Dexketoprofen ketoflix

Package leaflet: Information for the user

Dexketoprofen Ketoflix, 25 mg, coated tablets
Dexketoprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used as described in this patient leaflet or as directed by a doctor or
pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 4 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What Dexketoprofen Ketoflix is and what it is 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 pack and other information

1. What Dexketoprofen Ketoflix is and what it is 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 symptomatic treatment of mild to moderate pain, such as pain in the musculoskeletal system, painful menstruation (dysmenorrhoea), or toothache.
If there is no improvement after 3–4 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Dexketoprofen Ketoflix
When not to take Dexketoprofen Ketoflix:

• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (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 associated respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
• if you have previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly as redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• if you have or have had peptic ulcer disease of the stomach and/or duodenum, or bleeding from the stomach and/or intestines;
• if you have gastrointestinal discomfort (e.g. indigestion, heartburn);
• if you have previously experienced gastrointestinal bleeding or perforation due to taking NSAIDs used for pain relief;
• if you have inflammatory bowel diseases with chronic inflammation (Crohn’s disease or ulcerative colitis);
• if you have severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
• if you have bleeding disorders or coagulation disorders;
• if you are in the third trimester of pregnancy or are breastfeeding;
• if you are severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake.

Warnings and precautions
Before starting Dexketoprofen Ketoflix, discuss this with your doctor or
pharmacist:

• if you have allergies or have previously experienced allergy-related problems;
• if you have impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred in the past;
• in patients taking diuretics or in patients who have reduced hydration and reduced blood volume due to excessive fluid loss (e.g. excessive urination, diarrhoea, or vomiting);
• if you have heart problems, have had a stroke, or suspect you are at risk of such conditions (e.g. due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult your doctor before using Dexketoprofen Ketoflix. Use of medicines such as Dexketoprofen Ketoflix 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 you are elderly: there is an increased risk of adverse effects (see section 4). In any such case, contact your doctor immediately;
• in women with fertility problems or undergoing fertility investigations (Dexketoprofen Ketoflix may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment);
• if you have blood cell formation disorders or blood cell abnormalities;
• if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• if you have previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• if you have or have had other stomach or intestinal disorders;
• if you have chickenpox; in rare cases, non-steroidal anti-inflammatory drugs may exacerbate the disease;
• if you are 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 (SSRI class drugs, 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 the medicine; your doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs that inhibit gastric acid secretion);
• if you have 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;
• if you have an infection – see below, section titled “Infections”.

During treatment with dexketoprofen, allergic reactions to this medicine have been reported, including
difficulty breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms occur, stop taking Dexketoprofen Ketoflix immediately and contact your doctor or emergency services without delay.
Infections
Dexketoprofen Ketoflix may mask symptoms of infection such as fever and pain. Therefore, Dexketoprofen Ketoflix 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 you are taking this medicine during an existing infection and symptoms persist or worsen, consult your doctor immediately.
Children and adolescents
The use of Dexketoprofen Ketoflix has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore Dexketoprofen Ketoflix should not be used in children and adolescents.
Dexketoprofen Ketoflix and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take.
Some medicines should not be used together with Dexketoprofen Ketoflix, and in other cases dosage adjustments may be necessary when Dexketoprofen Ketoflix is taken concurrently.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexketoprofen Ketoflix:

• Not recommended for concomitant use:
• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs.
• Warfarin, heparin, or other anticoagulant drugs.
• 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.
• Concomitant use requiring caution:
• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart diseases.
• 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.
• Concomitant 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 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 medical termination of pregnancy.
• Antidepressants from the selective serotonin reuptake inhibitors (SSRI) group.
• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation.

