Seractil 400 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seractil 400 mg film-coated tablets

Dexibuprofen

Read the entire 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, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Seractil is and what it is used for
2. What you need to know before taking Seractil
3. How to take Seractil
4. Possible adverse effects
5. Storage of Seractil

Pack contents and additional information

1. What Seractil is and what it is used for

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

What Seractil is used for

Seractil is indicated in adults for the relief of:

• pain and inflammation caused by osteoarthritis (when joints wear down);

• menstrual pain;

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

2. What you need to know before taking Seractil

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 to other pain-relieving medicines (your allergy could cause difficulty breathing, asthma, runny nose, skin rash, or facial swelling);
• you have had gastrointestinal bleeding or perforation caused by NSAIDs;
• you currently have or have had recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea may be signs that your stomach or intestine is bleeding);
• you have cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding;
• you have an acute worsening of inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• you are severely dehydrated (e.g., due to 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 an undiagnosed condition that causes 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 alcohol-dependent;
• you have a coagulation disorder (see "Other medicines and Seractil");
• you have edema (fluid retention);
• you have heart problems or high blood pressure;
• you have systemic lupus erythematosus (a disease affecting joints, muscles, and skin) or mixed connective tissue disease (a collagen disorder affecting connective tissue);
• you are trying to become pregnant and are experiencing fertility problems;
• you currently have or have previously had asthma or allergic diseases, as breathing difficulties may occur;
• you have hay fever (allergic rhinitis), nasal polyps, or chronic obstructive respiratory disorders—this increases the risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's edema (swelling mainly in the face, 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.

Gastrointestinal bleeding, ulceration, or perforation, which may 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. If gastrointestinal bleeding or ulceration occurs, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of ulcers—especially 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 those requiring concomitant low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk. If you have previously experienced gastrointestinal toxicity, especially in old age, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the early stages of treatment.

Anti-inflammatory/analgesic medicines such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment with 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, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 medicine have been reported, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain. Stop using Seractil immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

You may experience headaches after prolonged treatment with high doses of analgesics (use outside approved indications). In such cases, consult your doctor; do not take higher doses of Seractil to treat headache.

In general, regular use of analgesics, especially combinations of more than one analgesic active ingredient, may cause permanent kidney damage, including risk of kidney failure (analgesic nephropathy).

Skin reactions

Serious skin reactions have been reported, 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), in association with treatment. Discontinue treatment with Seractil and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

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

You should avoid administration of NSAIDs if you have varicella zoster virus infection (chickenpox).

Other medicines and Seractil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

• anticoagulant medicines (e.g., to treat or prevent clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine, rivaroxaban, apixaban, or dabigatran) may prolong bleeding time.
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, 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 medicines may also affect or be affected by treatment with Seractil. Therefore, you should always consult your doctor or pharmacist before using Seractil with other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

You must not take the following medicines with Seractil unless under strict medical supervision:

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

You may take the following medicines, but for safety reasons you should inform your doctor:

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

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

? Diuretics (medicines used to increase urine output), as dexibuprofen may reduce the effectiveness of these medicines.

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

? Certain antidepressants (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.

? Digoxin (a medicine for treating heart disorders). Seractil may increase the adverse effects of digoxin.

? Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus), sulfonylureas (certain oral antidiabetic medicines), and aminoglycoside antibiotics (medicines for treating 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 medicine used to treat epilepsy. Seractil may increase the adverse effects of phenytoin.

? Pemetrexed (a medicine for treating certain types of cancer).

? Zidovudine (a medicine for treating HIV/AIDS); dexibuprofen may increase the risk of bleeding into a joint or hemorrhagic inflammation.

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

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

Taking Seractil with food, drinks, and alcohol

You may take Seractil alone, but it is recommended to take it with food to reduce the possibility of stomach discomfort, especially during prolonged treatment.

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

Pregnancy, fertility and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take Seractil during the last three months of pregnancy onwards, as it may seriously harm the unborn baby, even at very low doses. It may cause kidney and heart problems in your fetus. It may affect your bleeding tendency and that of your baby, and may delay or prolong labour beyond the expected duration.

You should not take Seractil during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is required during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time.

From week 20 of pregnancy, taking Seractil for more than a few days may cause kidney problems in your fetus, which could 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Fertility

You should also avoid taking Seractil if you are trying to become pregnant, as it may make it more difficult to conceive.

In rare cases, medicines such as Seractil may affect female fertility. Fertility will return to normal once treatment with Seractil is discontinued.

Breastfeeding

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

Driving and operating machinery

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

3. How to take Seractil

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Do not take more than 1 tablet of Seractil in a single dose.

Do not take more than 3 tablets of Seractil per day.

Osteoarthritis

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

Menstrual pain

The recommended dose is 1 tablet of Seractil twice daily.

Mild to moderate pain

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

The lowest effective dose should be used for the shortest duration 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 may be divided into two equal doses. To split the tablet, place it on a hard surface and press down with both index fingers or thumbs.

Patients with kidney and/or liver disease

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

Elderly patients

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

Use in children and adolescents

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

If you think that 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 accidentally taken this medicine, contact your doctor immediately or go to the nearest hospital for advice on the risk and measures to take.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, ataxia, confusion, and eye tremors. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood pressure, feeling of cold body, and breathing problems have been reported.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Seractil:

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

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

4. Possible adverse effects

Like all medicines, Seractil may produce adverse effects, although not everyone experiences them.

Adverse effects can be minimized by taking the lowest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients using this medicine are at higher risk of developing problems associated with adverse effects.

Adverse effects are mainly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal adverse effects depends on the dosage range and duration of treatment.

Stop taking Seractil and seek immediate medical help if you:

? experience severe stomach pain, especially when you start taking Seractil.

? have black stools, bloody diarrhoea, or vomit blood.

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

• develop flat, red, target-shaped or circular skin rashes on the trunk, often with blisters in the center, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• develop a widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).

• develop a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

? experience symptoms such as fever, sore throat and mouth, flu-like symptoms, feeling tired, nosebleeds, or bleeding from the skin. These symptoms may be caused by a reduction in white blood cells (agranulocytosis).

? have severe or persistent headache.

? develop yellowing of the skin or whites of the eyes (jaundice).

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

? pass less urine than normal, have swelling, cloudy urine, or feel generally unwell, as these could be early signs of kidney damage or kidney failure.

Very common: may affect more than 1 in 10 people

• Gastrointestinal discomfort such as abdominal pain, indigestion, diarrhoea, flatulence, constipation, heartburn, vomiting, and minor gastrointestinal bleeding which may exceptionally lead to anaemia.

Common: may affect up to 1 in 10 people

• Gastrointestinal ulcers, sometimes with bleeding and perforation (see section 2), black stools (melaena), vomiting blood (haematemesis), mouth ulcers and inflammation (ulcerative stomatitis), inflammation of the colon (colitis), worsening of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula).

• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, drowsiness, vertigo, fatigue.

Uncommon: may affect up to 1 in 100 people

• Gastritis
• Visual disturbances
• Hypersensitivity reactions such as urticaria, itching, purple bruising (purpura), and rash, as well as asthma attacks (possibly with low blood pressure)
• Swelling of the face or throat (angioedema)
• Anxiety
• Ringing in the ears (tinnitus)
• Nasal discharge (rhinitis)
• Skin rashes
• Development of oedema, 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
• Loss of vision (toxic amblyopia)
• Hearing disorders
• Kidney damage (papillary necrosis), elevated blood urea levels, elevated blood uric acid levels
• Liver function problems (usually 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 oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestine (intestinal stenosis, diaphragm-type)
• Oedema, high blood pressure, inflammation of blood vessels, palpitations, heart failure
• Liver dysfunction, liver damage (especially during long-term treatment), liver failure, acute inflammation of the liver (hepatitis), and jaundice
• Photosensitivity reactions
• Problems with blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds, and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. Do not treat these symptoms with painkillers or fever-reducing medicines (antipyretics).
• Worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been reported with certain painkillers (NSAIDs). If signs of infection appear or worsen during use of dexibuprofen, consult a doctor without delay to determine whether anti-infective/antibiotic treatment is needed.
• Exceptionally, severe skin infections and soft tissue complications during varicella infection
• Symptoms of aseptic meningitis such as neck stiffness, headache, malaise, fever, or altered consciousness have been observed with 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 red, blistering rash (e.g. Stevens-Johnson syndrome), erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, Lyell syndrome, hair loss (alopecia)
• Severe generalized hypersensitivity reactions (facial, tongue, and laryngeal oedema, dyspnoea, tachycardia, hypotension, severe shock), worsening asthma

Not known (frequency cannot be estimated from available data)

• A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell). A widespread, red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Seractil if you develop these symptoms and seek immediate medical attention. See also section 2.

Medicines such as Seractil may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Seractil

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Seractil

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

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

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

Appearance of the product and contents of the pack

The 400 mg tablets are white and biconvex, scored on both sides.

Length: approximately 18.2 mm
Width: approximately 8.2 mm
Height: approximately 5.9 mm

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

Not all pack 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 medicinal product is authorized in the European Economic Area (EEA) Member States 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 most recent review of this leaflet: December 2024

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