Ibuprofen Zentiva

Leaflet accompanying the packaging: patient information

Ibuprofen Zentiva, 200 mg, coated tablets

Ibuprofen

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 need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days for fever or migraine headache or 5 days for pain, no improvement occurs or you feel worse, consult your doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen Zentiva and what is it used for

Ibuprofen Zentiva belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines have analgesic, antipyretic, and anti-inflammatory effects. Adults and adolescents (12-18 years old, from 40 kg body weight): Ibuprofen Zentiva is used for short-term, symptomatic treatment of mild to moderate pain, such as:

• headache (including migraine headache),
• back pain and muscle and joint pain,
• toothache,
• menstrual cramps.

Ibuprofen Zentiva is used for acute painful conditions and fever associated with colds. Children aged 6-12 years (20-40 kg body weight) may be treated with Ibuprofen Zentiva, 200 mg for acute painful conditions and fever associated with colds. Ibuprofen Zentiva 200 mg is recommended for use in adults, adolescents, and children from 20 kg body weight (over 6 years old).

2. Important information before taking Ibuprofen Zentiva

When not to take Ibuprofen Zentiva

• if the patient has been diagnosed with hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had hypersensitivity reactions in the form of asthma, rhinitis, itchy rash on the skin, or swelling of the lips, face, tongue, or throat after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

the medicine, listed in section 6.

• if the patient has had recurrent stomach ulcers or bleeding from the stomach or small intestine (duodenum) with two or more such episodes in the past.
• if the patient has had bleeding from the gastrointestinal tract or perforation related to previous NSAID treatment.
• if the patient has blood clotting disorders or bleeding disorders.
• if the patient has severe heart, liver, or kidney failure.
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or inadequate fluid intake).
• if the patient has any active bleeding (including in the brain).
• if the patient is in the last three months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting to take Ibuprofen Zentiva, discuss it with your doctor or pharmacist:

• if the patient has kidney or liver function disorders.
• if the patient has asthma.
• if the patient has hay fever, nasal polyps, or chronic obstructive respiratory diseases, due to an increased risk of allergic reactions.
• if the patient is also taking medicines that may increase the risk of ulcers or bleeding (see below, section "Ibuprofen Zentiva and other medicines").
• if the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, bypass surgery, has peripheral arterial disease (poor blood circulation in the arms, legs, or feet due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack).
• if the patient has high blood pressure, diabetes, has high cholesterol levels, has a history of heart disease or stroke in the family, or if the patient smokes.
• if the patient has systemic lupus erythematosus (an immune system disorder) or mixed connective tissue disease (risk of aseptic meningitis).
• if the patient has gastrointestinal diseases, such as Crohn's disease or ulcerative colitis.
• if the patient has a problem with normal blood clotting.
• if the patient has recently undergone extensive surgery.
• if the patient is in the first six months of pregnancy.
• if the patient is breastfeeding (see section "Pregnancy, breastfeeding, and fertility").
• if the patient has an infection - see section "Infections" below.

During the use of ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including breathing problems, facial and neck swelling (angioedema), chest pain. If the patient notices any of these symptoms, they should stop taking Ibuprofen Zentiva immediately and contact their doctor or emergency services. Elderly patientsElderly patients should be aware of the increased risk of adverse reactions, especially gastrointestinal bleeding and perforation, which can be fatal. Ulcers, perforation, and bleeding in the stomach or intestinesBleeding, ulcers, or perforation of the stomach or intestines can occur without any warning symptoms, even in patients who have never had such problems before. This can be life-threatening. The risk of gastrointestinal bleeding, ulcers, or perforation is essentially increased with the use of high doses of ibuprofen. It is also higher in elderly patients, more information on this can be found in the section "Elderly patients" in the "How to take Ibuprofen Zentiva" section. The risk is also increased when taking certain other medicines at the same time as ibuprofen (see section "Ibuprofen Zentiva and other medicines"). Patients who have ever had stomach problems, especially elderly patients, should pay attention to any unusual symptoms from the stomach or intestines and report them to their doctor immediately. Treatment should be discontinued in case of bleeding or ulcers in the gastrointestinal tract during ibuprofen treatment. Impact on the heart and brainTaking anti-inflammatory and/or pain-relieving medicines, such as ibuprofen, 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 and duration of treatment. Any risk is more likely with high doses and long-term treatment. Skin reactionsSevere skin reactions have been reported with ibuprofen use, 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 related to these severe skin reactions described in section 4, they should stop taking Ibuprofen Zentiva immediately and seek medical attention. Impact on the kidneysIbuprofen may cause kidney function disorders, even in patients who have not had kidney diseases before. This can lead to swelling of the legs and, in susceptible individuals, to heart failure or high blood pressure. Ibuprofen may cause kidney damage, especially in patients who already have kidney, heart, or liver disease, or who are taking diuretics, ACE inhibitors, or are elderly. However, stopping ibuprofen usually leads to recovery. InfectionsIbuprofen Zentiva may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprofen Zentiva may delay the use of appropriate infection treatment and, as a consequence, lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately. Other warningsLong-term use of any pain-relieving medicine for headache can worsen its effect. If, despite (or because of) regular use of pain-relieving medicine, frequent or daily headaches occur, consult your doctor before taking another pain-relieving medicine. Treatment should be discontinued in case of medication overuse headache (MOH). Do not take Ibuprofen Zentiva if you are planning to become pregnant. Consult your doctor first. See also section "Pregnancy, breastfeeding, and fertility".

