IBUPROFEN VEGAL 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofeno Vegal 600 mg film-coated tablets EFG

Ibuprofen

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibuprofeno Vegal and what is it used for
2. What you need to know before you take Ibuprofeno Vegal
3. How to take Ibuprofeno Vegal
4. Possible side effects
5. Storing Ibuprofeno Vegal
6. Contents of the pack and other information

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

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

This medicine is used to treat fever, pain of mild to moderate intensity including migraine, arthritis (inflammation of the joints, including those in the 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 you take Ibuprofeno Vegal

Do not take Ibuprofeno Vegal:

• If you are allergic to the active substance, to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, runny nose, difficulty breathing, or asthma.
• If you have 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 (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines 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 before starting to take Ibuprofeno Vegal:

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• Tell your doctor if you are already receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine 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 due to dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent pain and/or black stools, or even without previous 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 medicine.

• If you take medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medicines 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 ibuprofen-like medicines may worsen these conditions.
• If you are being treated with diuretics (medicines to urinate), 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 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 treatment with ibuprofen.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the "Infections" section below.

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

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

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines 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 this medicine 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, have a family history of heart disease or stroke, or are a smoker.

Similarly, these types of medicines can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

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.

Children and adolescents

There is a risk of kidney failure in dehydrated children and adolescents.

The use of this medicine 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 these patients.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-like medicines has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that ibuprofen-like medicines have been associated with a decrease in fertility.

Interference with laboratory tests

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

Other medicines and Ibuprofeno Vegal

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

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

• Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan)
• Diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. The concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.

• Other non-steroidal anti-inflammatory drugs, such as aspirin.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine.
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medicine against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin. Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Ibuprofeno Vegal with food, drinks, and alcohol

You can take it alone or with food. In general, it is recommended to take it during meals or with milk to reduce the possibility of stomach discomfort.

Consuming alcohol during treatment may increase the risk of adverse gastrointestinal reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 ability to bleed and delay or prolong delivery 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 cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring. Ibuprofen and its degradation products are excreted in minimal amounts in breast milk. As no adverse effects are known in the infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses. Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, 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.

Ibuprofeno Vegal contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Ibuprofeno Vegal

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

Your doctor will indicate the duration of treatment with Ibuprofeno. Do not suspend treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

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.

Elderly patients

In elderly patients, the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

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.

Use in children and adolescents

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

Adolescents over 14 years will follow adult dosage recommendations, but the maximum recommended daily dose in these patients is 1600 mg.

This medication is administered orally.

If gastric discomfort is detected after taking the medication, it should be administered together with milk or during meals.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Vegal 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 immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go 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. In addition to a drop in blood pressure, kidney function disorders and loss of consciousness may occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

In cases of significant overdose, kidney failure and liver damage may occur.

It is rare for more severe symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, dyspnea/acute adult respiratory distress syndrome, and transient respiratory arrest in children (after ingesting large amounts).

If severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if large amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Ibuprofeno Vegal

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 doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people will experience them.

Adverse effects of medications like ibuprofeno are more common in people over 65 years.

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

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Very rare: Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs.

Note: If signs of infection or worsening occur during treatment with ibuprofeno, it is recommended to go to the doctor immediately, in case antibiotic therapy needs to be initiated.

Gastrointestinal disorders

The most frequent adverse effects that occur with medications like ibuprofeno are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal disorders such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases have also been observed. Uncommon gastrointestinal ulcers, potentially with bleeding and perforation, stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Other adverse effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal stricture, exacerbation of diverticular disease, hemorrhagic colitis. Very rare: esophagitis, pancreatitis, intestinal stenosis.

Cardiac and vascular disorders

Medications like ibuprofeno may be associated with a moderate increase in the risk of suffering a heart attack or stroke.

Edema, hypertension, and heart failure have also been observed in association with treatments with medications of the ibuprofeno type.

Disorders of the skin and subcutaneous tissue

Medications like ibuprofeno may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Other adverse effects are:

Frequent: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura. Very rare: hair loss, erythema multiforme, skin reactions due to light influence, inflammation of blood vessels in the skin. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: skin becomes sensitive to light. Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment. Stop taking this medication if you experience these symptoms and seek immediate medical attention. See also section 2.

Disorders of the immune system

Uncommon: hypersensitivity reactions with skin rash and itching, as well as asthma attacks. Very rare: severe hypersensitivity reactions.

Note: In the event of these symptoms, which can occur with the first use, immediate medical attention is required.

Disorders of the nervous system

Frequent: fatigue or drowsiness, headache, and dizziness or instability. Uncommon: headache, dizziness. Rare: paresthesia. Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofeno, the patient suffered from some form of autoimmune disease, which was a risk factor.

Psychiatric disorders

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability. Very rare: psychotic reactions, depression.

Disorders of the ear and labyrinth

Frequent: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular disorders

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

Disorders of the blood and lymphatic system

Rare: decreased platelets, decreased white blood cells, decreased red blood cells, decreased granulocytes, pancytopenia, agranulocytosis, aplastic anemia, or hemolytic anemia. 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 and urinary disorders

Very rare: edema; renal tissue damage; increased serum uric acid concentration.

Hepatobiliary disorders

Medications like ibuprofeno may be associated, in rare cases, with liver damage. Other rare adverse effects are: hepatitis, abnormal liver function, and jaundice. Very rare: liver dysfunction, liver damage, liver failure, acute hepatitis. Frequency unknown: liver failure.

General disorders

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with this medication, 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, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils.

If any of the following adverse effects occur, discontinue treatment and seek immediate medical attention:

• Red, non-elevated, target-like or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms.
• Generalized skin rash, elevated body temperature, and swollen lymph nodes.
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment.
• Allergic reactions such as skin rash, swelling of the face, wheezing in the chest, or difficulty breathing. Chest pain may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Vomiting blood or coffee-ground-like vomit.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.

• Severe or persistent headache.
• Yellowing of the skin.
• Signs of severe hypersensitivity.
• Swelling of the limbs or fluid accumulation in the arms or legs.

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 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 Vegal

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Keep the blister and/or bottle in the outer packaging to protect it from light.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Vegal

The active ingredient is ibuprofeno. Each film-coated tablet contains 600 mg of ibuprofeno.

The other ingredients are:

• Tablet core: hypromellose, sodium croscarmellose, lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E-171), talc, and propylene glycol (E-1520).

Appearance of Ibuprofeno Vegal and package contents

White, oval, biconvex film-coated tablets.

It is packaged in HDPE bottles with 40 tablets and in PVC-PVDC/aluminum blisters with 40 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Vegal Farmaceutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC.

28224 Pozuelo de Alarcón, Madrid, Spain.

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica. Calle C nº 4.

50016 Zaragoza, Spain.

or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36.

28750 San Agustín de Guadalix.

Madrid, Spain.

Date of the last revision of this prospectus:March 2023.

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