PATIENT INFORMATION LEAFLET:INFORMATION FOR THE USER

Seractil 400 mg film-coated tablets

Dexibuprofen

Read this leaflet carefully before you start taking this medicine because 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, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of the pack and additional information

Dexibuprofeno, the active substance of Seractil, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs, such as dexibuprofeno, are indicated for the treatment of pain and inflammation. They act by reducing the amount of prostaglandins (substances that control inflammation and pain) produced by the body.

What is Seractil used for

Seractil is indicated in adults to relieve:

?pain and inflammation caused by arthritis (when joints wear out);

?menstrual pain;

?mild to moderate pain, such as muscle and joint pain or dental pain.

Do not take Seractil if:

• You are allergic to dexibuprofen or any of the components of Seractil (listed in section 6);
• You are allergic to acetylsalicylic acid or other pain-relieving medications (your allergy may cause difficulty breathing, asthma, nasal secretion, skin rash, or facial swelling);
• You have had gastrointestinal bleeding or perforation caused by NSAIDs;
• You have recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea may be a sign that your stomach or intestines are bleeding);
• You have cerebral hemorrhage (cerebrovascular accident) or other active bleeding;
• You have a worsening of an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• You have severe dehydration (e.g., caused by vomiting, diarrhea, or inadequate fluid intake);
• You have severe heart failure or a serious liver or kidney disease;
• You are a woman in the third trimester of pregnancy;
• You have an unknown condition that results in abnormal blood cell formation.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Seractil if:

• You have had stomach or duodenal ulcers;
• You have had intestinal ulcers, ulcerative colitis, or Crohn's disease;
• You have kidney or liver disease or are an alcoholic;
• You have bleeding disorders (see "Other medications and Seractil");
• You have edema (fluid retention);
• You have heart disease or high blood pressure;
• You have systemic lupus erythematosus (a disease that affects joints, muscles, and skin) or mixed collagenosis (a disease that affects connective tissue);
• You are having difficulty getting pregnant and want to become pregnant;
• You have asthma or allergies, as you may experience difficulty breathing;
• You have hay fever (allergic rhinitis), nasal polyps, or chronic obstructive respiratory disease, as you may be at increased risk of allergic reactions. Allergic reactions may present as asthma (analgesic-induced asthma), Quincke's edema (swelling mainly in the facial area, lips, eyelids, or genitals), or urticaria;
• You have recently undergone major surgery;
• You have certain inherited blood disorders (e.g., acute intermittent porphyria);
• You have an infection - see the "Infections" section below.

Bleeding, ulceration, or perforation of the gastrointestinal tract, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of severe gastrointestinal adverse reactions. If bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of bleeding, ulceration, or perforation is higher with increased doses of NSAIDs, in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 2), and in elderly patients.

Patients at increased risk should start treatment with the lowest available dose. Consider concomitant treatment with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) for these patients, as well as for patients requiring low-dose aspirin concomitantly or other medications that may increase the risk of gastrointestinal bleeding. If you have had gastrointestinal toxicity, particularly in elderly patients, inform your doctor of any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.

NSAIDs, including dexibuprofen, may be associated with a small increase in the risk of myocardial infarction or stroke, especially at high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Seractil if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock with symptoms such as shortness of breath, wheezing, and decreased blood pressure) have been reported with dexibuprofen. With dexibuprofen, signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Seractil immediately and contact your doctor or emergency medical services if you observe any of these signs.

You may experience headaches after prolonged treatment with high doses of analgesics (off-label use). In this case, consult your doctor and do not take higher doses of Seractil for headaches.

Long-term use of analgesics, especially with combinations of more than one active analgesic principle, may cause permanent kidney damage, including the risk of renal insufficiency (analgesic nephropathy).

Cutaneous reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis, and generalized acute exanthematous pustulosis (PEGA), have been reported in association with treatment. Discontinue Seractil treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

Seractil may mask the signs of an infection, such as fever and pain. Therefore, Seractil may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid administering NSAIDs if you have varicella-zoster virus infection (chickenpox).

Other medications and Seractil

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take another medication.

Seractil may affect or be affected by other medications. For example:

-Anticoagulant medications (e.g., for treating bleeding disorders or preventing coagulation, such as acetylsalicylic acid, warfarin, ticlopidine, rivaroxaban, apixaban, or dabigatran) may prolong bleeding time.

-Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).

-Voriconazole and fluconazole (CYP2C9 inhibitors), used for fungal infections, as the effect of dexibuprofen may increase.

Other medications may also affect or be affected by Seractil treatment. Therefore, always consult your doctor or pharmacist before using Seractil with other medications.Particularly, inform your doctor or pharmacist if you are taking any of the following medications in addition to those mentioned above:

Youshould nottake the following medications with Seractil, unless under strict medical supervision:

• Nonsteroidal anti-inflammatory drugs (medications for pain relief, fever, and inflammation). There is an increased risk of developing ulcers or bleeding in the digestive system if you take Seractil with other NSAIDs or acetylsalicylic acid as an analgesic.

