Leaflet: information for the patient

Ibuprofen Zentiva 400mg film-coated tablets EFG

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

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

2.What you need to know before starting to take Ibuprofen Zentiva

3.How to take Ibuprofen Zentiva

4.Possible side effects

5.Storage of Ibuprofen Zentiva

6.Contents of the pack and additional information

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

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

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

This medication alsorelieves acute pain and fever associated with the common cold.

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

Do not take Ibuprofeno Zentiva

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section6).
• if you have had allergic reactions such as asthma, nasal congestion, skin rashes with itching or swelling of the lips, face, tongue, or throat after taking medications containing acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• if you have had two or more previous episodes of stomach ulcers or recurrent bleeding in the stomach or small intestine (duodenum).
• if you have a history of perforation or gastrointestinal bleeding related to previous treatment with NSAIDs.
• if you have a blood or bleeding disorder.
• if you have severe heart, liver, or kidney disease.
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• if you have active bleeding (including in the brain).
• if you are in the last 3months 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 respiratory tract obstruction, due to an increased risk of allergic reactions.
• if you are taking medications that may increase the risk of ulcers or bleeding (seeOther medicinesand Ibuprofeno Zentiva below).
• if you have heart problems such as heart failure or angina (chest pain), or if you have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the arms, legs, or feet due to narrowing or blockage of the arteries) or any type of stroke (including «microstroke» or transient ischemic attacks, «TIAs»).
• if you have high blood pressure, diabetes, high cholesterol, a 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 the normal mechanism of blood coagulation.
• if you have recently had 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.

Signs of allergic reaction to ibuprofen, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Zentiva immediately and contact your doctor or emergency medical services if you observe any of these signs.

Older patients

If you are an older 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 warning in patients who have never had such problems before. This can also be potentially fatal.

The risk of stomach ulcers or bleeding increases with higher doses of ibuprofen. It also increases in older patients, see «Older patients» in the «How to take Ibuprofeno Zentiva» section. The risk also increases if you take certain medications at the same time as ibuprofen (seeOther medicines and Ibuprofeno Zentiva, below).

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

If bleeding or ulceration of the digestive tract occurs, treatment with ibuprofen should be stopped.

Effects on the heart and brain

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when high doses are taken. Do not exceed the recommended dose or treatment duration. 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), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Stop treatment with this medicine and see 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 can 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 can 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 older patients. In general, recovery is achieved if ibuprofen is stopped.

Infections

This medicine may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Other precautions

The 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) the habitual use of painkillers, consult your doctor before taking another painkiller. Treatment should be discontinued if a diagnosis of medication-overuse headache (MOH) is made.

Do not take this medicine if you intend 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 weighing less than 40kg (under 12 years).

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 severe problems in the ears, throat, or trachea.

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

• the child has not drunk any liquids or has lost a large amount of liquid due to persistent vomiting or diarrhea.
• the treatment had no effect on the pain or fever after the first day.
• new symptoms appear or stomach or abdominal problems worsen or persist for a long time.

Other medicines and Ibuprofeno Zentiva

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

• anticoagulant medications (i.e., hypocoagulants or those that prevent coagulation, p.eg., acetylsalicylic acid, warfarin, or ticlopidine)
• medications that lower blood pressure (inhibitors of the enzyme angiotensin-converting enzyme (ACE) such as captopril, beta-blockers such as medications with atenolol, or angiotensin II receptor antagonists such as 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 intensify the effect of this medicine
• digoxin (used to treat various heart conditions), as ibuprofen may intensify the effect of this medicine
• phenytoin (used to prevent 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 cause hyperkalemia (high potassium levels in the blood)
• cholestyramine (used to treat high cholesterol),as it may reduce 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 reduce the elimination of aminoglycosides, thereby increasing the risk of toxicity
• selective serotonin reuptake inhibitors (SSRIs) such as paroxetine, sertraline, or citalopram,as they may increase the risk of gastrointestinal bleeding
• moclobemide (IRMA; a medication for treating depression or social anxiety disorder), as it may increase the effect of ibuprofen
• ciclosporin, tacrolimus (for immunosuppression after organ transplantation),as it may cause kidney damage
• zidovudine (used to treat HIV), as the administration of this medicine may increase the risk of bleeding in a joint or bleeding that causes inflammation in hemophiliacs infected with HIV
• ritonavir (used to treat HIV), as ritonavir may increase the concentration of ibuprofen
• mifepristone,as ibuprofen may reduce the effect of this medicine
• probencid 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 intensify the effect of these medicines
• corticosteroids (used for inflammation), as these medicines may increase the risk of stomach 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 stomach ulcers or bleeding
• pentoxifylline (oxpentifilina) (used to treat circulatory diseases of the arteries in the legs or arms),as they may increase the risk of stomach ulcers or bleeding
• baclofen (a muscle relaxant),as it may intensify its toxicity
• inhibitors of CYP2C9, as the concomitant administration of ibuprofen and CYP2C9 inhibitors (voriconazole or fluconazole) may increase exposure to ibuprofen (substrate of CYP2C9).

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 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 intend 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 delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed and cause delayed onset of labor or longer than expected labor. Do not take Ibuprofeno Zentiva during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, Ibuprofeno Zentiva may cause kidney problems in the fetus that 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 lactation if used for a short treatment period. However, if a longer treatment is prescribed, early cessation of breastfeeding should be considered.

