Seractil

Package leaflet: Information for the user

SERACTIL
400 mg, coated tablets
Dexibuprofen
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Seractil is and what it is used for
2. Important information before taking Seractil
3. How to take Seractil
4. Possible side effects
5. How to store Seractil
6. Contents of the pack and other information

1. What Seractil is and what it is used for

Seractil belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
The active substance in Seractil is dexibuprofen, which has analgesic and anti-inflammatory effects.
NSAIDs inhibit the production of prostaglandins, which are responsible for inflammatory processes in the body.
Indications for use include symptomatic treatment of:

• pain and inflammation in osteoarthritis,
• menstrual pain,
• other types of mild to moderate pain, such as musculoskeletal pain or toothache.

2. Important information before using Seractil

When not to use Seractil:

• if the patient is allergic to dexibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to acetylsalicylic acid or other pain-relieving medicines (allergy may cause breathing difficulties, asthma attacks, inflammation of the nasal mucosa, rash, facial swelling),
• if the patient has previously experienced gastrointestinal perforations or bleeding associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum (bloody vomiting, black stools, or diarrhoea with blood may be symptoms of bleeding from the stomach or intestines),
• if the patient has bleeding in the brain (cerebral haemorrhage) or other active bleeding,
• if the patient has an exacerbation of inflammatory bowel disease (Crohn’s disease, ulcerative colitis),
• if the patient has severe heart failure,
• if the patient has severe kidney dysfunction (glomerular filtration rate GFR below 30 mL/min),
• if the patient has severe liver dysfunction,
• from the beginning of the 6th month of pregnancy (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting to use Seractil, discuss this with your doctor or pharmacist:

• if the patient has previously had gastric or duodenal ulcers,
• if the patient has intestinal ulcers, ulcerative colitis, or Crohn’s disease,
• if the patient has impaired liver or kidney function,
• if the patient is alcohol-dependent,
• if the patient has blood clotting disorders (see section "Seractil with other medicines"),
• if the patient has oedema (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 causing changes, among others, in joints, muscles, and skin) or mixed connective tissue disease (a condition associated with abnormal structure, deficiency, or improper distribution of collagen in connective tissue),
• if the female patient has difficulty becoming pregnant (in rare cases, medicines such as Seractil may reversibly impair fertility in women. After discontinuation of Seractil, fertility returns to the pre-treatment state.),
• if the patient has an infection – see below, section titled "Infections".

Avoid using Seractil together with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.
Administering higher doses of Seractil to patients over 60 years of age and to patients who previously had gastric or duodenal ulcers is associated with an increased risk of gastrointestinal adverse effects. In such cases, the doctor should consider additional use of a gastroprotective agent.
Taking anti-inflammatory and pain-relieving medicines such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Allergic reactions to dexibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms occur, discontinue Seractil immediately and contact a doctor or emergency medical services without delay.

Infections
Seractil may mask symptoms of infection such as fever and pain. Therefore, Seractil may delay appropriate treatment of infection and consequently increase the 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 ongoing infection and infection symptoms persist or worsen, immediate consultation with a doctor is necessary.

Before using Seractil, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

The treating physician should periodically monitor the health status of:

• patients with impaired heart, liver, and/or kidney function,
• patients over 60 years of age,
• patients requiring long-term treatment. The treating physician will determine the frequency of periodic medical examinations individually for each of these patients.

Long-term use of high doses of painkillers (outside medical indication) may lead to headaches that should not be treated with higher doses of Seractil.
During chickenpox, avoid using NSAIDs, including Seractil.

Skin reactions
Serious skin reactions have occurred with the use of dexibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If the patient develops any symptoms related to these serious skin reactions described in section 4, Seractil should be discontinued immediately and medical help should be sought.

Seractil with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take, including those available without a prescription.
Concomitant use of dexibuprofen and other medicines may alter their effects and cause adverse reactions.

Do not take Seractil simultaneously with the following medicines unless under strict medical supervision:

• Other non-steroidal anti-inflammatory drugs (medicines used to treat pain, fever, and inflammation). There is an increased risk of gastrointestinal ulcers and bleeding when Seractil is used concomitantly with other NSAIDs or acetylsalicylic acid. The doctor may allow the use of low-dose acetylsalicylic acid (less than 100 mg per day) together with Seractil.
• Warfarin or other anticoagulant medicines. Concomitant use of Seractil and anticoagulants may prolong bleeding time and increase the risk of bleeding.
• Lithium, a medicine used to treat depression. Seractil may enhance the effects of lithium.
• Methotrexate. Seractil may increase methotrexate's adverse effects.

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

• Low-dose acetylsalicylic acid. Dexibuprofen may interfere with the blood-thinning effect of acetylsalicylic acid.
• Medicines used to treat high blood pressure or heart conditions (e.g., beta-blockers). Seractil may reduce the effectiveness of these medicines.
• ACE inhibitors and angiotensin II receptor antagonists. In rare cases, these medicines may cause kidney dysfunction.
• Diuretics.
• Corticosteroids. There is an increased risk of ulcers or bleeding.
• Antidepressants (selective serotonin reuptake inhibitors) due to increased risk of gastrointestinal bleeding.
• Digoxin (a medicine used to treat heart conditions). Seractil may increase digoxin's adverse effects.
• Medicines used in organ transplant recipients, 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 phenytoin's adverse effects.
• 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. Monitoring of blood glucose levels is recommended.
• Zidovudine (a medicine used to treat HIV infection). Concomitant use may increase the risk of bleeding into joints and formation of haematomas in patients with haemophilia.
• Pemetrexed (an anticancer medicine used, among others, in lung cancer treatment). In patients with impaired kidney function, avoid concomitant use of high-dose 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:

• anticoagulant medicines (i.e., blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may affect treatment with Seractil. Therefore, always consult a doctor or pharmacist before using Seractil with other medicines.

Seractil with food, drink, and alcohol
Tablets may be taken independently of meals, but it is better to take Seractil during meals with fluids to reduce gastrointestinal irritation.
Alcohol intake should be limited or avoided while taking Seractil, as it may increase the frequency and severity of gastrointestinal adverse effects.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Seractil from the beginning of the 6th month of pregnancy is absolutely contraindicated due to the risk of fetal developmental abnormalities and delivery complications.
Seractil may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and her child and may delay or prolong labour.
During the first 5 months of pregnancy, Seractil may be used only if necessary, after consultation with a doctor.
If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Seractil may cause kidney dysfunction in the unborn child if used for longer than a few days, potentially leading 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 is required for longer than a few days, the doctor may recommend additional monitoring.
Only small amounts of Seractil pass into breast milk. However, Seractil should not be used long-term or at high doses in breastfeeding women.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is transient and resolves after discontinuation of treatment.

Driving and operating machinery
Patients who experience dizziness or fatigue while taking Seractil should not drive or operate machinery (see section 4. "Possible adverse effects").

3. How to use Seractil

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Seractil should be 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 after a meal to reduce the risk of gastrointestinal discomfort, especially when the medicine is used long-term.
Do not take more than 1 tablet of Seractil 400 mg at a time.
Do not take more than 3 tablets of Seractil 400 mg per day.
Relief of pain and inflammation in osteoarthritis
The recommended dose is 1 tablet of Seractil 400 mg twice daily (1 in the morning and 1 in the evening).
If symptoms worsen, your doctor may recommend increasing the dose to 3 tablets of Seractil 400 mg per day.
For relief of menstrual pain
The recommended dose is 600 mg to 900 mg of dexibuprofen per day, administered in three divided doses. For example, this may be half a tablet of Seractil 400 mg taken three times daily. The maximum daily dose is 900 mg of dexibuprofen.
Relief of mild to moderate pain
The recommended dose is 200 mg of dexibuprofen (half a tablet of Seractil 400 mg) three times daily.
If higher doses are needed, your doctor may recommend taking 1 tablet of Seractil 400 mg up to three times daily. Depending on symptoms, your doctor may also recommend taking Seractil at a lower dose (200 mg or 300 mg).
The score line on the tablet (see also "What Seractil looks like and what the pack contains")
allows the tablet to be divided into halves.
Dosing in patients with liver or kidney function impairment
In patients with mild or moderate liver or kidney function impairment, the lowest effective dose of the medicine should be used. Do not exceed the dose prescribed by your doctor.
Dosing in elderly patients
In patients over 60 years of age, treatment should be initiated with the lowest effective doses of dexibuprofen. If the medicine is well tolerated, the dose may be increased to the recommended level.
Children and adolescents
There is insufficient data on the use of dexibuprofen in children and adolescents under 18 years of age; therefore, the use of Seractil is not recommended in this age group.
If you feel that the effect of Seractil is too strong or too weak, consult your doctor or pharmacist.
Taking more Seractil than recommended
If you take more Seractil than prescribed, contact your doctor immediately.
Missing a dose of Seractil
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
Stopping Seractil
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Taking Seractil at the lowest effective dose and for the shortest duration necessary to control disease symptoms reduces the risk of side effects.
You must stop taking Seractil and contact your doctor immediately if:

