Liderfeme 400 mg oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Liderfeme 400 mg oral suspension

ibuprofen

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for taking the medicine contained in this leaflet or those indicated 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should 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

1. What Liderfeme is and what it is used for
2. What you need to know before taking Liderfeme
3. How to take Liderfeme
4. Possible adverse effects
5. How to store Liderfeme
6. 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 in adults and adolescents over 12 years of age (weighing more than 40 kg) for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscular pain (muscle strains) or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before starting 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 indicating allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, difficulty breathing, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines simultaneously, 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 medicine:

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever—a key 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 for a prolonged period (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 are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as medicines like this one may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various 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 treatment with ibuprofen 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 closer 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.

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

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

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment. Stop taking this medicine and see your 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.

Cardiovascular precautions

Medicines such as ibuprofen, which are anti-inflammatory/analgesic, 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. Discuss your treatment with your doctor or pharmacist before taking this medicine if:

• You have heart problems, including heart failure, angina (chest pain), a previous heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked 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 smoke.

Children and adolescents

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

Pregnancy and fertility precautions

Because the use of medicines like this one has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine is contraindicated during the third trimester.

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

Infections

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

Other medicines and Liderfeme

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

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 ulcer and bleeding.
• Antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in 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).
• Sulfonamides 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 patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycemia.
• 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, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve 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 this medicine with other medicines.

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)
• Hematocrit or hemoglobin (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 testing and are taking or have recently taken ibuprofen.

Taking Liderfeme with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended in women 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 medicine.

This medicine should not be taken during pregnancy, especially during the third trimester (see section "Pregnancy and fertility precautions").

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

Driving and use of 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 necessary.

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 especially relevant when combined with alcohol.

Liderfeme contains Azorubine (E-122), Sodium benzoate (E-211), Liquid maltitol (E-965)

sodium and benzyl alcohol

This medicine contains 10 mg of Sodium benzoate (E-211) per sachet.

This medicine may cause allergic reactions because it contains Azorubine (E-122). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains Liquid maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 58 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 2.9% of the maximum daily intake of sodium recommended for an adult.

This medicine contains 0.00265 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.

3. How to take Liderfeme

Follow exactly the administration instructions for this medicine as described in this leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

This medicine is administered orally.

For occasional use only and during limited periods.

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

Take the medicine with food, especially if you experience gastrointestinal discomfort. The contents of the sachet can be taken directly or dissolved in water or juice.

Recommended dose:

Adults and adolescents over 12 years of age (weighing more than 40 kg): Take one sachet (400 mg of ibuprofen) every 6 to 8 hours, as needed. Do not exceed 3 sachets of 400 mg (1200 mg of ibuprofen) within 24 hours.

Elderly patients (> 65 years): Your doctor will determine the appropriate dose, as a reduction from the usual dose may be necessary.

Patients with kidney, liver, or heart impairment: Your doctor will determine the appropriate dose, as a reduction from the usual dose may be necessary.

Always use the lowest dose that is effective. Administration of the medicine should be based on the presence of pain or fever. As these symptoms subside, treatment should be discontinued.

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

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

Use in children and adolescents

This medicine is not recommended for use in children (under 12 years of age) or adolescents weighing less than 40 kg.

If you take more Liderfeme than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to assess the risk and receive advice on necessary measures.

Symptoms of overdose typically 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, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties have been reported. 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 occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

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 a missed dose.

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 usual time.

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

4. Possible adverse effects

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

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

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

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, 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, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, vision disorders, 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, dyspnoea (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.

• 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, oedema (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, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which constituted 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 difficulty breathing and pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and 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, mainly 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, severe skin infections and complications in soft tissue may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation associated with infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice promptly.

• 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, usually resulting in bloody diarrhoea).

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).

Generalized red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. 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 diarrhoea with blood.
• Severe stomach pain.
• Blisters or extensive 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.

Reporting of adverse effects:

If you experience any adverse effect, talk to 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. Store in the original packaging.

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

6. Package contents and other information

Composition of Liderfeme

The active substance 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 flavour (natural flavouring preparations and natural flavouring substances, non-flavouring components (containing corn maltodextrin, triethyl citrate (E-1505), propylene glycol (E-1520) and benzyl alcohol)), azorubine (E-122), glycerol (E-422) and purified water.

Appearance of Liderfeme and contents of the pack

White, strawberry-flavoured oral suspension.

Thermally sealed sachets made of polyethylene, glazed cellulose, aluminium and heat-sensitive resin. Each carton contains 12 sachets.

Marketing Authorization Holder

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

Manufacturer

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

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

Date of the most recent review of this leaflet: October 2024

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