Dektac

Leaflet accompanying the packaging: patient information

DEKTAC, 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 a 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 the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is DEKTAC and what is it used for

DEKTAC is a pain-relieving medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain, menstrual pain (dysmenorrhea), and toothache.

2. Important information before taking DEKTAC

Inform your pharmacist or doctor if:
the patient has an infection - see below, the section titled "Infections".
Infections
DECTAC may mask the objective signs of infection, such as fever and pain. As a result, [brand name] may delay the application of appropriate infection treatment, and consequently lead to an increased 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 the symptoms of the infection persist or worsen, they should consult their doctor immediately.

When not to take DEKTAC:

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;
If the patient has asthma or has had asthma attacks in the past, severe allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths inside the nasal cavity caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If the patient has had hypersensitivity reactions to light or phototoxic reactions (in the form of redness and/or peeling of the skin after exposure to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
If the patient has stomach or duodenal ulcer disease or bleeding from the gastrointestinal tract, or if they have had bleeding from the stomach or gastrointestinal tract in the past;
If the patient has chronic gastrointestinal diseases (e.g., indigestion, heartburn);
If the patient has had bleeding from the stomach or gastrointestinal tract or perforation of the gastrointestinal tract due to previous use of NSAIDs used to treat pain;
If the patient has chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe kidney or liver impairment;
If the patient has a tendency to bleed or coagulation disorders;
If the patient is in a state of severe dehydration (significant fluid loss) due to vomiting, diarrhea, or insufficient fluid intake;
If the patient is in the third trimester of pregnancy or breastfeeding;

Warnings and precautions:

Before starting DEKTAC, discuss it with your doctor or pharmacist if:
the patient has an allergy or has had allergy problems in the past;
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;
the patient is taking diuretics or has decreased hydration and reduced blood volume due to excessive fluid loss (e.g., due to frequent urination, diarrhea, or vomiting);
the patient has heart disease, has had a stroke, or is suspected to be at risk of these diseases (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking), consult a doctor or pharmacist before taking DEKTAC. Taking such medicines as DEKTAC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Long-term treatment and taking high doses of the medicine increase this risk. Do not take higher doses or longer treatment than recommended;
If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, consult a doctor immediately;
in women with fertility problems or undergoing infertility tests (DEKTAC may affect female fertility and should not be taken by women planning pregnancy or undergoing fertility tests);
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 chickenpox, as in rare cases, non-steroidal anti-inflammatory drugs may worsen the course of the infection;
if the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or gastrointestinal 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, consult a doctor before taking DEKTAC, who may decide to administer an additional medicine to protect the stomach (e.g., misoprostol or medicines that inhibit 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. Administration of this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Children and adolescents

DEKTAC has not been studied in children and adolescents. Therefore, the safety and efficacy of this medicine in children and adolescents have not been established, and it should not be used in this patient group.

DEKTAC and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those obtained without a prescription. Some medicines should not be taken at the same time as DEKTAC, and in the case of others, the dosage may need to be changed due to concurrent use.
Always inform your doctor, dentist, or pharmacist if the patient is taking any of the following medicines with DEKTAC:
Medicines whose concurrent use with DEKTAC is not recommended:
Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory medicines
Warfarin, heparin, or other anticoagulant medicines
Lithium used to treat certain mood disorders
Methotrexate used to treat rheumatoid arthritis and cancer
Hydantoin and phenytoin used to treat epilepsy
Sulfamethoxazole used to treat bacterial infections
Medicines whose concurrent use with DEKTAC requires caution:
ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease
Pentoxifylline and oxypentifylline used to treat ulcers in chronic venous insufficiency
Zidovudine used to treat viral infections
Aminoglycoside antibiotics used to treat bacterial infections
Chlorpropamide and glibenclamide used to treat diabetes
Medicines whose concurrent use with DEKTAC requires special consideration:
Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections
Cyclosporine and tacrolimus used to treat immune system diseases and in transplant patients
Streptokinase and other thrombolytic or fibrinolytic medicines (i.e., medicines used to dissolve clots)
Probenecid used to treat gout
Digoxin used to treat chronic heart failure
Mifepristone used for pharmacological termination of pregnancy
Antidepressant medicines from the group of selective serotonin reuptake inhibitors (SSRIs)
Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
In case of any doubts about taking other medicines with DEKTAC, consult a doctor or pharmacist.

