Ibuprofen Zentiva

Leaflet accompanying the packaging: patient information

Ibuprofen Zentiva, 400 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 advised 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 pack and other information

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

Ibuprofen Zentiva belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines have analgesic, antipyretic, and anti-inflammatory effects. Adults and adolescents (12-18 years, 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. Ibuprofen Zentiva, 400 mg is recommended for use in adults and adolescents from 40 kg body weight (over 12 years of age).

2. Important information before taking Ibuprofen Zentiva

When not to take Ibuprofen Zentiva

• if the patient has hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had hypersensitivity reactions such as asthma, rhinitis, urticaria, or angioedema after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• if the patient has recurrent ulceration or gastrointestinal bleeding (more than one episode) in the past.
• if the patient has had gastrointestinal bleeding or perforation related to previous NSAID treatment.
• if the patient has coagulation disorders or bleeding disorders.
• if the patient has severe heart failure, liver, or kidney disease.
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or inadequate fluid intake).
• if the patient has any active bleeding (including cerebral hemorrhage).
• if the patient is in the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Ibuprofen Zentiva, discuss 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 medications that may increase the risk of ulceration or gastrointestinal bleeding (see below, section "Ibuprofen Zentiva and other medicines").
• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, bypass surgery, or has peripheral arterial disease (poor blood circulation in the arms, legs, or feet due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack).
• if the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease, or has had a stroke, 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 disease, 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 "Pregnancy, breastfeeding, and fertility").
• if the patient has an infection - see "Infections" below.

During ibuprofen treatment, allergic reactions to this medicine have been reported, including breathing difficulties, facial and neck edema (angioedema), chest pain. If the patient notices any of these symptoms, they should stop taking Ibuprofen Zentiva and contact their doctor or emergency services immediately.

Elderly patients

Elderly patients should be aware of the increased risk of adverse reactions, especially gastrointestinal bleeding and perforation, which can be fatal. Ulcers, perforation, and gastrointestinal bleeding

Gastrointestinal bleeding, ulceration, or perforation can occur without warning symptoms, even in patients who have never had such problems before. This can be life-threatening.

The risk of gastrointestinal bleeding, ulceration, or perforation is increased with the use of high doses of ibuprofen. It is also higher in the elderly, for more information see "Elderly patients" in the "How to take Ibuprofen Zentiva" section. The risk is also increased when taking certain other medications concomitantly with ibuprofen (see section "Ibuprofen Zentiva and other medicines").

Impact on the heart and brain

Taking anti-inflammatory and/or pain-relieving medicines, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, particularly 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 reactions

Severe skin reactions have been reported with ibuprofen treatment, 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). Stop taking Ibuprofen Zentiva and seek medical attention immediately if any symptoms of severe skin reactions occur as described in section 4.

Impact on the kidneys

Ibuprofen may cause kidney function disorders, even in patients who have never had kidney problems before. This can lead to swelling of the feet 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. Infections

Ibuprofen Zentiva may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen Zentiva may delay the application of appropriate treatment for the infection, which may lead to 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 symptoms of the infection persist or worsen, they should consult their doctor immediately.

Other warnings

Long-term use of any pain-relieving medication for headache can worsen its effectiveness. If, despite (or because of) regular use of pain-relieving medication, headaches occur frequently or daily, consult a doctor before taking another pain-relieving medication. Treatment should be discontinued if medication overuse headache (MOH) is diagnosed. Do not take Ibuprofen Zentiva if you are planning to become pregnant. Consult your doctor first. See also "Pregnancy, breastfeeding, and fertility".

Children and adolescents

Do not give Ibuprofen Zentiva, 400 mg to children under 40 kg body weight (under 12 years of age). Consult a doctor before giving this medicine to a child if:

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

If the child has a fever, consult a 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 worked for 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, and about 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:

• anticoagulant medicines (such as blood thinners/anti-clotting agents, such as acetylsalicylic acid, warfarin, ticlopidine).
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic 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 cancer and autoimmune disease treatment), as ibuprofen may increase the effect of this medicine.
• digoxin (used in the treatment of various heart conditions), as the effect of digoxin may be enhanced.
• phenytoin (used to prevent seizures), as ibuprofen may increase the effect of this medicine.
• lithium (used in the treatment of depression and mania), as ibuprofen may increase the effect of this medicine.
• potassium-sparing diuretics, as this may lead to hyperkalemia (increased potassium levels in the blood).
• cholestyramine (used in the treatment of high cholesterol), as the effect of ibuprofen may be reduced. Medicinal products should be administered with at least a one-hour interval.
• aminoglycosides (antibiotics), as ibuprofen may reduce the elimination of aminoglycosides, and their concomitant 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-associated hemophilia.
• ritonavir (used in the treatment of HIV-infected patients), as ritonavir may increase the levels 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 gastrointestinal bleeding.
• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce high calcium levels in the blood), as they may increase the risk of ulcers or gastrointestinal bleeding.
• oxpentifylline (pentoxifylline) (used in the treatment of circulatory disorders in the legs or arms), as it may increase the risk of stomach ulcers or gastrointestinal 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, particularly those related to the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

Pregnancy

Do not take Ibuprofen Zentiva during 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, do not take Ibuprofen Zentiva unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose 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 can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is required for a longer period, your 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 necessary, breastfeeding should be discontinued.

