Package Leaflet: Information for the Patient

Dexketoprofen Alter 25 mg Film-Coated Tablets

Read this 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. 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 Alter and what it is used for

2.What you need to know before taking Dexketoprofen Alter

3.How to take Dexketoprofen Alter

4.Possible side effects

5.Storage of Dexketoprofen Alter

6.Contents of the pack and additional information

Dexketoprofeno Alter is 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 take Dexketoprofeno Alter

- If you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other components of this medication (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 rash), 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 (e.g., 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 take Dexketoprofeno Alter:

- If you are allergic or have had allergic problems 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 (e.g., excessive urination, diarrhea, or vomiting);

- If you have heart problems, a history of strokes, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Nonsteroidal anti-inflammatory drugs like dexketoprofen may be associated with a small increase in the risk of heart attacks or strokes. 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 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 (dexketoprofen may reduce your fertility, so do not take it if you are planning to become pregnant or 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 (immune system 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 medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, certain antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block stomach acid production).

Children and adolescents

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

Taking Dexketoprofeno Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. There are some medications that should not be taken together and other medications that may require a change in dose if taken together.

Inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno Alter, you are taking any of the following medications:

Not recommended associations:

- Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;

- Warfarin, heparin, and other medications used to prevent blood clots;

- 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 (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections;

- Cyclosporine or tacrolimus, used to treat immune system diseases and organ transplants;

- Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications 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);

- Selective serotonin reuptake inhibitors (SSRIs);

- Antiplatelet medications used to reduce platelet aggregation and blood clot formation.

If you have any doubts about taking other medications with Dexketoprofeno Alter, consult your doctor or pharmacist.

Taking Dexketoprofeno Alter 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 adverse effects in the stomach or intestines. 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 medication's action a little faster.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno Alter during pregnancy or breastfeeding.

Do not take Dexketoprofeno Alter 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 Dexketoprofeno Alter during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. 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, Dexketoprofeno Alter may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

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

Driving and operating machinery

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

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

The recommended dose of dexketoprofeno that you may need can vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets to 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 can be increased later according to the general recommended dose (75 mg of dexketoprofeno) if dexketoprofeno 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 Alter with food and drinks”).

The tablet can be divided into equal doses.

If you take more Dexketoprofeno Alter than you should

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

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

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

Like all medicines, this medicine may 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 manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood analysis), liver cell damage (hepatitis), acute renal insufficiency.

Very rare:

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 Dexketoprofeno Alter immediately if you notice the appearance of a skin rash or any lesions within the mouth or on the genitals, or any other sign of allergy.

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

Medicines like Dexketoprofeno Alter may be associated with a small increased risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with autoimmune disorders affecting 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 leaflet.

You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://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 in the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°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 the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Dexketoprofeno Alter Composition

The active ingredient is dexketoprofeno trometamol (36.90 mg) corresponding to Dexketoprofeno (DCI) 25 mg.

The other components are: cornstarch, microcrystalline cellulose, carboxymethylstarch sodium type A (from potato), glyceryl distearate, hypromellose, titanium dioxide (E171), macrogol 400.

Product appearance and packaging content

Coated, scored, white, biconvex, and cylindrical tablets marked with DT2 on one side. The tablet can be divided into equal doses.

Dexketoprofeno Alter 25 mg coated tablets with EFG film coating are presented in packaging containing 20, 50, and 500 coated tablets with film coating.Not all packaging sizes may be marketed.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10-Pol. Ind.Areta,

31620 Huarte, Navarra,

Spain

Last review date of this leaflet: March 2023.

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