Patient Information Leaflet

Dexketoprofen Teva 25 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1.What is Dexketoprofen Teva and what it is used for

2.What you need to know before taking Dexketoprofen Teva

3.How to take Dexketoprofen Teva

4.Possible side effects

5.Storage of Dexketoprofen Teva

6.Contents of the pack and additional information

Dexketoprofeno Tevais a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), and toothache pain.

Do not takeDexketoprofeno Teva:

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (for example, indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding or perforation due to previous use of nonsteroidal 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 kidney failure, or severe liver failure;
• If you have bleeding disorders or blood clotting disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years old.

Warnings and precautions:

Consult your doctor or pharmacist before starting to takeDexketoprofeno Teva:

• If you are allergic or have had allergic reactions in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had these conditions in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medicines likeDexketoprofeno Tevamay be associated with a small increase in the risk of suffering heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly person, 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 (Dexketoprofeno Tevamay decrease your fertility, so do not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);
• If you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had in the past gastrointestinal or intestinal disorders;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before takingDexketoprofeno Teva: your doctor may prescribe an additional medicine to protect your stomach (for example, misoprostol or other medicines that block stomach acid production).

Children and adolescents

Do not take Dexketoprofeno Teva if you are under 18 years old.

Taking Dexketoprofeno Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medicine.

There are some medicines that should not be taken together and other medicines that may require a dose change if taken together.

Inform your doctor, dentist, or pharmacist if, in addition toDexketoprofeno Teva, you are taking any of the following medicines:

Not recommended associations:

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

Associations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used to control 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
• Chlorpropamide and glibenclamide, used to treat diabetes;

Associations to consider:

• Quinolones (for example, ciprofloxacin, levofloxacin) used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Taking Dexketoprofeno Teva with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of experiencing stomach or intestinal adverse effects. However, in the case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medicine's action a little faster.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno Teva if you are in 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 fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take dexketoprofen during the first 6 months of pregnancy unless it is clearly necessary and as your doctor tells you. If you need treatment during this period or while trying to become pregnant, you should take the minimum 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 cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Driving and using machines

Dexketoprofeno Tevamay slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free."

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose of Dexketoprofeno Teva that you may need 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.

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from any kidney or liver disease, it is recommended to start therapy with a maximum of 2 tablets per day (50 mg).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofeno) if Dexketoprofeno Teva has been well tolerated.

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Teva with food and drinks”).

The tablet can be divided into equal doses.

If you take more Dexketoprofeno Teva than you should

If you have taken too much medication, immediately inform your doctor or pharmacist or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofeno Teva

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to take Dexketoprofeno Teva”).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency. The following table indicates how many patients may experience these side effects:

Frequent side effects

Nausea and/or vomiting, stomach pain, diarrhea, digestive disorders (dyspepsia).

Infrequent side effects

Dizziness, vertigo, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general discomfort.

Rare side effects

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may be manifested by vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral edema (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual irregularities, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

Very rare side effects

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty due to airway constriction (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, tinnitus, sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

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

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

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

Medicines like dexketoprofen may be associated with a small increase in the risk of suffering a heart attack (myocardial infarction) or stroke (cerebrovascular accident).

In patients with autoimmune disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medications may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30° C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Dexketoprofeno Teva Composition

• The active ingredient is dexketoprofeno trometamol. Each film-coated tablet contains 25 mg of dexketoprofeno, which is equivalent to 36.90 mg of dexketoprofeno trometamol.
• The other components are: cornstarch, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, glyceryl distearate, hypromellose (E464), titanium dioxide (E171), macrogol 400.

Appearance of the product and contents of the packaging

Dexketoprofeno Teva 25 mg are scored, white, biconvex, cylindrical tablets marked with DT2 on one side. The tablet can be divided into equal doses.

Dexketoprofeno Teva 25 mg film-coated tablets EFG are presented in packaging containing 20 and 50 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U

Anabel Segura 11, Edificio Albatros B, 1st Floor

28108, Alcobendas, Madrid

Spain

Responsible Manufacturer

Galenicum Health, S.L.

San Gabriel, 50Esplugues de Llobregat

08950 Barcelona(Spain)

SAG Manufacturing, S.L.U.

Ctra N-I, km. 36

28750 San Agustín del Guadalix

Madrid - Spain

Last review date of this leaflet: February 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.