DEXKETOPROFEN KRKA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dexketoprofen Krka 25 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dexketoprofen Krka and what is it used for
2. What you need to know before you take Dexketoprofen Krka
3. How to take Dexketoprofen Krka
4. Possible side effects
5. Storing Dexketoprofen Krka
6. Package Contents and Further Information

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

Dexketoprofen is a pain reliever belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild or moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhea), toothache, in adults.

2. What you need to know before you take Dexketoprofen Krka

Do not take Dexketoprofen Krka

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), hives (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If you have had photoallergic or phototoxic reactions (a special form of redness or sunburn of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Dexketoprofen Krka:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (high blood pressure and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("stroke"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient: you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (dexketoprofen may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a blood disorder and blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If you have had stomach or intestinal disorders in the past;
  • If you have an infection; see the "Infections" heading later.

• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking dexketoprofen: it may be that your doctor prescribes an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric acid production).
  • If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may hide the signs of an infection, such as fever and pain. Consequently, dexketoprofen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Children and Adolescents

Dexketoprofen has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children or adolescents.

Other Medicines and Dexketoprofen Krka

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. There are some medicines that should not be taken together and others that may need a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to dexketoprofen, you are taking any of the following medicines:

Not Recommended Combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (a medicine for cancer and immunosuppression), used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations that Require Precaution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure control and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week.

Combinations to be Considered:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
  • Beta-blockers, used for high blood pressure and heart disorders;
  • Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with Dexketoprofen Krka, consult your doctor or pharmacist.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as dexketoprofen may not be suitable for you.

Do not take dexketoprofen if you are in the last 3 months of pregnancy, as it may harm your fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take dexketoprofen during the first 6 months of pregnancy unless it is clearly necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum possible dose. If you take it for more than a few days from the 20th week of pregnancy, dexketoprofen may cause kidney problems in your fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment during a period of more than a few days, your doctor may recommend additional checks.

The use of dexketoprofen is not recommended while trying to conceive or while studying a fertility problem.

Regarding potential effects on female fertility, see also section 2, "Warnings and Precautions".

Driving and Using Machines

Dexketoprofen may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

Dexketoprofen Krka Contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to Take Dexketoprofen Krka

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose of dexketoprofen you need may vary, depending on the type, intensity, and duration of the pain. Your doctor will indicate how many tablets you should take per day and for how long.

In general, the recommended dose is ½ tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

If you are an elderly patient or suffer from kidney or liver disease, therapy should be started with a maximum of 2 tablets per day (50 mg).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if dexketoprofen has been well tolerated.

Method of Administration

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of suffering from side effects in the stomach or intestine. However, if your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before meals) as they will be absorbed more easily.

Use in Children and Adolescents

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

If You Take More Dexketoprofen Krka Than You Should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to always carry the medicine package or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget to Take Dexketoprofen Krka

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due (according to section 3 "How to Take Dexketoprofen Krka").

If you have any doubts 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 everybody gets them.

Possible side effects are listed below by frequency.

Common Side Effects (may affect up to 1 in 10 people)

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhea, digestive disorders (dyspepsia).

Uncommon Side Effects (may affect up to 1 in 100 people)

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general malaise.

Rare Side Effects (may affect up to 1 in 1,000 people)

Peptic ulcer, perforation of peptic ulcer, or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent 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 also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or bleeding), if you have previously suffered from these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are an elderly patient.

Stop taking dexketoprofen immediately if you notice the appearance of a skin rash or any lesion inside the mouth or on the genitals, or any other sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("stroke").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

The most common side effects observed are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, especially in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis, and Crohn's disease have been reported. Less frequently, gastritis (inflammation of the stomach wall) has been observed.

As with other NSAIDs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may appear.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofeno Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after CAD/EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dexketoprofeno Krka

The active substance is dexketoprofen.

Each film-coated tablet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).

The other ingredients (excipients) are microcrystalline cellulose, sodium croscarmellose, corn starch, hypromellose, anhydrous colloidal silica, and magnesium stearate in the tablet core, and hypromellose, macrogol 6000, propylene glycol, and titanium dioxide (E171) in the coating. See section 2 "Dexketoprofeno Krka contains sodium".

Appearance and Package Contents of the Product

Film-coated tablet, white to almost white, round, biconvex, and scored on one side. The tablet can be divided into equal doses.

This medicine is available in packs containing 10, 20, 30, and 50 tablets in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:October 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es//.