Dektac
Poland
Table of Contents
Package leaflet: Information for the patient
DEKTAC, 25 mg, coated tablets
Dexketoprofen
Please read this leaflet carefully before using the medicine, because
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 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 or if you feel worse, contact your doctor.
Table of contents
- What DEKTAC is and what it is used for
- Important information before taking DEKTAC
- How to take DEKTAC
- Possible side effects
- How to store DEKTAC
- Contents of the pack and other information
1. What DEKTAC is and what it is used for
DEKTAC is an analgesic 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 (dysmenorrhoea), and toothache.
2. Information before using DEKTAC
Inform the pharmacist or doctor if:
the patient has an infection — see below, section titled "Infections".
Infections
DEKTAC may mask objective signs of infection, such as fever and pain. Therefore, [brand name] 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 is taking this medicine during an existing infection and symptoms of infection persist or worsen, medical advice should be sought immediately.
When not to use DEKTAC:
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 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 nasal cavity caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, tongue or respiratory tract) or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions or phototoxic reactions (such as 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 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 of the gastrointestinal tract;
If the patient has chronic gastrointestinal disorders (e.g. dyspepsia, 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 or liver 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 breastfeeding;
Warnings and precautions:
Before starting treatment with DEKTAC, consult a doctor or pharmacist if:
the patient has allergies or a history of allergic reactions;
the patient has impaired kidney, liver or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred previously;
the patient is taking diuretics or is dehydrated with reduced blood volume due to excessive fluid loss (e.g. from frequent urination, diarrhoea or vomiting);
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 or smoking). Before using DEKTAC, consult a doctor or pharmacist. Medicines such as DEKTAC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Long-term treatment and high doses increase this risk. Do not exceed the recommended dose or duration of treatment;
the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
the patient is a woman experiencing fertility problems or undergoing fertility investigations (DEKTAC may impair female fertility and should not be used in women planning pregnancy or undergoing fertility testing);
the patient has blood cell formation disorders or blood cell abnormalities;
the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
the patient has a history of chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
the patient has or has had other stomach or intestinal diseases;
the patient has chickenpox, as in rare cases, use of non-steroidal anti-inflammatory drugs may worsen the course of infection;
the patient is taking other medicines that increase the risk of gastric and/or duodenal ulceration or gastrointestinal bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. serotonin reuptake inhibitors), antithrombotic agents such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult a doctor before taking DEKTAC. The doctor may decide to prescribe an additional medicine to protect the stomach (e.g. misoprostol or drugs that inhibit gastric acid production).
If the patient has asthma, chronic rhinitis, chronic sinusitis and/or nasal polyps, the risk of hypersensitivity 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 hypersensitive to acetylsalicylic acid and/or NSAIDs.
Children and adolescents
The use of DEKTAC has not been studied in children and adolescents. Therefore, safety and efficacy have not been established in this population, and the medicine should not be used in these patient groups.
DEKTAC with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to use. Some medicines should not be used together with DEKTAC, while others may require dose adjustments when taken concomitantly.
Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines together with DEKTAC:
Medicinal products not recommended for concomitant use with DEKTAC:
Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs
Warfarin, heparin or other antithrombotic agents
Lithium used to treat certain mood disorders
Methotrexate used to treat rheumatoid arthritis and cancer
Hydantoins and phenytoin used to treat epilepsy
Sulfamethoxazole used to treat bacterial infections
Medicinal products requiring caution when used with DEKTAC:
ACE inhibitors, diuretics, beta-blockers 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
Chlorpropamide and glibenclamide used to treat diabetes
Medicinal products requiring special consideration when used with DEKTAC:
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 drugs (i.e. drugs used to dissolve blood clots)
Probenecid used to treat gout
Digoxin used to treat chronic heart failure
Mifepristone used for pharmacological termination of pregnancy
Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants
Antiplatelet drugs used to reduce platelet aggregation and prevent blood clots
If in doubt about taking other medicines together with DEKTAC, consult a doctor or pharmacist.
DEKTAC with food and drink
Take the medicine with sufficient water. It is recommended to take the medicine with food, as this helps reduce the risk of gastrointestinal adverse effects. 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, to allow faster onset of action.
Pregnancy, breastfeeding and effects on fertility
Do not use DEKTAC during the third trimester of pregnancy or while breastfeeding. Consult a doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine, as DEKTAC may not be appropriate.
Avoid using DEKTAC in women who are planning pregnancy or are already pregnant. Regardless of gestational stage, treatment should only occur under medical supervision. This medicine is not recommended for women trying to conceive or undergoing fertility investigations.
Driving and operating machinery
DEKTAC may have a minor influence on the ability to drive or operate machinery, as it may cause dizziness and drowsiness, which are adverse effects of the medicine. If such symptoms occur, do not drive or operate machinery until symptoms resolve. If in doubt, consult a doctor.
3. How to use DEKTAC
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2). This medicine should always be taken exactly as described in the patient information leaflet or as directed by a physician. In case of doubt, consult your doctor.
DEKTAC tablets are intended for short-term use only, and treatment should be limited to the period during which symptoms are present.
Adults
The dose of DEKTAC depends on the type, severity, and duration of pain symptoms.
Depending on the type and intensity of pain, the recommended dose is 12.5 mg every 4 to 6 hours or 25 mg every 8 hours.
The total daily dose should not exceed 75 mg.
In elderly patients or in patients with kidney or liver disease, the initial total daily dose should not exceed 2 tablets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the recommended dose for the general population (75 mg), provided the drug is well tolerated.
In cases of acute pain requiring faster onset of action, 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 drug (see section 2 DEKTAC with food and drink).
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
Taking more DEKTAC than recommended
If more than the recommended dose has been taken, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.
If you forget to take DEKTAC
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 DEKTAC").
If you have any further questions about the use of DEKTAC, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions listed below are categorized according to how likely they are to occur.
Common adverse reactions (may affect up to 1 in 10 people):
Nausea and (or) vomiting, abdominal pain, diarrhoea, indigestion.
Uncommon adverse reactions (may affect up to 1 in 100 people):
Vertigo, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, facial flushing, gastric disorders, constipation, dry mouth, bloating, rash, fatigue, pain, feeling of increased body temperature, chills, malaise.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Peptic ulcer, gastrointestinal bleeding or perforation of the stomach ulcer, which may present as vomiting blood or black stools, fainting, hypertension, respiratory depression, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensations, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal failure.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Anaphylactic reaction (hypersensitivity reaction which may lead to anaphylactic shock), skin ulceration, 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 caused by airway constriction (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity, photosensitivity, pruritus, kidney disorders, decreased white blood cell count (neutropia), decreased platelet count (thrombocytopenia).
Patients should inform their doctor immediately if they experience any adverse reactions affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if they have previously experienced similar adverse reactions due to long-term use of anti-inflammatory medicines, particularly in elderly patients.
If a skin rash, any mucosal damage inside the mouth or on the genital organs, or any allergic symptoms occur, the medicine should be discontinued immediately.
Fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure may occur during treatment with non-steroidal anti-inflammatory drugs.
Use of medicines such as DEKTAC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In patients with immunological connective tissue disorders (systemic lupus erythematosus or mixed connective tissue disease), administration of anti-inflammatory medicines may cause fever, headache and neck stiffness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safe use of the medicine.
5. How to store Dektac
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C. Blister packs should be kept in the outer 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. These measures help protect the environment.
6. Contents of the packaging and other information
What DEKTAC contains
The active substance is dexketoprofen (25 mg) in the form of 36.90 mg of dexketoprofen trometamol.
The other components are corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glycerol distearate, and tablet coating (Opadry Y-1-7000): hypromellose, titanium dioxide (E 171), macrogol/PEG 400.
What DEKTAC looks like and contents of the pack
DEKTAC is available as white, cylindrical, biconvex tablets with a score line and the engraved mark DT2 on one side. The tablets can be divided into equal doses.
DEKTAC is supplied in packs containing 10 or 30 coated tablets in blisters (PVC/PVDC/Aluminium), packed in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Bankowa 4 Street
44-100 Gliwice
Poland
Logo of the Marketing Authorisation Holder
Manufacturer
SAG MANUFACTURING 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