DEXAK 25 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Dexak 25 mg
   1. Dexketoprofen
   2. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Dexak and what is it used for
4. Important information before taking Dexak
   1. When not to take Dexak:
   2. Warnings and precautions
   3. Infections
   4. Children and adolescents
   5. Dexak and other medicines
   6. Taking Dexak with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Dexak contains sodium
5. How to take Dexak
   1. Use in children and adolescents
   2. Overdose of Dexak
   3. Missing a dose of Dexak
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1000 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Reporting side effects
7. How to store Dexak
8. Contents of the pack and other information
   1. What Dexak contains
   2. What Dexak looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Leaflet accompanying the packaging: information for the user

Dexak 25 mg

coated tablets

Dexketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3-4 days there is no improvement or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dexak and what is it 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 is Dexak and what is it used for

Dexak is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation, toothache.
If after 3-4 days there is no improvement or if the patient feels worse, they should consult their doctor.

2. Important information before taking Dexak

When not to take Dexak:

• If the patient is allergic to 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 has had asthma attacks in the past, severe allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or other NSAIDs;
• If the patient has had photosensitivity reactions in the past: photoallergic or phototoxic reactions (especially redness and/or blisters on sun-exposed skin) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcers or bleeding from the stomach or intestines, or if they have had bleeding from the stomach or intestines, ulcers, or perforation in the past;
• If the patient has chronic gastrointestinal problems (e.g., indigestion, heartburn);
• If the patient has had gastrointestinal bleeding or perforation due to previous use of NSAIDs used to treat pain;
• 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 coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before taking Dexak, the patient should discuss it with their doctor or pharmacist:

• If the patient has an allergy or has had allergy-related problems;
• If the patient has kidney, liver, or heart problems (hypertension and/or heart failure), as well as fluid retention or if any of these problems have occurred in the patient in the past;
• For patients taking diuretics or patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g., frequent urination, diarrhea, or vomiting);
• If the patient has heart problems, has had a stroke, or is suspected to be at risk for these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor before taking Dexak. Taking such medicines 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 of the medicine. The patient should not take higher doses or use the medicine for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, the patient should contact their doctor immediately;
• For women with fertility problems or undergoing infertility tests (this medicine may affect female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
• If the patient has blood disorders 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 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 stomach ulcers and/or duodenal ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulant medicines such as acetylsalicylic acid or warfarin. In such cases, the patient should consult their doctor before taking this medicine, who may decide to prescribe an additional protective medicine (e.g., misoprostol or medicines that reduce stomach acid production);
• If the patient has asthma and chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Taking this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

the patient should consult their doctor.

Infections

Dexketoprofen may mask the symptoms of an infection, such as fever and pain. Therefore, this medicine may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.
It is recommended to avoid taking this medicine during chickenpox.

Children and adolescents

This medicine has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore, it should not be used in children and adolescents.

Dexak and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines should not be taken with Dexak, and for others, the dose may need to be changed due to concomitant use with Dexak.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak:

• 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
• Methotrexate (anticancer or immunosuppressive medicine) 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 oxypentifylline used to treat chronic venous insufficiency ulcers
• 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 diseases and transplants
• 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 abortifacient (to induce abortion)
• Antidepressant medicines from the SSRI group (selective serotonin reuptake inhibitors)
• Antiplatelet medicines used to reduce blood clot formation and platelet aggregation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed.

In case of any doubts about taking Dexak, the patient should consult their doctor or pharmacist.

Taking Dexak with food and drink

Dexak tablets should be swallowed with a sufficient amount of water. Taking the tablets with food can reduce the risk of stomach or intestinal side effects. However, in case of acute pain, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will allow for faster absorption of the medicine (see section 2 "Taking the medicine with food and drink").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken if the patient is in the last 3 months of pregnancy or breastfeeding. It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor.
During the first 6 months of pregnancy, this medicine should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Dexak, if taken for more than a few days, may cause: kidney problems in the unborn child - this can lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility tests. Information on potential fertility effects can be found in section 2 "Warnings and precautions".

