IBUPROFEN ZENTIVA KS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofen Zentiva 400 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet (see section 4).

Contents of the Package Leaflet

1. What is Ibuprofen Zentiva and what is it used for
2. What you need to know before taking this medication
3. How to take this medication
4. Possible side effects
5. Storage of Ibuprofen Zentiva
6. Package contents and additional information

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

This medication contains ibuprofen, which belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). This medication is used for the relief of pain, fever, and inflammation.

This medication is used to treat rheumatic disorders, such as arthritic diseases (e.g., rheumatoid arthritis, osteoarthritis), non-articular rheumatic disorders, or other muscular and articular disorders, and soft tissue injuries.

This medication is recommended for adults, adolescents, and children weighing 40 kg or more (over 12 years old).

In addition, ibuprofen 400 mg is used for the short-term symptomatic treatment of mild to moderate pain, such as headaches (including migraines), back pain, muscle and joint pain, toothache, menstrual pain, and acute pain and fever associated with the common cold.

2. What you need to know before taking this medication

Do not take this medication

• if you are allergic to ibuprofen or any of the other ingredients of this medication (listed in section 6).
• if you have had allergic reactions such as asthma, runny nose, skin rash with itching, or swelling of the lips, face, tongue, or throat after taking medications containing acetylsalicylic acid or other NSAIDs.
• if you have had two or more episodes of stomach or duodenal ulcers or bleeding in the past.
• if you have had gastrointestinal bleeding or perforation related to previous NSAID treatment.
• if you have a blood disorder or coagulation disorder.
• if you have severe heart, liver, or kidney failure.
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• if you have any active bleeding (including in the brain).
• if you are in the third trimester of pregnancy (see section "Pregnancy, Breastfeeding, and Fertility").

Warnings and Precautions

Consult your doctor or pharmacist before taking this medication:

• if you have kidney or liver problems.
• if you have asthma.
• if you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, due to an increased risk of allergic reactions.
• if you are taking medications that may increase the risk of ulceration or bleeding (see Other Medications and Ibuprofen Zentiva, below).
• if you have heart problems such as heart failure or angina (chest pain), or if you have had a heart attack, surgical revascularization, peripheral arteriopathy (poor circulation in the arms, legs, or feet due to narrowing or blockage of the arteries), or any type of stroke (including 'mini-stroke' or transient ischemic attacks, "TIA").
• if you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.
• if you have systemic lupus erythematosus (a disease of the immune system) or mixed connective tissue disease (due to the risk of aseptic meningitis).
• if you have inflammatory bowel diseases, such as Crohn's disease or ulcerative colitis.
• if you have problems with normal blood coagulation mechanisms.
• if you have recently undergone major surgery.
• if you are in the first six months of pregnancy.
• if you are breastfeeding (see section "Pregnancy, Breastfeeding, and Fertility").
• if you have an infection; see the heading "Infections" below.

Ibuprofen has been associated with signs of allergic reactions to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibuprofen Zentiva immediately and contact your doctor or emergency medical services if you notice any of these signs.

Elderly Patients

If you are an elderly patient, you are more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal.

Ulcers, Perforation, or Bleeding in the Stomach or Intestine

Bleeding, ulcers, or perforations in the stomach or intestine can occur without warning signs in patients who have never had problems of this type before. This can also be potentially fatal.

The risk of ulcers or bleeding in the stomach or intestines generally increases with the dose of ibuprofen. It also increases in elderly patients; for more information, see "Elderly Patients" in the section "How to Take Ibuprofen Zentiva". The risk also increases if certain medications are taken at the same time as ibuprofen (see Other Medications and Ibuprofen Zentiva, below).

Patients who have never had stomach problems, especially elderly patients, should be aware of any unusual symptoms in the stomach or intestine and notify their doctor immediately.

If gastrointestinal bleeding or ulcers occur, treatment with ibuprofen should be discontinued.

Effects on the Heart and Brain

Anti-inflammatory or analgesic medications like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when taken in high doses. Do not exceed the recommended dose or duration of treatment. Any risk is more likely with high doses and prolonged treatments.

Skin Reactions

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Effects on the Kidneys

Ibuprofen may cause kidney problems, even in patients who have not had kidney problems before. This can lead to swelling of the legs and may even result in heart failure or high blood pressure in predisposed individuals.

Ibuprofen may cause kidney damage, especially in patients who have had kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors, as well as elderly patients. In general, recovery is achieved if ibuprofen is discontinued.

Infections

This medication may hide the signs of an infection, such as fever and pain. Consequently, this medication may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other Precautions

Prolonged use of any type of pain reliever for headaches can worsen them. If you experience frequent or daily headaches despite (or because of) the habitual use of pain relievers, consult your doctor before taking another pain reliever. Treatment should be discontinued if medication-overuse headache (MOH) is diagnosed.

Do not take this medication if you plan to become pregnant. Consult your doctor first. See also the section "Pregnancy, Breastfeeding, and Fertility".

Children and Adolescents

This medication should not be used in adolescents who weigh less than 40 kg or in children under 12 years old.

Other Medications and Ibuprofen Zentiva

Inform your doctor or pharmacist if you are taking, have recently taken, or may take other medications. This medication may affect or be affected by other medications. For example:

• medications that are anticoagulants (i.e., anti-coagulants or blood thinners, e.g., acetylsalicylic acid, warfarin, or ticlopidine)
• medications that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin II receptor antagonists such as losartan)

• other NSAIDs or acetylsalicylic acid, as these medications may increase the risk of gastrointestinal ulcers or bleeding
• methotrexate (used to treat cancer and autoimmune diseases), as ibuprofen may enhance the effect of this medication
• digoxin (used to treat various heart disorders), as the effect of digoxin may be enhanced
• phenytoin (used to prevent epileptic seizures), as ibuprofen may enhance the effect of this medication
• lithium (used to treat depression and mania), as ibuprofen may enhance the effect of this medication
• potassium-sparing diuretics, as this may result in hyperkalemia (high potassium levels in the blood)
• cholestyramine (used to treat high cholesterol), as it may decrease the effect of ibuprofen. Medications should be administered with a minimum interval of one hour.
• aminoglycosides (medications against certain types of bacteria), as ibuprofen may decrease the elimination of aminoglycosides, so their co-administration may increase the risk of toxicity
• SSRIs (medications against depression) such as paroxetine, sertraline, or citalopram, as they may increase the risk of gastrointestinal bleeding
• moclobemide (RIMA; a medication for treating depressive disease or social phobia), as it may enhance the effect of ibuprofen
• cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur
• zidovudine (used to treat HIV-infected patients), as the administration of this medication may increase the risk of bleeding in a joint or bleeding that causes inflammation in HIV-infected hemophiliacs
• ritonavir (used to treat HIV-infected patients), as ritonavir may increase the concentration of ibuprofen
• mifepristone, as ibuprofen may decrease the effect of this medication
• probenecid or sulfinpyrazone (for treating gout), as they may delay the excretion of ibuprofen
• quinolone antibiotics, as they may increase the risk of seizures
• sulfonylureas (for treating type 2 diabetes), as they may enhance the effect of these medications
• corticosteroids (used against inflammation), as these medications may increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in osteoporosis, Paget's disease, and to decrease high calcium levels in the blood), as they may increase the risk of gastrointestinal ulcers or bleeding
• pentoxifylline ([oxpentifylline] used in the treatment of circulatory diseases of the arteries of the legs or arms), as they may increase the risk of gastrointestinal ulcers or bleeding
• baclofen (a muscle relaxant), as its toxicity may be enhanced
• CYP2C9 inhibitors, as the concomitant administration of ibuprofen and CYP2C9 inhibitors (voriconazole or fluconazole) may increase the exposure to ibuprofen (a CYP2C9 substrate).

Ibuprofen Zentiva with Food and Alcohol

If you have a sensitive stomach, it is recommended to take this medication with food.

