Patient Information Leaflet

Delprofex, 25 mg, film-coated tablets
Dexketoprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by the physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Delprofex is and what it is used for
What you need to know before taking Delprofex
How to take Delprofex
Possible side effects
How to store Delprofex
Contents of the pack and other information

1. What Delprofex is and what it is used for

Delprofex is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Delprofex is used in adults for the 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 previously experienced hypersensitivity reactions such as asthma, 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, tongue or breathing difficulties), or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
If the patient has previously experienced photoallergic or phototoxic reactions (a specific type of redness and/or blistering of the skin due to exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood fat levels);
If the patient currently has or has previously had peptic ulcer disease, gastrointestinal bleeding, or chronic digestive disorders (e.g. indigestion, heartburn);
If the patient currently has or has previously experienced 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 function disorders;
If the patient has bleeding disorders or coagulation disorders;
If the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake;
If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting treatment with Delprofex, discuss this with your doctor or pharmacist:

If you have allergies or a history of allergic reactions.
If you have impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or a history of any of these conditions.
If you are taking diuretics or are severely dehydrated with reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, or vomiting).
If you have heart disease, have had a stroke, or are at high risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), discuss treatment with your doctor or pharmacist; taking medicines such as Delprofex may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk increases with higher doses and longer duration of treatment. Do not exceed the recommended dose or duration of treatment.
In elderly patients: elderly individuals may be more susceptible to adverse effects (see section 4). If any occur, consult your doctor immediately.
In women with fertility disorders (Delprofex may impair female fertility; therefore, women planning pregnancy or undergoing fertility investigations should not use this medicine).
If you have blood or blood cell production disorders.
If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue).
If you have a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
If you have a history of other stomach or intestinal disorders.
If you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs – selective serotonin reuptake inhibitors), anticoagulants such as warfarin, or antiplatelet drugs such as aspirin. In such cases, consult your doctor before taking this medicine; your doctor may recommend taking an additional protective medicine for the stomach (e.g. misoprostol or acid-suppressing medicines).
If you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Taking this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.
If you have an infection, see the section "Infections" below.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, Delprofex may delay appropriate treatment of an infection, potentially increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and symptoms persist or worsen, consult your doctor immediately. In the case of chickenpox, the use of this medicine is not recommended.

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

Delprofex and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines. Some medicines should not be taken together, while others may require dose adjustments when used in combination.

Always inform your doctor, dentist, or pharmacist if you are taking or have taken any of the following medicines along with Delprofex:

Concomitant use not recommended:

Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines;
Warfarin, heparin, or other anticoagulant medicines;
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 (ACE) 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;
Zidovudine, used to treat viral infections;
Aminoglycoside antibiotics, used to treat bacterial infections;
Sulfonylurea derivatives (e.g. chlorpropamide, 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 in organ transplantation;
Streptokinase and other thrombolytic or fibrinolytic medicines, 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), antidepressants;
Antiplatelet medicines used to reduce platelet aggregation and prevent clot formation;
Tenofovir, deferasirox, pemetrexed.

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

Taking Delprofex with food, drink, and alcohol
Taking NSAIDs with alcohol may worsen adverse effects caused by the active substance, especially those affecting the gastrointestinal tract or central nervous system. More information is provided in section 3 "How to take".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Pregnancy
Delprofex must not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. This medicine may cause kidney and heart problems in the unborn child. Delprofex may increase the tendency to bleed in both the pregnant woman and the child and may delay or prolong labour. During the first 6 months of pregnancy, Delprofex should not be used unless absolutely necessary and only on the advice of a doctor. If Delprofex is to be used when trying to conceive or during the first and/or second trimester of pregnancy, the lowest effective dose for the shortest possible duration should be used. Taking Delprofex for longer than a few days after the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If Delprofex is taken for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding
This medicine must not be used during breastfeeding.

Fertility
Women planning pregnancy and pregnant women should avoid using Delprofex. Treatment during any stage of pregnancy should only be undertaken on the advice of a doctor. The use of Delprofex is not recommended in women trying to conceive or undergoing fertility diagnosis.

Driving and using machines
Delprofex may cause dizziness and fatigue and therefore may slightly affect the ability to drive and use machines. If such symptoms occur, do not drive or operate machinery until symptoms have resolved. If in doubt, consult your doctor.

Delprofex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Delprofex

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The tablet may be divided into equal doses.

