Seractil

Leaflet accompanying the packaging: information for the user

SERACTIL

400 mg, coated tablets

Dexibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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. Contents of the pack and other information

1. What is Seractil and what is it used for

Seractil belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
The active substance of 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 are:

• 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 taking Seractil

When not to take Seractil:

• if you are allergic to dexibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to acetylsalicylic acid or other painkillers (allergy may cause difficulty breathing, asthma attacks, nasal passage inflammation, rash, facial swelling),
• if you have a history of perforation or gastrointestinal bleeding associated with the use of NSAIDs,
• if you have active or recurrent peptic ulcer disease (bleeding vomiting, black stools or bloody diarrhea may be symptoms of gastrointestinal bleeding),
• if you have cerebral bleeding (cerebral hemorrhage) or other active bleeding,
• if you have exacerbation of inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• if you have severe heart failure,
• if you have severe kidney dysfunction (glomerular filtration rate (GFR) below 30 ml/minute),
• if you have severe liver dysfunction,
• from the beginning of the 6th month of pregnancy (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Seractil, discuss with your doctor or pharmacist:

• if you have had stomach or duodenal ulcers,
• if you have intestinal ulcers, ulcerative colitis or Crohn's disease,
• if you have liver or kidney dysfunction,
• if you are an alcohol addict,
• if you have blood coagulation disorders (see section "Seractil and other medicines"),
• if you have edema (fluid accumulation in body tissues),
• if you have heart disease or high blood pressure,
• if you have asthma or other breathing difficulties,
• if you have 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 you have difficulty becoming pregnant (In rare cases, medicines like Seractil may reversibly affect female fertility. After stopping treatment with Seractil, fertility returns to the state before treatment.).
• if you have an infection - see below, section entitled "Infections".

Avoid taking Seractil with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.

Taking higher doses of Seractil in patients over 60 years of age and in 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 taken in high doses. Do not exceed the recommended dose and duration of treatment.
During treatment with dexibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial swelling, chest pain. If you notice any of these symptoms, stop taking Seractil and seek medical attention immediately.
Infections
Seractil may mask the symptoms of infection, such as fever and pain. Therefore, Seractil may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, seek medical attention immediately.
Before taking Seractil, the patient should discuss treatment with a 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 narrowing or blockage of 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 dysfunction,
• patients over 60 years of age,
• patients requiring long-term use of the medicine. The attending physician will determine the frequency of periodic medical examinations individually for each of these patients.

Long-term use of high doses of painkillers (without medical prescription) may lead to the appearance of headaches, which should not be alleviated with higher doses of Seractil.
During chickenpox, avoid taking NSAIDs, including Seractil.
Skin reactions
Severe skin reactions have occurred with dexibuprofen, such as 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 severe skin reactions described in section 4, stop taking Seractil and seek medical attention immediately.

Seractil and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, including those obtained without a prescription.
Taking dexibuprofen and other medicines at the same time may change their effects and cause side effects.
Do nottake Seractil at the same time as the following medicines, unless you are under close medical supervision:

• Other non-steroidal anti-inflammatory drugs (pain, fever, inflammatory conditions). There is an increased risk of stomach ulcers and gastrointestinal bleeding when Seractil is taken with other non-steroidal anti-inflammatory drugs or acetylsalicylic acid. The doctor may allow the use of acetylsalicylic acid in small doses (less than 100 mg per day) at the same time as Seractil.
• Warfarin or other blood-thinning medicines. Taking Seractil and anticoagulant medicines at the same time may prolong bleeding time and increase the risk of bleeding.
• Lithium, a medicine used to treat depression. Seractil may increase the effect of lithium.
• Methotrexate. Seractil may increase the adverse effects of methotrexate.

Taking the following medicines at the same time is possible, but for safety reasons, tell your doctor about their use:

• Acetylsalicylic acid in small doses. Dexibuprofen may interfere with the effect of acetylsalicylic acid in thinning the blood.
• Medicines used to treat high blood pressure or heart disease (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 stomach ulcers or bleeding.
• Antidepressants (selective serotonin reuptake inhibitors) due to increased risk of gastrointestinal bleeding.
• Digoxin (a medicine used to treat heart disease). Seractil may increase the adverse effect of digoxin.
• Medicines used in organ transplant patients, such as cyclosporin. Potassium-increasing medicines: ACE inhibitors, angiotensin II receptor antagonists, cyclosporin, 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. Concurrent use may decrease the effect of dexibuprofen. Oral anti-diabetic medicines (sulfonylurea derivatives, e.g. glibenclamide, glimepiride). Concurrent use may cause fluctuations in blood glucose levels. It is recommended to monitor blood glucose levels.
• Zidovudine (a medicine used to treat HIV infection). Concurrent use may increase the risk of bleeding into the joint and the formation of hematomas in patients with hemophilia.
• Pemetrexed (an anti-cancer medicine used to treat lung cancer). In patients with kidney dysfunction, avoid concurrent use of high doses of Seractil for two days before and two days after administration of pemetrexed.