Avoid alcohol, as it may enhance the side effects of this medication, especially those affecting the stomach, intestines, or brain.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Do not take this medication if you are in the third trimester of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney or heart problems in the fetus. It may affect your tendency and that of your baby to bleed and may cause delayed onset of labor or longer labor than expected. You should not take Ibuprofen Zentiva during the first six months of pregnancy unless absolutely necessary and under medical supervision. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If you take this medication for more than a few days from the 20th week of pregnancy, Ibuprofen Zentiva may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk, but it is unlikely to have any effect on the breastfed infant when used for short-term treatment. However, if long-term treatment is prescribed, early discontinuation of breastfeeding should be considered.

Fertility

This medication may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or have difficulty becoming pregnant. This product belongs to a group of medications (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medication.

Driving and Using Machines

In general, ibuprofen does not have side effects on the ability to drive or use machines. However, at high doses, side effects such as fatigue or dizziness may occur, and the ability to drive a car or use machines may be impaired. Concurrent consumption of alcohol enhances this effect.

This Medication Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to take this medication

Follow the administration instructions for this medication exactly as described in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

How to take this medication

Swallow the tablet with the help of a glass of water. Do not crush, chew, or suck the tablet to avoid irritating the stomach and throat. If you are a patient with a sensitive stomach, it is recommended to take this medication with food.

How much medication to take

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). In the long-term treatment of rheumatic diseases, the goal should be a low maintenance dose.

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

This medication should not be used in adolescents with a weight of less than 40 kg or in children under 12 years of age.

Doses higher than those recommended may pose serious risks. Do not use different types of pain relief medications at the same time without a medical prescription.

The recommended dose is:

Rheumatic diseases

Adults:

Maximum daily dose: 2,400 mg.

The dose should be taken as follows:

One 400 mg tablet, 3 times a day. Allow at least 4 to 6 hours between doses. Your doctor may prescribe lower doses.

Adolescents from 40 kg (over 12 years old):

The daily dose is 20 mg/kg to a maximum of 40 mg/kg of body weight, divided into 3 or 4 doses of the 400 mg tablet. The maximum daily dose is 2,400 mg.

Mild to moderate pain, acute pain, and fever associated with the common cold

Adults and adolescents from 40 kg (over 12 years old):

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

One tablet taken as a single dose or up to 3 times a day as needed. Allow at least 4 to 6 hours between doses.

Migraine

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

One 400 mg tablet as needed, 1 to 3 times a day. Allow at least 4 to 6 hours between doses.

More than 400 mg at a time does not provide better pain relief.

Menstrual pain

Adults and adolescents from 40 kg (over 12 years old):

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

One 400 mg tablet at the first sign of menstrual problems, 1 to 3 times a day. Allow at least 4 to 6 hours between doses.

Elderly patients

If you are an elderly patient, you should always consult your doctor before taking this medication. If you are an elderly patient, you are more prone to side effects, especially bleeding and perforation of the digestive tract, which can be fatal. Your doctor will advise you accordingly.

Decreased liver and kidney function

If you suffer from decreased liver or kidney function, always consult a doctor before using this medication.

If you take more Ibuprofeno Zentiva than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, always consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and unstable eye movements. At high doses, loss of consciousness, seizures (especially in children), slow heart rate, weakness, and dizziness (low blood pressure), blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take this medication

If you forget to take a dose, take it as soon as you can, except if there are less than four hours left for the next dose.

Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Undesirable effects are more likely with higher doses and longer treatment durations.

Stop taking this medication and go to the doctor immediately if you experience any of the following symptoms:

• Angioedema (may affect up to 1 in 10,000 people) with symptoms such as:
• • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.
• Black stools or bloody vomit (may affect up to 1 in 10 people).
• Severe skin and mucous membrane changes, such as necrotizing epidermolysis and/or erythema multiforme (a very rare side effect), have been reported. Additionally, a severe skin reaction called DRESS syndrome may occur. The symptoms of DRESS syndrome are: skin rash, fever, swelling of the lymph nodes, and increased eosinophils (a type of white blood cell). The frequency is unknown (cannot be estimated from available data).
• A red, scaly, and widespread rash with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). The frequency is unknown (cannot be estimated from available data).
• Blurred vision and other eye problems, such as sensitivity to light, loss of vision (may affect up to 1 in 1,000 people).
• Red, non-raised, target-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. 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 in groups according to frequency:

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

• Heartburn, stomach pain, or indigestion.
• Changes in the digestive tract, such as diarrhea, nausea, vomiting, gas, or constipation.

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

• Ulcer in the digestive tract with or without perforation.
• Inflammation of the intestine and worsening of colitis (inflammation of the colon) and Crohn's disease (inflammation of the digestive tract), and complications of diverticulitis (perforation or fistula).
• Microscopic bleeding in the intestine that can lead to anemia.
• Mouth ulcers and inflammation.
• Headache, drowsiness, dizziness, lightheadedness, fatigue, agitation, insomnia, or irritability.

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

• Inflammation of the gastric mucosa.

• Kidney problems, including edema, kidney inflammation, and kidney failure.
• Runny nose, asthma
• Rash, increased sensitivity of the skin to the sun.
• Hypersensitivity reaction, such as hives or itching.

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

• Depression, confusion, hallucinations.

• Systemic lupus erythematosus.
• • Increased urea nitrogen and other liver enzymes in the blood, decreased hemoglobin and hematocrit values, inhibited platelet aggregation, and prolonged bleeding time, decreased serum calcium, and increased serum uric acid values.

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

• Unpleasant sensation of heartbeats, heart failure, heart attack, or high blood pressure.
• Disorders of blood cell production (with symptoms such as fever, sore throat, superficial oral ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding).
• Ringing or buzzing in the ears.
• Inflammation of the esophagus or pancreas.
• Narrowing of the intestine.
• Liver damage that causes yellowing of the skin or the whites of the eyes and fluid retention in the body.
• Inflammation of the brain membrane (without bacterial infection).
• Kidney tissue damage.
• Hair loss.
• Psychotic reactions.
• Inflammation of blood vessels.
• Ibuprofen may mask signs and symptoms of infections, worsening of infections, or complications of infections. If you take this medication while having an infection and your infection symptoms persist or worsen, consult a doctor without delay.

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

• Numbness or tingling in the hands and feet.
• Anxiety.
• Hearing impairment.
• General feeling of discomfort.
• Inflammation of the optic nerve that can cause vision problems.
• Low neutrophil count (a type of white blood cell).
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medications like this may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), high blood pressure, and heart failure have been reported in association with NSAIDs.

This medication may decrease the number of white blood cells and their resistance to infection may be reduced. If you have an infection with symptoms such as fever and a significant deterioration of your general condition, or fever with symptoms of local infection such as a sore throat, pharynx, or mouth, or urinary problems, you should go to the doctor immediately. A blood test will be performed to check for possible decreased white blood cell count (agranulocytosis). It is essential that you inform your doctor about your medication.

During treatment with ibuprofen, some cases of meningitis (which manifests as stiffness of the neck, headache, nausea, vomiting, fever, or disorientation) 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, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno Zentiva

Keep this medication out of the sight and reach of children.

Store below 25°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date shown on the carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

• The active ingredient is ibuprofen.
  • Each tablet contains 400 mg of ibuprofen.

• Other components are:
  • Core of the tablet: microcrystalline cellulose, sodium croscarmellose, hypromellose, stearic acid, anhydrous colloidal silica, and magnesium stearate.
  • Coating for the tablet: hypromellose; macrogol; talc; titanium dioxide (E171).

Appearance of Ibuprofeno Zentiva and package contents

White to off-white, round, film-coated tablets, 12 mm in diameter.

The tablets are packaged in PVC/Alu blisters.

Package sizes: 10, 12, 20, 24, 30, 36, 40, 48, 50, 100, 250 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Zentiva k.s.

U Kabelovny 130

Prague 10, Dolni Mecholupy

10237, Czech Republic

Manufacturer

S.C. ZENTIVA S.A.

B-dul Theodor Pallady nr.50, sector 3,

Bucharest, 032266,

Romania

or

Zentiva k.s.

U Kabelovny 130

Dolní Mecholupy, Prague 10

10237, Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Date of the last revision of this leaflet:January 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.