DEXKETOPROFEN NORMON 25 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the Patient

Dexketoprofen NORMON 25 mg Granules for Oral Solution EFG

Dexketoprofen Trometamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• -Keep this package leaflet, as you may need to read it again.
• -If you have any doubts, consult your doctor or pharmacist.
• -This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• -If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Dexketoprofen NORMON and what is it used for
2. What you need to know before taking Dexketoprofen NORMON
3. How to take Dexketoprofen NORMON
4. Possible side effects
5. Storage of Dexketoprofen NORMON
6. Package contents and additional information

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

Dexketoprofen NORMON is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of acute pain of mild or moderate intensity, such as acute muscle or joint pain, menstrual pain (dysmenorrhea), or toothache.

2. What you need to know before taking Dexketoprofen Normon

Do not take Dexketoprofeno NORMON

• If you are allergic to dexketoprofen trometamol or any of the other components of this medication (see section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or another non-steroidal anti-inflammatory medication;
• 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), 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 medications;
• If you have suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn of exposed skin) during the intake of ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications used to reduce blood fat levels);
• If you have or have had in the past a peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (such as indigestion, heartburn);
• If you have suffered from stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory medications (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 severely dehydrated (have lost a lot 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 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;
• 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;
• Are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• Have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) and should consult your doctor or pharmacist about this treatment. Medications like Dexketoprofeno NORMON may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") 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;
• Are elderly, as you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• Are a woman with fertility problems (Dexketoprofeno NORMON may decrease your fertility, so you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• Suffer from a blood disorder or blood cell production disorder;
• Have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• Suffer from or have suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• Suffer from or have suffered from stomach or intestinal disorders;
• Have chickenpox, as non-steroidal anti-inflammatory medications (NSAIDs) can exceptionally worsen the infection;
• Are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), or anticoagulants like warfarin or acenocoumarol (Sintrom). 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 medications that block gastric acid production).

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 recently taken, or may need to take any other medication. There are some medications that should not be taken together, and others may require a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno NORMON, you are taking any of the following medications:

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin or acenocoumarol (Sintrom), heparin, and other medications used to prevent clot formation;
• Lithium, used to treat 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 considered:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications, i.e., medications 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 medications with Dexketoprofeno NORMON, consult your doctor or pharmacist.

Taking Dexketoprofeno NORMON with food, drinks, and alcohol

In case of acute pain, take the sachets on an empty stomach, i.e., at least 15 minutes before meals, as this facilitates the medication's action.

Pregnancy, breastfeeding, and fertility

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

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

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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take Dexketoprofeno 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, Dexketoprofeno Normon may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Driving and using machines

Dexketoprofeno 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 they disappear. Ask your doctor for advice.

Dexketoprofeno NORMON contains sucrose and orange yellow S (E-110)

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains the colorant orange yellow S (E-110), which may cause allergic reactions.

3. How to take Dexketoprofen Normon

Follow your doctor's instructions for administering this medication exactly.

In case of doubt, consult your doctor or pharmacist again.

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

Generally, it is recommended to take 1 sachet (25 mg of dexketoprofen) every 8 hours, not 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 can be increased later according to the recommended general dose (75 mg of dexketoprofen) if Dexketoprofeno NORMON has been well tolerated.

If your pain is intense and you need quick relief, take the sachets on an empty stomach (at least 15 minutes before meals), as they will be absorbed more easily (see section 2 "Taking Dexketoprofeno NORMON with food and drinks").

Instructions for proper use

Dissolve the entire contents of a sachet in a glass of water; shake 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 medication, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to always carry the medication package or this package 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 medication and the amount ingested.

If you forget to take Dexketoprofeno NORMON:

Do not take a double dose to make up for forgotten doses. Take the next dose when scheduled (according to section 3).

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

4. Possible side effects

Like all medications, Dexketoprofeno NORMON can cause side effects, although not everyone will experience them.

Possible side effects are listed below according to their frequency. Since the list is based in part on side effects observed with the use of dexketoprofen tablets, and dexketoprofen granules are absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with dexketoprofen granules. 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 sensation, 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 (e.g., swelling of the ankles), loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), acute kidney failure.

Very rare:

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling 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, liver cell damage (hepatitis), blurred vision, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, 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), especially if you have previously suffered from 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 in the mouth or genitals, or any other sign of allergy.

During treatment with non-steroidal anti-inflammatory medications, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medications like Dexketoprofeno NORMON may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident").

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Dexketoprofen Normon

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store at a temperature below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dexketoprofen NORMON

• The active ingredient is dexketoprofen. Each sachet contains 36.90 mg of dexketoprofen trometamol, which is equivalent to 25 mg of dexketoprofen.
• The other components are: Colloidal silica, orange essence, Xanthan gum, orange-yellow colorant (E-110), and compression sucrose

Appearance of the Product and Container Content

Dexketoprofen NORMON 25 mg is presented in the form of a granulate for oral solution, orange-yellow in color. Each container contains 20 sachets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos- Madrid (SPAIN)

Date of the Last Revision of this Leaflet: March 2023

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