Ibuprofen Farmalid 600 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofeno Farmalid 600 mg film-coated tablets EFG

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ibuprofeno Farmalid is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used to treat fever and moderate pain, including migraine. It is also used to treat arthritis (joint inflammation, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno Farmalid

Do not take Ibuprofeno Farmalid:

if you are allergic 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, breathing difficulties or asthma.
if you have previously had a stomach or duodenal ulcer with bleeding or have experienced a perforation of the digestive tract.
if you are vomiting blood.
if you have black stools or bloody diarrhoea.
if you suffer from severe heart failure.
if you have severe liver or kidney disease.
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 are in the third trimester of pregnancy.
if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions

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

Inform your doctor:

if you have oedema (fluid retention).
if you suffer from or have previously suffered from heart problems or have high blood pressure.
if you have asthma or any other respiratory disorder.
if you are being treated with 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 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 experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of dehydration.
if you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, 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 and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protective medicine.
if you are simultaneously 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 inhibitors (SSRIs).
if you suffer from Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
if you are taking diuretics (medicines to increase urination), as your doctor should monitor your kidney function.
if you suffer from 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 may occur.
if you suffer from 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 stricter monitoring if you receive ibuprofen after major surgery.
it is advisable not to take this medicine if you have chickenpox.
allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported. Stop taking Ibuprofeno Farmalid immediately and contact your doctor or medical emergency services immediately if you notice any of these signs.

If you have an infection; see the section «Infections» below.

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

Ibuprofeno Farmalid may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno Farmalid 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 the symptoms of infection persist or worsen, consult a doctor without delay.

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 may 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. Discuss your treatment with your doctor or pharmacist before taking this medicine if:

you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery 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 are a smoker.

These types of medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in patients who suffer from 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.

Skin reactions

Serious skin reactions have been reported with Ibuprofeno Farmalid treatment. Stop taking Ibuprofeno Farmalid and see a doctor immediately if you develop

any skin rash, lesions of mucous membranes, blisters or other signs of

allergy, as these may be the first signs of a very serious skin reaction. See

section 4.

Serious 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 Farmalid and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because administration of ibuprofen-type medicines has been associated with an increased risk of congenital anomalies/abortion, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, dose and duration should be limited to the minimum possible. The risk is believed to increase with dose and duration of treatment.

In the third trimester, ibuprofen administration is contraindicated.

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

Adolescents

There is a risk of kidney damage in dehydrated adolescents.

Other medicines and Ibuprofeno Farmalid

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

The following medicines may interact and therefore should not be taken together with ibuprofen without first consulting your doctor:

Do not take this medicine if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin).
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).
Baclofen (used to treat involuntary and persistent muscle contractions).
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 (abortion-inducing agent).
Digoxin (cardiac glycosides) (used in the treatment of heart disorders).
Hydantoins such as phenytoin (used in the treatment of epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Diuretics (medicines used to increase urine elimination).
Corticosteroids such as cortisone and prednisolone, used in inflammatory conditions.
Selective serotonin reuptake inhibitors (SSRIs), used for depression.
Pentoxifylline (for intermittent claudication).
Probenecid (used in gout patients or together with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Ion-exchange resins such as cholestyramine (used to reduce blood cholesterol levels).
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes).
Tacrine (used in the treatment of Alzheimer’s disease).
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV drug).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
Herbal extracts: Ginkgo biloba.

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

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Ibuprofeno Farmalid with food, drinks and alcohol

You may take it alone or with food. It is generally recommended to take it before meals to reduce the possibility of stomach discomfort.

If you consume alcohol while taking this medicine, you may be more likely to experience adverse effects.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take Ibuprofeno Farmalid 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 delay or prolong labour beyond expected. You should not take Ibuprofeno Farmalid 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 become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Farmalid may cause kidney problems in your fetus if taken for more than a few days, which may lead 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.

Pregnancy

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age).

Fertility

The use of this medicine is not recommended in women attempting to become pregnant.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

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

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are not usually necessary.

Ibuprofen may slow your reaction time, which should be taken into account before performing activities requiring heightened alertness, such as driving and operating machinery.

This is particularly relevant when combined with alcohol.

Ibuprofeno Farmalid contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ibuprofeno Farmalid

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment earlier, as otherwise the expected results would not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

It is important that you use the smallest dose that relieves/controls the pain, and you should not take this medicine for longer than necessary to control your 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).

Adults and adolescents over 12 years:

The recommended dose for adults and adolescents aged 12 to 18 years is one tablet (400 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

In some conditions, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 12 to 18 years.

Use in children:

The use of this medicine is not recommended in children weighing less than 40 kg or under 12 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing regimen in this patient group.

Elderly patients:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

Method of administration:

This medicine is administered orally.

To achieve a faster onset of action, the dose may be taken on an empty stomach. Patients with a sensitive stomach are advised to take ibuprofen with food.

Take ibuprofen with a sufficient amount of water. The tablets should be swallowed whole with a glass of water, without chewing, breaking, crushing, or sucking them, to avoid mouth discomfort and throat irritation.

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

If you take more Ibuprofeno Farmalid than you should

If you have taken more ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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

If you have taken more Ibuprofeno Farmalid than you should, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to learn about the risks and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

Rarely, cases of rapid involuntary eye movements, increased acidity of blood plasma (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also occurred.

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

In case of ingestion of large quantities, activated charcoal should be administered. Gastric lavage should be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofeno Farmalid

Do not take a double dose to make up for missed doses.

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

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the maximum recommended dose.

The following adverse effects have been observed:

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, 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), 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, vision 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, irritability, nervousness, psychotic reaction, dizziness, tinnitus (ringing or noises in the ear), hearing disturbance, 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 the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was 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) and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce different 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, unexplained bleeding and bruising.

Very rare adverse effects (may affect up to 1 in 10,000 people): pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), 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), hair loss, erythema multiforme. Rarely, serious skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to see 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, usually resulting in bloody diarrhea)

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, lymph node swelling 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 Ibuprofeno Farmalid 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 immediately and consult your doctor without delay:

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 extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in 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, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
Generalized, 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 adverse effect, consult your doctor, pharmacist or nurse, even if it is an 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 Ibuprofen Farmalid

Keep this medicine out of sight and reach of children.

Store below 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 drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ibuprofeno Farmalid

The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
- The other components (excipients) are:

Core

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

Coating

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

Appearance of the product and contents of the package

White, oval-shaped, biconvex tablets.

Packaged in packs of 40 tablets and clinical pack of 500 tablets in aluminum-PVC/PVdC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmalider, S.A.

C/ La Granja 1,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Farmalider, S.A,

C/Aragoneses 2,

28108 Alcobendas (Madrid)

Spain

FROSST IBÉRICA, S.A.,

Vía Complutense, 140,

28805 Alcalá de Henares, Madrid

Spain

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

This leaflet was last reviewed in: November 2024

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