• you develop severe abdominal pain, especially at the beginning of treatment with Seractil,
• you have black (tarry) stools, bloody diarrhoea, or vomiting blood,
• you develop fever, sore throat and mouth, flu-like symptoms, feeling tired, or nosebleeds or bleeding from the skin. These symptoms may be due to a reduction in white blood cells in the body. This condition is known as agranulocytosis,
• you develop sudden or persistent headache,
• you develop yellowing of the skin or whites of the eyes (jaundice),
• you develop swelling of the face, tongue or throat, difficulty swallowing or breathing (angioedema),
• you develop chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• you develop red, flat, target-like or circular skin rashes on the trunk, often with blisters in the centre, skin peeling, or ulcers in the mouth, throat, nose, genital organs or eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• you develop widespread rash, high fever and swollen lymph nodes (DRESS syndrome),
• you develop a red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).

Side effects occurring very commonly (in more than 1 in 10 patients) include:

• indigestion, abdominal pain.

Side effects occurring commonly (in less than 1 in 10 patients but more than 1 in 100 patients) include:

• diarrhoea, nausea, vomiting,
• feeling tired, drowsiness, headache, dizziness,
• skin rash.

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

• gastric and/or duodenal ulceration, gastrointestinal bleeding, inflammation of the stomach lining, ulcerative inflammation of the oral mucosa, black (tarry) stools,
• urticaria, itching, purpura (purple bruises),
• swelling of the face and throat (angioedema),
• difficulty sleeping, restlessness, anxiety, visual disturbances, sensation of ringing or buzzing in the ears (tinnitus),
• nasal inflammation, breathing difficulties.

Side effects occurring rarely (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 disturbances,
• bloating, constipation, oesophagitis, oesophageal stricture, gastrointestinal perforation (symptoms include severe abdominal pain, fever, nausea and vomiting), exacerbation of diverticular disease (infection or inflammation of small pouches in the intestinal wall), colitis or Crohn's disease,
• liver function abnormalities, hepatitis and jaundice (yellowing of the skin or eyes),
• transient visual disturbances,
• blood disorders, including reduced numbers of white blood cells, red blood cells or platelets.

Side effects occurring very rarely (in less than 1 in 10,000 patients) include:

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

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

• Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, you must stop taking Seractil and seek immediate medical attention. See also section 2.

Oedema (swelling of hands and feet), high blood pressure and heart failure may also occur during treatment with NSAIDs.
Use of medicines such as Seractil may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorisation holder.

5. How to store the medicine Seractil

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Seractil contains

• The active substance is dexibuprofen. Each coated tablet contains 400 mg of dexibuprofen.
• Other ingredients are:
  Tablet core: hypromellose, microcrystalline cellulose, calcium carmellose, anhydrous colloidal silicon dioxide, talc.
  Tablet coating: hypromellose, titanium dioxide (E171), glyceryl triacetate, talc, macrogol 6000.

What Seractil looks like and contents of the pack
White, elongated, biconvex coated tablets with a dividing score line on both sides, free from spots and chipping.
The tablet can be divided into halves.
Seractil is packed in PVDC/PVC/Aluminium foil blisters.
The blisters are placed in a cardboard box together with the patient leaflet.
Available pack sizes: 10, 30 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. +48 61 66 51 500
Fax: +48 61 66 51 505
E-mail: [email protected]