Delprofex

Leaflet attached to the packaging: patient information

Delprofex, 25 mg, coated tablets

Dexketoprofen

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Delprofex and what is it used for

Delprofex is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Delprofex is used in adults for short-term symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, painful menstruation, and toothache.

2. Important information before taking Delprofex

When not to take Delprofex

• If the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If the patient has had hypersensitivity reactions such as asthma, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory problems) or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has had photoallergic or phototoxic reactions (a particular type of redness and/or blistering of the skin due to exposure to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood fat levels);
• If the patient has or has had stomach or duodenal ulcers, bleeding from the stomach or intestines, or chronic digestive disorders (e.g., indigestion, heartburn);
• If the patient has or has had bleeding or perforation of the stomach or intestines due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) as painkillers;
• If the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney failure, or severe liver dysfunction;
• If the patient has bleeding or coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Delprofex, the patient should discuss it with their doctor or pharmacist

• In case of allergies or a history of allergies.
• In case of kidney, liver, or heart disorders (hypertension and/or heart failure), as well as fluid retention or a history of these conditions.
• In case of taking diuretics or in case of very poor hydration and decreased blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting).
• In case of heart disorders, a history of stroke, or suspected high risk of these conditions (e.g., high blood pressure, diabetes, or high cholesterol, or smoking), the patient should discuss treatment with their doctor or pharmacist: taking medicines like Delprofex may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with increasing doses and duration of treatment. The recommended dose and treatment duration should not be exceeded.
• In case of elderly patients: elderly patients may be more prone to side effects (see section 4). If any occur, the patient should immediately consult their doctor.
• In case of women with fertility disorders (Delprofex may affect female fertility, so women planning to become pregnant or undergoing fertility tests should not take it).
• In case of blood disorders or blood cell disorders.
• In case of systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue).
• In case of a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• In case of a history of other stomach or intestinal disorders.
• In case of taking other medicines that increase the risk of stomach ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, selective serotonin reuptake inhibitors), anticoagulants (e.g., warfarin), or antiplatelet agents (e.g., aspirin). In these cases, the patient should consult their doctor before taking this medicine: the doctor may recommend taking an additional medicine to protect the stomach (e.g., misoprostol or acid-reducing medicines).
• In case of asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, there is a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the rest of the population. Administration of this medicine may trigger asthma or bronchospasm attacks, especially in patients allergic to acetylsalicylic acid or NSAIDs.
• In case of infections, see the "Infections" subsection below.

Infections
Dexketoprofen may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Delprofex may delay proper treatment of the infection, which may lead to increased risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections in chickenpox. If the patient is taking this medicine during an infection and the symptoms persist or worsen, they should immediately consult their doctor. In case of chickenpox, it is recommended to avoid taking this medicine.

Children and adolescents

Dexketoprofen has not been studied in children and adolescents. Therefore, the safety of using the medicine in children and adolescents has not been established, and it should not be used in children and adolescents.

Delprofex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription. There are certain medicines that should not be taken together, and others whose doses may need to be changed when taken in certain combinations.
The patient should always inform their doctor, dentist, or pharmacist about the use or planned use of any of the following medicines in addition to Delprofex:

• Concomitant use not recommended:
• acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines,
• warfarin, heparin, or other anticoagulants,
• lithium, used to treat certain mood disorders,
• methotrexate, used to treat rheumatoid arthritis and cancer,
• hydantoin derivatives, e.g., phenytoin, used to treat epilepsy,
• sulfamethoxazole, used to treat bacterial infections.

Concomitant use requiring caution:

• angiotensin-converting enzyme inhibitors, diuretics, beta-blockers, and angiotensin II receptor antagonists, used to treat high blood pressure and heart disorders,
• pentoxifylline and oxpentifylline, used to treat chronic venous ulcers,
• zydovudine, used to treat viral infections,
• aminoglycoside antibiotics, used to treat bacterial infections,
• sulfonylurea derivatives (e.g., chlorpropamide and glibenclamide), used to treat diabetes.

Concomitant use requiring special consideration:

• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections,
• cyclosporine or tacrolimus, used to treat immune system disorders and organ transplants,
• streptokinase and other thrombolytic or fibrinolytic agents, e.g., medicines used to dissolve blood clots,
• probenecid, used to treat gout,
• digoxin, used to treat chronic heart failure,
• mifepristone, used as an abortifacient (to terminate pregnancy),
• selective serotonin reuptake inhibitors (SSRIs), a type of antidepressant,
• antiplatelet agents used to limit platelet aggregation and blood clot formation,
• tenofovir, deferazirox, pemetrexed.

In case of any doubts about taking other medicines with Delprofex, the patient should consult their doctor or pharmacist.

Taking Delprofex with food, drink, and alcohol

Taking NSAIDs with alcohol may increase the risk of side effects caused by the active substance, especially those affecting the gastrointestinal tract or central nervous system. More information can be found in section 3 "Method of administration".

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.
Pregnancy
Delprofex should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. Delprofex may increase the risk of bleeding in pregnant women and their children and may lead to delayed or prolonged labor. During the first 6 months of pregnancy, Delprofex should not be taken unless absolutely necessary and only on the advice of a doctor. If Delprofex is to be taken during an attempt to conceive or in the first and/or second trimester of pregnancy, the lowest effective dose should be used for the shortest possible duration.
Taking Delprofex for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If Delprofex is taken for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Delprofex should not be taken during breastfeeding.
Fertility
Women planning to conceive and pregnant women should avoid taking Delprofex. Treatment initiated at any stage of pregnancy should only be done under the advice of a doctor.
Delprofex is not recommended for women trying to conceive or during fertility testing.

Driving and using machines

Delprofex may cause dizziness and fatigue, and therefore may slightly affect the ability to drive vehicles and operate machines. If such symptoms are observed, the patient should not drive vehicles or operate machines until the symptoms have resolved.
In case of doubts, the patient should consult their doctor.

Delprofex contains sodium

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

3. How to take Delprofex

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The tablet can be divided into equal doses.
Adults aged 18 and over
The recommended dose is usually half a tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours, not more than 3 tablets per day (75 mg).
In elderly patients or in case of mild kidney or liver disorders, treatment should be started with a total daily dose not exceeding 2 tablets (50 mg).
In elderly patients, this dose may be increased later to the generally recommended dose of 3 tablets (75 mg) if Delprofex is well tolerated.
The medicine should not be taken in case of moderate or severe kidney failure or severe liver failure. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Use in children and adolescents

This medicine should not be taken by children and adolescents under 18 years of age.

Duration of treatment

The patient should consult their doctor if symptoms persist or worsen after 3-4 days.
This medicine is not intended for long-term use, and treatment should be limited to the symptomatic period.
The patient should use the lowest effective dose for the shortest time necessary to relieve symptoms. If the patient has an infection, they should consult their doctor immediately if symptoms (such as fever or pain) persist or worsen (see section 2).

Method of administration

The tablet should be swallowed with a sufficient amount of liquid (e.g., one glass of water). The medicine should be taken with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of acute pain and the need for rapid relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), as this will facilitate absorption of the medicine.

Taking a higher dose of Delprofex than recommended

In case of taking too much of this medicine, the patient should immediately inform their doctor or pharmacist or go to the emergency department of the nearest hospital. The patient should remember to take the packaging of this medicine or the attached leaflet with them.

Missing a dose of Delprofex

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose at the usual time (as described in section 3 "How to take Delprofex").
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, Delprofex can cause side effects, although not everybody gets them.
The following is a list of possible side effects, according to their frequency of occurrence.
Common(may affect up to 1 in 10 people):
Nausea and/or vomiting, stomach pain, diarrhea, digestive problems (indigestion).
Uncommon(may affect up to 1 in 100 people):
Dizziness (feeling of spinning), drowsiness, sleep disorders, nervousness, headache, palpitations, flushing, gastritis (stomach inflammation), constipation, dry mouth, bloating, skin rash, fatigue, pain, feeling of heat and chills, general malaise (weakness).
Rare(may affect up to 1 in 1,000 people):
Ulcers, perforation, or bleeding from ulcers (which may manifest as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral edema (e.g., swollen ankles), laryngeal edema, loss of appetite (anorexia), unusual sensations, pruritic rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver test results (blood test), liver cell damage (hepatitis), acute kidney failure.
Very rare(may affect up to 1 in 10,000 people):
Anaphylactic shock (allergic reaction that can also lead to fainting), open sores on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or edema of the lips and throat (angioedema), shortness of breath due to bronchial constriction (bronchospasm), dyspnea, tachycardia, hypotension, pancreatitis, blurred vision, tinnitus (ringing in the ears), sensitive skin, photosensitivity, itching, kidney disorders. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
The patient should immediately inform their doctor if they notice any gastrointestinal symptoms at the start of treatment (e.g., stomach pain, heartburn, or bleeding) and if they have experienced such side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
Delprofex should be discontinued immediately if a rash or any changes in the mouth or genital areas occur, or if any signs of allergy appear.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and edema (especially in the legs and ankles) have been reported, as well as increased blood pressure and heart failure.
Medicines like Delprofex may be associated with a small increased risk of heart attack (myocardial infarction) or 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. Ulcers, perforation, or bleeding from the gastrointestinal tract may occur, sometimes fatal, especially in elderly patients. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, black stools, vomiting blood, oral ulceration, worsening of colitis and Crohn's disease have been reported. Less frequently, gastritis (stomach inflammation) has been observed. As with other NSAIDs, hematologic reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, as well as agranulocytosis and bone marrow hypoplasia) may occur.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Delprofex

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Store below 30°C. Store in the outer 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Delprofex contains

The active substance is dexketoprofen trometamol (36.90 mg), equivalent to 25 mg of dexketoprofen.
The other ingredients (excipients) of the medicine are: corn starch, microcrystalline cellulose (E 460), sodium carboxymethylcellulose (type A), glycerol distearate, hypromellose/HPMC 2910 (E 464), titanium dioxide (E 171), macrogol 400.

What Delprofex looks like and contents of the pack

White, biconvex, cylindrical tablets with a break line and the inscription "DT2" on one side.
Delprofex is available in blister packs (PVC-PVDC/aluminum) containing 10, 20, and 30 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
Email: [email protected]

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 under the following names:

Poland, Portugal, Spain, Germany, Italy: Delprofex
Czech Republic, Slovakia: Xeldinor
Estonia, Lithuania, Latvia: Xeldaxin

Date of last revision of the leaflet: