramnios) or narrowing 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.
Dexak may reduce fertility; therefore, its use is not recommended in women planning pregnancy or undergoing infertility investigations.

Driving and operating machinery
Dexak may have a minor influence on the ability to drive vehicles and operate machinery, as it may cause dizziness and drowsiness. If such symptoms occur, do not drive or operate mechanical equipment until symptoms resolve. Consult your doctor.

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

3. How to use Dexak

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 dose of Dexak will depend on the type, severity and duration of the pain experienced by the patient.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If symptoms of an infection (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).
Use in elderly patients and patients with kidney or liver disease
In elderly patients or those with mild impairment of kidney function or mild to moderate impairment of liver function, treatment should be initiated with a lower total daily dose corresponding to no more than 2 sachets (50 mg).
If Dexak is well tolerated in elderly patients, this initial dose may subsequently be increased to the recommended dose for the general population (75 mg).
Dexak should not be used in patients with moderate or severe impairment of kidney function or severe impairment of liver function. In case of doubt, consult your doctor or pharmacist.
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
Method of administration
The entire dose of granules should be placed on the tongue and swallowed immediately as it dissolves in the mouth, or taken with a glass of water.
This medicine may be taken with or without food. Taking the medicine with food may reduce the risk of gastrointestinal discomfort. However, in cases of acute pain when rapid relief is required, it is recommended to take the medicine on an empty stomach (at least 30 minutes before any food or drink), which will result in faster absorption of the medicine (see section 2, "Dexak with food, drink and alcohol").
Duration of treatment
If there is no improvement after 3 to 4 days, or if the patient feels worse, medical advice should be sought.
Taking more Dexak than recommended
If an overdose is suspected, 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.
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 questions about 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 are listed below and categorized according to their likelihood of occurrence.

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

Uncommon adverse effects (may affect up to 1 in 100 people):
Vertigo of labyrinthine origin, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the gastric mucosa (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, 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 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 lips, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of 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 number of white blood cells (neutropia), reduced platelet count (thrombocytopenia).

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

Drug-induced fixed 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. Skin pigmentation changes in the 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 the patient experiences 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 the patient has previously experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly individuals.

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

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

Use of such medicines as Dexak 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 individuals, gastric ulcer disease, perforation or bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcome.

Following administration of the medicine, the following have been reported: 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. Gastritis was 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the 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.
This medicine does not require any special storage conditions.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• Other ingredients are: basic butyl methacrylate copolymer, anhydrous colloidal silicon dioxide, mannitol (E 421), lemon flavour (containing natural lemon flavour, gum arabic, medium-chain triglycerides), sucralose.

What Dexak looks like and contents of the pack
Light yellow to white granules packed in single-dose sachets.
Dexak is available in packs containing 4 or 10 sachets of PET/Aluminium/PE foil in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Manufacturer
LOSAN PHARMA GmbH
Otto-Hahn-Strasse 13
79395 Neuenburg, Baden-Wuerttemberg
Germany
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Spain, Italy: Ketesse
Czech Republic: Dexoket Neo
Estonia, Lithuania, Latvia: Dolmen
Hungary: Ketodex
Ireland, United Kingdom (Northern Ireland): Keral
Austria, Belgium, Luxembourg, Portugal: Ketesse
Netherlands: Stadium
Greece: Nosatel
Poland: Dexak
Slovakia: Dexadol
For further information, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. (22) 566 21 00
Fax. (22) 566 21 01