LIDERFEME 400 mg ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Liderfeme 400 mg Oral Suspension

ibuprofen

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your fever worsens or does not improve after 3 days or if your pain does not improve after 5 days (3 days in adolescents)

Contents of the Package Leaflet

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

1. What is Liderfeme and what is it used for

Liderfeme contains ibuprofen as the active ingredient and belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is used in adults and adolescents over 12 years old (weight over 40 kg) for the symptomatic relief of occasional mild to moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as in febrile conditions.

2. What you need to know before taking Liderfeme

Do not take Liderfeme

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication (listed in section 6) or to other medications in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. 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 dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• 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 this medication:

• 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.
• If you are receiving treatment with this medication, 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 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 ulcers, 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 like aspirin. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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 this can worsen these conditions.
• If you are being treated 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 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 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.
• If you have an infection: see the "Infections" section below.

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

Ibuprofen has been associated with signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Liderfeme immediately and contact your doctor or medical emergency services if you observe any of these signs.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. Stop taking this medication and consult your doctor immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See 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 this medication 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.

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Since the administration of medications like this has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication 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 this medication is contraindicated.

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

Infections

This medication may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 your doctor without delay.

Other medications and Liderfeme

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

This medication may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs like aspirin, as the risk of ulcers and gastrointestinal bleeding may increase.
• Antiplatelet agents (which 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., aspirin, warfarin, ticlopidine).
• Colestyramine (a medication used to treat high cholesterol)
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• 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 in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as the risk of kidney toxicity may increase.
• Pentoxifylline (for 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), as hypoglycemia may occur.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• 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: Ginkgo biloba tree
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluticonazole (used to treat fungal infections).

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

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

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

Taking Liderfeme with food, drinks, and alcohol

It is recommended to take this medication with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

The use of this medication is not recommended in women who are trying to become pregnant. 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.

This medication should not be taken during pregnancy, especially during the third trimester (see section 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.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and using machinery.

This applies to a greater extent to the combination with alcohol.

Liderfeme contains Azorubine (E-122), Sodium Benzoate (E-211), Liquid Maltitol (E-965)

sodium and benzyl alcohol

This medication contains 10 mg of Sodium Benzoate (E-211) in each sachet

This medication may cause allergic reactions because it contains Azorubine (E-122). It can cause asthma, especially in patients allergic to aspirin.

This medication contains Liquid Maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 58 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 2.9% of the maximum recommended daily sodium intake for an adult.

This medication contains 0.00265 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.

3. How to take Liderfeme

Follow the administration instructions of this medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

This medication is administered orally.

Only for occasional use and during limited periods.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Take the medication with meals, especially if you notice digestive discomfort. You can take the contents of the sachet directly or dissolved in water or juice.

The recommended dose is:

Adults and adolescents over 12 years old (over 40 kg in weight):Take one sachet (400 mg of ibuprofen) every 6 to 8 hours, if necessary. Do not take more than 3 sachets of 400 mg (1200 mg of ibuprofen) within 24 hours.

Elderly patients (> 65 years):Your doctor will indicate the dose you should take, as you may need a reduction in the usual dose.

Patients with kidney, liver, or heart failure: your doctor will indicate the dose you should take, as you may need a reduction in the usual dose.

Always take the lowest effective dose. The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

If the symptoms worsen, if the fever persists for more than 3 days or the pain for more than 5 days (3 days in adolescents), you should consult your doctor.

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

Use in children and adolescents

The use of this medication is not recommended in children (under 12 years old) or adolescents with a weight of less than 40 kg.

If you take more Liderfeme than you should

If you have taken more medication 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.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate).

If a severe poisoning has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

If you forget to take Liderfeme

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 of the next dose is very close, skip the forgotten dose and take the next dose at its usual time.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. The incidence of adverse effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

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

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Frequent adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), hypersensitivity, paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs), and somnolence, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by proteins in the urine and body swelling), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock) may appear), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). 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 and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects are 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 pale skin), neutropenia (decreased neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, severe bullous reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and desquamation of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension.

A exacerbation of inflammation related to infections has been observed with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Frequency not known (cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

A serious skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and localized blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

If any of the following adverse effects occur, interrupt treatment andgo to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like vomit.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting adverse effects:

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

5. Conservation of Liderfeme

Keep this medication out of sight and reach of children. Keep in the original packaging.

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 in the pharmacy. 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

Liderfeme composition

The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen.

The other excipients are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), thaumatin (E-957), strawberry flavor (natural flavoring preparations and natural flavoring substances, non-flavoring components (contains corn maltodextrin, triethyl citrate (E-1505), propylene glycol (E-1520), and benzyl alcohol)), azorubine (E-122), glycerol (E 422), and purified water.

Liderfeme appearance and package contents

White oral suspension with strawberry flavor

Heat-sealed sachets, made of polyethylene, satin-finish cellulose, aluminum, and heat-sensitive resin. Each box contains 12 sachets.

Marketing authorization holder

Laboratorios Farmalider, S.A. C/La Vega nº 6, Carriches (Toledo)

ManufacturerIndustrial Farmacéutica Cantabria, S.A. Carretera Cazoña/Adarzo s/n 39011 Santander

Laboratorios Farmalider, S.A. C/Aragoneses nº 15 Alcobendas (Madrid)

Date of last revision of this prospectus:October 2024

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/