Package Insert: Information for the Patient

Dexketoprofen Normon 25 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isDexketoprofen Normonand for what it is used

2. What you need to know before starting to takeDexketoprofen Normon

3. How to takeDexketoprofen Normon

4. Possible adverse effects

5. Storage ofDexketoprofen Normon

6. Contents of the package and additional information

Dexketoprofeno Normon is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

Do not take Dexketoprofeno Normon

• If you are allergic to dexketoprofen trometamol or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;
• If you have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy formations in the interior of the nose due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have had phototoxic or photoallergic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood fat levels);
• If you have or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (for example, indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding or perforation due to previous use of nonsteroidal 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 renal insufficiency, or severe liver insufficiency;
• If you have bleeding disorders or blood clotting disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate 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 Dexketoprofeno Normon:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these diseases in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications likeDexketoprofeno Normonmay be associated with a small increase in the risk of suffering heart attacks (“myocardial infarction”) or strokes (“cerebral vascular accident”). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient, 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 (Dexketoprofeno Normonmay reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• 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 exacerbate your disease;
• If you have had or have had in the past gastrointestinal or intestinal disorders, you should monitor the appearance of these disorders, especially bleeding;
• If you have chickenpox, as NSAIDs may occasionally worsen the infection;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocoumarol (Sintrom). In these cases, consult your doctor before takingDexketoprofeno Normon: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).

Children and adolescents

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

Other medications and Dexketoprofeno Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are some medications that should not be taken together and other medications that may require a change in dose 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 associations:

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

Associations 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 to treat diabetes;

Associations to consider:

• Quinolones (for example, ciprofloxacin, levofloxacin) used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• 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 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 will facilitate the medication's action a little faster.

Pregnancy and breastfeeding

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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Dexketoprofeno Normon during the first 6 months of pregnancy unless it is clearly necessary and as your doctor indicates. 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 week 20 of pregnancy, Dexketoprofeno Normon may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Do not take Dexketoprofeno Normon during breastfeeding.

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

Dexketoprofeno 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 notice these effects, do not use machines or drive until these symptoms disappear. Seek advice from your doctor.

Excipients

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated 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 tell you how many capsules to take per day and for how long.

The recommended dose is 1 capsule (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 capsules per day (75 mg). When a dose lower than 25 mg of dexketoprofeno per intake is required, other presentations of dexketoprofeno 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 can be increased later according to the general recommended dose (75 mg of dexketoprofeno) if Dexketoprofeno 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 eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Normon with food and drinks”).

If you takemore Dexketoprofeno Normon than you should

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

If you forgot to take Dexketoprofeno Normon

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to take Dexketoprofeno Normon”).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below according to their frequency. Since the list is based in part on the side effects observed with the use of Dexketoprofeno trometamol tablets, and since Dexketoprofeno trometamol capsules are absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with Dexketoprofeno 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

Rotatory sensation (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, 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 side effects

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

Frequency unknown

Throat edema, liver cell damage (hepatitis), acute renal failure.

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g. stomach pain or burning, bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially if you are an elderly patient.

Stop taking Dexketoprofeno 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 nonsteroidal 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 Dexketoprofeno may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacistorpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

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

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 in the blister pack, after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Normon 25 mg hard capsules EFG

• Each capsule contains 36.9 mg of dexketoprofeno trometamol corresponding to dexketoprofeno 25 mg.

• The other components are:

• Caplet content: Maize pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch (Type A) from potato, and diestearoyl glycerol.
• Composition of the capsule (body and cap): Gelatin, titanium dioxide (E171), quinoline yellow (E104), and patent blue V (E131).

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6.

28760 Tres Cantos,

Madrid (Spain).

Last review date of this leaflet:March 2023

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices:http://www.aemps.gob.es