Children and adolescents

Do not use Ibuprofen Zentiva, 200 mg in children under 20 kg body weight (under 6 years old). Consult your doctor before using this medicine if:

• the child is seriously ill or has stomach pain, stiff neck, or back pain.
• the child has severe ear, throat, or trachea diseases.

If the child has a fever, consult your doctor if:

• the child has not drunk any fluids or has lost a lot of fluid due to persistent vomiting or diarrhea.
• treatment has not had any effect on pain or fever after the first day.
• new symptoms have appeared or stomach pain or gastrointestinal problems have worsened or persisted for a longer period.

Ibuprofen Zentiva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. Ibuprofen Zentiva may affect the action of other medicines or other medicines may affect the action of Ibuprofen Zentiva. For example:

• blood-thinning medicines (such as anticoagulants/antiplatelet agents, such as acetylsalicylic acid, warfarin, ticlopidine).
• blood pressure-lowering medicines (such as ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).
• other NSAIDs or acetylsalicylic acid, as these medicines may increase the risk of stomach ulcers or gastrointestinal bleeding.
• methotrexate (used in the treatment of cancer and autoimmune diseases), as ibuprofen may enhance the effect of this medicine.
• digoxin (used in the treatment of various heart diseases), as the effect of digoxin may be enhanced.
• phenytoin (used to prevent seizures), as ibuprofen may enhance the effect of this medicine.
• lithium (used in the treatment of depression and mania), as ibuprofen may enhance the effect of this medicine.
• potassium-sparing diuretics, as this may lead to hyperkalemia (elevated potassium levels in the blood).
• cholestyramine (used in the treatment of high cholesterol), as the effect of ibuprofen may be reduced. Medicines should be administered with at least a one-hour interval.
• aminoglycosides (antibiotics), as ibuprofen may reduce the elimination of aminoglycosides, and their concurrent use may increase the risk of toxicity.
• SSRIs (antidepressant medicines), such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding.
• moclobemide (RIMA - a medicine used in the treatment of depression or social phobia), as the effect of ibuprofen may be enhanced.
• cyclosporine, tacrolimus (to reduce immunity after organ transplantation), as kidney damage may occur.
• zidovudine (used in the treatment of HIV-infected patients), as the use of this medicine may increase the risk of bleeding into the joint or bleeding leading to swelling in patients with HIV-related hemophilia.
• ritonavir (used in the treatment of HIV-infected patients), as ritonavir may increase the level of ibuprofen.
• mifepristone, as ibuprofen may reduce the effect of this medicine.
• probenecid or sulfinpyrazone (in the treatment of gout), as the elimination of ibuprofen may be delayed.
• quinolone antibiotics, as the risk of seizures may be increased.
• sulfonylurea derivatives (in the treatment of type 2 diabetes), as the effect of these medicines may be enhanced.
• corticosteroids (used in inflammatory conditions), as these medicines may increase the risk of stomach ulcers or bleeding.
• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce elevated calcium levels in the blood), as they may increase the risk of ulcers or bleeding.
• oxpentifylline (pentoxifylline) (used in the treatment of circulatory disorders in the arms or legs), as it may increase the risk of stomach ulcers or bleeding.
• baclofen (a muscle relaxant), as the toxicity of baclofen may be increased.
• CYP2C9 inhibitors, as concomitant administration of ibuprofen with CYP2C9 inhibitors (voriconazole, fluconazole) may increase exposure to ibuprofen (CYP2C9 substrate).