Driving and using machines

This medicine may cause dizziness and drowsiness, and therefore, it may have a minor or moderate effect on the ability to drive vehicles and operate machinery. If such symptoms are observed, the patient should not drive vehicles or operate moving machinery until the symptoms have resolved. In case of doubts, the patient should consult their doctor.

Dexak contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Dexak

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The tablets can be divided into equal doses by breaking them at the score line.
The recommended daily dose is usually 1/2 tablet (12.5 mg) every 4 to 6 hours or 1 tablet (25 mg) every 8 hours, but no more than 3 tablets per day (75 mg).
If after 3-4 days there is no improvement or the patient feels worse, they should contact their doctor. The doctor will inform the patient how many tablets to take per day and for how long.
The dose of this medicine will depend on the type, severity, and duration of the patient's pain.
In elderly patients or patients with kidney or liver disease, it is recommended to start treatment with a lower total daily dose not exceeding 2 coated tablets (50 mg).
In elderly patients with good tolerance, the initial dose can be increased to the recommended dose for the general population (75 mg).
In case of acute pain, when rapid relief is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will allow for faster absorption of the medicine (see section 2 "Taking the medicine with food and drink").

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Overdose of Dexak

In case of suspected overdose, the patient should inform their doctor or pharmacist or go to the emergency department of the nearest hospital. The patient should remember to take the medicine packaging or patient leaflet with them.

Missing a dose of Dexak

The patient should 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 take Dexak").
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to their frequency of occurrence.

Common side effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, stomach pain, mainly in the upper quadrants, diarrhea, indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):

Dizziness (of vestibular origin), drowsiness, sleep disturbances, nervousness, headaches, palpitations, facial flushing, stomach inflammation (gastritis), constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare side effects (may affect up to 1 in 1000 people):

Stomach ulcers, bleeding, or perforation of the digestive tract (which may manifest as bloody vomiting or black stools), fainting, high blood pressure, slowed breathing rate, fluid retention and peripheral edema (e.g., swollen ankles), throat swelling, 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 side effects (may affect up to 1 in 10,000 people):

Anaphylactic reactions (acute allergic reactions that can lead to anaphylactic shock), skin, lip, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or lip and throat swelling (angioedema), shortness of breath caused by bronchospasm, shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity, itching, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
The patient should inform their doctor if they notice any side effects, especially those related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding), if they have had similar side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
If a skin rash or any mucosal lesions (e.g., in the mouth) or any signs of allergy occur, the patient should stop taking this medicine immediately.
During the use of non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure.
Taking such medicines as this one may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), taking anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.
The most commonly observed side effects were related to the stomach and intestines. Especially in elderly patients, stomach ulcers, perforation, or bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes.
After taking the medicine, the following side effects have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral ulcerative stomatitis, exacerbation of colitis, and Crohn's disease. Less frequently, stomach inflammation has been observed. As with other NSAIDs, hematologic reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, rarely agranulocytosis, and bone marrow hypoplasia) may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dexak

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
[PVC/Aluminum blister:]
Do not store above 30°C. Store blisters in the outer packaging to protect from light.
[Aclar/Aluminum or Aluminum/Aluminum blister:]
No special temperature storage recommendations. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 of the medicine is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
• Other ingredients are: Tablet core: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol distearate. Coating: dry coating (consisting of hypromellose, titanium dioxide, macrogol 6000), propylene glycol.

What Dexak looks like and contents of the pack

White, round, biconvex coated tablets with a score line, in blisters.
The medicine is available in packs containing 10, 20, or 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l. Campo di Pile, L'Aquila, Italy

or
Laboratorios Menarini S.A.
C/Alfonso XII, 587 E–08918-Badalona (Barcelona), Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain (RMS), Austria, Belgium, Finland, France, Italy, Luxembourg, Portugal: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom (Northern Ireland): Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01
Date of last revision of the leaflet: 08/2023