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

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

Also, some other medicines may be affected or have an effect on treatment with Seractil. Therefore, before taking Seractil with other medicines, always consult a doctor or pharmacist.

Seractil with food, drink and alcohol

Tablets can be taken independently of meals, but it is better to take Seractil with meals, drinking a liquid to reduce irritation of the gastrointestinal tract.
Alcohol consumption should be limited or avoided during treatment with Seractil, as it may increase the frequency and severity of adverse reactions affecting the gastrointestinal tract.

Pregnancy, breastfeeding and fertility

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.
Taking the medicine from the beginning of the 6th month of pregnancy is absolutely contraindicated due to the possibility of fetal developmental disorders 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 her child and cause delayed or prolonged labor.
In the first 5 months of pregnancy, Seractil may only be used in case of necessity, after consulting a doctor.
If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Seractil may cause kidney dysfunction 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 a long time or in high doses.
This medicine belongs to a group of medicines (non-steroidal 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 drowsiness 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 taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Use the smallest effective dose for the shortest duration necessary to control the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, seek medical attention immediately (see section 2).
Seractil is taken orally, with a glass of water or other liquid. Seractil works faster when taken on an empty stomach. However, it is recommended to take the medicine after a meal to reduce the risk of gastrointestinal side effects, especially when taken for a long time.
Do not take more than 1Seractil 400 mg tablet at a time.
Do not take more than 3Seractil 400 mg tablets per day.

Reducing pain and inflammation in osteoarthritis

The recommended dose is 1 Seractil 400 mg tablet twice a day (1 in the morning and 1 in the evening).
In case of exacerbation of symptoms, the doctor may recommend increasing the dose to 3 Seractil 400 mg tablets per day.

Relieving menstrual pain

The recommended dose is from 600 mg to 900 mg of dexibuprofen per day, divided into 3 doses.
For example, it is half a Seractil 400 mg tablet three times a day. The maximum daily dose is 900 mg of dexibuprofen.

Reducing mild to moderate pain

The recommended dose is 200 mg of dexibuprofen (half a Seractil 400 mg tablet) three times a day.
If higher doses are necessary, the doctor may recommend taking 1 Seractil 400 mg tablet up to three times a day. Depending on the symptoms, the doctor may also recommend taking a lower dose of Seractil (200 mg or 300 mg).
The notch on the tablet (see also "What Seractil looks like and what the pack contains") allows the tablet to be divided into two halves.
Dosing in patients with liver or kidney dysfunction
In patients with mild or moderate liver or kidney dysfunction, use the smallest effective dose of the medicine. Do not take a dose higher than prescribed by your doctor.
Dosing in the elderly
In patients over 60 years of age, 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 of age, so 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, contact your doctor or pharmacist.

Taking a higher dose of Seractil than recommended

If you have taken a higher dose than recommended, seek medical attention 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 treatment with Seractil

If you have any further questions about taking this medicine, ask your 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 of the disease reduces the risk of side effects.

Stop taking Seractil and seek medical attention immediately if:

• severe stomach pain occurs, especially at the beginning of treatment with Seractil,
• 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. This condition is called agranulocytosis,
• sudden 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) occurs,
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• red, non-raised, target-like or circular spots 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 syndrome),
• red, scaly rash with lumps under the skin and blisters, usually occurring at the beginning of treatment, with fever (acute generalized exanthematous pustulosis).

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

• indigestion, stomach pain.

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

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

Rare side effects (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 are: severe stomach pain, fever, nausea and vomiting), exacerbation of diverticulitis (infection or inflammation of small bulges in the intestinal wall), 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 (less than 1 in 10,000 patients) include:

• allergic reactions, including symptoms such as fever, skin rash, stomach pain, headache, nausea and vomiting,
• photosensitivity reaction (sensitivity to light),
• aseptic meningitis (symptoms are: headache, fever, neck stiffness and general malaise), severe allergic reactions (symptoms are: difficulty breathing, asthma attacks, rapid heartbeat, low blood pressure and shock), allergic reactions combined with inflammation of small blood vessels,
• skin redness, mucous membrane or throat redness,
• blisters on the palms and soles (Stevens-Johnson syndrome),
• skin peeling, skin separation (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, which include tissue surrounding the muscles.

Side effects with unknown 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, with fever (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Seractil and seek medical attention immediately. See also section 2.

Edema (swelling of hands and feet), high blood pressure and heart failure may also occur during treatment with 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 you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Seractil

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Seractil contains

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

What Seractil looks like and what the pack contains

White, oblong, biconvex coated tablets with a notch on both sides, without spots and 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 packs: 10, 30 or 60 coated tablets.
Not all pack 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: