Ibuprofen Tarbis 600 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen Tarbis 600 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine, as 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 or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents:

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

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

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, usually affecting the hands and feet, resulting in swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spinal column), 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, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.

• If you have severe liver or kidney disease.

• If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.

• If you are vomiting blood.

• If you have black stools or bloody diarrhoea.

• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, 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.

Medicines with anti-inflammatory/analgesic properties such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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 arterial disease (circulation problems in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
• You have an infection; see the section «Infections» below.

Allergic reactions to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately stop taking Ibuprofeno Tarbis and contact your doctor or medical emergency services immediately if you experience any of these symptoms.

Skin reactions

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

Children and adolescents

The use of this medicine is not recommended in children or adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing in this patient group.

Take special care with Ibuprofen Tarbis:

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are receiving treatment with ibuprofen, as it may mask fever—a key sign of infection—making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise how often these checks should occur.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to kidney failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medication.
• If you are taking concomitant drugs that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually leads to bloody diarrhea) or ulcerative colitis, as drugs like ibuprofen may worsen these conditions.
• If you are taking diuretics (medications to increase urine output), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting your blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.

It is important to use the lowest effective dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

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

Infections: Ibuprofen may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

Taking Ibuprofen Tarbis with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin.
• Anticoagulant medicines (e.g., to treat or prevent clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (used for medical abortion).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Antihypertensives: to reduce high blood pressure.
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

Other medicines may also interact with or be affected by treatment with Ibuprofen Tarbis. Therefore, always consult your doctor or pharmacist before using Ibuprofen Tarbis with other medicines.

Taking Ibuprofen Tarbis with food and drinks

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

If you have a sensitive stomach, take the medicine 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 medicine.

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 medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and use of machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, do not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are not usually necessary.

Precautions during pregnancy and in women of childbearing age

Do not take ibuprofen during 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 may delay or prolong labor beyond expected duration. Because the use of drugs like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, you should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, potentially leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.

Important information about some of the ingredients of Ibuprofen Tarbis:

Ibuprofen Tarbis contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ibuprofeno Tarbis

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

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

The lowest effective dose for the shortest necessary duration should be used to relieve 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 medicine is administered orally. The tablet should be swallowed whole with a little water. Patients experiencing stomach discomfort should take the medicine with milk or during meals.

Recommended dosage:

Adults:

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

Higher doses may be required in some conditions; however, in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents aged 12 to 18 years.

Use in children and adolescents

The use of this medicine is not recommended in children or adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing regimen in this patient group.

Elderly population:

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

Patients with kidney and/or liver disease:

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

If you think that the effect of this medicine 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 accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ibuprofeno Tarbis

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

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

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

4. Possible adverse effects

Like all medicines, Ibuprofeno Tarbis can cause adverse effects, although not everyone will experience them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis presenting with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments using ibuprofen-like medicines.

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

Dermatological:

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

• Flat, red, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other adverse effects are:

Frequent: skin rash.

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

Very rare: hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of blood vessels in the skin. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Immune system:

Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi obstructing airflow to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, 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 sensation of instability. Rare: paresthesia (numbness, tingling, "pins and needles," more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most reported cases of aseptic mening游戏副本

5. Storage of Ibuprofen Tarbis

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Tarbis:

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

The other components (excipients) are:

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

Appearance of the medicinal product and contents of the pack

Ibuprofen Tarbis 600 mg tablets are presented as film-coated, oval, biconvex, white tablets. Each pack contains 40 tablets in aluminum-PVC/PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturers:

Amarox Pharma B.V.

Rouboslaan 32

Voorschooten, 2252 TR

The Netherlands

This summary of product characteristics was approved in January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS): http://www.aemps.gob.es/