DEXKETOPROFEN NORMON 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dexketoprofen Normon 25 mg Hard Capsules EFG

Read the 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 questions, 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. See section 4.

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. Contents of the pack and further 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 muscular or joint pain, menstrual pain (dysmenorrhea), or toothache.

2. What you need to know before taking Dexketoprofen Normon

Do not take Dexketoprofen Normon

• If you are allergic to dexketoprofen trometamol or any of the other ingredients of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medications;
• If you 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 medications;
• If you have suffered from photoallergic or phototoxic reactions (a special type of skin redness or burn due to sun exposure) during treatment with 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 peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (e.g., 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) 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 impairment, or severe liver impairment;
• 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.

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 (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, 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) you should consult your doctor or pharmacist about this treatment. Medications like Dexketoprofen Normon may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or 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 an elderly patient, you may experience 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 or blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), as it may worsen your condition; If you suffer or have suffered from stomach or intestinal disorders in the past, you should monitor the appearance of these disorders, especially the appearance of bleeding;
• If you have chickenpox, as non-steroidal anti-inflammatory medications (NSAIDs) can exceptionally worsen the infection;
• If you are taking other medications that increase the risk of peptic ulcer or bleeding, such as 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 or acenocoumarol (Sintrom). In these cases, consult your doctor before taking Dexketoprofen 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 Dexketoprofen Normon if you are under 18 years old.

Other medications and Dexketoprofen Normon

Tell 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 other medications that may need a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofen 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 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 (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 Dexketoprofen Normon, consult your doctor or pharmacist.

Taking Dexketoprofen Normon with food and drinks

Take the capsules with a sufficient amount of water. In case of acute pain, take the capsules on an empty stomach, i.e., at least 15 minutes before meals, as this will allow the medication to act a little faster.

Pregnancy and 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 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 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 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.

Do not take Dexketoprofen Normon during breastfeeding.

Consult your doctor or pharmacist before using any medication.

• Tell 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. 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, dizziness, and blurred vision 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.

Excipients

This medication contains less than 23 mg of sodium (1 mmol) per dose unit, i.e., it is essentially "sodium-free".

3. How to take Dexketoprofen Normon

Follow exactly the administration instructions of this medication 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 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 lower doses of dexketoprofen are required per intake, other presentations of dexketoprofen should be used that adapt to the required dosage.

If you are an elderly person 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 be increased later according to the general recommended dose (75 mg of dexketoprofen) if Dexketoprofen Normon has been well tolerated.

If your pain is intense and you need quick relief, take the capsules on an empty stomach (at least 15 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

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 Dexketoprofen Normon

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

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

4. Possible side effects

Like all medications, this medication 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 trometamol tablets, and dexketoprofen trometamol capsules are absorbed faster than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with dexketoprofen capsules. 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 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).

Very rare

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, tinnitus (ringing in the ears), skin sensitivity, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Frequency not known

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

Tell 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 suffered from any of these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are an elderly patient.

Stop taking Dexketoprofen immediately if you notice the appearance of a skin rash or any lesion inside 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 Dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or stroke.

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.

Reporting 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

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

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 the 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 Dexketoprofeno Normon 25 mg hard capsules EFG

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

• The other components are:

• Capsule content: Pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethyl starch (Type A) of 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 Container Content

Dexketoprofeno Normon 25 mg hard capsules EFG are hard gelatin capsules of green color, containing a white or almost white crystalline powder.

The capsules are presented in single-dose blisters 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 the Last Revision of this Prospectus:March 2023

Other Sources of Information

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