Liderfeme 400 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Liderfeme 400 mg film-coated tablets

ibuprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for taking this medicine as contained in this leaflet or as advised by your doctor, pharmacist or nurse.

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

Contents of the leaflet:

What Liderfeme is and what it is used for
What you need to know before taking Liderfeme
How to take Liderfeme
Possible side effects
How to store Liderfeme
Contents of the pack and other information

1. What Liderfeme is and what it is used for

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

This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscular pain (cramps), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Liderfeme

Do not take Liderfeme:

if you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine (listed in section 6) or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
if you have severe liver or kidney disease
if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract
if you are vomiting blood
if you have black stools or diarrhoea with blood
if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your doctor will perform blood coagulation tests.
if you have severe dehydration (caused by vomiting, diarrhoea or insufficient 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 oedema (fluid retention).
If you have or have had heart problems or high blood pressure
If you have asthma or any other respiratory disorder
inform your doctor if you are taking this medicine, as it may mask fever, 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 medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed
If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions may occur with this medicine.
Your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
If you have an infection; see the section «Infections» below.

Serious allergic reactions to this medicine, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

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

Infections

Liderfeme may mask signs of infection, such as fever and pain. Therefore, Liderfeme may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. Stop taking this medicine and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious 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 syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek immediate medical attention if you notice any 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 such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such 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 of age without consulting a doctor.

Precautions during pregnancy and in women of childbearing age

Because administration of ibuprofen-type medicines has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be kept to a minimum.

Administration of this medicine is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with reduced fertility.

Other medicines and Liderfeme:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding
Antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine
Anticoagulant medicines (e.g. to treat or prevent coagulation problems, e.g. acetylsalicylic acid, warfarin, ticlopidine)
Cholestyramine (a medicine used to treat high cholesterol)
Selective serotonin reuptake inhibitors (medicines used for depression)
Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent)
Digoxin and cardiac glycosides (used to treat heart disorders)
Hydantoins such as phenytoin (used to treat epilepsy)
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
Corticosteroids such as cortisone and prednisolone
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity
Pentoxifylline (used to treat intermittent claudication)
Probenecid (used in gout patients or together with penicillin in infections)
Quinolone antibiotics such as norfloxacin
Sulfinpyrazone (for gout)
Sulfonylureas such as tolbutamide (for diabetes), as hypoglycaemia may occur
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
Zidovudine (an anti-HIV medicine)
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan)
Thrombolytics (medicines that dissolve blood clots)
Aminoglycoside antibiotics such as neomycin
Herbal extracts: Ginkgo biloba
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 ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using Liderfeme with other medicines.

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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

Taking Liderfeme with food, drinks and alcohol:

You may take it with or without food. In general, it is recommended to take it with food or milk to reduce the possibility of stomach discomfort.

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

Pregnancy, breastfeeding and fertility:

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

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

Do not take Liderfeme during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond expected duration. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, Liderfeme may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and using machines:

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not required.

Ibuprofen may delay your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is particularly relevant when combined with alcohol.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Liderfeme

Follow exactly the instructions for use of this medicine provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

This medicine is administered orally.

The tablet may be divided into equal doses.

For occasional use only and during limited periods.

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

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

Recommended dose:

Adolescents aged 12 to 18 years: one half-tablet (200 mg) every 4–6 hours, if needed. Do not administer more than 6 half-tablet doses (1200 mg) within 24 hours.
Adults: one half-tablet (200 mg) every 4–6 hours, if needed. If pain or fever does not respond to the half-tablet dose, doses of one tablet (400 mg) may be taken every 6–8 hours. Do not exceed 1200 mg of ibuprofen within 24 hours.
Elderly patients: dosage must be determined by the doctor, as a reduction from the usual dose may be required.
Patients with kidney, liver, or heart disease: reduce dose and consult your doctor.
Children aged 8 to 12 years:

The doses in the table below may be repeated every 6–8 hours, without exceeding the daily amount shown in the third column.

IBUPROFEN DOSING IN CHILDREN

Age

Dosage

Maximum daily dose

8-12 years

half tablet (200 mg) per dose

800 mg

(four half-tablet doses)

A dosing regimen of 5 to 10 mg/kg body weight per dose every 6 to 8 hours may also be established; maximum daily dose: 20 mg/kg body weight.

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

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Method of administration

This medicine is administered orally.

Take the medicine with food or milk, especially if you experience gastrointestinal discomfort.

If you take more Liderfeme than you should:

If you have taken more of this medicine than you should, or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount taken, or go to the nearest hospital to learn about the risks and receive advice on the measures to be taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At higher doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may occur. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed. In cases of severe poisoning, kidney failure and liver damage may occur. In such 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 scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

Frequent adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue have also been observed.
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), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), 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 protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.
Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising.
Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, serious skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of infection-related inflammation has been observed with concurrent use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, 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 condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea).

A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Widespread red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue this medicine immediately 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, stop treatment and consult your doctor immediately:

Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or significant peeling of the skin.
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 arms or legs.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Liderfeme

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Liderfeme

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
The other components (excipients) are:

Tablet core: Croscarmellose sodium, hypromellose, lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.

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

Appearance of Liderfeme and contents of the pack

Film-coated, oblong, biconvex tablets, scored on both sides, white in color.

Available in blister packs or bottles containing 12 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ Aragoneses, 15.

28108 – Alcobendas (Madrid)

Spain

Manufacturer

FROSST IBERICA, S.A.
Via Complutense, 140 –
Alcala de Henares (Madrid)
28805 – Spain

Farmalider, S.A.
C/ Aragoneses, 2
28108 Alcobendas
(Madrid) Spain

TOLL MANUFACTURING SERVICES, S.L.
C/ Aragoneses, 2
28108 Alcobendas
(Madrid) Spain

PHARMEX ADVANCED LABORATORIES, S.L.
Crta. A-431, Km 19
14720 Almodóvar del Río
(Córdoba) Spain

Date of the most recent revision of this leaflet: November 2024

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