DEXKETOPROFEN NORMON 12.5 mg FILM-COATED TABLETS

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

Do not takeDexketoprofen Normon:

• If you are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory medicines;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), hives (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• If you have or have had in the past peptic ulcer, stomach or intestinal bleeding or have chronic digestive problems (such as indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation due to previous use of non-steroidal 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 coagulation 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 Dexketoprofen Normon:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (for example, due to excessive urination, diarrhea or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medicines like Dexketoprofen Normon may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("stroke"). 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 elderly, you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofen Normon may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you suffer from a blood disorder and blood cell disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you suffer or have suffered in the past from stomach or intestinal disorders;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofen Normon: it may be that your doctor prescribes an additional medicine to protect your stomach (for example, misoprostol or other medicines that block the production of gastric acid).

Children and adolescents

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

Taking Dexketoprofen Normon with other medicines

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

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

Not recommended combinations:

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

Combinations that require caution:

• ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes;

Combinations to be taken into account:

• Quinolones (for example, ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

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

Taking Dexketoprofen 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 suffering from adverse effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the action of the medicine a little faster.

Pregnancy, breastfeeding and fertility

Do not take Dexketoprofen Normon during breastfeeding.

Do not take Dexketoprofen Normon if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Dexketoprofen Normon 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 the 20th week of pregnancy, Dexketoprofen Normon may cause kidney problems in your fetus if taken for more than a few days, which can 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.

Consult your doctor or pharmacist before using any medicine.

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

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

Driving and using machines

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

Dexketoprofen Normon contains sodium

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

3. How to take Dexketoprofen Normon

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

The dose of Dexketoprofen Normon you need may vary, depending on the type, intensity and duration of the pain. Your doctor will indicate how many tablets you should take per day and for how long.

It is generally recommended to take 1 tablet (12.5 mg of dexketoprofen) every 4-6 hours, without exceeding 6 tablets per day (75 mg).

If you are elderly or suffer from 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 according to the recommended general dose (75 mg of dexketoprofen) if Dexketoprofen 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 meals) as they will be absorbed more easily (see section 2 "Taking Dexketoprofen Normon with food and drinks").

If you take more Dexketoprofen Normon than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofen Normon

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due (according to section 3 "How to take Dexketoprofen Normon").

If you stop taking Dexketoprofen Normon:

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

4. Possible side effects

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

Possible side effects are listed below by 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).

Uncommon side effects:

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling and chills, general malaise.

Rare side effects:

Peptic ulcer, perforation of peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral edema (such as swelling of the ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare:

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers on the skin, mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell 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, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

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

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

During treatment with non-steroidal 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 Dexketoprofen Normon may be associated with a small increased risk of suffering from a heart attack ("myocardial infarction") or stroke ("stroke").

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

Reporting of side effects

If you experience 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 through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Normon

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

Do not use this medicine after the expiry date that appears on the packaging after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Normon

• The active ingredient is dexketoprofen trometamol (18.45 mg) corresponding to dexketoprofen (DCI) 12.5 mg.
• The other ingredients (excipients) are: Tablet core: corn starch, microcrystalline cellulose, sodium carboxymethylcellulose Type A (potato starch), anhydrous colloidal silica, magnesium stearate. Coating: titanium dioxide (E-171), hypromellose, macrogol 6000 and talc.

Appearance of the product and contents of the pack

Dexketoprofen Normon 12.5 mg are white or almost white, round and biconvex tablets. They are available in packs containing 20 or 40 film-coated tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

(SPAIN)

Date of last revision of this leaflet: March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/