Dexketoprofen Normon 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno Normon 25 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dexketoprofeno Normon is and what it is used for
2. What you need to know before taking Dexketoprofeno Normon
3. How to take Dexketoprofeno Normon
4. Possible adverse effects
5. How to store Dexketoprofeno Normon
6. Contents of the pack and other information

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

Dexketoprofeno Normon is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscular or joint pain, menstrual pain (dysmenorrhea), and dental pain.

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

Do not take Dexketoprofen 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 or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose 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 non-steroidal anti-inflammatory drugs;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or suffer from chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief;
• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal impairment, or severe hepatic impairment;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofen Normon:

• If you are allergic or have previously had allergic problems;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously suffered from any of these conditions;
• If you are taking diuretics or are inadequately hydrated and have reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart conditions, a history of stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofen Normon may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• 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 Normon may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you have a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), as your condition may worsen;
• If you currently suffer from or have previously had stomach or intestinal disorders, you should monitor for recurrence of these problems, especially the onset of bleeding;
• If you have chickenpox, as NSAIDs may exceptionally worsen the infection;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocoumarol (Sintrom). In such cases, consult your doctor before taking Dexketoprofen Normon: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

Allergic reactions to dexketoprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Dexketoprofen Normon and contact your doctor or the nearest emergency service if you experience any of these symptoms.

Children and adolescents

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

Other medicines and Dexketoprofen Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines should not be taken together, while others may require dose adjustments when used concomitantly.

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

Combinations not recommended:

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

Combinations 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 for diabetes;

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic drugs; that is, medicines used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Selective serotonin reuptake inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Taking Dexketoprofen Normon with food and drinks

Take the capsules with an adequate amount of water. In case of acute pain, take the capsules on an empty stomach; that is, at least 15 minutes before meals, as this allows the medicine to act slightly faster.

Pregnancy and breastfeeding

Do not take Dexketoprofen Normon during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take Dexketoprofen Normon during the first 6 months of pregnancy unless clearly necessary and specifically instructed by your doctor. If treatment is needed during this period or when trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, Dexketoprofen Normon may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Do not take Dexketoprofen Normon while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or planning to become pregnant, as Dexketoprofen Normon may not be suitable for you.
• Do not take Dexketoprofen Normon if you are breastfeeding. Seek advice from your doctor.

Driving and using machines

Dexketoprofen Normon may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until these symptoms resolve. Seek advice from your doctor.

Excipients

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; this is essentially "sodium-free".

3. How to take Dexketoprofeno Normon

Follow exactly the instructions for use of this medicine provided 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 indicate how many capsules you should take per day and for how long.

The recommended dose is 1 capsule (25 mg of dexketoprofen) every 8 hours, not exceeding 3 capsules per day (75 mg). When doses lower than 25 mg of dexketoprofen per administration are required, other presentations of dexketoprofen that are suitable for the required dosing should be used.

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

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

If your pain is severe and you need rapid relief, take the capsules on an empty stomach (at least 15 minutes before a meal), as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Normon with food and drink”).

If you take more Dexketoprofeno Normon than you should

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

If you forget to take Dexketoprofeno Normon

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (according to section 3 “How to take Dexketoprofeno Normon”).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The possible adverse effects are detailed below according to their frequency. Since this list is partly based on adverse effects observed with the use of dexketoprofen trometamol tablets, and because dexketoprofen trometamol capsules are absorbed faster than tablets, the actual frequency of adverse effects (gastrointestinal) may be higher with dexketoprofen capsules. The following table indicates how many patients may experience these adverse effects:

Frequent adverse effects

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

Uncommon adverse effects

Sensation of spinning (vertigo), dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general malaise.

Rare adverse effects

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests).

Very rare

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of pancreas, blurred vision, ringing in the ears (tinnitus), skin sensitivity, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Frequency unknown: frequency cannot be estimated from available data

Laryngeal oedema, liver cell damage (hepatitis), interruption of kidney function (acute renal failure).

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Drug eruption (fixed drug eruption)

An allergic skin reaction known as fixed drug eruption, which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Fixed drug eruption usually recurs in the same location or locations if the medicine is taken again.

Inform your doctor immediately if you notice any gastrointestinal adverse effects at the start of treatment (e.g. stomach pain or burning, or bleeding), especially if you have previously experienced such adverse effects during long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Stop taking Dexketoprofen immediately if you develop a skin rash or any lesions in the mouth or genital area, or any other signs 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 such as Dexketoprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse 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 stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Keep the blister pack in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Dexketoprofen Normon 25 mg hard capsules EFG

• Each capsule contains 36.9 mg of dexketoprofen trometamol equivalent to 25 mg of dexketoprofen.

• Other components are:

• Capsule contents: Pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethyl starch (Type A) from potato, and glycerol distearate.

• Capsule composition (body and cap): Gelatin, titanium dioxide (E171), quinoline yellow (E104), and patent blue V (E131).

Appearance of the product and contents of the container

Dexketoprofen Normon 25 mg hard capsules EFG are hard green gelatin capsules containing white or almost white crystalline powder.

The capsules are presented in single-dose blisters made of Aluminum/PVC-ACLAR® (PCTFE) or Aluminum/PVC-PE-PVDC(90), containing 20 hard capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6.

28760 Tres Cantos,

Madrid (Spain).

Date of latest review of this leaflet: September 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85811/P_85811.html.