IBUPROFEN TIVA 400 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Ibuprofen Teva 400 mg Soft Capsules

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

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if the pain worsens or does not improve after 5 days or the fever does not improve after 3 days.

Contents of the Package Leaflet

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

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

Ibuprofen, the active ingredient in this medicine, acts by reducing pain and fever.

It is used for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), as well as in febrile conditions.

2. What you need to know before taking Ibuprofen Teva

Do not take Ibuprofen Teva if:

• you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• you have had allergic reactions of an asthmatic type when taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics
• you suffer from or have suffered from asthma, rhinitis, or urticaria
• you have a serious liver, kidney, or heart disease (heart failure)
• you have bleeding or blood coagulation disorders
• you vomit blood, have black stools, or bloody diarrhea
• you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen Teva.

• Do not take more than 3 soft capsules (1200 mg of ibuprofen) per day to avoid possible circulatory or heart problems.
• If you have had stomach or intestinal diseases (e.g., ulcers), you should not consume this medicine without medical supervision. Stomach or intestinal pain should not be treated with this medicine.
• If you experience stomach burning or pain when taking the medicine, you should stop treatment and consult your doctor. If you have another illness or suffer from any type of allergy, consult your doctor or pharmacist before taking this medicine.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen medications can worsen these conditions.
• If your doctor has prescribed an antiplatelet medication (to prevent blood clots) that contains acetylsalicylic acid, and you are also taking Ibuprofen Teva, you should separate the administration of both medications. To do this, you can follow either of the following guidelines:
• • Take the acetylsalicylic acid dose and wait at least half an hour before administering the ibuprofen dose.
  • Take the ibuprofen dose at least 8 hours before administering the acetylsalicylic acid.
• If you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker, you should consult your doctor before taking this medicine.

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

Ibuprofen may mask 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.

Interference with diagnostic tests:

If you are going to undergo any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Other medicines and Ibuprofen Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of one of them or discontinue treatment:

• Baclofen (used to treat involuntary and persistent muscle contractions)
• Cyclosporin and tacrolimus (used to prevent organ rejection in transplants)
• Digoxin (used for heart conditions)
• Phenytoin (used to treat epilepsy)
• Furosemide and other thiazide diuretics (used for urine elimination)
• Insulin and oral hypoglycemics (used to decrease blood sugar levels)
• Lithium (used to treat depression)
• Methotrexate (used in cancer and rheumatoid arthritis treatment)
• Mifepristone (abortion inducer)
• Pentoxifylline (used in circulatory disorders)
• Probenecid (used in patients with gout or with penicillin in infections)
• Quinolones (used in infections)
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels)
• Sulfonamides (used in infections)
• Sulfinpyrazone (used to treat gout)
• Tacrine (used in Alzheimer's disease treatment)
• Thrombolytics (medicines that dissolve or break down blood clots)
• Zidovudine (used in HIV-infected patients)
• Do not use with other analgesic and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation without consulting your doctor.

Ibuprofen may affect or be affected by other medicines. For example:

• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II antagonists such as losartan)

Other medicines may also affect or be affected by ibuprofen treatment. Therefore, you should always consult your doctor or pharmacist before using this medicine with other medicines.

Taking Ibuprofen Teva with food and drinks

Take this medicine with meals or with milk.

Do not administer ibuprofen with alcohol to avoid damaging the stomach.

The use of ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages per day) may cause stomach bleeding.

Use in children

Do not administer this medicine to children under 18 years of age without consulting a doctor.

Use in people over 65 years of age

Elderly people are more likely to experience its effects, so the dose may need to be reduced. Consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

IMPORTANT FOR WOMEN:

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Ibuprofen belongs to a group of medicines that may decrease fertility (ability to become pregnant) in women. This effect is reversible when the medicine is stopped.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Although it is not expected to have effects in this regard, it should be used with caution if you experience drowsiness or dizziness.

Ibuprofen Teva contains sorbitol

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Ibuprofen Teva

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults: take one soft capsule (400 mg of ibuprofen) every 6 or 8 hours, if necessary.

Do not take more than 3 soft capsules (1200 mg of ibuprofen) within 24 hours.

• People over 65 years of age: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

• Patient with kidney or severe liver failure: should not take this medicine (see section 2, Do not take).
• Children and adolescents: consult a doctor before using this medicine in adolescents (over 12 years of age).

Due to the dose of ibuprofen, this medicine should not be used in children or adolescents weighing less than 40 kg.

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

This medicine is administered orally.

Swallow the soft capsules whole with plenty of liquid.

Take the medicine with meals or with milk, especially if you experience digestive discomfort.

The administration of this medicine is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

If the symptoms worsen, if the fever persists for more than 3 days or the pain for more than 5 days, you should consult a doctor.

If you take more Ibuprofen Teva than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested, or go immediately 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 bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

4. Possible side effects

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

Common(may affect up to 1 in 10 people): fatigue, headache, stomach and intestine disorders (stomach burning, diarrhea, nausea, vomiting), skin disorders (rash, itching), and ringing in the ears.

Uncommon(may affect up to 1 in 100 people): allergic reactions, asthma, rhinitis, and urticaria, gastrointestinal bleeding and ulcers, sleep disorders and mild restlessness, blurred vision, decreased visual acuity, or changes in color perception, and hearing disorders.

Rare(may affect up to 1 in 1,000 people): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice), kidney disorders consisting of acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine), and occasionally nephrotic syndrome; depression, vision disorders (vision obscuration), neck stiffness, and bronchospasm (sudden feeling of suffocation), dyspnea (difficulty breathing), and angioedema (circulatory reaction that affects the deep layers of the skin with inflammation and swelling).

Very rare(may affect up to 1 in 10,000 people): aseptic meningitis (inflammation of the meninges not caused by bacteria), blood and coagulation disorders, hypertension, and heart failure, severe skin disorders, eyes, and mucous membranes, such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin shedding) and erythema multiforme.

Frequency not known:

The skin becomes sensitive to light.

Fixed drug eruption.

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Discontinue ibuprofen treatment and seek immediate medical attention if you notice any of the following symptoms:

• red, non-elevated, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno Teva

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.

In this way, you will help protect the environment.

6. Packaging contents and additional information

Composition of Ibuprofeno Teva

Each soft capsule contains 400 mg of ibuprofen as the active ingredient.

The other components are: Macrogol 600, potassium hydroxide, anhydrous colloidal silica, purified water, gelatin, and sorbitol (E-420).

Appearance of Ibuprofeno Tevaand packaging contents

Transparent soft gelatin capsules, oval in shape, with a smooth and regular appearance.

It is presented in packaging that contains 10 or 20 soft capsules in an Aluminum/PVC + PVDC blister pack.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Pol. Ind. Miralcampo, Avenida Miralcampo nº7

19200, Azuqueca de Henares (Guadalajara), Spain

Date of the last revision of this prospectus: June 2025

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