Ibuprofen Zentiva with food, drink, and alcohol

If the patient has a sensitive stomach, it is recommended to take this medicine with food. Alcohol should be avoided, as it may enhance the adverse effects of this medicine, especially those related to the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor before taking this medicine. Pregnancy Do not take Ibuprofen Zentiva in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolongation or delay of labor. During the first six months of pregnancy, Ibuprofen Zentiva should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Zentiva may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a period longer than a few days, the doctor may recommend additional monitoring. Breastfeeding Ibuprofen passes into breast milk, but it is unlikely to affect the breastfed baby when used for short-term treatment. However, if long-term treatment is recommended, breastfeeding should be considered for early termination. Fertility Ibuprofen Zentiva may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or are having problems becoming pregnant. The medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen generally does not affect the ability to drive or operate machinery. However, as adverse effects caused by high doses of the medicine, such as fatigue and dizziness, may occur, the ability to drive or operate machinery may be impaired. This is especially important when consuming alcohol.

Ibuprofen Zentiva contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., the medicine is considered "sodium-free".

3. How to take Ibuprofen Zentiva

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. How to take Ibuprofen Zentiva The tablet should be swallowed with a glass of water. Do not crush, chew, or suck the tablet to avoid irritating the stomach or throat. If the patient has a sensitive stomach, it is recommended to take this medicine with food. How much to take of Ibuprofen Zentiva The smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If the patient has an infection, they should consult their doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2). Adults: If the patient does not feel better or feels worse after 3 days for fever or migraine headache or 5 days for pain, they should consult their doctor. Children and adolescents: If it is necessary to use this medicine for more than 3 days or if symptoms worsen, consult your doctor. The dose of ibuprofen for children and adolescents depends on the patient's age and body weight. Do not use Ibuprofen Zentiva, 200 mg in children under 20 kg body weight or under 6 years old. Higher doses than recommended may pose a serious risk. Do not use different types of pain-relieving medicines at the same time without consulting your doctor. Mild to moderate pain and acute pain and fever associated with coldsFor dosing in children, Ibuprofen Zentiva, 200 mg should be used. Children with a body weight of 20-29 kg (6-9 years old):Maximum daily dose: 600 mg (3 tablets of 200 mg). One 200 mg tablet, 1 to 3 times a day as needed. There should be at least 4 to 6 hours between doses. Children with a body weight of 30-40 kg (10-12 years old):Maximum daily dose: 800 mg (4 tablets of 200 mg). One 200 mg tablet, 1 to 4 times a day, with at least 4 to 6 hours between doses. Adults and adolescents with a body weight of 40 kg or more (over 12 years old):Maximum daily dose: 1200 mg. The dose should be taken as follows: 200 mg tablets: One to two tablets taken as a single dose or 3 to 4 times a day. There should be at least 4 to 6 hours between doses. The maximum daily dose should not exceed 6 tablets. A single dose greater than 400 mg does not provide better pain relief. Migraine headacheAdults and adolescents with a body weight of 40 kg or more (over 12 years old):Maximum daily dose: 1200 mg. The dose should be taken as follows: Two 200 mg tablets taken as needed, 1 to 3 times a day. There should be at least 4 to 6 hours between doses. A single dose greater than 400 mg does not provide better pain relief. Menstrual crampsAdults and adolescents with a body weight of 40 kg or more (over 12 years old):Maximum daily dose: 1200 mg. The dose should be taken as follows: One to two 200 mg tablets at the first symptoms of menstruation, 1 to 3 times a day. There should be at least 4 to 6 hours between doses. A single dose greater than 400 mg does not provide better pain relief. Elderly patients If the patient is elderly, they should always consult their doctor before taking Ibuprofen Zentiva. If the patient is elderly, they will be more susceptible to adverse reactions, especially gastrointestinal bleeding and perforation, which can be fatal. The doctor will provide appropriate advice. Kidney or liver function disorders If the patient has kidney or liver function disorders, they should always consult their doctor before taking Ibuprofen Zentiva.

Taking a higher dose of Ibuprofen Zentiva than recommended

If the patient has taken a higher dose of Ibuprofen Zentiva than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. After taking high doses, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing problems have been observed. Additionally, low blood pressure may occur.

Missing a dose of Ibuprofen Zentiva

Do not take a double dose to make up for a missed dose. In case of any further doubts 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 gets them. Side effects are more likely to occur after taking high doses and long-term treatment.

Stop taking Ibuprofen Zentiva and contact your doctor immediately if you experience any of the following side effects:

• Angioedema (may affect up to 1 in 10,000 people) with symptoms such as:
• swelling of the face, tongue, or throat
• difficulty swallowing
• rash and difficulty breathing.
• Black, tarry stools or vomiting with blood (may affect up to 1 in 10 people).
• Severe skin and mucous membrane disorders, such as toxic epidermal necrolysis and (or) erythema multiforme (very rare side effects). Additionally, severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell). Frequency not known (frequency cannot be estimated from the available data).

A red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). Frequency not known (frequency cannot be estimated from the available data).

• Blurred vision or other eye problems, such as sensitivity to light, loss of vision (may affect up to 1 in 1,000 people).
• These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (may affect up to 1 in 10,000 people). Other side effects that may occur are listed below by frequency of occurrence:

Very common(may affect more than 1 in 10 people):

• Heartburn, stomach pain, indigestion.
• Gastrointestinal disorders, such as diarrhea, nausea, vomiting, gas, constipation.

Common(may affect up to 1 in 10 people):

• Gastrointestinal ulcer with or without perforation.
• Inflammation of the intestine and exacerbation of ulcerative colitis (inflammation of the colon) and gastrointestinal diseases (Crohn's disease) and complications of diverticulitis (perforation or fistula).
• Microscopic bleeding from the intestine, which can cause anemia.
• Ulcers and inflammation of the mouth.
• Headache, drowsiness, dizziness, fatigue, excitement, insomnia, and irritability.

Uncommon(may affect up to 1 in 100 people):

• Gastritis.
• Kidney diseases, including the development of edema, kidney inflammation, and kidney failure.
• Rhinitis, asthma.
• Rash, increased skin sensitivity to sunlight.
• Allergic reaction, such as hives, itching.

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

• Depression, confusion, hallucinations.
• Systemic lupus erythematosus.
• Increased levels of urea in the blood and other liver enzymes, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, and prolonged bleeding time, decreased calcium levels in the serum, and increased uric acid levels in the serum.

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

• Unpleasant heartbeat, heart failure, or heart attack, or high blood pressure.
• Blood disorders (with symptoms such as fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding).
• Ringing or buzzing in the ears.
• Esophagitis or pancreatitis.
• Constriction of the intestine.
• Liver damage causing yellowing of the skin or whites of the eyes and fluid retention.
• Meningitis (without bacterial infection).
• Kidney tissue damage.
• Hair loss.
• Psychotic reactions
• Vasculitis.
• Ibuprofen may mask the symptoms of an infection, worsening of the infection, or complications of the infection. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

Frequency not known(frequency cannot be estimated from the available data):

• Numbness of hands and feet.
• Restlessness.
• Decreased hearing.
• General malaise.
• Optic neuritis, which can cause vision problems.
• Low levels of neutrophils (a type of white blood cell).
• Chest pain, which can be a symptom of a potentially serious allergic reaction called Kounis syndrome.

The use of medicines like Ibuprofen Zentiva may slightly increase the risk of heart attack or stroke. NSAID use has been associated with fluid retention, high blood pressure, and heart failure. Ibuprofen Zentiva may cause a decrease in white blood cell count, and the body's ability to fight infection may be reduced. If the patient develops an infection with symptoms such as fever and serious deterioration of general health or fever with local signs of infection such as sore throat, mouth ulcers, or urinary problems, they should consult their doctor immediately. A blood test will be performed to check for a possible decrease in white blood cell count (agranulocytosis). It is important to inform the doctor that you are taking this medicine. During ibuprofen treatment, several cases of meningitis (without bacterial infection) have been observed in patients with existing autoimmune disorders, such as systemic lupus erythematosus or mixed connective tissue disease.

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, 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 Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Zentiva

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

6. Contents of the packaging and other information

What Ibuprofen Zentiva contains

The active substance of the medicine is ibuprofen. Each tablet contains 200 mg of ibuprofen. The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910/5, stearic acid, silicon dioxide, anhydrous, magnesium stearate. Tablet coating: hypromellose 2910/5, macrogol 300, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Ibuprofen Zentiva looks like and contents of the pack

Light yellow to beige, round, coated tablets with a diameter of 9 mm. The tablets are packaged in PVC/Aluminum blisters. Pack sizes: 10, 12, 20, 24, 50, 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, 032266 Bucharest, Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Poland Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00 Date of last revision of the leaflet:January 2025