Youmaytake the following medications, but for safety reasons, inform your doctor:

?Lithium: a medication used to treat certain mood disorders.Seractilmay increase the effect of lithium.

?Metotrexate (a medication for cancer or rheumatoid arthritis treatment).Seractilmay increase the adverse effects of metotrexate.

?Diuretics (medications used to increase urine production), as dexibuprofen may decrease the effects of these medications.

?Corticosteroids: There may be an increased risk of gastrointestinal ulcers and bleeding.

?Some antidepressant medications (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.

?Digoxin (a medication for heart disease treatment). Seractil may increase the adverse effects of digoxin.

?Immunosuppressants (such as ciclosporin, tacrolimus, sirolimus), sulfonilurea (certain oral diabetes medications), and aminoglycoside antibiotics (medications for infections) - may cause kidney damage.

?Quinolone antibiotics, as they may increase the risk of seizures.

?Potassium-sparing diuretics, as they may increase potassium levels in the blood.

?Fenitoína, a medication used to treat epilepsy. Seractil may increase the adverse effects of fenitoína.

?Pemetrexed (a medication for certain types of cancer).

?Zidovudine (a medication for HIV/AIDS treatment); dexibuprofen may increase the risk of bleeding in a joint or bleeding that causes inflammation.

?Baclofeno (a muscle relaxant): You may develop baclofeno side effects after starting dexibuprofen treatment.

?Sulfinpirazona, probenecid (medications for gout), as the excretion of dexibuprofen may be delayed.

Taking Seractil with food, drinks, and alcohol

You can take Seractil alone, but it is recommended to take it with meals to reduce the risk of stomach discomfort, especially during prolonged treatment.

Limit or avoid alcohol consumption while taking Seractil, as it may increase gastrointestinal problems.

Pregnancy, fertility, and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take Seractil in the last 3 months of pregnancy or later, as it may seriously harm your fetus, even at very low doses.Seractil may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and may delay or prolong labor.

You should not take Seractil 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 lowest dose for the shortest time possible.

From week 20 of pregnancy, Seractil may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Fertility

You should not take Seractil if you are trying to become pregnant, as it may make it difficult to become pregnant.

In rare cases, medications like Seractil may affect a woman's fertility. Your fertility will return to normal when you stop taking Seractil.

Lactation

Only small amounts of Seractil pass into breast milk. However, if you are breastfeeding your baby, do not take Seractil for long periods or at high doses.

Driving and operating machinery

If you experience side effects such as dizziness, fatigue, vertigo, or blurred vision after taking Seractil, do not drive or operate hazardous machinery (see section 4. "Possible side effects").

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

You should take Seractil with a glass of water or another liquid. Seractil acts faster if taken without food. Nevertheless, it is recommended to take it with food as it may help you avoid stomach problems, particularly if taken for prolonged periods.

Do not take more than1Seractil tabletin a single dose.

Do not take more than3Seractil tabletsper day.

Osteoarthritis

The recommended dose is 1 Seractil tablet twice a day (1 tablet in the morning and 1 at night). For acute symptoms, your doctor may increase the dose up to 3 Seractil tablets per day.

Menstrual pain

The recommended dose is 1 Seractil tablet twice a day.

Mild to moderate pain

The recommended dose is 200 mg of Seractil (half of a 400 mg tablet) three times a day. If you need higher doses, your doctor may prescribe up to 3 Seractil tablets per day.

You should use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The tablet can be divided into two equal doses. To divide the tablet, place it on a hard surface and press down with your two index fingers or thumbs.

Patients with kidney and/or liver diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. Do not increase the prescribed dose.

Older patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Use in children and adolescents

There is not enough experience in children and adolescents; therefore, Seractil should not be used in patients under 18 years old.

If you estimate that the action of Seractil is too strong or too weak, inform your doctor or pharmacist.

If you take more Seractil than you should:

If you have taken more tablets than you should, or if children have taken this medication accidentally, contact your doctor immediately or visit the nearest hospital to obtain an opinion on the risk and advice on the measures to take.

Symptoms may include nausea, stomach pain, vomiting (which may be bloody), headache, ringing in the ears, ataxia, confusion, and eye tremors. In high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low blood pressure, feeling cold, and respiratory problems have been reported.

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

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Seractil:

Do not take a double dose to compensate for the missed doses. Take the next tablet at the next scheduled time.

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

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

Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Patients over 65 years old who use this medicine have a higher risk of developing problems associated with side effects.

Side effects depend mainly on the dose and vary from patient to patient, especially the risk of gastrointestinal side effects depends on the dosage range and treatment duration.

Stop taking Seractil and seek immediate medical help:

?If you have severe stomach pain, especially when starting to take Seractil.

?If you have black stools, bloody diarrhea, or vomit blood.

?If you have chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

• If you have flat, red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• If you have a generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• If you have a generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

?If you have symptoms such as fever, sore throat, and mouth, flu-like symptoms, fatigue, nosebleeds, and skin bleeding. These symptoms may be caused by a reduction in white blood cells in your body (agranulocytosis).

?If you have severe or persistent headaches.

?If you have yellowing of the skin and eyes (jaundice).

