SERACTIL 400 mg FILM-COATED TABLETS

2. What you need to know before you take Seractil

Do not take Seractil if:

• you are allergic to dexibuprofen or any of the other ingredients of Seractil (listed in section 6);
• you are allergic to acetylsalicylic acid or other pain-relieving medicines (your allergy could cause you difficulty breathing, asthma, nasal discharge, skin rash, or swelling of the face);
• you have had gastrointestinal bleeding or perforation caused by NSAIDs;
• you have or have had recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea could be a sign that your stomach or intestine is bleeding);
• you have cerebral bleeding (cerebrovascular hemorrhage) or other active bleeding;
• you have a worsening of an inflammatory disease of the intestines (ulcerative colitis, Crohn's disease);
• you suffer from severe dehydration (e.g., caused by vomiting, diarrhea, or insufficient fluid intake);
• you have severe heart failure or severe kidney or liver disease;
• you are a woman in the third trimester of pregnancy;
• you have a condition of unknown origin that results in the abnormal formation of blood cells.

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 addicted to alcohol;
• you have a coagulation disorder (see "Other medicines and Seractil");
• you have edema (fluid retention);
• you have a heart disorder or high blood pressure;
• you have systemic lupus erythematosus (a disease that affects the joints, muscles, and skin) or mixed connective tissue disease (a disease of the connective tissue that affects the joints, muscles, and skin);
• you want to become pregnant and have difficulty doing so;
• you suffer from asthma or allergic diseases, as you may experience difficulty breathing;
• you have hay fever (allergic rhinitis), nasal polyps, or chronic obstructive respiratory disorders, there is a higher risk of allergic reactions. Allergic reactions can present as asthma attacks (called analgesic 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 hereditary disorders that affect your blood (e.g., acute intermittent porphyria);
• you have an infection - see the "Infections" section below.

Gastrointestinal bleeding, ulcers, or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal side effects. When gastrointestinal bleeding or ulcers occur, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulcers, or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 2), and in elderly patients.

These patients should start treatment with the lowest available dose. Concomitant treatment with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients who require low-dose acetylsalicylic acid or other medications that may increase the gastrointestinal risk.

If you have previously had gastrointestinal toxicity, particularly in the elderly, you should inform your doctor of any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment.

Anti-inflammatory/analgesic medications like dexibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Seractil if:

• you have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), 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 observed. With dexibuprofen, signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported. Stop using Seractil immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

You may experience headaches after prolonged treatment with high doses of painkillers (use outside approved indications). In this case, consult your doctor; you should not take higher doses of Seractil for the headache.

In general, the habitual use of painkillers, especially with combinations of more than one active analgesic ingredient, can cause permanent kidney damage, including the risk of kidney failure (analgesic nephropathy).

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment. Discontinue treatment with Seractil and seek medical attention immediately if you notice any of the 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. Consequently, Seractil may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

You should avoid taking NSAIDs if you have a chickenpox virus infection (varicella).

Other medicines and Seractil

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

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

• anticoagulant medications (e.g., to treat blood clotting problems/prevent clotting, e.g., 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 treatment with Seractil. Therefore, you should always consult your doctor or pharmacist before using Seractil with other medications. In particular, you should inform your doctor or pharmacist if you are taking any of the following medications, in addition to those mentioned above:

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

• Non-steroidal anti-inflammatory drugs (medicines for pain, fever, and inflammation). There is an increased risk of developing ulcers or gastrointestinal bleeding if you take Seractil with other NSAIDs or acetylsalicylic acid as an analgesic.

You maytake the following medications, but for safety reasons, you should inform your doctor:

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

? Methotrexate (a medication used to treat cancer or rheumatoid arthritis). Seractil may increase the adverse effects of methotrexate.

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

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

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

? Digoxin (a medication used to treat heart disorders). Seractil may increase the adverse effects of digoxin.

? Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus), sulfonylureas (certain oral antidiabetic medications), and aminoglycoside antibiotics (medications used to treat infections) - kidney damage may occur.

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

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

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

? Pemetrexed (a medication used to treat certain types of cancer).

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

? Baclofen (a muscle relaxant): baclofen side effects may develop after starting dexibuprofen treatment.

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

Taking Seractil with food, drinks, and alcohol

You can take Seractil on its own, but it is recommended to take it with meals to reduce the possibility of stomach upset, especially in prolonged treatments.

You should limit or avoid alcohol consumption while taking Seractil, as it may increase gastrointestinal problems.

Pregnancy, fertility, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take Seractil during the last 3 months of pregnancy or later, as it may seriously harm the fetus, even at very low doses. 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 labor more than expected.

You should not take Seractil during the first 6 months of pregnancy unless it is clearly necessary and as directed 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, Seractil may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment during a period longer 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.

Rarely, medications like Seractil may affect female fertility. Your fertility will return to normal when you stop taking Seractil.

Breastfeeding

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

Driving and using machines

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

3. How to take Seractil

Follow the instructions for administration of this medicine exactly as directed by your doctor. If you are unsure, 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. However, it is recommended to take it with food, as it may help you avoid stomach problems, especially if taken for prolonged periods.

Do not take more than 1Seractil tablet at a time.

Do not take more than 3Seractil tablets per day.

Osteoarthritis

The recommended dose is 1 Seractil tablet twice a day (1 tablet in the morning and 1 in the evening). For acute symptoms, your doctor may increase the dose 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 a 400 mg tablet) three times a day. If you need higher doses, your doctor may prescribe up to 3 Seractil tablets per day.

The effective lowest dose should be used for the shortest necessary duration to relieve symptoms. If you have an infection, consult a doctor immediately if the 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 index fingers or thumbs.

Patients with kidney and/or liver disease

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

Elderly 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 checked 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 think the effect of Seractil is too strong or too weak, tell 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 or visit the nearest hospital for advice on the risk and measures to be taken.

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 of cold, and respiratory problems have been reported.

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

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

If you forget to take Seractil:

Do not take a double dose to make up for forgotten doses. Take the next tablet at the next scheduled time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, Seractil can cause adverse effects, although not all people suffer from them.

Adverse effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Elderly patients using this medication have a higher risk of developing problems associated with adverse effects.

Adverse effects depend mainly on the dose and vary from one patient to another, especially the risk of gastrointestinal adverse 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 can be a sign of a potentially severe allergic reaction called Kounis syndrome

• if you have reddish, non-raised spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• if you have a widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• if you have a generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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

? if you have severe or persistent headaches.

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

? if you have swelling of the face, tongue, or pharynx, difficulty swallowing or breathing (angioedema), worsened asthma.

? if you urinate less than usual, have swelling, cloudy urine, or general discomfort, as these could be the first signs of kidney damage or kidney failure.

Very common: may affect more than 1 in 10 people

• Gastrointestinal disorders, such as abdominal pain, discomfort, and indigestion, diarrhea, flatulence, constipation, heartburn, vomiting, and mild bleeding in the stomach and/or intestine that can 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 (melena), bloody vomit (hematemesis), mouth ulcers and inflammation (ulcerative stomatitis), colon inflammation (colitis), worsening of inflammatory bowel disease, complications of colon diverticula (perforation, fistula).
• Central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability, or drowsiness, vertigo, fatigue.

Uncommon: may affect up to 1 in 100 people

• Gastritis
• Visual disturbances
• Hypersensitivity reactions such as hives, itching, purple spots (purpura), and exanthema, as well as asthma attacks (possibly with a drop in blood pressure)
• Swelling of the face or throat (angioedema)
• Anxiety
• Ringing in the ears (tinnitus)
• Nasal discharge (rhinitis)
• Skin rashes
• Development of edema, especially in patients with high blood pressure or kidney problems, including kidney inflammation and kidney failure

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

• Psychotic reaction
• Vision loss (toxic amblyopia)
• Hearing disorders
• Kidney damage (papillary necrosis), elevated urea levels in the blood, and elevated uric acid levels in the blood
• Liver function problems (generally reversible)
• Depression, confusion, hallucinations

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

• Difficulty breathing (predominantly in patients with bronchial asthma)
• Inflammation of the esophagus or pancreas, formation of a membrane-like narrowing in the small and large intestine (intestinal stenosis, diaphragm type)
• Edema, high blood pressure, blood vessel inflammation, palpitations, heart failure
• Liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute liver inflammation (hepatitis), and jaundice
• Photosensitivity reactions
• Blood cell production problems (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, you should stop treatment immediately and consult a doctor. Do not treat these symptoms with pain relievers or fever-reducing medications (antipyretics)
• A worsening of infection-related inflammation (e.g., necrotizing fasciitis) associated with the use of certain pain relievers (NSAIDs) has been described. If signs of infection or worsening appear during the use of dexibuprofen, consult a doctor without delay to investigate if anti-infective/antibiotic treatment is necessary.
• Exceptionally, severe skin infections and soft tissue complications during chickenpox
• Symptoms of aseptic meningitis with neck stiffness, headache, feeling of discomfort, fever, or altered consciousness have been observed when using dexibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs
• Severe forms of skin reactions, such as a rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, Lyell syndrome, hair loss (alopecia)
• Severe general hypersensitivity reactions (swelling of the face, tongue, and larynx, shortness of breath, tachycardia, hypotension, severe shock), worsened 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 on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Seractil if you develop these symptoms and seek immediate medical attention. See also section 2.

Medications like Seractil may be associated with a slight increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Seractil

Keep this medication out of sight and reach of children.

Do not store above 25°C.

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

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. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofSeractil

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

Core of the tablet: hypromellose, microcrystalline cellulose, calcium carmellose, colloidal anhydrous silica, talc.

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

Appearance of the product and package contents

The 400 mg tablets are white and have a score line on both sides.

Length: approximately 18.2 mm

Width: approximately 8.2 mm

Height: approximately 5.9 mm

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo 29

08022 Barcelona (Spain)

Manufacturer

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

This medication is authorized in the Member States of the European Economic Area (EEA) under 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 recubiertos con película

Greece: Seractil 400 mg film-coated tablets

Italy: Seractil 400 mg compresse rivestite con film

Date of the last revision of this prospectus:December 2024

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/