Dexketoprofen Sandoz 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dexketoprofen Sandoz 25 mg film-coated tablets EFG

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

• Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dexketoprofeno Sandoz is and what it is used for

Dexketoprofeno Sandoz is an analgesic 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, menstrual pain (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno Sandoz

Do not take Dexketoprofeno Sandoz if:

• you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6),
• you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• you have asthma or have experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (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 NSAIDs,
• you have previously experienced photoallergic or phototoxic reactions (a special type of redness or blistering of the skin upon exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels),
• you currently have or have previously had peptic ulcer, gastrointestinal bleeding, ulceration, or perforation,
• you have chronic digestive problems (e.g., indigestion, heartburn),
• you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief,
• you have an inflammatory bowel disease (Crohn’s disease or ulcerative colitis),
• you have severe heart failure, moderate to severe kidney failure, or severe liver failure,
• you have bleeding disorders or blood coagulation disorders,
• you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake,
• you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking dexketoprofen if:

• you have allergies or a history of allergic reactions,
• you have kidney, liver, or heart problems (hypertension and/or heart failure), fluid retention, or have had any of these conditions in the past,
• you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting),
• you have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., if you have high blood pressure, diabetes, high cholesterol, or are a smoker); you should discuss this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes. This risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment,
• you are elderly: you may be more likely to experience adverse effects (see section 4). If you experience any of these, consult your doctor immediately,
• you are a woman with fertility problems (dexketoprofen may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations),
• you have a disorder affecting blood or blood cell production,
• you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue),
• you currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease),
• you currently have or have previously had stomach or intestinal disorders,
• you have an infection; see the “Infections” section below,
• you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting like aspirin or anticoagulants such as warfarin. In such cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production),
• you have asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, which increases your risk of allergy to acetylsalicylic acid or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs,
• you have recently undergone major surgery.

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately. During chickenpox, it is advisable to avoid using this medicine.

Allergic reactions to dexketoprofen, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately discontinue treatment with dexketoprofen and contact your doctor or nearest emergency service if you experience any of these symptoms.

During prolonged use of dexketoprofen, your doctor will regularly monitor your liver enzymes, kidney function, and blood counts.

Children and adolescents

Dexketoprofen has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and it should not be used in children or adolescents under 18 years of age.

Other medicines and Dexketoprofeno Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines should not be taken together, while others may require dose adjustments when used concurrently.

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

Combinations not recommended:

• acetylsalicylic acid, corticosteroids, and other anti-inflammatory medicines,
• warfarin, heparin, and other medicines used to prevent blood clotting,
• lithium, used to treat certain mood disorders,
• methotrexate (a cancer and immunosuppressive medicine), when used at high doses of 15 mg/week,
• hydantoins 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 to treat viral infections,
• aminoglycoside antibiotics, used to treat bacterial infections,
• sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes,
• methotrexate, when used at low doses (less than 15 mg/week).

Combinations to be aware of:

• 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 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 termination of pregnancy),
• selective serotonin reuptake inhibitors (SSRIs),
• antiplatelet agents used to reduce platelet aggregation and blood clot formation,
• beta-blockers, used for high blood pressure and heart conditions,
• tenofovir, deferasirox, pemetrexed.

If you have any questions about taking other medicines with Dexketoprofeno Sandoz, consult your doctor or pharmacist.

Taking Dexketoprofeno Sandoz with food and drinks

Take the film-coated tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal side effects. However, in cases of acute pain, take the tablets on an empty stomach, i.e., at least 30 minutes before meals, as this allows the medicine to act slightly faster.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take dexketoprofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may also affect your tendency and your baby’s tendency to bleed and may delay or prolong labor more than expected.

You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time.

From week 20 of pregnancy, this medicine may cause kidney problems in your fetus if taken for more than a few days, which could 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

The use of dexketoprofen is not recommended if you are trying to conceive or undergoing fertility investigations.

Regarding potential effects on female fertility, see also section 2, “Warnings and precautions.”

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as side effects. If you experience these effects, do not operate machinery or drive until they subside. Consult your doctor.

Dexketoprofeno Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Dexketoprofeno Sandoz

Follow exactly the instructions for use of this medicine provided by your doctor. If you have any doubts, consult your doctor or pharmacist again.

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

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

In general, the recommended dose is 1 tablet (25 mg) every 8 hours, without exceeding 3 tablets per day (75 mg).

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

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

The tablet may be divided into equal doses.

If your pain is severe and you need rapid relief, take the tablet on an empty stomach (at least 30 minutes before food), as it will be absorbed more easily (see section 2 “Taking Dexketoprofeno Sandoz with food and drink”).

Use in children and adolescents

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

If you take more Dexketoprofeno Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested. Remember to bring the container or package leaflet of this medicine with you.

If you forget to take Dexketoprofeno Sandoz

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (according to section 3 “How to take Dexketoprofeno Sandoz”).

If you have any other questions about 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 everyone will experience them.

The possible adverse effects are listed below according to their frequency.

Frequent adverse effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, mainly upper abdominal pain, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish 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 present as vomiting blood or black stools, fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, 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 may also lead to collapse), open ulcers on skin, mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Frequency not known (frequency cannot be estimated from the available data):

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Drug-induced fixed eruption

An allergic skin reaction known as drug-induced fixed eruption, which may include round or oval red patches and skin swelling, blisters and itching. Skin darkening in affected areas may also occur, which may persist after healing. Drug-induced fixed eruption usually reappears in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning, or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with anti-inflammatory medicines, and particularly if you are an elderly patient.

Stop taking Dexketoprofeno Sandoz immediately if you notice the appearance of a skin rash or lesions in the mouth or genital area, or any other sign of allergy.

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

Medicines such as Dexketoprofeno Sandoz may be associated with a small increased risk of having a heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

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 effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Sandoz

The active substance is dexketoprofen trometamol.

Each tablet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.

The other components are corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A, from potato), glycerol distearate, hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and contents of the pack

Film-coated tablets, white, biconvex and cylindrical, scored on one side and marked with "DT2" on one face.

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

Pack sizes

10, 20, 30, 40, 50 and 500 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

or

SAG Manufacturing, S.L.U.
Ctra N-I, km 36
28750 San Agustín de Guadalix
Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria: ?????????????? ?????? 25 mg ????????? ????????

Ireland: Dexketoprofen Rowex 25 mg Film-coated Tablets

Portugal: Dexcetoprofeno Sandoz

Romania: Dexketoprofen trometamol Sandoz 25 mg comprimate filmate

Date of the most recent review of this leaflet: November 2025.

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