DEKTAC with food and drink

The medicine should be taken with a sufficient amount of water. It is recommended to take the medicine with a meal, as this helps reduce the risk of side effects related to the stomach and intestines. In case of acute pain, it is recommended to take the medicine on an empty stomach, e.g., at least 30 minutes before a meal, which allows the medicine to start working faster.

Pregnancy, breastfeeding, and fertility

Do not take DEKTAC in the third trimester of pregnancy or during breastfeeding.
Consult a doctor.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before taking this medicine, as taking DEKTAC may be inappropriate.
DEKTAC should be avoided in patients who plan to become pregnant or are pregnant.
Regardless of the stage of pregnancy, treatment should only be carried out in accordance with the doctor's recommendations. It is not recommended to take this medicine in patients trying to conceive or undergoing fertility tests.

Driving and using machines

DEKTAC may have a minor effect on the ability to drive and operate machines, as it can cause dizziness and drowsiness, which are side effects of the medicine. If such symptoms are observed, the patient should not drive or operate mechanical devices until the symptoms have resolved. In case of doubts, consult a doctor.

3. How to take DEKTAC

Take 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, consult a doctor immediately (see section 2).
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor.
DEKTAC tablets are intended for short-term use only, and treatment should be limited to the period of symptoms.
Adults
The dose of DEKTAC depends on the type, severity, and duration of pain.
Depending on the type and severity of pain, the recommended dose is 12.5 mg every 4 to 6 hours or 25 mg every 8 hours.
Do not take a total daily dose greater than 75 mg.
In elderly patients, with kidney or liver disease, the initial total daily dose should not exceed 2 tablets (50 mg).
In elderly patients, this initial dose can be increased to the recommended dose for the general population (75 mg) provided that the medicine is well tolerated.
In case of acute pain, when faster action is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine (see section 2 DEKTAC with food and drink).
Use in children and adolescents
This medicine should not be taken by children and adolescents (under 18 years of age)

Taking a higher dose of DEKTAC than recommended

In case of a higher dose of the medicine than recommended, immediately inform a doctor or pharmacist or go to the nearest hospital emergency department. Remember to take the medicine packaging or patient leaflet with you.

Missing a dose of DEKTAC

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 take DEKTAC").
In case of any further doubts about taking DEKTAC, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, DEKTAC can cause side effects, although not everybody gets them.
Possible side effects are listed below and grouped according to their frequency of occurrence.
Common side effects(may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain, diarrhea, indigestion.
Uncommon side effects(may affect up to 1 in 100 people):
Dizziness, drowsiness, sleep disorders, nervousness, headaches, palpitations, facial flushing, stomach disorders, constipation, dry mouth, bloating, rash, fatigue, pain, feeling of elevated body temperature, chills, malaise.
Rare side effects(may affect up to 1 in 1,000 people):
Stomach ulcers, gastrointestinal bleeding or perforation, 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), laryngeal edema, loss of appetite (anorexia), abnormal sensation, itching 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 reaction (hypersensitivity reaction that can lead to anaphylactic shock), skin ulcers, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or lip and throat edema (angioedema), shortness of breath caused by bronchial constriction (bronchospasm), rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity, hypersensitivity to light, itching, kidney disease, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

• Blood and lymphatic system disorders: decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia)

Immediately inform your doctor if the patient experiences any side effects related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding) at the start of treatment, if the patient has 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 damage to the mucous membranes inside the mouth or on the genitals or any symptoms of allergy occur, stop taking the 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 DEKTAC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), the administration of anti-inflammatory medicines may cause fever, headache, and neck stiffness.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, inform your doctor or pharmacist.
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
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine

5. How to store DEKTAC

Keep the medicine out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. The blisters should be stored in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does DEKTAC contain?

The active substance of the medicine is dexketoprofen (25 mg), in the form of 36.90 mg dexketoprofen trometamol.
Other ingredients are cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), glycerol distearate, tablet coating (Opadry Y-1-7000): hypromellose, titanium dioxide (E 171), macrogol/PEG 400.

What DEKTAC looks like and contents of the packaging

DEKTAC is available in the form of white, biconvex, cylindrical tablets with a dividing line and the imprint DT2 on one side. The tablets can be divided into equal doses.
DEKTAC is supplied in packages containing 10 or 30 coated tablets in blisters (PVC/PVDC/Aluminum), in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o.
ul. Bankowa 4
44-100 Gliwice
Logo of the marketing authorization holder

Manufacturer

SAG MANUFACTRUING S.L.U.
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª Edificio LEKLA
Esplugues de Llobregat
08950 Barcelona
Spain

Date of last revision of the leaflet: 10.02.2023