Fertility

This medicine may make it more difficult to become pregnant. Inform your doctor if you have difficulty becoming pregnant.

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

Driving and operating machinery

In general, ibuprofen does not have side effects on the ability to drive or operate 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 consumption of alcohol may enhance this effect.

Ibuprofeno Zentiva contains sodium

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

Follow exactly the administration instructions of this medication 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 stomach and throat irritation.If you are a patient with a delicate stomach, it is recommended to take this medication with food.

How muchmedicationto take

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicationshould not be used in adolescents weighing less than 40kg or in children under 12years.

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

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

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

Daily maximum dose:1,200mg.

The dose should be taken as follows:

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

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

Migraine

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

Daily maximum dose:1,200mg.

The dose should be taken as follows:

A 400mg tablet taken on demand, 1 to 3 times a day. Leave at least 4 to 6 hours between doses.

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

Menstrual pain

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

Daily maximum dose:1,200mg.

The dose should be taken as follows:

A 400mg tablet taken at the first signs of menstrual problems, 1 to 3 times a day.Leave at least 4 to 6 hours between doses.

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

Older patients

If you are an older patient, you should always consult a doctor before usingthis medication. If you are an older patient, you are more prone to side effects, especially bleeding and perforation in 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, 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, consult a doctor or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Symptoms 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) have been reported. Blood in the urine, chills, and breathing difficulties have also been reported.

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

If you forgot to take Ibuprofeno Zentiva

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Unwanted effects are more likely to occur with higher doses and longer treatment durations.

Stop taking this medicine and seek immediate medical attention if any of the following symptoms appear:

• Angioedema (may affect up to 1 in 10,000 people) with symptoms such as:
• • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Urticaria and difficulty breathing.
• Black stools or bloody vomiting(may affect up to 1 in 10 people).
• Severe skin and mucous membrane changes, such as Stevens-Johnson syndrome and/or toxic epidermal necrolysis (a very rare side effect). Additionally, a severe skin reaction called DRESS syndrome may occur. The symptoms of DRESS syndrome are: skin rash, fever, lymph node swelling, and increased eosinophils (a type of white blood cell). The frequency is unknown (the frequency cannot be estimated with the available data).
• A red, scaly, and generalized rash with bumps under the skin and localized blisters, mainly on the trunk and upper limbs, accompanied by fever at the start of treatment(acute generalized pustular psoriasis). The frequency is unknown (the frequency cannot be estimated with the available data).
• Blurred vision and other eye problems such as photophobia, loss of vision(may affect up to 1 in 1,000 people).
• Flat, circular, or target-shaped red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, 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, abdominal pain, or indigestion.
• Alterations 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.
• Intestinal inflammation and worsening of colon inflammation (colitis) and digestive tract inflammation (Crohn's disease) and complications of intestinal diverticula (perforation or fistula).
• Microscopic bleeding in the intestine that may lead to anemia.
• Mouth ulcers and inflammation.
• Headache, drowsiness, vertigo, dizziness, fatigue, agitation, insomnia, or irritability.

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

• Gastric mucosa inflammation.

• Renal problems, including edema, kidney inflammation, and renal insufficiency.
• Nasal discharge, asthma
• Rash, increased skin sensitivity to the sun.
• Hypersensitivity reaction such as urticaria or pruritus.

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

• Depression, confusion, hallucinations.

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

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

• Unpleasant perception of heartbeats, heart failure, myocardial infarction, or high blood pressure.
• Blood disorders (with symptoms such as: fever, sore throat, superficial oral ulcers, flu-like symptoms, excessive fatigue, and nasal or cutaneous bleeding).
• Tinnitus or ringing in the ears.
• Esophageal or pancreatic inflammation.
• Intestinal narrowing.
• Liver damage that causes yellowing of the skin or white of the eyes and fluid retention in the body.
• Cerebral membrane inflammation (without bacterial infection).
• Renal tissue damage.
• Hair loss.
• Psychotic reactions.
• Arterial inflammation.
• Ibuprofen may mask signs and symptoms of infections, worsening of infections, or complications of infections. If you take this medicine while having an infection and your infection symptoms persist or worsen, consult a doctor without delay.

Frequency unknown(cannot be estimated from the available data):

• Hand and foot tingling.
• Anxiety.
• Decreased hearing.
• General feeling of discomfort.
• 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 severe allergic reaction called Kounis syndrome.

Medicines 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 medicine may decrease the number of white blood cells and reduce their resistance to infection. If you have an infection with symptoms such as fever and a significant deterioration in your general condition, or fever with local infection symptoms such as sore throat, pharynx, or mouth ulcers, or urinary problems, seek immediate medical attention. A blood test will be performed to check for possible leukopenia (agranulocytosis). It is essential to inform your doctor about your medicine.

During ibuprofen treatment, some cases of meningitis (manifesting with neck stiffness, 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 of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 that appears on the carton packaging CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Zentiva

• The active ingredient is ibuprofen.

Each tablet contains 400 mg of ibuprofen.

• The other components are:

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

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

Appearance of Ibuprofeno Zentivaand packaging contents

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

The tablets are packaged in PVC/Alu blisters.

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

Only some packaging 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

Responsible for manufacturing

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:

Last review date of this leaflet: July 2024

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