IBUPROFEN ZENTIVA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno Zentiva 400mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack

1. What is Ibuprofeno Zentiva and what is it used for
2. What you need to know before you take Ibuprofeno Zentiva
3. How to take Ibuprofeno Zentiva
4. Possible side effects
5. Storage of Ibuprofeno Zentiva
6. Contents of the pack and other information

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

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

Adults and adolescents (12-18 years, with a weight of 40 kg or more): this medicine is used for the short-term symptomatic treatment of mild or moderate pain, such as

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

This medicine also relieves acute pain and fever associated with the common cold.

This medicine is recommended for adults and adolescents with a body weight of 40 kg or more (from 12 years of age).

2. What you need to know before you take Ibuprofeno Zentiva

Do not take Ibuprofeno Zentiva

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions such as asthma, nasal discharge, skin rash with itching or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid or other NSAIDs.
• if you have or have had two or more episodes of stomach or duodenal ulcers or bleeding.
• if you have a history of gastrointestinal perforation or bleeding, 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 (even in the brain).
• if you are in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• 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 ulcers or bleeding (see Other medicines and Ibuprofeno 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 artery disease (poor circulation in arms, legs, or feet due to narrowing or blockage of 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 (an immune system disease) 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.
• if you have recently undergone major surgery.
• if you are in the first 6 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 reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno Zentiva immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Elderly patients

If you are an elderly patient, you are more prone to side effects, especially bleeding and perforation in the digestive tract, 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 any 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, in general, increases with the dose of ibuprofen. It also increases in elderly patients; for more information, see "Elderly patients" in the section "How to take Ibuprofeno Zentiva". The risk also increases if you are taking certain medications at the same time as ibuprofen (see Other medicines and Ibuprofeno 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 report them immediately to their doctor.

If bleeding or ulcers in the digestive tract occur, treatment with ibuprofen should be discontinued.

Effects on the heart and brain

Anti-inflammatory or analgesic medicines like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when given 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 medicine and consult a 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 cause swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals.

Ibuprofen may cause kidney damage, especially in patients who have already 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 medicine may hide the signs of an infection, such as fever and pain. Consequently, this medicine 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 medicine 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 suffer from 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 medicine if you plan to become pregnant. Consult your doctor first. See also the section "Pregnancy, breastfeeding, and fertility".

Children and adolescents

This medicine should not be used in children who weigh less than 40 kg (under 12 years of age).

Consult your doctor before using this medicine if:

• the child is seriously ill or has abdominal pain, stiff neck, or back pain.
• the child has serious ear, throat, or trachea problems.

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 had no effect on pain or fever after the first day.
• new symptoms appear or stomach problems or abdominal pain worsen or persist for a long time.

Other medicines and Ibuprofeno Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This medicine may affect or be affected by other medicines. For example:

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

• other NSAIDs or acetylsalicylic acid, as these medicines may increase the risk of stomach ulcers or bleeding
• methotrexate (used to treat cancer and autoimmune diseases), as ibuprofen may enhance the effect of this medicine
• digoxin (for the treatment of various heart disorders), as the effect of digoxin may be enhanced
• phenytoin (used to prevent the onset of epileptic seizures), as ibuprofen may enhance the effect of this medicine
• lithium (used to treat depression and mania), as ibuprofen may enhance the effect of this medicine
• potassium-sparing diuretics, as this may result in hyperkalemia (high potassium levels in the blood)
• colestyramine (used in the treatment of high cholesterol), as it may decrease the effect of ibuprofen. Medicines should be administered with a minimum interval of one hour.
• aminoglycosides (medicines against certain types of bacteria), as ibuprofen may decrease the elimination of aminoglycosides, so that their co-administration may increase the risk of toxicity
• SSRIs (medicines against depression) such as paroxetine, sertraline, or citalopram, as they may increase the risk of gastrointestinal bleeding
• moclobemide (RIMA; a medicine 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 patients), as the administration of this medicine may increase the risk of bleeding into a joint or bleeding that causes inflammation in HIV-infected hemophiliacs
• ritonavir (used to treat HIV patients), as ritonavir may increase the concentration of ibuprofen
• mifepristone, as ibuprofen may decrease the effect of this medicine
• probenecid or sulfinpyrazone (for the treatment of gout), as they may delay the excretion of ibuprofen
• quinolone antibiotics, as they may increase the risk of seizures
• sulfonylureas (for the treatment of type 2 diabetes), as they may enhance the effect of these medicines
• corticosteroids (used against inflammation), as these medicines may increase the risk of stomach 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 stomach 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 stomach 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).

Ibuprofeno Zentiva with food and alcohol

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

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

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.

Pregnancy

Do not take this medicine 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 than expected labor. You should not take Ibuprofeno Zentiva during the first 6 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 taken for more than a few days from the 20th week of pregnancy, Ibuprofeno 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 an effect on breastfeeding if used for short-term treatment. However, if long-term treatment is prescribed, early weaning should be considered.

Fertility

This medicine may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having problems becoming pregnant.

This medicine belongs to a pharmacological group (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is stopped.

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.

Ibuprofeno Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ibuprofeno Zentiva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in 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).

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

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

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

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

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

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

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

Migraine

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

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

One 400 mg tablet taken 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 40kg (over 12 years):

Maximum daily dose: 1,200 mg.

The dose should be taken as follows:

One 400 mg tablet at the first signs of menstrual problems, 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.

Elderly patients

If you are an elderly patient, you should always consult your doctor before using 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 have decreased liver or kidney function, always consult your 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 your 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. Low blood pressure may also occur.

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 Ibuprofeno Zentiva

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

If you have any other doubts 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 (the frequency cannot be estimated from the available data).
• A red, scaly, and widespread rash with bumps under the skin and blisters, mainly in skin folds, torso, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). The frequency is unknown (the frequency cannot be estimated from the 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 torso, often with blisters in the center, skin peeling, mouth ulcers, and ulcers on the 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:

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 intestinal bleeding that can lead to anemia.
• Mouth ulcers and inflammation.
• Headache, drowsiness, dizziness, lightheadedness, fatigue, agitation, insomnia, or irritability.

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

• Inflammation of the stomach lining.

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

Very rare(may affect up to 1 in 10,000 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 levels.

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

• Unpleasant sensation of heartbeats, heart failure, or heart attack, or high blood pressure.
• Disorders of blood cell formation (with symptoms such as fever, sore throat, superficial oral ulcers, flu-like symptoms, excessive fatigue, and nasal or 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 the available data):

• Numbness or tingling of 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 ibuprofen 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 done 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 with stiffness in 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 Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing 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 cardboard box. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Zentiva

• The active ingredient is ibuprofen.

Each tablet contains 400 mg of ibuprofen.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose, sodium croscarmellose, hypromellose, stearic acid, anhydrous colloidal silica, and magnesium stearate.

• Coating of the tablet: hypromellose, macrogol, talc, titanium dioxide (E171).

Appearance of Ibuprofeno Zentiva and package contents

White or 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 Spain S.L.U.

Avenida de Europa, 19,

Edificio 3, planta 1,

28224 Pozuelo de Alarcón - (Madrid)

Spain

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

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) https://www.aemps.gob.es/.