Prospect: information for theuser

Dexketoprofeno Normon 12.5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, 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 should not give it to other peopleeven if they 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 prospect. See section 4.

1.What isDexketoprofeno Normonand for what it is used

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

3.How to take Dexketoprofeno Normon

4.Possible adverse effects

5.Storage of Dexketoprofeno Normon

6.Contents of the package and additional information

Dexketoprofeno Normon 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 takeDexketoprofeno Normon:

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medication (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 nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have or have had peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had 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 Normon:

• 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 (e.g., excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk for 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 Dexketoprofeno Normon may be associated with a small increased 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 (Dexketoprofeno Normon may decrease your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have a disorder in blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• If you have or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had stomach or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs), anticoagulants like aspirin or warfarin. In these cases, consult your doctor before taking Dexketoprofeno Normon: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other acid-blocking medications).

Children and adolescents

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

Taking Dexketoprofeno Normon with other medications

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

Inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno Normon, 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 clotting;
• Lithium, used to treat 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;
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to terminate pregnancy);
• SSRI antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Taking Dexketoprofeno Normon with food, drinks, and alcohol

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of stomach or intestinal adverse effects. However, in case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this allows the medication to act a bit faster.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno Normon during breastfeeding.

Do not take Dexketoprofeno Normon 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 and your baby's predisposition to bleeding and delay or prolong delivery. Do not take Dexketoprofeno Normon during the first 6 months of pregnancy unless it 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 the shortest time possible. After 20 weeks of pregnancy, Dexketoprofeno Normon 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). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Consult your doctor or pharmacist before using any medication.

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

• Do not take Dexketoprofeno Normon if you are breastfeeding. Consult your doctor.

Driving and operating machinery

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

Dexketoprofeno Normon contains sodium

This medication 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 (12.5 mg of dexketoprofeno) every 4-6 hours, without exceeding 6 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 4 tablets per day (50 mg).

In elderly patients, this initial dose may be increased later in accordance with the general recommended 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 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: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofeno Normon

Do not take a double dose to make up for the missed doses. Take the next dose when it is 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:

Dizziness, vertigo, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, 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 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, prostatic disorders, abnormal liver function tests (blood tests),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), breathing difficulty due to narrowing of airways (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 drugs, 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 swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno Normon 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 affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs 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 leaflet. You can also report them directly to 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 the packaging and medications you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Dexketoprofeno Normon

• The active ingredient is dexketoprofeno trometamol (18.45 mg) corresponding to dexketoprofeno (DCI) 12.5 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 12.5 mg are white or almost white, round, and biconvex tablets. They are presented in packaging that contains 20 or 40 coated tablets.

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