If you have any doubts regarding the use of Dexketoprofen Ketoflix, consult your doctor or pharmacist.
Dexketoprofen Ketoflix with food and drink
Dexketoprofen Ketoflix tablets should be swallowed with sufficient water. Taking the tablets with food may reduce the risk of gastrointestinal side effects. However, in the 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
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Do not take Dexketoprofen Ketoflix if you are in the last three 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 tendency to bleeding in both mother and child and may delay or prolong labour. Dexketoprofen Ketoflix should not be used during the first 6 months of pregnancy unless your 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, Dexketoprofen Ketoflix may cause kidney function disturbances in the unborn child if used for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Do not use Dexketoprofen Ketoflix if you are breastfeeding.
Dexketoprofen Ketoflix may impair fertility; its use is not recommended in women with fertility problems, those planning pregnancy, or during fertility investigations.
Driving and operating machinery
Dexketoprofen Ketoflix may have a minor influence on the ability to drive and use machines due to possible side effects such as dizziness or drowsiness. If such symptoms occur, do not drive or operate machinery until symptoms resolve. If in doubt, consult your doctor.
Dexketoprofen Ketoflix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Dexketoprofen Ketoflix

This medicine should always be taken exactly as described in the patient information leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dexketoprofen Ketoflix is intended for short-term use only, and treatment should be limited to the period during which symptoms are present.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The recommended daily dose depends on the type, severity, stage, and duration of pain in the patient, and is usually half a 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 or in patients with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
If well tolerated, in elderly patients this initial dose may subsequently be increased to the dose recommended for the general population (75 mg).
In cases of acute pain requiring faster onset of action, Dexketoprofen Ketoflix should be taken on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine (see "Dexketoprofen Ketoflix with food and drink").

Taking more Dexketoprofen Ketoflix than recommended
If an overdose is suspected, contact your 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 Dexketoprofen Ketoflix
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 take Dexketoprofen Ketoflix").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below and grouped according to how likely they are to occur:
Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain, diarrhoea, indigestion (dyspepsia).
Uncommon side effects (may affect up to 1 in 100 people):
Vertigo, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations,
facial flushing, gastric disturbances, constipation, dryness of the oral mucosa, bloating with flatulence,
rash, fatigue, pain, feeling of fever and chills, malaise.
Rare side effects (may affect up to 1 in 1,000 people):
Gastric ulcer, gastrointestinal bleeding or perforation, which may present as vomiting blood or black stools,
fainting, hypertension, reduced respiratory rate, fluid retention in limbs and peripheral oedema (e.g. swollen ankles),
throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain,
increased urination, menstrual disorders, prostate gland disorders, abnormal liver function tests, liver cell damage
(hepatitis), acute renal failure.
Very rare side 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 skin, lips, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome),
facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to constriction of respiratory muscles
(bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, tinnitus,
skin hypersensitivity reactions and photosensitivity, itching, kidney function disorders, reduced white blood cell count
(neutropenia), reduced platelet count (thrombocytopenia).
You should inform your doctor if you notice any gastrointestinal side effects (e.g. stomach pain, heartburn or bleeding)
at the beginning of treatment, or if you have previously experienced any similar adverse effects due to long-term use
of anti-inflammatory medicines; this particularly applies to elderly patients.
If a skin rash or any skin changes or lesions of mucous membranes (e.g. inside the mouth or on genital organs)
or any allergic symptoms occur, treatment with Dexketoprofen Ketoflix should be stopped immediately.
During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of ankles and legs),
increased blood pressure and heart failure may occur.
Use of medicines such as Dexketoprofen Ketoflix may be associated with a small increased risk of heart attack
("myocardial infarction") 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.
Frequency not known: cannot be estimated from available data
Chest pain, which may be a symptom of an allergic reaction with potentially severe course, known as Kounis syndrome.
Fixed drug eruption
Allergic skin reaction known as fixed drug eruption, which may include round or oval areas of redness and swelling of the skin,
formation of blisters and itching. Skin darkening in affected areas may also occur, which may persist after healing.
Fixed drug eruptions usually recur in the same location(s) upon re-administration of the drug.
Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dexketoprofen Ketoflix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the blister.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dexketoprofen Ketoflix contains
The active substance is dexketoprofen trometamol. One coated tablet contains 25 mg of dexketoprofen in the form of 36.90 mg of dexketoprofen trometamol.
Other ingredients are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate, Opadry Y-1-7000 coating (hypromellose, titanium dioxide (E-171), polyethylene glycol 400).

What Dexketoprofen Ketoflix looks like and contents of the pack
Dexketoprofen Ketoflix is available as white, biconvex, cylindrical coated tablets, with a score line and engraved with the mark "DT2" on one side. The tablets can be divided into equal doses.
PVC/PVDC/Aluminium blister packs 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Manufacturer
SAG MANUFACTURING S.L.U.
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain

Galenicum Health, S.L.U
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain