Package Insert: Information for the User

Dexketoprofen Normon 25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other peoplealthoughthey may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Dexketoprofen Normon

3. How to take Dexketoprofen Normon

4. Possible adverse effects

5. Storage of Dexketoprofen Normon

6. Contents of the pack and additional information

Dexketoprofeno Normon is a pain reliever belonging to the group of medications known as non-steroidal 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 Normon:

• 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 (aspirin) or to another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths in the inside of the nose 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 renal insufficiency, or severe liver insufficiency;
• 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 Normon:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these diseases 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 like Dexketoprofeno Normon may be associated with a small increase in the risk of having heart attacks ("myocardial infarctions") or strokes ("cerebral vascular accidents"). 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 (Dexketoprofeno Normon 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 the production of blood 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 such as acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking Dexketoprofeno Normon: 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 Normon if you are under 18 years old.

Taking Dexketoprofeno Normon with other medicines

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

Inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno Normon, 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 be taken into account:

• 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 dissolve 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 clotting.

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

Taking Dexketoprofeno Normon with food, drinks, and alcohol

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps to reduce the risk of experiencing 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 medicine's action a little more quickly.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno Normon during breastfeeding.

Do not take Dexketoprofeno Normon 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 bleeding and delay or prolong delivery more than expected. Do not take Dexketoprofeno Normon 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, Dexketoprofeno Normon 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 monitoring.

Consult your doctor or pharmacist before using any medicine.

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

• Do not take Dexketoprofeno Normon if you are breastfeeding. Ask your doctor for advice.

Driving and using machines

Dexketoprofeno Normon may 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. Ask your doctor for advice.

Dexketoprofeno Normon contains sodium

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

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

The dose of Dexketoprofeno Normon you need may 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 elderly or have 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 in accordance with the recommended general dose (75 mg of dexketoprofeno) if Dexketoprofeno Normon 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 Normon with food and drinks”).

If you take more Dexketoprofeno Normon 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: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dexketoprofeno Normon

Do not take a double dose to make up for the missed doses. Take the next dose when due (in accordance with section 3 “How to Take Dexketoprofeno Normon”).

If you interrupt treatment with Dexketoprofeno Normon:

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:

Rotatory sensation (vertigo), dizziness, 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 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 disorders, prostatic 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, ringing in the ears (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 Normon 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 Dexketoprofeno Normon 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 of 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 Spanish Medicines Vigilance System: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 after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30º C.

Storeintheoriginalpackagingtoprotectitfromlight.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of packaging and medications that you no longer need. This will help protect the environment.

Composition of Dexketoprofeno Normon

• The active ingredient is dexketoprofeno trometamol (36.90 mg) corresponding to dexketoprofeno (DCI) 25 mg.
• The other components (excipients) are:Tablet core:cornstarch,microcrystalline cellulose, carboxymethylstarch sodium Type A (potato starch),anhydrous colloidal silica, magnesium stearate.Covering:titanium dioxide (E-171), hypromellose, macrogol 6000, and talc.

Appearance of the product and contents of the packaging

Dexketoprofeno Normon 25 mg are white or almost white, round, biconvex tablets with a breaking bar on one face. They are presented in packaging containing 20 and 500 coated tablets (clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

(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/