Dexfenia

Package leaflet: Information for the patient

Dexfenia 25 mg film-coated tablets

dexketoprofen
Generic medicine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Please read all of this leaflet carefully before taking this medicine, because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, ask your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after 3-4 days.

Contents of this leaflet:

1. What Dexfenia is and what it is used for
2. What you need to know before taking Dexfenia
3. How to take Dexfenia
4. Possible side effects
5. How to store Dexfenia
6. Contents of the pack and other information

1. What Dexfenia is and what it is used for

Dexfenia is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful menstrual periods (dysmenorrhoea), and toothache, in adults.

2. What you should know before taking Dexfenia

Do not take Dexfenia:

• If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid or to 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 mucosa), nasal polyps (nodules inside the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties), or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have previously experienced photoallergic or phototoxic reactions (a specific type of skin redness and/or blistering on sun-exposed skin) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels).
• If you have a peptic ulcer or gastrointestinal bleeding, or if you have previously experienced stomach or intestinal bleeding, ulceration, or perforation.
• If you suffer from chronic digestive problems (e.g. indigestion, heartburn).
• If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain.
• If you have inflammatory bowel diseases (Crohn’s disease or ulcerative colitis).
• If you have severe heart failure, or moderate to severe kidney problems, or severe liver problems.
• If you have bleeding disorders or blood coagulation disorders.
• If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake.
• If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dexfenia:

• If you suffer from allergies, or if you have previously had allergic reactions.
• If you have kidney, liver, or heart problems (hypertension and/or heart failure), including fluid retention, or if you have previously suffered from any of these conditions.
• If you are taking diuretics or if you have very poor hydration or a reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, or vomiting).
• If you have heart conditions, have had a stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss treatment with your doctor or pharmacist; medicines such as Dexfenia may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• If you are elderly: you may be more likely to experience side effects (see section 4). If any of these occur, consult your doctor immediately.
• If you are a woman with fertility problems (Dexfenia may impair fertility; therefore, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations).
• If you have a disorder affecting blood and blood cell formation.
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue).
• If you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease).
• If you have or have previously had other stomach or intestinal disorders.
• If you have an infection, see the section “Infections” below.
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting, such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking Dexfenia: your doctor may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that block gastric acid production).
• If you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexfenia may mask signs of infection such as fever and pain. Therefore, Dexfenia could delay appropriate treatment of the infection, potentially increasing the risk of complications.
This has been observed in bacterial pneumonia and bacterial skin infections caused by varicella. If you take this medicine while having an infection and your symptoms persist or worsen, consult a doctor immediately.

Children and adolescents
Dexfenia has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children and adolescents.

Other medicines and Dexfenia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, while others may require dose adjustments when taken concomitantly.
Always inform your doctor, dentist, or pharmacist if you are using or are prescribed any of the following medicines in addition to Dexfenia:

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other medicines used to prevent blood clot formation
• Lithium, used to treat certain mood disorders
• Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
• Phenytoin and phenytoin, used for epilepsy
• Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:

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

Combinations requiring careful evaluation:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots
• Probenecid, used to treat gout
• Digoxin, used in the treatment of chronic heart failure
• Mifepristone, used as an abortifacient (to terminate pregnancy)
• Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation
• Beta-blockers, used for high blood pressure and heart problems
• Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Dexfenia, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
Do not use Dexfenia during the last three months of pregnancy or while breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Dexfenia may not be suitable for you.
The use of Dexfenia should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be undertaken under direct medical supervision.
The use of Dexfenia is not recommended while planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, “Warnings and precautions”.

Driving and using machines
Dexfenia may slightly affect the ability to drive and use machines due to the possibility of side effects such as dizziness and fatigue associated with treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Dexfenia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Dexfenia

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.
The dose of Dexfenia you need depends on the type, intensity, and duration of your pain. Your doctor will tell you
how many tablets you should take each day and for how long.
The recommended dose is generally ½ tablet (12.5 mg) every 4–6 hours and 1 tablet (25 mg)
every 8 hours, with no more than 3 tablets per day (75 mg).
Always follow exactly the instructions provided in this leaflet or those given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is generally ½ tablet (12.5 mg) every 4–6 hours and 1 tablet (25 mg)
every 8 hours, with no more than 3 tablets per day (75 mg).
If you do not feel better or feel worse after 3–4 days, consult your doctor. Your doctor will tell you
how many tablets you should take each day and for how long. The dose of Dexfenia you need depends on the type, intensity, and duration of your pain.
You should use the lowest effective dose for the shortest duration necessary to relieve your symptoms. If you have
an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen
(see section 2).
If you are elderly or suffer from kidney or liver disease, you should start treatment with a total daily dose of no more than 2 tablets (50 mg).
If Dexfenia has been well tolerated, even in elderly patients this initial dose may subsequently be increased to the generally recommended dose (75 mg).

Method of administration
Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of stomach or intestinal side effects. However, if the pain is severe and you wish to achieve faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption.

Use in children and adolescents
This medicine must not be taken by children and adolescents (under 18 years of age).

If you take more Dexfenia than you should
If you take too much of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine’s packaging or this patient information leaflet with you.

If you forget to take Dexfenia
Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time (refer to section 3 “How to take Dexfenia”).

If you have any 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, grouped according to their frequency of occurrence.

Common side effects: may affect up to 1 in 10 people:
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people:
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the gastric wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, general malaise.

Rare side effects: may affect up to 1 in 1,000 people:
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may present with blood in vomit or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), changes in skin sensation (pruritic rash, acne, increased sweating), back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 people:
Anaphylactic reaction (hypersensitivity reaction which may lead to collapse), skin ulceration, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), breathing difficulties due to narrowing of the airways (bronchospasm), laboured breathing, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), skin sensitivity, photosensitivity, itching, kidney disorders. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Immediately inform your doctor if you notice any gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medicines, particularly if you are elderly.

Stop taking Dexfenia immediately if you notice the appearance of a skin rash, or any lesions inside the mouth or on the genitals, or any signs of allergy.

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

Medicines such as Dexfenia may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).

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

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, especially in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the gastric wall (gastritis) has been observed.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexfenia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dexfenia contains:

• The active substance is dexketoprofen. Each film-coated tablet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).
• The other components (excipients) are microcrystalline cellulose, sodium croscarmellose, maize starch, anhydrous colloidal silica, magnesium stearate in the tablet core; and hypromellose, macrogol 6000, propylene glycol, titanium dioxide (E171) in the coating. See section 2 "Dexfenia contains sodium".

Description of the appearance of Dexfenia and pack sizes
White or almost white, round, biconvex, film-coated tablets, with a score on one side.
Size: approximately 10 mm in diameter.
The tablet can be divided into equal doses.
Dexfenia is available in packages containing 10 x 1, 20 x 1, 30 x 1 and 50 x 1 film-coated tablet(s) in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l. – Milan – Italy

Manufacturer
KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
TAD Pharma GmbH,
Heinz-Lohmann-Straße 5,
27472 Cuxhaven,
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names: