Prospect: information for the user

Liderfeme 400 mg film-coated tablets

ibuprofen

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

- Keep this prospect as you may need to read it again.

- If you need advice or more information, consult the pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

-You should consult a doctor if the fever worsens or does not improve after 3 days or the pain after 5 days (3 days in adolescents)

1. What is Liderfeme and for what it is used

2. What you need to know before starting to take Liderfeme

3. How to take Liderfeme

4. Possible adverse effects

5. Storage of Liderfeme

6.Contents of the package and additional information

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

This medication is used for the symptomatic relief of occasional mild to moderate pains, such as headaches, toothaches, menstrual cramps, muscle spasms (contractures) or back pain (lumbago), as well as in febrile states.

Do not take Liderfeme:

• if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (see section 6) or to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include skin rash with itching, facial swelling, lip or tongue swelling, 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 bleeding, 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 or clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake)
• if you have severe heart failure
• if you are in the last trimester of pregnancy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medicine:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure
• If you have asthma or any other respiratory problems
• Inform your doctor if you are taking this medicine as it may mask fever, an important sign of infection, making its diagnosis more 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 tell you how often these checks should be done
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medicine
• If you are taking anticoagulants (medicines used to "thin" the blood) or other medicines that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs)
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions
• If you are being treated with diuretics (medicines to increase urine production), as your doctor should monitor your kidney function
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria)
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, bloody urine, or liver disease), so 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 medicine
• It is possible to experience allergic reactions with this medicine
• Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery
• It is not recommended to take this medicine if you have chickenpox
• If you have an infection; see the "Infections" heading below
• With ibuprofen, signs of allergic reaction to this medicine 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

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

Infections

Liderfeme may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, consult a doctor without delay

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking this medicine and see a 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.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Interrupt 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.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Nonsteroidal anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary bypass surgery, peripheral artery disease, 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 are a smoker.

Respiratory problems

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

Children and adolescents

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

Do not administer this medicine to children under 8 years old without consulting a doctor.

Precautions during pregnancy and in fertile women

Due to the administration of ibuprofen-type medicines being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medicine during the first and second trimesters of pregnancy, except in strictly necessary cases. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of this medicine is contraindicated.

For fertile women, it should be taken into account that ibuprofen-type medicines have been associated with a decrease in the ability to conceive.

Other medicines and Liderfeme:

Inform your doctor or pharmacist that you are using, or have used recently, or may need to use any other medicine, including those purchased without a prescription.

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

• Other nonsteroidal anti-inflammatory drugs like aspirin, as it may increase the risk of stomach ulcers and bleeding
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) like ticlopidine.
• Anticoagulants (medicines used to "thin" the blood), such as acetylsalicylic acid, warfarin, ticlopidine
• Colestiramine (medicine used to treat high cholesterol)
• Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
• Lithium (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 (induces abortion)
• Digoxin and cardiac glycosides (used to treat heart problems),
• Hydantoins like phenytoin (used to treat epilepsy)

• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections)
• Corticosteroids like cortisone and prednisolone
• Diuretics (medicines used to increase urine production), as it may increase the risk of kidney toxicity
• Pentoxifylline (used to treat intermittent claudication)
• Probenecid (used in patients with gout or with penicillin in infections)
• Quinolone antibiotics like norfloxacin
• Sulfinpyrazone (used to treat gout)
• Sulfonylureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
• Zidovudine (medicine used to treat HIV/AIDS)
• Medicines that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)
• Trombolytics (medicines that dissolve blood clots)
• Aminoglycoside antibiotics like neomycin
• Herbal extracts: from the Ginkgo biloba tree
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections)

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

Interference with laboratory tests

The use of 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)

•Urea nitrogen concentrations in the blood and serum creatinine and potassium concentrations (may increase)

•Liver function tests: increased values of transaminases

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

Taking Liderfeme with food, drinks, and alcohol:

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

Do not take alcohol, as it may increase gastrointestinal adverse reactions. The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine is not recommended in women who are trying to conceive.

Do not take Liderfeme 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 predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take this medicine during the first 6 months of pregnancy unless it is clearly necessary and as your doctor tells you. If you need treatment during this period or while trying to conceive, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Liderfeme may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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.

Although only small amounts of the medicine 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, visual disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery.

If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary

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

This applies to a greater extent when combined with alcohol.

This medicine contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. If in doubt, ask your doctor, pharmacist or nurse.

This medication is administered orally.

The tablet can be divided into equal doses.

Only for occasional use and for limited periods.

The adverse effects can be minimized by using the smallest dose that relieves/controls pain for the shortest time necessary to control symptoms.

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

The recommended dose is:

•Adolescents 12 to 18 years old: take a dose of half a tablet (200 mg) every 4-6 hours, if necessary. Do not administer more than 6 doses of half a tablet (1200 mg) in 24 hours.

•Adults: take a dose of half a tablet (200 mg) every 4-6 hours, if necessary. If pain or fever does not respond to half a tablet dose, you can use doses of a tablet (400 mg) every 6-8 hours. Do not take more than 1200 mg of ibuprofen in 24 hours.

• Older patients: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

•Patients with kidney, liver or heart diseases: reduce the dose and consult the doctor.

•Children 8 to 12 years old:

The doses in the following table can be repeated every 6-8 hours, without exceeding the daily amount shown in the third column

A dosage schedule of 5 to 10 mg/kg of body weight and per dose, every 6-8 hours; maximum 20 mg/kg of body weight and per day can also be established.

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

The administration of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

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

Administration form

This medication is administered orally

Take the medication with meals or with milk, especially if digestive discomfort is noticed.

If you take more Liderfeme than you should:

.

If you have taken more of this medication than you should, or if a child has accidentally ingested the medication, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount used or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported. If a severe intoxication has occurred, renal insufficiency 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 compensate for the missed doses.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

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

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

• Less frequent side effects(can affect up to 1in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-sensitive skin reactions, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs) and somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities, jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare side effects(can affect up to 1 in 1,000 people): Disorientation or confusion, depression,vertigo, tinnitus (ear ringing), auditory disturbances, reversible toxic amblyopia,liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, may include facial swelling, tongue, and larynx, shortness of breath, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock). In most cases where meningitis aséptica has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of meningitis aséptica observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia,leukopenia (decreased white blood cells, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin),neutropenia (decreased neutrophils) and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency 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, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas.

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

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Unknown frequency(cannot be estimated from available data):

Exacerbation ofcolitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

A severe 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 primarily on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See section 2.

The skinbecomes sensitive to light.

If any of the following side effects appear, discontinue treatment and seek medical attention immediately:

• Reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like appearance.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Dyspnea, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Reddish patches that are not elevated, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

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

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

Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

the medication you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist

how to dispose of the packaging and the medication you no longer need. By doing so, you will help protect the environment.

Composition of Liderfeme

-The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.

-The other components are (excipients):

Tablet core: Sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating: Titanium dioxide (E-171), purified talc, and propylene glycol.

Appearance of Liderfeme and content of the container

Coated tablets, oblong, biconvex, scored on both sides, and white in color.

They are presented in blister packs or bottles with 12 tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Farmalider, S.A.

C/ Aragoneses, 15.

28108 – Alcobendas (Madrid)

Spain

Responsible for manufacturing

FROSST IBERICA, S.A.Via Complutense, 140 –

Alcala de Henares (Madrid)28805 – Spain

or

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

(Madrid) Spain

or

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas

(Madrid) Spain

or

PHARMEX ADVANCED LABORATORIES, S.L.

Crta. A-431, Km 19

14720 Almodóvar del Río

(Córdoba) Spain

Last review date of this leaflet:November 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/