?If you have facial, tongue, or throat swelling, difficulty swallowing or breathing (angioedema), or worsening asthma.

?If you are urinating less than normal, have swelling, cloudy urine, or general discomfort, as these may be the first signs of kidney damage or renal insufficiency.

Very common::may affect more than 1 in 10 people

• Gastrointestinal discomfort, such as abdominal pain, discomfort, and indigestion, diarrhea, flatulence, constipation, stomach burning, vomiting, and mild bleeding in the stomach and/or intestines that may cause anemia in exceptional cases.

Common::may affect up to 1 in 10 people

- Gastrointestinal ulcers, sometimes with bleeding and perforation (see section 2), black stools (melaena), vomiting with blood (hematemesis), mouth ulcers, and inflammation (stomatitis ulcerosa), colon inflammation (colitis), worsening of inflammatory bowel disease, complications of diverticulitis of the colon (perforation, fistula).

- Central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability, or drowsiness, vertigo, fatigue.

Rare::may affect up to 1 in 100 people

• Gastritis
• Visual disorders
• Hypersensitivity reactions such as urticaria, itching, purple hematoma (purpura), and exanthema, as well as asthma attacks (possibly with a drop in blood pressure)
• Swelling of the face or throat (angioedema)
• Anxiety
• Tinnitus (ringing in the ears)
• Nasal secretion (rhinitis)
• Skin eruptions
• Edema, especially in patients with high blood pressure or kidney problems, including kidney inflammation and renal insufficiency

Rare::may affect up to 1 in 1,000 people

• Psychotic reaction
• Loss of vision (amblyopia)
• Auditory disorders
• Renal damage (papillary necrosis), elevated urea levels in the blood, and elevated uric acid levels in the blood
• Liver function problems (usually reversible)
• Depression, confusion, hallucinations

Very rare::may affect up to 1 in 10,000 people

- Difficulty breathing (mainly in patients with asthma)

- Inflammation of the esophagus or pancreas, formation of a membrane-like narrowing in the small and large intestine (intestinal stenosis, type diaphragm)

- Edema, high blood pressure, inflammation of blood vessels, palpitations, heart failure

- Liver dysfunction, liver damage, especially during long-term treatment, liver insufficiency, acute liver inflammation (hepatitis), and jaundice

- Photosensitivity reactions

- Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In these cases, stop treatment immediately and consult a doctor. Do not treat these symptoms with painkillers or antipyretic medications.

- There have been reports of worsening of infections related to infection (e.g., necrotizing fasciitis) associated with the use of certain analgesics (NSAIDs). If you experience signs of infection or worsening during the use of dexibuprofen, seek medical attention without delay to investigate if antibiotic treatment is necessary.

- Exceptionally, severe skin infections and complications of soft tissue during varicella infection

- There have been reports of symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, fever, or loss of consciousness when using dexibuprofen. Patients with autoimmune disorders (LES, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs

- Severe skin reactions, such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, dermatitis exfoliativa, toxic epidermal necrolysis, Lyell syndrome, hair loss (alopecia)

- Severe hypersensitivity reactions (edema of the face, tongue, and larynx, dyspnea, tachycardia, hypotension, severe shock), worsening asthma

Unknown (frequency cannot be estimated from available data)

- A severe skin reaction known as DRESS syndrome may occur. DRESS symptoms include: skin rash, fever, lymph node inflammation, and an increase in eosinophils (a type of white blood cell). A red, scaly, and generalized rash with bumps under the skin and blisters, mainly located on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop using Seractil if you develop these symptoms and seek medical attention immediately. See section 2.

Medicines like Seractil may be associated with a slight increase in the risk of suffering heart or brain attacks (“myocardial infarction”).

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://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 store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD.The expiration date is the last day of the month indicated.

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

Composition ofSeractil

• The active ingredient is dexibuprofen. A film-coated tablet contains 400 mg of dexibuprofen.
• The other components are:

Tablet core:hypromellose, microcrystalline cellulose, calcium carmelose, anhydrous colloidal silica, talc.

Coating:hypromellose, titanium dioxide (E171), triacetin, talc, macrogol 6000.

Appearance of the product and contents of the package

The 400 mg tablets are white and have a scored surface on both sides.

Length: approximately 18.2 mm

Width: approximately 8.2 mm

Height: approximately 5.9 mm

Seractil is presented in packages of 4, 10, 20, 30, 50, 60, 90, and 100 film-coated tablets in PVC/PVDC/aluminum blisters, transparent and colorless.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo 29

08022 Barcelona (Spain)

Responsible manufacturer

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

This medicinal product is authorized in the Member States of the European Economic Area (EEA) with the following names:

Austria:Dexibuprofen "Gebro" 400 mg Filmtabletten

Portugal:Seractil 400 mg comprimidos revestidos

Sweden:Tradil 400 mg filmdragerade tabletter

Denmark:Seractiv 400 mg filmovertrukne tabletter

Spain:Seractil 400 mg comprimidos recubiertoswith film

Greece:Seractil 400 mg film-coated tablets

Italy:Seractil400 mg compresse rivestite con film

Last review date of this leaflet:December 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/