IBUPROFEN LIDERFARM 600 mg FILM-COATED TABLETS

Introduction

Prospect: Patient Information

Ibuprofen Liderfarm 600 mg film-coated tablets EFG

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the Prospectus

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

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

Ibuprofen belongs to the 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. Taking Ibuprofen Liderfarm

Do not take Ibuprofen Liderfarm:

• if you are allergic to ibuprofen, other non-steroidal anti-inflammatory medications (NSAIDs), 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 ibuprofen:

• if you have edema (fluid retention),
• if you have or have had any heart disorder or have high blood pressure.
• if you have asthma or any other respiratory disorder,
• if you are receiving treatment with Ibuprofen, 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), it is possible that your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks,
• if you have had or developed 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 previous warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication,
• if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. 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 or ulcerative colitis, as medications of the Ibuprofen type 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, as it may cause aseptic meningitis.
• if you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections

Ibuprofeno Liderfarm may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Liderfarm may delay the 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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

Skin reactions

Severe skin reactions have been reported in association with ibuprofen treatment. Stop taking ibuprofen and go to the doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications 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 Liderfarm 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.

Precautions during pregnancy and in women of childbearing age

Because the administration of medications of the Ibuprofen type 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 medications of the Ibuprofen type have been associated with a decrease in fertility.

Taking Ibuprofeno Liderfarm with other medications

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

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

Other non-steroidal anti-inflammatory medications, such as aspirin

• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (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 (induction of abortion),
• Digoxin and other 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,
• Diuretics (medications used to increase urine production),
• 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 cyclosporine (used in organ transplants to prevent rejection),
• Zidovudine (medication against the AIDS virus),
• Antihypertensive medications: that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan)
• Thrombolytics (medications that dissolve blood clots),
• Aminoglycoside antibiotics such as neomycin,
• Herbal extracts: from the Ginkgo biloba tree

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing 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

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

Taking Ibuprofeno Liderfarm with food and beverages

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

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 Ibuprofeno Liderfarm 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 Ibuprofeno Liderfarm 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, Ibuprofeno Liderfarm 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) 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.

Pregnancy

Ibuprofen should not be taken during pregnancy, especially during the third trimester.

Breastfeeding

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

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

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

Ibuprofeno Liderfarm 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 Liderfarm

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

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

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

This medication is administered orally.

The effective lowest dose should be used for the shortest necessary time to alleviate 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).

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, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly patients

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 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, inform your doctor or pharmacist.

If you take more Ibuprofeno Liderfarm than you should

If you have taken more Ibuprofeno than you should, or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication prospectus to the healthcare professional. If a severe overdose has occurred, the doctor will take the necessary measures.

If you have taken more Ibuprofeno Liderfarm than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose include nausea, vomiting, abdominal pain (which may contain bloody vomit), 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 the urine, chills, and breathing problems have been reported. Rarely, more severe symptoms such as gastrointestinal bleeding, low potassium levels in the blood, low blood pressure, convulsions, and respiratory changes may occur.

If you forget to take Ibuprofeno Liderfarm

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.

4. Possible Adverse Effects

Like all medications, Ibuprofeno Liderfarm may produce adverse effects, although not all people suffer from them.

Adverse effects of medications like Ibuprofeno 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.

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (may affect up to 1 in 100 people); rare (may affect up to 1 in 1000 people); very rare (may affect up to 1 in 10,000 people); unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal

The most frequent adverse effects that occur with medications like Ibuprofeno are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, 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, hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular

Medications like Ibuprofeno may be associated with a moderate increased 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 Ibuprofeno type.

Dermatological

Medications like Ibuprofeno may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson Syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis). 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. Unknown frequency: a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Generalized red scaly rash, with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis), the skin becomes sensitive to light (unknown frequency). Stop taking ibuprofeno if you experience these symptoms and seek medical attention immediately. See also section 2.

Immunological

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 occur. Very rare: joint pain and fever (lupus erythematosus).

Central Nervous System

Frequent: fatigue or somnolence, headache, and dizziness or feeling of instability. Rare: paresthesia (sensation of numbness, tingling, burning, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofeno, 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.

Hematological

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 paleness), decreased granulocytes (a type of white blood cell that may 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 types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-influenza symptoms, extreme fatigue, nasal 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 ibuprofeno 600 mg 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 ibuprofeno 600 mg, 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 occur, discontinue treatment and seek medical attention 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.
• Severe skin blistering or 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.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• ? Red, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• ? Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• ? Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Adverse Effect Reporting

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 national reporting system included in www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibuprofeno Liderfarm

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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 away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment. 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

Ibuprofeno Liderfarm Composition

• The active ingredient is ibuprofeno. Each tablet contains 600 mg of ibuprofeno.
• The other components are:

Core

Croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate, purified water.

Coating

Hypromellose, titanium dioxide (E-171), talc, purified water, and propylene glycol.

Product Appearance and Package Contents

Oval, biconvex, and white film-coated tablets. They are available in packages of 40 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

1. Alcobendas. Madrid

Spain

Manufacturer:

FARMALIDER, S.A,

C/Aragoneses, 15 28108

Alcobendas (Madrid)

Spain

Or

FROSST IBÉRICA, S.A.,

Vía Complutense, 140, 28805

Alcalá de Henares, Madrid

Spain

Or

PHARMALOOP, S.L.

C/ Bolivia, 15 - Polig Industrial Azque

Alcalá de Henares, 28806 Madrid

Spain

Date of the last revision of this prospectus:November2024

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