Dexketoprofen Normon 25 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno NORMON 25 mg granules for oral solution EFG

Dexketoprofen trometamol

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even 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 effects not listed in this leaflet.

Leaflet contents:

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 Dexketoprofen Normon is and what it is used for

Dexketoprofen Normon is an analgesic belonging to a 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 (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketopro Normon

Do not take Dexketoprofeno NORMON

• If you are allergic to dexketoprofen trometamol or to any of the other components of this medicine (see section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or to any other non-steroidal anti-inflammatory drug (NSAID);
• 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 inside the nose due to allergy), urticaria (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 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 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 failure, or severe hepatic failure;
• 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;
• If you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno NORMON if you:

• Are allergic or have previously had allergic problems;

• Have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously had any of these conditions;

• Are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);

• Have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker). You should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno NORMON may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment;

• Are elderly, as you may be more susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;

• Are a woman with fertility problems (Dexketoprofeno NORMON may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);

• Have a disorder affecting blood or blood cell production;

• Have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);

• Have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

• Have or have previously had stomach or intestinal disorders;

• Have chickenpox, as NSAIDs may exceptionally worsen the infection;

• 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 Dexketoprofeno NORMON: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric acid production).

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

Children and adolescents

Do not take Dexketoprofeno NORMON if you are under 18 years of age.

Taking Dexketoprofeno NORMON with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. 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 Dexketoprofeno 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 for controlling 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 medicines; i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

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

For acute pain, take the sachets on an empty stomach; that is, at least 15 minutes before meals, as this helps the medicine to act more quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as Dexketoprofeno NORMON may not be suitable for you.

• Do not take Dexketoprofeno NORMON during the third trimester of pregnancy or while breastfeeding.
• Do not take Dexketoprofeno NORMON if you are breastfeeding. Seek advice from your doctor.

Do not take Dexketoprofeno Normon during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's ability to stop bleeding and may delay or prolong labor more than expected. You should not take Dexketoprofeno Normon during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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, leading 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.

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 experience these effects, do not operate machinery or drive until the symptoms have resolved. Seek advice from your doctor.

Dexketoprofeno NORMON contains sucrose and sunset yellow FCF (E-110)

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains the colouring agent sunset yellow FCF (E-110). It may cause allergic-type reactions.

3. How to take Dexketoprofeno Normon

Follow exactly the instructions for use of this medicine as given by your doctor.

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 sachets you should take each day and for how long.

In general, the recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets 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 2 sachets per day (50 mg).

In elderly patients, this initial dose may subsequently 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 sachets 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”).

Instructions for proper use

Dissolve the entire contents of one sachet in a glass of water; stir to help dissolve. The resulting solution should be taken immediately after reconstitution.

If you take more Dexketoprofeno 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 bring the medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 at the scheduled time (according to section 3).

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

4. Possible adverse effects

Like all medicines, Dexketoprofeno NORMON may produce 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 tablets, and because dexketoprofen granules are absorbed faster than tablets, the actual frequency of adverse effects (gastrointestinal) may be higher with dexketoprofen granules. The following table indicates how many patients may experience these adverse effects:

Common adverse effects:

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

Uncommon adverse effects:

Spinning sensation (vertigo), dizziness, drowsiness, sleep disorders, 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), interruption of kidney function (acute renal failure).

Very rare:

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

Frequency unknown: frequency cannot be estimated from the available data

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

Drug eruption

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 reappears 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 sensation or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with non-steroidal anti-inflammatory drugs, and particularly if you are elderly.

Stop taking Dexketoprofen 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 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 NORMON 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Dexketoprofeno Normon

Keep this medicine out of sight and reach of children.

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

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofeno NORMON

• The active substance is dexketoprofen. Each sachet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.
• The other components are: Colloidal silica, orange flavour, xanthan gum, orange-yellow colour (E-110), and compressible sucrose.

Appearance of the product and contents of the pack

Dexketoprofeno NORMON 25 mg is presented as an orange-yellow granulate for oral solution. Each pack contains 20 sachets.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the latest review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/