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. This 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 use machines. However, as adverse effects such as drowsiness and dizziness may occur after taking high doses of the medicine, the ability to drive or use machines 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, which is essentially "sodium-free".

3. How to take Ibuprofen Zentiva

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

How to take Ibuprofen Zentiva

Swallow the tablet 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 a doctor.

The dose of ibuprofen for children and adolescents depends on the patient's age and body weight.

Do not give Ibuprofen Zentiva, 400 mg to adolescents with a body weight below 40 kg or under 12 years of age.

Taking higher doses than recommended may pose a serious risk. Do not take different types of pain-relieving medications at the same time without consulting a doctor.

Mild to moderate pain and acute pain and fever associated with colds

For administration of doses in children, Ibuprofen Zentiva 200 mg should be used.

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age):

Maximum daily dose: 1200 mg.

The dose should be taken as follows:

400 mg tablets: One tablet taken as a single dose or up to 3 times a day. There should be at least 4 to 6 hours between doses. The maximum daily dose should not exceed 3 tablets.

A single dose greater than 400 mg does not provide better pain relief.

Migraine headache

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age):

Maximum daily dose: 1200 mg.

The dose should be taken as follows:

One 400 mg tablet 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 pain

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age):

Maximum daily dose: 1200 mg.

The dose should be taken as follows:

One 400 mg tablet taken 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.

Impaired liver or kidney function

If the patient has impaired kidney or liver function, they should always consult their doctor before taking Ibuprofen Zentiva.

Overdose of Ibuprofen Zentiva

If the patient has taken more than the recommended dose of Ibuprofen Zentiva or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital for advice on possible risks to their health and the actions to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. After taking large doses, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties have been observed. Additionally, low blood pressure may occur.

Missed 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 with 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 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. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased 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 on the folds of the skin, 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).
• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, 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] (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 disease (Crohn's disease) and complications of diverticulitis (perforation or fistula).
• Microscopic gastrointestinal bleeding, which may 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):

• Inflammation of the stomach lining.
• Kidney diseases, including the development of edema, kidney inflammation, and kidney failure.
• Rhinitis, asthma.
• Skin rash, increased sensitivity of the skin 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 blood urea nitrogen and other liver enzymes, decreased hemoglobin and hematocrit, inhibited platelet aggregation and prolonged bleeding time, decreased serum calcium and increased serum uric acid.

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

• Unpleasant palpitations, heart failure, or myocardial infarction or high blood pressure.
• Disorders of blood cell production (with symptoms such as fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding).
• Ringing or buzzing in the ears.
• Inflammation of the esophagus or pancreas.
• Constriction of the intestine.
• Liver damage causing yellowing of the skin or whites of the eyes and fluid retention.
• Inflammation of the meninges (without bacterial infection).
• Kidney tissue damage.
• Hair loss.
• Psychotic reactions.
• Vasculitis. Ibuprofen may mask the symptoms of infection, such as fever and pain. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

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

• Numbness or tingling in hands and feet.
• Restlessness.
• Impaired hearing.
• General malaise.
• Inflammation of the optic nerve, which may cause vision problems.
• Low neutrophil count (a type of white blood cell).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The use of medicines such as Ibuprofen Zentiva may slightly increase the risk of heart attack or stroke. NSAIDs have been reported to cause 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 infection symptoms such as sore throat or mouth ulcers, 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, a few cases of meningitis (with symptoms such as stiff neck, headache, nausea, vomiting, fever, or disorientation) have been reported in patients with pre-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 this 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 pack and other information

What Ibuprofen Zentiva contains

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen. The other ingredients are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910/5, stearic acid, silicon dioxide, magnesium stearate.

Tablet coating: hypromellose 2910/5, macrogol 300, talc, titanium dioxide (E 171).

What Ibuprofen Zentiva looks like and contents of the pack

White to almost white, round, coated tablets with a diameter of 12 mm. The tablets are packaged in PVC/Aluminum blisters.

Package sizes:

10, 12, 20, 24, 30, 36, 40, 48, 50, 100, 250 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 further information on 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