IBUPROFEN TARBIS 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofeno Tarbis 600 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Contents of the package leaflet:

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

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

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

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

2. What you need to know before taking Ibuprofeno Tarbis

Do not take Ibuprofeno Tarbis

• If you are allergic (hypersensitive) to ibuprofen, other medications of the NSAID group, aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.

• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer 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 disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation 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.

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a 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 if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the 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 if you are a smoker.
• if you have an infection; see the "Infections" section below.

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

Skin reactions

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

Children and adolescents

The use of this medication is not recommended in children and adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Be careful with Ibuprofeno Tarbis:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving ibuprofen treatment, as it may mask fever, which is an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure in this case due to dehydration.
• If you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications like ibuprofen may worsen these conditions.
• If you are undergoing treatment with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.

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

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

Infections: Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Taking Ibuprofeno Tarbis with other medications

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

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medications that lower high blood pressure (e.g., 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 (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 disorders).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Antihypertensives: to decrease 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 treatment with Ibuprofeno Tarbis. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno Tarbis with other medications.

Taking Ibuprofeno Tarbis with food and drinks

Ibuprofeno Tarbis is a tablet for oral administration. You should swallow the tablet whole with a little water.

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

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.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age).

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 using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Precautions during pregnancy and in women of childbearing age

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. Because the administration of medications like ibuprofen has been associated with an increased risk of congenital anomalies/abortions, 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 can cause 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.

For women of childbearing age, it should be noted that medications like ibuprofen have been associated with a decrease in fertility.

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

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

Important information about some components of Ibuprofeno Tarbis:

Ibuprofeno Tarbis contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ibuprofeno Tarbis

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment before, as the expected results will not be achieved. Similarly, do not use ibuprofeno for longer than indicated by your doctor.

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 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, take one tablet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and 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

The use of this medication is not recommended in children and adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly population:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has checked 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 so, take the exact dose prescribed by your doctor.

If you think the effect of this medication is too strong or too weak, tell 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 accidentally ingested the medication, consult a doctor or go to the nearest hospital immediately 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 blood), 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 urine, chills, and breathing problems have been reported.

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

If you forget to take Ibuprofeno Tarbis

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible Adverse Effects

Like all medications, Ibuprofeno Tarbis can produce adverse effects, although not all people suffer from them.

The adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

The following adverse effects have been observed:

Gastrointestinal:

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

Other adverse effects are: Infrequent: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulitis, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

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

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the ibuprofen type.

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

Cutaneous:

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

• red patches, not elevated, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Other adverse effects are:

Frequent: skin rash.

Infrequent: skin redness, itching or skin swelling, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Immune System:

Infrequent: transient edema in skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear. Very rare: joint pain and fever (lupus erythematosus).

Central Nervous System:

Frequent: fatigue or drowsiness, headache, and dizziness or instability. Rare: paresthesia (numbness, tingling, acalculia, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from 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: vertigo. Infrequent: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Infrequent: vision changes. Rare: abnormal or blurred vision.

Blood:

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 difficulty breathing and skin pallor), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different cell types), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medications like ibuprofen may be associated, in rare cases, with liver damage. Other rare adverse effects are: hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver failure (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects appear, discontinue treatment and consult your doctor immediately:

Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.

• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Others:

Unknown frequency: skin becomes sensitive to light.

Reporting Adverse Effects

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

5. Conservation of Ibuprofeno Tarbis

Keep this medication out of 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 thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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)), corn starch, colloidal anhydrous silica, magnesium stearate
• Coating: Hypromellose, titanium dioxide (E-171), purified talc, and propylene glycol.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturers:

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 Health Products (AEMPS) http://www.aemps.gob.es/