Ibuprofeno tarbis 600 mg comprimidos recubiertos con pelÍcula efg

Prospecto: Information for the User

Ibuprofen Tarbis 600 mg Film-Coated Tablets

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

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

3.How to take Ibuprofen Tarbis.

4.Possible adverse effects.

5.Storage of Ibuprofen Tarbis.

6.Contents of the package and additional information.

Ibuprofeno Tarbis belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno Tarbis

• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.

-If you are in the third trimester of pregnancy.

Warnings and precautions

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased 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 Ibuprofeno Tarbis if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), 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.
• If you have an infection; see the "Infections" section below.

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

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 (GPP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Tarbis treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medication is not recommended for use in children or adolescents under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Be especially careful with Ibuprofeno Tarbis:

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Infections:Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen 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.

Taking Ibuprofeno Tarbis with other medications

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin.
• Anticoagulant medications (e.g., for treating blood clotting problems or preventing clotting, e.g., aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against HIV/AIDS).
• Antihypertensives: to lower high blood pressure.
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

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

Taking Ibuprofeno Tarbis with food and drinks

Ibuprofeno Tarbis are tablets for oral administration. Swallow the tablet whole with a little water.

If you have a sensitive stomach, take the medication with meals.

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 medication.

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women).

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Precautions during pregnancy and in fertile women

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 predisposition to bleeding and delay or prolong delivery. Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, 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 result in low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with laboratory tests

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Clearance of creatinine (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Serum concentrations of urea nitrogen and creatinine and potassium (may increase)
• With liver function tests: increased values of transaminases

Inform your doctor if you are about to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Important information about some of the components of Ibuprofeno Tarbis:

Ibuprofeno Tarbis contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Your doctor will indicate the duration of treatment with ibuprofen. Do not discontinue treatment beforehand, as this would not yield the expected results. Similarly, do not use ibuprofen for a longer period than indicated by your doctor.

The most effective dose should be used for the shortest duration necessary to alleviate 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 is administered orally.You should swallow the tablet whole with a little water.Patients with stomach discomfort should take the medication with milk or during meals.

The recommended dose is:

Adults:

In adults and adolescents from 14 to 18 years, one tablet (600 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents from 12 to 18 years.

Use in children and adolescents

This medication is not recommended for use in children or adolescents under 14 years, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Geriatric population:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If this is the case, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If this is the case, take the exact dose prescribed by your doctor.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Tarbis than you should

If you have taken more ibuprofen than you should, or if a child has ingested the medication accidentally, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and seek advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained 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.

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 Tarbis

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

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medications, Ibuprofen Tarbis may cause side effects, although not everyone will experience them.

Side effects of medications such as ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The following side effects have been observed:

Gastrointestinal:

The most frequent side effects that occur with medications such as ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Infrequent: Inflammation of the oral mucosa with the formation of ulcers. Rare: Inflammation of the esophagus, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with diarrhea and blood). Very rare: Pancreatitis.

Cardiovascular:

Medications such as ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with ibuprofen treatments.

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

Cutaneous:

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

• Flat, red, circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption with skin protuberances and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Other side effects are:

Frequent: Skin rash.

Infrequent: Redness of the skin, itching or swelling of the skin, purpura (purple patches on the skin).

Very rare: Hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Immune system:

Infrequent: Transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs). Rare: Severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reactions, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: Joint pain and fever (lupus erythematosus).

Central nervous system:

Frequent: Fatigue or drowsiness, headache, dizziness, or feeling unsteady. Rare: Paresthesia (numbness, tingling, burning, etc. more common in hands, feet, arms, or legs). Very rare: Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Infrequent: Insomnia, anxiety, restlessness. Rare: Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Frequent: Dizziness. Infrequent: Ringing or buzzing in the ears. Rare: Hearing difficulty.

Ocular:

Infrequent: Vision disturbances. Rare: Abnormal or blurred vision.

Haematological:

Rare: Decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as respiratory difficulty and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nasal and cutaneous bleeding. Very rare: Prolonged bleeding time.

Renal:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Heptatic:

Medications such as ibuprofen may be associated, in rare cases, with liver damage. Other rare side effects are: Hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Unknown frequency: Liver insufficiency (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

No severe allergic reactions have been reported with ibuprofen to date, although they cannot be ruled out. The manifestations of this type of reaction may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, respiratory difficulty, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, stop treatment and seek immediate medical attention:

Allergic reactions such as skin rash, facial swelling, chest tightness, or respiratory difficulty.

· Vomiting blood or coffee grounds-like material.

· Blood in stool or diarrhea with blood.

· Severe stomach pain.

· Important blisters or peeling of the skin.

· Severe headache or persistent headache.

· Yellowing of the skin (jaundice).

· Signs of severe hypersensitivity (allergy) (see above in this same section).

· Swelling of the extremities or fluid accumulation in the arms or legs.

Others:

Unknown frequency: Skin becomes sensitive to light.

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 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 side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Tarbis:

The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.

The other components (excipients) are:

• Core: Sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose (E-460(i)), cornstarch, anhydrous colloidal silica, magnesium stearate
• Coating: Hypromellose, titanium dioxide (E-171), purified talc, and propylene glycol.

Appearance of the product and contents of the packaging

Ibuprofeno Tarbis 600 mg tablets are presented in the form of coated tablets with a film, oval, biconvex, and white in color. Each package contains 40 tablets conditioned in aluminum-PVC/PVDC blister.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturing responsible:

Amarox Pharma B.V.

Rouboslaan 32

Voorschooten, 2252 TR

Netherlands

This prospectus was approved in January 2024

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