Seractil

Leaflet accompanying the packaging: information for the user

SERACTIL

200 mg, coated tablets

Dexibuprofen

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Seractil and what is it used for
• 2. Important information before taking Seractil
• 3. How to take Seractil
• 4. Possible side effects
• 5. How to store Seractil
• 6. Package contents and other information

1. What is Seractil and what is it used for

Seractil belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The active substance of Seractil is dexibuprofen, which has analgesic and anti-inflammatory effects. NSAIDs inhibit the production of prostaglandins responsible for inflammatory processes in the body.

Indications for use are:

• symptomatic treatment of menstrual pain,
• other types of mild to moderate pain, such as musculoskeletal pain or toothache.

2. Important information before taking Seractil

When not to take Seractil:

• if the patient is allergic to dexibuprofen or any other component of this medicine (listed in section 6),
• if the patient is allergic to acetylsalicylic acid or other painkillers (allergy may cause breathing difficulties, asthma attacks, nasal mucosal inflammation, rash, or facial swelling),
• if the patient has a history of gastrointestinal perforation or bleeding associated with the use of NSAIDs,
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum (bleeding vomiting, black stools, or bloody diarrhea may be symptoms of gastrointestinal bleeding),
• if the patient has cerebral bleeding (cerebral hemorrhage) or other active bleeding,
• if the patient has exacerbation of inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• if the patient has severe heart failure,
• if the patient has severe liver and/or kidney disease,
• from the beginning of the 6th month of pregnancy (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Seractil, the patient should discuss it with their doctor or pharmacist:

• if the patient has had stomach or duodenal ulcers,
• if the patient has intestinal ulcers, ulcerative colitis, or Crohn's disease,
• if the patient has liver or kidney function disorders,
• if the patient is addicted to alcohol,
• if the patient has blood coagulation disorders (see section "Seractil and other medicines"),
• if the patient has edema (fluid accumulation in body tissues),
• if the patient has heart disease or high blood pressure,
• if the patient has asthma or other breathing difficulties,
• if the patient has systemic lupus erythematosus (a disease that causes changes in joints, muscles, and skin) or mixed connective tissue disease (a disease related to abnormal collagen structure, deficiency, or distribution in connective tissue),
• if the patient has difficulty becoming pregnant (in rare cases, medicines like Seractil may reversibly impair female fertility. After stopping Seractil, fertility returns to the pre-treatment state.),
• if the patient has an infection - see below, section titled "Infections".

Seractil should be avoided with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Administering higher doses of Seractil to patients over 60 years old and patients who have previously had stomach or duodenal ulcers is associated with an increased risk of adverse reactions affecting the gastrointestinal tract. In such cases, the doctor should consider additional use of a medicine that protects the gastrointestinal tract. Taking anti-inflammatory and analgesic medicines, such as dexibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the treatment duration should not be prolonged. During dexibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including breathing difficulties, facial swelling, and chest pain. If any of these symptoms are noticed, Seractil should be discontinued, and medical help should be sought immediately. Infections Seractil may mask the symptoms of infection, such as fever and pain. Therefore, Seractil may delay the use of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately. Before taking Seractil, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• they have high blood pressure, diabetes, high cholesterol levels, have a family history of heart disease or stroke, or smoke.

The attending physician should periodically monitor the health of:

• patients with heart, liver, and/or kidney function disorders,
• patients over 60 years old,
• patients requiring long-term use of the medicine. The attending physician will determine the frequency of periodic medical examinations for each of these patients.

Long-term use of high doses of painkillers (without medical indication) may lead to the appearance of headaches that should not be alleviated with higher doses of Seractil. During chickenpox, NSAIDs, including Seractil, should be avoided. Skin reactions Serious skin reactions have occurred with dexibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these serious skin reactions described in section 4, they should immediately discontinue Seractil and seek medical attention.

Seractil and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Concomitant use of dexibuprofen and other medicines may alter their effects and cause side effects. Do nottake Seractil with the following medicines, unless under close medical supervision:

• Other nonsteroidal anti-inflammatory drugs (medicines used to treat pain, fever, and inflammation). There is an increased risk of ulcers and gastrointestinal bleeding when Seractil is used with other nonsteroidal anti-inflammatory drugs or acetylsalicylic acid. The doctor may allow the use of acetylsalicylic acid in low doses (less than 100 mg per day) with Seractil.
• Warfarin or other medicines that reduce blood clotting. Concomitant use of Seractil and anticoagulant medicines may prolong bleeding time and increase the risk of bleeding.
• Lithium, a medicine used to treat depression. Seractil may enhance the effect of lithium.
• Methotrexate. Seractil may increase the adverse effects of methotrexate.

Concomitant use of the following medicines is possible, but for safety reasons, the patient should inform their doctor:

• Acetylsalicylic acid in low doses. Dexibuprofen may interfere with the effect of acetylsalicylic acid in blood thinning.
• Medicines used to treat high blood pressure or heart disease (e.g., beta-blockers). Seractil may reduce the effectiveness of these medicines.
• Medicines that inhibit the angiotensin-converting enzyme (ACE) and angiotensin II receptor antagonists. In rare cases, these medicines may cause kidney function disorders.
• Diuretics.
• Corticosteroids. There is an increased risk of ulcers or bleeding.
• Antidepressants (selective serotonin reuptake inhibitors) due to the increased risk of gastrointestinal bleeding.
• Digoxin (a medicine used to treat heart disease). Seractil may increase the adverse effects of digoxin.
• Medicines used in organ transplantation, such as cyclosporine. Medicines that increase potassium levels: ACE inhibitors, angiotensin II receptor antagonists, cyclosporine, tacrolimus, trimethoprim, and heparins.
• Medicines that inhibit or prevent blood clotting. Seractil may prolong bleeding time.
• Phenytoin (a medicine used to treat epilepsy). Seractil may increase the adverse effects of phenytoin.
• Phenytoin, phenobarbital, and rifampicin. Concomitant use may reduce the effect of dexibuprofen. Oral antidiabetic medicines (sulfonylurea derivatives, e.g., glibenclamide, glimepiride). Concomitant use may cause fluctuations in blood glucose levels. It is recommended to monitor blood glucose levels.
• Zidovudine (a medicine used to treat HIV infection). Concomitant use may increase the risk of bleeding into the joint and the formation of hematomas in patients with hemophilia.
• Pemetrexed (an anticancer medicine used to treat lung cancer). In patients with kidney function disorders, it is recommended to avoid concomitant use of high doses of Seractil for two days before and two days after pemetrexed administration.

Seractil may affect the action of other medicines or other medicines may affect the action of Seractil. For example:

• medicines with anticoagulant effects (i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Other medicines may also be affected or have an impact on Seractil treatment. Therefore, before taking Seractil with other medicines, the patient should always consult their doctor or pharmacist.

Seractil with food, drink, and alcohol

Tablets can be taken independently of meals, but it is recommended to take Seractil with meals, drinking a liquid to reduce gastrointestinal irritation. The patient should limit or avoid drinking alcohol while taking Seractil, as it may increase the frequency and severity of adverse reactions affecting the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Taking the medicine from the beginning of the 6th month of pregnancy is absolutely contraindicated due to the possible risk of fetal developmental abnormalities and complications during delivery. Seractil may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. In the first 5 months of pregnancy, Seractil should only be used if necessary, after consulting a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Seractil may cause kidney function disorders in the unborn child if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring. Only small amounts of Seractil pass into breast milk. However, breastfeeding women should not take Seractil for extended periods or in high doses. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and disappears after treatment is stopped.

Driving and using machines

Patients who experience dizziness or fatigue while taking Seractil should not drive vehicles or operate machines (see section 4, "Possible side effects").

3. How to take Seractil

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The patient should use the smallest effective dose for the shortest duration necessary to control the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2). Seractil is taken orally, with a glass of water or another liquid. Seractil acts faster when taken on an empty stomach. However, it is recommended to take the medicine with a meal to reduce the risk of gastrointestinal side effects, especially when used long-term. The patient should not take more than 2Seractil 200 mg tablets at a time.The patient should not take more than 6Seractil 200 mg tablets per day.

In relieving menstrual pain

The recommended dose is 600 mg to 900 mg of dexibuprofen per day, divided into 3 doses. For example, the patient can take one Seractil 200 mg tablet three times a day. The maximum daily dose is 900 mg of dexibuprofen.

Reducing mild to moderate pain

The recommended dose of Seractil is 1 tablet of 200 mg three times a day. In case of exacerbation of symptoms, the doctor may recommend increasing the dose to 6 Seractil 200 mg tablets per day. The notch on the tablet (see also "What Seractil looks like and what the package contains") allows the tablet to be divided into two halves. To do this, the Seractil 200 mg tablet should be placed on a hard surface and pressed with two index fingers or thumbs.

Dosing in patients with liver or kidney function disorders

In patients with mild or moderate liver or kidney function disorders, the smallest effective dose of the medicine should be used. The dose prescribed by the doctor should not be exceeded.

Dosing in elderly patients

In patients over 60 years old, it is recommended to start treatment with the smallest effective dose of dexibuprofen. If the medicine is well tolerated, the dose can be increased to the recommended dose.

Children and adolescents

There is no data on the use of dexibuprofen in children and adolescents under 18 years old; therefore, the use of Seractil is not recommended in this age group. If the patient feels that the effect of Seractil is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Seractil than recommended

In case of taking a higher dose of Seractil than recommended, the patient should immediately consult their doctor.

Missing a dose of Seractil

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.

Stopping Seractil treatment

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Seractil can cause side effects, although not everybody gets them. Taking Seractil in the smallest effective dose and for the shortest duration necessary to control the symptoms reduces the risk of side effects.

The patient should stop taking Seractil and immediately consult their doctor if:

• severe stomach pain occurs, especially at the beginning of Seractil treatment,
• black (tarry) stools, bloody diarrhea, or vomiting blood occur,
• fever, sore throat, and mouth, flu-like symptoms, fatigue, or nose or skin bleeding occur. These symptoms may be caused by a decrease in the number of white blood cells in the body, a condition known as agranulocytosis,
• severe or persistent headache occurs,
• yellowing of the skin and whites of the eyes (jaundice) occurs,
• swelling of the face, tongue, or throat, difficulty swallowing or breathing (angioedema),
• chest pain, which may be a symptom of a potentially severe allergic reaction known as Kounis syndrome,
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread rash, high body temperature, and swollen lymph nodes (DRESS),
• red, scaly rash with lumps under the skin and blisters, usually occurring at the beginning of treatment, accompanied by fever (acute generalized exanthematous pustulosis).

Very common side effects (occurring in more than 1 in 10 patients) include:

• indigestion, stomach pain.

Common side effects (occurring in less than 1 in 10 patients but more than 1 in 100 patients) include:

• diarrhea, nausea, vomiting,
• fatigue, drowsiness, headache, dizziness,
• skin rash.

Uncommon side effects (occurring in less than 1 in 100 patients but more than 1 in 1,000 patients) include:

• stomach or duodenal ulcers, gastrointestinal bleeding, stomach mucosal inflammation, oral ulcerative stomatitis, black (tarry) stools,
• hives, itching, purpura (purple spots),
• facial and throat swelling (angioedema),
• sleep disorders, anxiety, fear, vision disturbances, ringing or buzzing in the ears (tinnitus),
• nasal inflammation, breathing difficulties.

Rare side effects (occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients) include:

• severe allergic reactions,
• psychotic reactions, depression, irritability,
• disorientation, confusion, agitation,
• hearing disorders,
• bloating, constipation, esophageal inflammation, esophageal narrowing, gastrointestinal perforation (symptoms include severe stomach pain, fever, nausea, and vomiting), exacerbation of diverticulitis (infection or inflammation of small pouches in the intestinal wall), ulcerative colitis, or Crohn's disease,
• abnormal liver function, hepatitis, and jaundice (yellowing of the skin or eyes),
• transient vision loss,
• blood disorders, including decreased white or red blood cell count or platelet count.

Very rare side effects (occurring in less than 1 in 10,000 patients) include:

• allergic reactions, including symptoms such as fever, skin rash, stomach pain, headache, nausea, and vomiting,
• photosensitivity (sensitivity to light),
• aseptic meningitis (symptoms include headache, fever, neck stiffness, and general malaise), severe allergic reactions (symptoms include breathing difficulties, asthma attacks, rapid heartbeat, low blood pressure, and shock), allergic reactions combined with vasculitis,
• redness of the skin, mucous membranes, or throat,
• blisters on the palms and soles (Stevens-Johnson syndrome),
• skin peeling, exfoliation (toxic epidermal necrolysis - Lyell's syndrome),
• hair loss, alopecia,
• kidney inflammation, nephrotic syndrome, or kidney failure,
• systemic lupus erythematosus (an autoimmune disease),
• exacerbation of very rare bacterial infections that affect the tissues surrounding the muscles.

Side effects with unknown frequency (frequency cannot be estimated from available data) include:

• red, scaly rash with lumps under the skin and blisters, usually occurring at the beginning of treatment, accompanied by fever (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Seractil and seek medical attention immediately. See also section 2.

Edema (swelling of the hands and feet), high blood pressure, and heart failure may also occur during the use of NSAIDs. Taking medicines like Seractil may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw tel.: +48 22 49 21 301, fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Seractil

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Seractil contains

• The active substance of Seractil is dexibuprofen. Each coated tablet contains 200 mg of dexibuprofen.
• The medicine also contains: Tablet core: hypromellose, microcrystalline cellulose, calcium carmellose, colloidal anhydrous silica, talc. Tablet coating: hypromellose, titanium dioxide (E 171), trioctanoin, talc, macrogol 6000.

What Seractil looks like and what the package contains

The tablets are white, round, biconvex, with a notch on one side, without spots or cracks. The tablet can be divided into two halves. Seractil is packaged in PVDC/PVC/Aluminum blisters. The blisters are placed in a cardboard box with a patient leaflet. Available packages: 6, 10, 20, 30, or 60 coated tablets. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

BIOFARM Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań tel.: +48 61 66 51 500 fax: +48 61 66 51 505 e-mail: [email protected]

Date of last revision of the leaflet: