Ibuprofen Zentiva 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Zentiva 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet (see section 4).

Leaflet contents

1. What Ibuprofen Zentiva is and what it is used for
2. What you need to know 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 Ibuprofen Zentiva is and what it is used for

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

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

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

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

This medicine is recommended for adults and adolescents weighing 40 kg or more (over 12 years of age).

2. What you need to know before taking Ibuprofeno Zentiva

Do not take Ibuprofeno Zentiva

• if you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• if you have had allergic reactions such as asthma, runny nose, itchy skin rash, 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 past episodes of ulcer or recurrent bleeding in the stomach or small intestine (duodenum).
• if you have a history of gastrointestinal perforation or bleeding related to previous treatment with NSAIDs.
• if you have a blood production or blood clotting 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 last 3 months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Talk to 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 medicines that could increase the risk of ulceration 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 myocardial infarction, surgical revascularization, peripheral arterial disease (poor circulation in arms, legs, or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-strokes" or transient ischemic attacks, "TIA").
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.
• if you have systemic lupus erythematosus (an immune system disorder) or mixed connective tissue disease (due to the risk of aseptic meningitis).
• if you have inflammatory ulcerative diseases of the digestive tract, such as Crohn's disease or ulcerative colitis.
• if you have problems with normal blood clotting mechanisms.
• if you have recently undergone major surgery.
• if you are in the first six months of pregnancy.
• if you are breastfeeding (see section "Pregnacy, breastfeeding, and fertility").
• if you have an infection; see the "Infections" heading below.

Signs of an allergic reaction to this medicine, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno Zentiva immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Elderly patients

If you are elderly, 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, ulceration, or perforation in the stomach or intestine may occur without warning signs in patients who have never had such problems before. This can also be potentially life-threatening.

The risk of stomach or intestinal ulcers or bleeding generally increases with higher doses of ibuprofen. The risk also increases in elderly patients; for more information, see "Elderly patients" in the section "How to take Ibuprofeno Zentiva". The risk also increases if certain medicines are taken 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 alert to any unusual symptoms in the stomach or intestine and report them immediately to their doctor.

If gastrointestinal bleeding or ulceration occurs, treatment with ibuprofen must be stopped.

Effects on the heart and brain

Anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when high doses are used. Do not exceed the recommended dose or duration of treatment. Any risk is more likely with high doses and prolonged treatment.

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 syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop taking this medicine and see a doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Effects on the kidneys

Ibuprofen may cause problems with kidney function, even in patients who have not previously had kidney problems. This may 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 previously had kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors, as well as in elderly patients. Recovery is generally achieved if ibuprofen is discontinued.

Infections

This medicine may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or worsen, consult a doctor without delay.

Other precautions

Long-term use of any type of painkiller for headaches may worsen them. If you suffer from frequent or daily headaches despite (or because of) regular use of headache medicines, consult your doctor before taking another painkiller. Treatment should be discontinued if medication-overuse headache (MOH) is diagnosed.

Do not take this medicine if you are trying to become pregnant. Consult your doctor first. See also section "Pregnancy, breastfeeding, and fertility".

Children and adolescents

This medicine should not be used in children weighing 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, neck stiffness, or back pain.
• the child has serious problems with the ears, throat, or trachea.

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

• the child has not taken any fluids or has lost a large amount of fluid due to persistent vomiting or diarrhea.
• the 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 need to take any other medicines. This medicine may affect or be affected by other medicines. For example:

• medicines that are anticoagulants (i.e., blood thinners or that prevent clotting, e.g., acetylsalicylic acid, warfarin, or ticlopidine)

• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, or angiotensin II receptor antagonists such as losartan)

• other NSAIDs or acetylsalicylic acid, as these medicines can increase the risk of gastrointestinal ulcers or bleeding

• methotrexate (used to treat cancer and autoimmune diseases), as ibuprofen may intensify the effect of this medicine

• digoxin (used to treat various heart disorders), as the effect of digoxin may be intensified

• phenytoin (used to prevent epileptic seizures), as ibuprofen may intensify the effect of this medicine

• lithium (used to treat depression and mania), as ibuprofen may intensify the effect of this medicine

• potassium-sparing diuretics, as this may lead to hyperkalemia (high potassium levels in the blood)

• cholestyramine (used to treat high cholesterol), as it may reduce the effect of ibuprofen. The medicines should be administered at least one hour apart.

• aminoglycosides (medicines against certain types of bacteria), as ibuprofen may reduce the elimination of aminoglycosides, so their co-administration may increase the risk of toxicity

• SSRIs (antidepressants) such as paroxetine, sertraline, or citalopram, as they may increase the risk of gastrointestinal bleeding

• moclobemide (an IRMA; a medicine to treat depressive illness or social phobia), as it may increase the effect of ibuprofen

• cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur

• zidovudine (used to treat HIV patients), as administration of this medicine may increase the risk of bleeding into a joint or bleeding causing inflammation in HIV-infected hemophiliacs

• ritonavir (used to treat HIV patients), as ritonavir may increase ibuprofen concentrations

• mifepristone, as ibuprofen may reduce the effect of this medicine

• probenecid or sulfinpyrazone (to treat gout), as they may delay ibuprofen excretion

• quinolone antibiotics, as they may increase the risk of seizures

• sulfonylureas (to treat type 2 diabetes), as they may intensify the effect of these medicines

• corticosteroids (used against inflammation), as these medicines may increase the risk of gastrointestinal ulcers or bleeding

• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce high calcium levels in the blood), as they may increase the risk of gastrointestinal ulcers or bleeding

• pentoxifylline (oxpentifylline) (used to treat circulatory disorders in 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 intensified

• CYP2C9 inhibitors, as concomitant administration of ibuprofen and CYP2C9 inhibitors (voriconazole or fluconazole) may increase exposure to ibuprofen (a CYP2C9 substrate).

Ibuprofeno Zentiva with food and alcohol

If you have a sensitive stomach, you are advised to take this medicine with food.

Avoid alcohol, as it may intensify 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 become pregnant, consult your doctor or pharmacist 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 childbirth. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may cause delayed or prolonged labor. You should not take Ibuprofeno Zentiva during the first 6 months of pregnancy unless absolutely necessary and directed by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days beyond 20 weeks of pregnancy, Ibuprofeno Zentiva may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk, but it is unlikely to affect breastfeeding if used for short-term treatment. However, if longer-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 are planning to become pregnant or have difficulty becoming pregnant.

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

Driving and using machines

Generally, ibuprofen does not have side effects on the ability to drive or use machinery. However, at high doses, side effects such as fatigue or dizziness may occur, and the ability to drive a car or operate machinery may be impaired. Concurrent alcohol consumption may enhance this effect.

Ibuprofeno Zentiva contains sodium

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

3. How to take Ibuprofen Zentiva

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How to take this medicine

Swallow the tablet with a glass of water. Do not crush, chew or suck the tablet, to avoid irritation of the stomach and throat. If you are a patient with a sensitive stomach, you are advised to take this medicine with food.

How much medicine to take

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicine must not be used in adolescents weighing 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 medicines simultaneously without medical prescription.

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

Adults and adolescents weighing 40 kg and over (over 12 years of age):

Maximum daily dose: 1,200 mg.

The dose should be taken as indicated below:

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

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

Migraine headache

Adults and adolescents weighing 40 kg and over (over 12 years of age):

Maximum daily dose: 1,200 mg.

The dose should be taken as indicated below:

One 400 mg tablet taken as needed, 1 to 3 times daily. Leave at least 4 to 6 hours between doses.

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

Menstrual pain

Adults and adolescents weighing 40 kg and over (over 12 years of age):

Maximum daily dose: 1,200 mg.

The dose should be taken as indicated below:

One 400 mg tablet at the first signs of menstrual discomfort, 1 to 3 times daily. Leave at least 4 to 6 hours between doses.

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

Elderly patients

If you are an elderly patient, you should always consult your doctor before using this medicine. Elderly patients are more prone to side effects, especially gastrointestinal bleeding and perforation, which may be fatal. Your doctor will advise you accordingly.

Impaired liver or kidney function

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

If you take more Ibuprofen Zentiva than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion and unstable eye movements. At high doses, loss of consciousness, seizures (especially in children), slow heartbeat, weakness and dizziness (due to low blood pressure), blood in the urine, low blood potassium levels, chills and breathing difficulties may occur. Low blood pressure may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ibuprofen Zentiva

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Stop taking this medicine and contact your 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.
• Tarry stools or bloody vomiting (may affect up to 1 in 10 people).
• Serious skin and mucous membrane reactions have been reported, such as toxic epidermal necrolysis and/or erythema multiforme (a very rare adverse effect). Additionally, a severe skin reaction 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). The frequency is unknown (frequency cannot be estimated from the available data).
• A widespread, red, scaly rash with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Frequency is unknown (frequency cannot be estimated from the available data).
• Blurred vision and other eye problems such as sensitivity to light, vision loss (may affect up to 1 in 1,000 people).
• Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious 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 group:

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

• Heartburn, abdominal pain, or indigestion.
• Gastrointestinal disturbances such as diarrhea, nausea, vomiting, gas, or constipation.

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

• Ulceration in the gastrointestinal tract, with or without perforation.
• Intestinal inflammation and worsening of colonic inflammation (colitis) and gastrointestinal tract (Crohn's disease), and complications of colonic diverticula (perforation or fistula).
• Microscopic gastrointestinal bleeding that may lead to anemia.
• Mouth ulcers and inflammation.
• Headache, drowsiness, dizziness, vertigo, fatigue, restlessness, insomnia, or irritability.

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

• Inflammation of the gastric mucosa.
• Kidney problems, including edema, kidney inflammation, and renal failure.
• Runny nose, asthma.
• Rash, increased skin sensitivity to sunlight.
• Hypersensitivity reactions such as hives or pruritus.

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

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

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

• Palpitations, heart failure, heart attack, or high blood pressure.
• Disorders in blood cell formation (with symptoms such as: fever, sore throat, superficial oral ulcers, flu-like symptoms, excessive fatigue, and nosebleeds or skin bleeding).
• Ringing or buzzing in the ears.
• Inflammation of the esophagus or pancreas.
• Intestinal narrowing.
• Liver damage causing yellowing of the skin or whites of the eyes and fluid retention in the body.
• Inflammation of the meninges (without bacterial infection).
• Kidney tissue damage.
• Hair loss.
• Psychotic reactions.
• Inflammation of blood vessels.
• Ibuprofen may mask signs and symptoms of infections, worsen infections, or lead to complications from infections. If you take this medicine 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):

• Tingling in the hands and feet.
• Anxiety.
• Hearing impairment.
• General feeling of malaise.
• Optic nerve inflammation that 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.

Medicines such as ibuprofen may be associated with a small increased 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 medicine may reduce the number of white blood cells, potentially reducing your resistance to infection. If you develop an infection with symptoms such as fever and a significant worsening of your general condition, or fever with signs of localized infection such as sore throat, pharynx, or mouth, or urinary problems, you should contact your doctor immediately. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis). It is important that you inform your doctor about this medication.

During treatment with ibuprofen, some cases of meningitis (manifested by neck stiffness, headache, nausea, vomiting, fever, or disorientation) have been observed in patients with pre-existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Zentiva

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

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

Do not use this medicine after the expiry date stated on the cardboard package CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Zentiva

• The active substance is ibuprofen.

Each tablet contains 400 mg of ibuprofen.

• The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose, stearic acid, colloidal anhydrous silica, and magnesium stearate.

• Tablet coating: hypromellose, macrogol, talc, titanium dioxide (E171).

Appearance of Ibuprofen Zentiva and contents of the pack

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

The tablets are packed in PVC/Alu blisters.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Zentiva Spain S.L.U.

Avenida de Europa, 19,

Building 3, 1st floor,

28224 Pozuelo de Alarcón - (Madrid)

Spain

Manufacturer responsible

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

Austria	Ibuprofen Zentiva
Spain	Ibuprofen Zentiva 400 mg film-coated tablets EFG
Estonia	Ibuprofen Zentiva
Iceland	Ibetin
Latvia	Ibuprofen Zentiva
Lithuania	Ibuprofen Zentiva
Poland	Ibuprofen Zentiva
Romania	Inflanor
Sweden	Ibetin

Date of the most recent review of this leaflet: January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es/.