Adults aged 18 years and older
The usual recommended dose is half a tablet (12.5 mg) every 4 to 6 hours or one tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).
For elderly patients or patients with mild renal impairment or mild to moderate hepatic impairment, treatment should be initiated with a total daily dose not exceeding 2 tablets (50 mg).
In elderly patients, this dose may later be increased to the generally recommended dose of 3 tablets (75 mg), provided Delprofex is well tolerated.
Do not use this medicine in cases of moderate or severe renal impairment or severe hepatic impairment. If in doubt, consult your doctor, pharmacist, or nurse.

Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Duration of treatment
Consult your doctor if symptoms persist or worsen after 3 to 4 days.
This medicine is not intended for long-term use, and treatment should be limited to the symptomatic period.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection, consult a doctor immediately if 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., one glass of water). The medicine should be taken with food, as this helps reduce the risk of gastrointestinal adverse effects. However, in the case of acute pain requiring rapid relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), as this facilitates easier absorption of the medicine.

Accidental overdose of Delprofex
If you have taken too much of this medicine, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine’s packaging or the enclosed leaflet with you.

Missed dose of Delprofex
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time (according to section 3, "How to use Delprofex").
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of possible adverse effects, classified according to their frequency of occurrence.
Common (may occur in no more than 1 in 10 people):
Nausea and (or) vomiting, stomach pain, diarrhoea, indigestion (dyspepsia).
Uncommon (may occur in no more than 1 in 100 people):
Dizziness (feeling of spinning), drowsiness, sleep disturbances, nervousness, headache, palpitations,
flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth,
bloating, skin rash, fatigue, pain, feeling of heat and chills, general malaise (weakness).
Rare (may occur in no more than 1 in 1,000 people):
Peptic ulcer, perforation or bleeding from ulcer (which may present as vomiting
blood or black stools), fainting, high blood pressure, slowed breathing, fluid retention
and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), unusual
sensations, itchy rash, acne, increased sweating, back pain, frequent urination,
menstrual disorders, prostate disorders, abnormal liver function tests (blood
test), liver cell damage (hepatitis), acute kidney failure.
Very rare (may occur in no more than 1 in 10,000 people):
Anaphylactic shock (allergic reaction which may also lead to fainting), open
ulcerations on the skin, mouth, eyes and genital areas (Stevens-Johnson syndrome
and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to
narrowing of the airways (bronchospasm), dyspnoea, rapid heartbeat, low blood pressure,
pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin,
photosensitivity, itching, kidney disorders. Decreased white blood cell count (neutropenia),
lowered platelet count in blood (thrombocytopenia).
Immediately inform your doctor if you notice any gastrointestinal symptoms
at the beginning of treatment (e.g. abdominal pain, heartburn or bleeding), as well as if
the patient has previously experienced any such adverse effects due to long-term
use of anti-inflammatory medicines, especially in elderly patients.
Discontinue Delprofex immediately upon observing any rash, or any changes inside the mouth or on genital organs, or any symptoms of allergy.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of legs and ankles) have been reported, as well as elevated blood pressure and heart failure.
Medicines such as Delprofex may be associated with a small increased risk of myocardial infarction ("heart attack") 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. Peptic ulcer disease, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients. After administration, nausea, vomiting, diarrhoea, bloating, constipation, dyspepsia, abdominal pain, black tarry stools, coffee-ground vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported.
Less frequently, inflammation of the gastric mucosa (gastritis) has been observed.
As with other NSAIDs, haematological reactions may occur (thrombocytopenia, aplastic anaemia and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 .
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Delprofex

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 the stated month.
Store below 30 °C. Keep in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: maize starch, microcrystalline cellulose
(E 460), sodium carboxymethyl starch (type A), glycerol distearate, hypromellose/HPMC 2910
(E 464), titanium dioxide (E 171), polyethylene glycol 400.
What Delprofex looks like and contents of the pack
White, biconvex, cylindrical coated tablets with a score line and engraved with "DT2" on one side.
Delprofex is available in blisters made of foil (PVC-PVDC/aluminium) containing 10, 20 or 30 coated tablets in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [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 medicinal product is authorised for sale in the European Economic Area countries under the following names:
Poland, Portugal, Spain, Germany, Italy: Delprofex
Czech Republic, Slovakia: Xeldinor
Estonia, Lithuania, Latvia: Xeldaxin