Package Leaflet: Information for the User

Ibuprofen Teva 400 mg Soft Capsules

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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.

1. What is Ibuprofen Teva and what it is 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. Contents of the pack and additional information

The active ingredient ibuprofen in this medication acts by reducing pain and fever.

It is used for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle spasms, or lower back pain, as well as in febrile states.

Do not take Ibuprofeno Teva if:

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

Warnings and precautions

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

• Do not take more than 3 soft capsules (1200 mg of ibuprofen) per day to avoid possible cardiovascular or heart problems
• If you have had stomach or intestinal diseases (e.g., ulcers), you should not consume this medication without medical supervision. Do not treat stomach or intestinal pain with this medication.
• If you experience stomach or intestinal burning or pain, discontinue treatment and consult your doctor. If you have another disease or suffer from an allergy, consult your doctor or pharmacist before taking this medication.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen can worsen these conditions
• If your doctor has prescribed an antiplatelet medication (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Ibuprofeno Teva, separate the intake of both medications. 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 dose.
• If you have hypertension, reduced renal, cardiac, or hepatic function, bleeding disorders, or are taking anticoagulants, consult your doctor before taking this medication.
• Do not exceed the recommended dose in section 3. How to take Ibuprofeno Teva
• If you have chickenpox (a childhood infection), do not take ibuprofen.
• In case of dehydration, severe diarrhea, or vomiting, especially in children, take plenty of liquid and seek medical attention immediately.
• If you have intermittent acute porphyria (a rare disorder in which a large amount of porphyrin is eliminated in urine and feces)
• If you have an infection; see the "Infections" heading below.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may increase the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

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 exanthematous pustulosis (PEGA), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the 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. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Interference with diagnostic tests:

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

Other medications and Ibuprofeno Teva

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

In particular, if you are using any of the following medications, you may need to modify the dose of one of them or discontinue treatment:

• Baclofen (used to treat involuntary and persistent muscle contractions)
• Ciclosporin and tacrolimus (used to prevent rejection in organ transplants)
• Digoxin (used for the heart)
• Fenitoin (in the treatment of epilepsy)
• Furosemide and other thiazide diuretics (used for urine elimination)
• Insulin and oral hypoglycemic agents (used to reduce blood glucose)
• Lithium (used to treat depression)
• Metotrexate (used in cancer and rheumatoid arthritis treatment)
• Mifepristone (inducer of abortion)
• Pentoxifylline (used in circulatory disorders)
• Probenecid (used in patients with gout or with penicillin in infections)
• Quinolones (used in infections)
• Ion exchange resins like cholestyramine (used to reduce blood cholesterol)
• Sulfonamides (used in infections)
• Sulfinpyrazone (for gout treatment)
• Tacrine (used in Alzheimer's disease treatment)
• Thrombolytics (medications that dissolve or break down blood clots)
• Zidovudine (used in treatment of patients infected with the human immunodeficiency virus, causing AIDS)
• Do not use with other analgesics and anti-inflammatory medications (nonsteroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation, without consulting a doctor.

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

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

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using this medication with other medications.

Taking Ibuprofeno Teva with food and drinks

Take this medication with meals or with milk.

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

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages – beer, wine, liquor... per day) may cause stomach bleeding.

Use in children

Do not administer this medication to children under 18 years old without consulting a doctor.

Use in people over 65 years old

Older adults are more prone to its effects, so sometimes you may need to reduce the dose. Consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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.Ibuprofen may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected.Do 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 time possible.From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Ibuprofen belongs to a group of medications that may reduce female fertility (ability to become pregnant). This effect is reversible when the medication is discontinued.

Lactation

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machines

Although not expected, use with caution if you notice drowsiness or dizziness.

Ibuprofeno 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 disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

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

The recommended dose is:

• Adults: one soft capsule (400 mg of ibuprofen) will be taken every 6 or 8 hours as needed.

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

• Individuals over 65 years?The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

• Patients with severe renal impairment or liver failure:do not take this medication (see section 2, Do not take).
• Children and adolescents: Consult a doctor before using this medication in adolescents (over 12 years).

Due to the ibuprofen dose, this medication should not be used in children or adolescents with a weight of less than 40 kg.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally.

Swallow the soft capsules whole with plenty of liquid.

Take the medication with meals or with milk, especially if digestive discomfort is noted.

The administration of this medication is dependent on the appearance of pain or fever. As these symptoms disappear, discontinue medication.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, 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 medication, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested or go immediately to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, chills, and breathing difficulties have also been reported.

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

Frequent(may affect up to 1 in 10 people): fatigue, headache, gastrointestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (skin rashes, itching) and ear buzzing.

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

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

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

Unknown frequency:

The skin becomes sensitive to light.

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Stop taking ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• flat, red, non-elevated spots, in the form of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• generalized skin eruption, elevated body temperature and hypertrophied lymph nodes (DRESS syndrome).

Generalized, red and scaly rash, with skin protuberances and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of the medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging. 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 medications you no longer need at the SIGRE pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.

By doing so, you will help protect the environment.

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 Teva and content of the packaging

Soft, transparent gelatin capsules, oval in shape, and having a smooth and regular appearance.

It is presented in packaging containing 10 or 20 soft capsules in an aluminum/PVC + PVDC blister.

Marketing authorization holder title

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Laboratorios Liconsa S.A.

Pol. Ind. Miralcampo, Avenida Miralcampo nº7

19200, Azuqueca de Henares (Guadalajara), Spain

Last review date of this leaflet:November 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/