DELPROFEX 25 mg FILM-COATED TABLETS

2. What you need to know before you take Delprofex

Do not take Delprofex:

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction such as asthma, allergic rhinitis, nasal polyps, urticaria, angioedema, or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have had photoallergic or phototoxic reactions (a special type of skin redness or burns when exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels).
• If you have or have had peptic ulcers, stomach or intestinal bleeding, or have suffered from stomach or intestinal bleeding, ulcers, or perforation (e.g., indigestion, heartburn).
• If you have had stomach or intestinal bleeding or perforation in the past due to previous 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 renal impairment, or severe hepatic impairment.
• 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:

• 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 your doctor or pharmacist about this treatment. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment.
• If you are an elderly patient, you may experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately.
• If you are a woman with fertility problems (this medicine may reduce 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 or a disorder of blood cell production.
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue).
• If you have or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have or have had stomach or intestinal disorders.
• 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 clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking this medicine; your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block the production of stomach acid).
• If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, 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.
• If you have an infection; see the "Infections" section below.

Infections

Dexketoprofen may hide the signs of an infection, such as fever and pain. Consequently, this medicine 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 you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay. During chickenpox, it is recommended to avoid the use of this medicine.

Children and adolescents

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

Other medicines and Delprofex

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 may need a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to this medicine, 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 clot formation
• Lithium, used to treat some mood disorders
• Methotrexate, used for rheumatoid arthritis and cancer
• Hydantoins and phenytoin, used for epilepsy
• Sulfamethoxazole, used for bacterial infections.

Combinations that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart disorders
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Aminoglycoside antibiotics, used to treat bacterial infections
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes.

Combinations to be taken into account:

• Quinolone antibiotics (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 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 clot formation
• Tenofovir, deferasirox, pemetrexed.

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

Taking Delprofex with food, drinks, and alcohol:

The use of NSAIDs with alcohol may worsen the adverse reactions caused by the active substance, especially if they affect the gastrointestinal tract or the central nervous system.

For more information, see section 3 "Method of administration".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take dexketoprofen during the last three months of pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney and heart problems in your baby. It may affect your and your baby's ability to clot and delay or prolong delivery more than expected. You should not take this medicine during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

If you take it for more than a few days from the 20th week of pregnancy, this medicine may cause kidney problems in your baby, 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 for more than a few days, your doctor may recommend additional checks.

Breastfeeding

This medicine should not be taken during breastfeeding.

Fertility

Women who are planning a pregnancy or are pregnant should avoid the use of dexketoprofen. Treatment at any time during pregnancy should only be done under the guidance of a doctor. The use of this medicine is not recommended while trying to conceive or while undergoing fertility studies.

Driving and using machines

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

Delprofex 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 Delprofex

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The tablet can be divided into equal doses.

In adults over 18 years

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

If you are an elderly patient or have kidney or liver disease, it is recommended to start therapy 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 of 3 tablets (75 mg) if dexketoprofen has been well tolerated.

Do not use this medicine if you have moderate to severe renal impairment or severe hepatic impairment. Consult your doctor, pharmacist, or nurse if you are unsure.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years.

Duration of treatment

This medicine is not intended for prolonged use, and treatment should be limited to the symptomatic period.

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if the symptoms (such as fever and pain) persist or worsen (see section 2).

Method of administration

Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water). Take your tablets with food, as it helps reduce the risk of stomach or intestinal side effects. If your pain is severe and you need faster relief, take the tablets on an empty stomach (at least 30 minutes before meals) because they will be absorbed more easily.

If you take more Delprofex 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 immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Delprofex

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 Delprofex").

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible adverse effects are detailed below according to their frequency.

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

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

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

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

Peptic ulcer, peptic ulcer perforation, or bleeding, which may manifest with vomiting blood or black stools, fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (e.g., ankle swelling), 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 Adverse Effects (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (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. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

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

Stop taking this medicine 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 an allergic reaction.

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 this one may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("stroke").

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

The most frequently observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, may occur. 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, stomach wall inflammation (gastritis) 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Delprofex

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister. The expiration date is the last day of the month indicated.

Store below 30 °C. Keep the blister in the outer packaging to protect it from light.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Delprofex:

The active ingredient is dexketoprofen trometamol (36.90 mg) equivalent to 25 mg of dexketoprofen.

The other components are: cornstarch, microcrystalline cellulose (E460), sodium carboxymethylcellulose (type A), glycerol distearate, hypromellose/HPMC 2910 (E464), titanium dioxide (E171), and macrogol 400.

Appearance of Delprofex and Package Contents:

White, biconvex, cylindrical, scored, and engraved with DT2 on one side.

The tablets are supplied in blisters (PVC-PVDC/aluminum blisters).

Delprofex is presented in packages containing 10, 20, or 30 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer:

SAG MANUFACTURING, S.L.U.

Carretera Nacional 1 Km 36

San Agustín Del Guadalix

28750 Madrid

Spain

Galenicum Health S.L.U.

Carrer De Sant Gabriel 50

Esplugues De Llobregat

08950 Barcelona

Spain

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

Germany: Delprofex 25 mg Filmtabletten

Slovakia: Xeldinor 25 mg filmom obalené tablety

Spain: Delprofex 25 mg comprimidos recubiertos con película EFG

Estonia: Xeldaxin 25 mg õhukese polümeerikattega tabletid

Italy: Delprofex 25 mg compresse rivestite con film

Latvia: Xeldaxin 25 mg apvalkotas tabletes

Lithuania: Xeldaxin 25 mg plevele dengtos tabletes

Poland: Delprofex, 25 mg, tabletki powlekane

Portugal: Delprofex, 25mg, comprimidos revestidos por película

Czech Republic: Xeldinor 25 mg potahované tablety

Date of the Last Revision of this Prospectus:

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