Dexketoprofen Ketoflix

Leaflet accompanying the packaging: information for the user

Dexketoprofen Ketoflix, 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 as described in this leaflet for the patient or as directed by a doctor or
pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 to 4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Dexketoprofen Ketoflix and what is it used for

Dexketoprofen Ketoflix 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 and bone pain, painful menstruation, toothache.
If after 3-4 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Dexketoprofen Ketoflix

When not to take Dexketoprofen Ketoflix:

• if the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has asthma or has had asthma attacks or acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nasal passages caused by allergy), hives (blistering rash), angioedema (swelling of the face, eyes, lips, tongue, or respiratory tract) or wheezing after taking acetylsalicylic acid or other NSAIDs;
• if the patient has had reactions to sunlight: photoallergic or phototoxic reactions (in particular, redness and/or blisters on sun-exposed skin) when taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
• if the patient has or has had stomach or duodenal ulcers, or gastrointestinal bleeding;
• if the patient has gastrointestinal disorders (e.g., indigestion, heartburn);
• if the patient has had gastrointestinal bleeding or perforation due to taking NSAIDs for pain relief;
• if the patient has inflammatory bowel disease (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 bleeding or blood clotting disorders;
• if the patient is in the third trimester of pregnancy or breastfeeding;
• if the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake.

Warnings and precautions

Before taking Dexketoprofen Ketoflix, 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 (high blood pressure and/or heart failure), as well as fluid retention or if any of these problems have occurred in the past;
• in patients taking diuretics or in patients with low blood volume and decreased blood pressure due to excessive fluid loss (e.g., frequent urination, diarrhea, or vomiting);
• if the patient has heart problems, has had a stroke, or is at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor before taking Dexketoprofen Ketoflix. Taking such medicines as Dexketoprofen Ketoflix may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. 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 any such case, the patient should contact their doctor immediately;
• in women with fertility problems or undergoing fertility tests (Dexketoprofen Ketoflix 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 disease (ulcerative colitis, Crohn's disease);
• if the patient has or has had other stomach or intestinal disorders;
• if the patient has chickenpox, as NSAIDs may rarely worsen the disease;
• if the patient is taking other medicines that increase the risk of stomach ulcers or gastrointestinal bleeding, such as oral steroids, certain antidepressants (SSRIs, e.g., selective serotonin reuptake inhibitors), anticoagulants (e.g., warfarin), or antiplatelet agents. In such cases, the patient should consult their doctor before taking the medicine, as their doctor may decide to prescribe an additional protective medicine (e.g., misoprostol or a medicine that reduces stomach acid production);
• if the patient has asthma and chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of hypersensitivity 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 with hypersensitivity to acetylsalicylic acid and/or NSAIDs;
• if the patient has an infection - see below, "Infections" section.

Infections

Dexketoprofen Ketoflix may mask the symptoms of an infection, such as fever and pain. Therefore, Dexketoprofen Ketoflix may delay the use of appropriate infection treatment, which may 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.

Children and adolescents

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

Dexketoprofen Ketoflix and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, including those available without a prescription, and about any medicines they plan to take.
Some medicines should not be taken with Dexketoprofen Ketoflix, and for others, the dose may need to be changed when taken with Dexketoprofen Ketoflix.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexketoprofen Ketoflix:

• Not recommended for concurrent use:
• 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 derivatives and phenytoin used to treat epilepsy.
• Sulfamethoxazole used to treat bacterial infections.
• Concurrent use requiring 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 chronic venous insufficiency ulcers.
• Zidovudine used to treat viral infections.
• Aminoglycoside antibiotics used to treat bacterial infections.
• Chlorpropamide and glibenclamide used to treat diabetes.
• Concurrent 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 transplants.
• Streptokinase and other thrombolytic or fibrinolytic medicines used to dissolve blood clots.
• Probenecid used to treat gout.
• Digoxin used to treat chronic heart failure.
• Mifepristone used for medical termination of pregnancy.
• Antidepressant medicines from the selective serotonin reuptake inhibitor (SSRI) group.
• Antiplatelet medicines used to reduce blood clotting.

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

Dexketoprofen Ketoflix with food and drink

Dexketoprofen Ketoflix tablets should be swallowed with a sufficient amount of water. Taking the tablets with food can reduce the risk of gastrointestinal 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 onset of action (see "Dexketoprofen Ketoflix 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 child, they should consult their doctor or pharmacist before taking this medicine.
Dexketoprofen Ketoflix should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Dexketoprofen Ketoflix 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, Dexketoprofen Ketoflix may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios). If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Dexketoprofen Ketoflix should not be used in breastfeeding women.
Dexketoprofen Ketoflix may affect fertility, and its use is not recommended in women with fertility problems, planning pregnancy, or undergoing fertility treatment.

Driving and using machines

Dexketoprofen Ketoflix may have a minor effect on the ability to drive vehicles and operate machinery due to possible side effects such as dizziness or drowsiness. 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.

Dexketoprofen Ketoflix contains sodium

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

3. How to take Dexketoprofen Ketoflix

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Dexketoprofen Ketoflix is intended for short-term use only, and treatment should be limited to the period of symptoms.
The patient should use the smallest effective dose for the shortest necessary time.
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 recommended daily dose depends on the type, severity, and duration of the pain, usually 1/2 tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours. The total daily dose should not exceed 3 coated tablets (75 mg).
In elderly patients, with kidney or liver disease, it is recommended to start treatment with a lower total daily dose equivalent to no more than 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 faster action is needed, it is recommended to take Dexketoprofen Ketoflix on an empty stomach (at least 30 minutes before a meal), which will allow for faster absorption of the medicine (see "Dexketoprofen Ketoflix with food and drink").

Taking a higher dose of Dexketoprofen Ketoflix than recommended

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 Dexketoprofen Ketoflix

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 Dexketoprofen Ketoflix").
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, Dexketoprofen Ketoflix can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to their frequency:

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

Nausea and/or vomiting, stomach pain, diarrhea, indigestion (dyspepsia).

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

Dizziness, drowsiness, sleep disorders, nervousness, headaches, palpitations, facial flushing, gastrointestinal disorders, constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling of heat and 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), 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 hypersensitivity reactions that can lead to anaphylactic shock), skin, lip, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial or lip and throat swelling (angioedema), shortness of breath caused by bronchospasm, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions, skin hypersensitivity to sunlight, itching, kidney function disorders, 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; this is especially important for elderly patients.
If a skin rash or any skin changes or mucosal lesions (e.g., inside the mouth or on the genitals) or any symptoms of allergy occur, the patient should stop taking Dexketoprofen Ketoflix immediately.
During the administration 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 Dexketoprofen Ketoflix may be associated with a small increased risk of heart attack or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration of anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dexketoprofen Ketoflix

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton and blister.
The expiration date refers to the last day of the month.
Store in a temperature below 25°C.
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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dexketoprofen Ketoflix contains

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

What Dexketoprofen Ketoflix looks like and contents of the pack

Dexketoprofen Ketoflix is available in the form of white, biconvex, cylindrical coated tablets with a dividing line and engraved with "DT2" on one side. The tablets can be divided into equal doses.
PVC/PVDC/Aluminum blister pack in a cardboard box.
Dexketoprofen Ketoflix is supplied in packs containing: 10, 20, 30, 40, or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
email: [email protected]

Manufacturer

SAG MANUFACTURING S.L.U.
N-I Road, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Galenicum Health, S.L.U
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
Date of last revision of the leaflet 25.10.2023