Dexketoprofen is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used to treat mild to moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhoea), dental pain.

Do not take dexketoprofen pensavital

• 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 other non-steroidal anti-inflammatory medicines;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of swelling of the lining of the nose), nasal polyps (fleshy formations 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 aspirin or other non-steroidal anti-inflammatory drugs;
• If you have experienced photoallergic or phototoxic reactions (a special kind of reddening or burning of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to reduce blood fat levels);
• If you have peptic ulcer, stomach or intestinal bleeding, or if you have had bleeding, ulceration or perforation of the stomach or intestine in the past;
• If you have chronic digestive problems (e.g. indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation, due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have bowel disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
• If you have severe heart failure, moderate or severe kidney problems or severe liver problems;
• If you have a bleeding disorder or a blood clotting disorder;
• If you are severely dehydrated (have lost a lot of body fluids) due to vomiting, diarrhoea or insufficient intake of fluids;
• If you are in the third trimester of pregnancy or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking dexketoprofen:

• If you suffer from an allergy, or if you have had allergy problems in the past;
• If you have kidney, liver or heart problems (hypertension and/or heart failure) as well as fluid retention, or have suffered from any of these problems in the past;
• If you are taking diuretics or you suffer from very poor hydration and reduced blood volume due to an excessive loss of fluids (e.g. from excessive urination, diarrhoea or vomiting);
• If you have heart problems, a history of stroke or think you may be at risk for these conditions (for example, you have high blood pressure, have diabetes, have increased cholesterol or are a smoker) you should discuss this treatment with your doctor or pharmacist. Medicines such as dexketoprofen may be associated with a small increased risk of heart attacks (“myocardial infarction”) or stroke (“cerebrovascular accident”). 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 adverse effects (see section 4). If any of these occur, consult your doctor immediately;
• If you are a woman with fertility problems (dexketoprofen may decrease your fertility so you should not take it if you are planning to become pregnant or if you are undergoing fertility tests);
• If you suffer from a disorder in the formation of blood and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
• If you have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis, Crohn’s disease);
• If you have or have suffered in the past from other stomach or bowel problems;
• If you have an infection; see the heading “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral corticosteroids, some antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), clot-preventing agents such as acetylsalicylic acid (aspirin) or anticoagulants such as warfarin. In these cases, consult your doctor before taking dexketoprofen, as 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 suffer from asthma combined with chronic rhinitis, chronic sinusitis and/or nasal polyps as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine can cause asthma attacks or bronchospasm, particularly in patients who are allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

Dexketoprofen pensavital has not been studied in children and adolescents. Therefore, its safety and efficacy have not been established and the medicinal product should not be used in children and adolescents.

Other medicines and Dexketoprofen pensavital

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. There are some medicines that should not be taken together and others that may need their doses to be altered when taken together.

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

Inadvisable combinations:

• Acetylsalicylic acid (aspirin), corticosteroids and other anti-inflammatory drugs;
• Warfarin, heparin or other medicines used to prevent blood clots;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics and angiotensin II antagonists, used for the control of high blood pressure and heart problems;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycosides antibiotics, used to treat bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes.

Combinations to be considered carefully:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and in organ transplant;
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to break-up blood clots;
• Probenecid, used in gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitors type (SSRIs);
• Anti-platelet agents used to reduce platelet aggregation and the formation of blood clots;
• Tenofovir, deferasirox, pemetrexed.

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

Dexketoprofen pensavital with food and drink

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of stomach or intestinal side effects. However, if you have acute pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, as this helps the medicine start working a little faster.

Pregnancy, breast-feeding and fertility

Do not take dexketoprofen during the last three months of pregnancy, as it may harm the foetus or cause problems during delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take dexketoprofen during the first 6 months of pregnancy unless its is 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 as short a time as possible. From the 20th week of pregnancy, Dexketoprofen pensavital may cause kidney problems in your unborn baby, which can 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 longer than a few days, your doctor may recommend additional monitoring.

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

Women who are planning a pregnancy or are pregnant should avoid using dexketoprofen. Treatment at any time during pregnancy should only take place as directed by a doctor. The use of Dexketoprofen pensavital is not recommended while trying to conceive or while an infertility problem is being investigated.

Driving and using machines

Dexketoprofen may slightly affect your ability to drive and handle machines, due to the possibility of dizziness or drowsiness as side effects of treatment. If you notice these effects, do not drive or use machines until these symptoms disappear. Ask your doctor for advice.

Dexketoprofen pensavital contains sodium

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose is generally 1 tablet (25 mg) every 8 hours, with no more than 3 tablets daily (75 mg).

If you are elderly or suffer from kidney or liver disease, it is recommended to start treatment with a total daily dose of no more than 2 tablets (50 mg).

In elderly patients, this initial dose can later be increased to that generally recommended (75 mg) if dexketoprofen has been well tolerated.

If your pain is intense and you need quicker relief, take the film-coated tablets on an empty stomach (at least 30 minutes before food) because they will be more easily absorbed (see section 2 “Dexketoprofen pensavital with food and drink”).

Use in children and adolescents

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

If you take more dexketoprofen pensavital than you should

If you have taken too much medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone (+34) 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take dexketoprofen pensavital

Do not take a double dose to make up for a forgotten dose. Take the next dose at the corresponding time (according to section 3 “How to take Dexketoprofen pensavital”).

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below according to how likely they are to occur:

Common (may affect up to 1 in 10 people):

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

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

Spinning sensation (vertigo), dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, general malaise.

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

Peptic ulcer, peptic ulcer perforation or bleeding, which may be seen 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 (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers of the skin, mouth, eyes and genital areas (Stevens Johnson syndrome and Lyell’s syndrome), swelling of the face or swelling of the 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, sensitivity to light, itching, kidney problems. Reduced white blood cell count (neutropenia), fewer platelets in the blood (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g. stomach pain, heartburn or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are elderly.

Stop taking Dexketoprofen pensavital immediately if you notice the appearance of a skin rash or lesion inside the mouth or on the genitals, or any other sign of allergy.

Fluid retention and swelling (especially in the ankles and legs), increased blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs.

Medicines such as Dexketoprofen pensavital may be associated with a small increased risk of heart attack (“myocardial infarction”) or cerebrovascular accident (“stroke”).

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es

By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after CAD. The expiry date refers to the last day of that month.

Do not store at temperatures above 30°C. Keep blister packs in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Dispose of containers and medicines that you do not need at the SIGRE Point  in the pharmacy. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What dexketoprofen pensavital contains

• The active substance is dexketoprofen trometamol (36.90 mg), which is equivalent to 25 mg dexketoprofen.
• The other ingredients (excipients) are maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate, hypromellose, titanium dioxide and macrogol 400.

What Dexketoprofen pensavital looks like and contents of the pack

Dexketoprofen pensavital film-coated tablets are white, biconvex, cylindrical, scored tablets, marked with “DT2” on one side.

The tablet can be divided into equal doses.

Dexketoprofen pensavital is available in packs containing 10 and 20 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

SAG Manufacturing, S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

Madrid, 28750 – Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

Barcelona, 08950 – Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal: Dexcetoprofeno Pensavital 25mg comprimidos revestidos por película

Italy: Dexketoprofene Pensavital 25mg, compresse rivestite con film

Spain: Dexketoprofeno pensavital 25mg comprimidos recubiertos con película EFG

This leaflet was last revised in:

February 2023.

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

Detailed and updated information on this product is available by scanning the QR code included in the outer carton with a smartphone. The same information is also available at the following URL: https://www.pensapharma.es/info/pensavital-dexketoprofeno-25mg-comprimidos and on the following website: https://cima.aemps.es/cima/dochtml/p/88796/P_88796.html.