Dexdoless 25 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dexdoless 25 mg film-coated tablets

dexketoprofen

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 4 days.

Contents of this leaflet

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

1. What Dexdoless is and what it is used for

Dexdoless is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as muscular or joint pain, menstrual pain (dysmenorrhoea), or dental pain.

This medicine is intended for use in adult patients.

2. What you need to know before taking Dexdoless

Do not take Dexdoless:

• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or to another non-steroidal anti-inflammatory drug (NSAID);
• if 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 (aspirin) or other non-steroidal anti-inflammatory drugs;
• if you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• if you have peptic ulcer, gastrointestinal bleeding, or have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
• if you have 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) 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 failure, or severe hepatic failure;
• if you have bleeding disorders or blood coagulation disorders;
• if you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• if you are in the third trimester of pregnancy or during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexdoless:

• if you are allergic or have previously had allergic problems;
• if you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention, or have previously had any of these conditions;
• if you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• if you have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., 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 (“cerebrovascular accident”). Any risk is more likely when high doses or prolonged treatment are used. Do not exceed the recommended dose or duration of treatment;
• if you are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• if you are a woman with fertility problems (see section 2, “Pregnancy, breastfeeding, and fertility”);
• if you have a disorder affecting blood and blood cell production;
• if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• if you have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• if you have or have previously had stomach or intestinal disorders;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, certain antidepressants (SSRIs, Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting 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 gastric acid production);
• if you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Children and adolescents

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

Other medicines and Dexdoless

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, while others may require dose adjustments when used concomitantly.

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

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate, an anticancer 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, beta-blockers, and angiotensin II antagonists, used for high blood pressure control 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 glyburide), used for diabetes;
• Methotrexate, when used at low doses, less than 15 mg/week;

Combinations to be aware of:

• Quinolones (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 clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Antidepressants of the Selective Serotonin Reuptake Inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexdoless with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the possibility of causing stomach problems (see also section 3, “How to take Dexdoless”).

Using NSAIDs together with alcohol may worsen adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding, and fertility

Do not take this medicine during the last 3 months of pregnancy or during breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond what is expected.

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

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

This medicine may impair fertility and therefore its use is not recommended while trying to conceive or while being evaluated for infertility.

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until these symptoms resolve. Seek advice from your doctor.

3. How to take Dexdoless

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The required dose of the medicine may vary depending on the type, intensity, and duration of pain.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The tablets may be divided into equal doses.

Adults from 18 years of age

The recommended dose is generally 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets per day (75 mg).

Elderly patients or those with renal or hepatic impairment

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

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

Dexketoprofen must not be used if you have moderate or severe kidney problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

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

Method of administration

Take the tablets with an adequate amount of water.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disturbances. However, if your pain is severe and you need rapid relief, take the tablets on an empty stomach (at least 30 minutes before food or other intake), as the medicine will be absorbed more easily (see section 2 "Taking Dexdoless with food, drinks, and alcohol").

Duration of treatment

Treatment must not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, discontinue treatment and consult your doctor or pharmacist.

If you take more Dexdoless than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20 immediately, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Dexdoless

Do not take a double dose to make up for a missed dose.

Take the next dose as scheduled (according to section 3 "How to take Dexdoless").

If you have any further 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 pain in the upper abdominal quadrant, 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, rash, fatigue, pain, feverish feeling and chills, general malaise.

Rare adverse effects (may affect up to 1 in 1,000 people):

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting blood or black stools), fainting, elevated 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, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Inform your doctor immediately 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 elderly.

Stop taking the medicine immediately if you develop a skin rash, lesions inside the mouth or on the genitals, or any other sign of allergy.

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 such as dexketoprofen 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. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially 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 it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system available at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexdoless

PVC-PVDC-Aluminum packaging: Do not store above 25°C. Keep in the original packaging to protect from light.

Polyamide/Alu/PVC-Alu packaging: Do not store above 30°C.

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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexdoless

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each tablet contains 25 mg of dexketoprofen.
• The other components are:

Tablet core: maize starch, pregelatinized maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

Tablet coating: Opadry White (hypromellose, titanium dioxide, polyethylene glycol 400).

Appearance of Dexdoless and contents of the pack

Film-coated, scored, white, round tablets, packed in blisters.

Pack containing 10 tablets.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th floor

28046 Madrid, Spain

Manufacturer:

Kern Pharma S.L.

C/ Venus, 72

Pol. Ind. Colón, 2

08228 Terrassa

OR

LABORATORIOS MEDICAMENTOS INTERNACIONALES, S.A.

C/Solana 26, Torrejón de Ardoz, 28850

Madrid, Spain

OR

Toll Manufacturing Services S.L.

C/ Aragoneses, 2. 28108 Alcobendas (Madrid)

OR

Farmalider S.A.

C/ Aragoneses, 2.

28108 Alcobendas, Madrid

Spain

Date of the most recent revision of this leaflet: February 2024

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”