Prospect: information for the patient

Ibuprofen Farmalider 200 mg film-coated tablets

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 or pharmacist.

• Keep this prospect, 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 or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you get worse or do not improve
• • after 3 days, in adolescents:
  • after 3 days in the treatment of fever and after 4 days in the treatment of pain, in adults

1. What is Ibuprofen Farmalider and what it is used for

2. What you need to know before starting to take Ibuprofen Farmalider

3. How to take Ibuprofen Farmalider

4. Possible adverse effects

5. Storage of Ibuprofen Farmalider

6. Contents of the package and additional information

Ibuprofeno belongs to a group ofmedicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic treatment of short duration of fever and mild to moderate pain, such as toothache, headache, or caused by small injuries, in adolescents weighing more than 40 kg (from 12 years old) and in adults.

Do not take Ibuprofeno Farmalider:

- If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).

- If you have had a reaction such as bronchospasm, asthma attack, nasal mucosa inflammation, angioedema, or skin eruptions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

- If you have unexplained bleeding disorders.

- If you have a severe liver or kidney disease.

- If you have had gastrointestinal bleeding or perforation (i.e., of the digestive tract) related to NSAID treatment.

- If you have or have had recurrent stomach or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more confirmed episodes of ulcers or bleeding).

- If you have severe heart failure.

- If you are in the third trimester of pregnancy (see section 2, Pregnancy, breastfeeding, and fertility).

- In case of cerebral hemorrhage or other active bleeding.

- In case of severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

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

Ibuprofen should only be used after a strict evaluation of the benefit-risk ratio in the following cases:

- Certain hereditary blood disorders (e.g., intermittent acute porphyria);

- Certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease).

Careful medical supervision is required in the following cases:

- Gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

- Kidney or liver dysfunction;

- Dehydration;

- Hypertension or heart failure;

- Allergies (e.g., skin reactions to other substances, asthma, seasonal allergies), nasal polyps, chronic nasal mucosa inflammation, or chronic obstructive pulmonary disease, as the risk of hypersensitivity reactions is higher;

- Recent major surgery.

- If you have an infection; see the heading "Infections" below.

The adverse effects can be reduced by using the lowest effective dose for the shortest possible time to control symptoms.

Other NSAIDs

The use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Geriatric population

Older patients are more likely to experience adverse effects of NSAIDs, especially gastrointestinal perforations and bleeding, which can be fatal. They are also at higher risk of experiencing the consequences of adverse effects.

Gastrointestinal bleeding, ulcers, and perforations

Gastrointestinal bleeding, ulcers, and perforations, which can be fatal, have been reported with all NSAIDs, at any time during treatment, with or without previous warning symptoms, and with or without a history of previous severe gastrointestinal episodes.

The risk of ulcer, perforation, or gastrointestinal bleeding is higher with higher doses of NSAIDs, if you have previously had a ulcer, especially if it was complicated by bleeding or perforation, and if you are an older patient. You should start treatment with the lowest possible dose. Consult your doctor, as they may prescribe a combined treatment with protective agents (e.g., misoprostol or proton pump inhibitors). The same applies if you take low doses of acetylsalicylic acid (aspirin) or other medications that may increase the risk of gastrointestinal bleeding.

If you have previously experienced adverse gastrointestinal effects, especially if you are an older patient, you should inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding) especially in the early stages of treatment. You should be cautious if you take other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents like acetylsalicylic acid (see section 2, Other medications and Ibuprofeno Farmalider).

In case of gastrointestinal bleeding or ulcer during treatment with ibuprofen, treatment should be discontinued and your doctor consulted.

If you have had or have any gastrointestinal disorder (ulcerative colitis, Crohn's disease), you should be careful when taking NSAIDs, as they may worsen (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 (GAP), have been reported in association with ibuprofen treatment. Discontinue 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.

It is recommended to avoid the use of ibuprofen during chickenpox.

Ibuprofeno Farmalider may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno Farmalider 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 bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

CARDIOVASCULAR PRECAUTIONS

NSAIDs like ibuprofen may be associated with a small increase in the risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

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

Consult your doctor or pharmacist before taking ibuprofen if you:

- Have heart problems such as heart failure or angina pectoris (chest pain) or if you have had a myocardial infarction, undergone coronary artery bypass surgery, have peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries), or have had any type of stroke (including transient ischemic attack).

- Have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Renal effects

Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease, due to its effects on renal perfusion. This may cause edema (fluid retention) or even heart failure or hypertension in predisposed patients. Cases of acute interstitial nephritis and renal toxicity have been reported. Patients at higher risk are those with kidney disease, heart failure, or liver disease, those taking diuretics and ACE inhibitors, and older patients.

The suspension of NSAID treatment usually leads to recovery to the pre-treatment state.

ALLERGIC REACTIONS

Rare cases of acute severe hypersensitivity reactions (e.g., anaphylactic shock) have been observed. Treatment should be discontinued at the first signs of a hypersensitivity reaction after taking/administering ibuprofen. According to symptoms, specialized personnel should apply the necessary medical procedures.

OTHER INFORMATION

Ibuprofen, the active ingredient in this medication, may temporarily inhibit platelet function in the blood (platelet aggregation). Patients with bleeding disorders should be closely monitored.

In long-term ibuprofen treatments, liver enzymes and renal function should be checked regularly, as well as a hemogram if necessary.

It is recommended to drink enough fluids during treatment, especially in case of fever, diarrhea, or vomiting.

NSAIDs like ibuprofen may mask the symptoms of an infection or fever.

The consumption of alcohol when using NSAIDs may worsen the adverse effects related to the active ingredient, especially those affecting the digestive tract and the central nervous system.

Prolonged use of any type of analgesic for treating headaches may worsen them. If this occurs or is suspected to occur, consult your doctor and discontinue treatment. You should suspect analgesic abuse in patients who suffer from daily or very frequent headaches despite (or because of) the habitual use of medications to treat them.

Generally, habitual consumption of analgesics, especially a combination of several analgesic substances, may cause permanent renal damage with a risk of renal insufficiency (analgesic nephropathy).

Children and adolescents

There is a risk of renal insufficiency in dehydrated adolescents.

This medication should not be administered to adolescents weighing less than 40 kg or to children under 12 years old.

Other medications and Ibuprofeno Farmalider

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

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

• Anticoagulant medications (i.e., to prevent blood clotting; e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications to lower blood pressure (ACE inhibitors like captopril, beta-blockers like products containing atenolol, and angiotensin II receptor antagonists like losartan).

Other medications may also affect or be affected by ibuprofen. Therefore, always seek advice from your doctor or pharmacist before using ibuprofen with other medications.

Enhance their action, with a possible increase in adverse effects:

• The acetylsalicylic acid and other NSAIDs, as well as corticosteroids (medications containing cortisone and substances similar to cortisone), may increase the risk of gastrointestinal bleeding.
• Metotrexate (to treat cancer and certain types of rheumatic diseases): the administration of ibuprofen in the 24 hours before or after metotrexate administration may increase metotrexate concentrations and its adverse effects.
• Anticoagulants (to prevent blood clotting) like warfarin.
• Digoxin (to strengthen the heart), phenytoin (to treat seizures), or lithium (to treat certain psychiatric disorders); ibuprofen may increase the concentration of these medications in the blood. If ibuprofen is taken as recommended (for 3 or 4 days at most), no monitoring of blood concentrations of these medications is necessary.
• Antiplatelet agents, as well as selective serotonin reuptake inhibitors (to treat depression), may also increase the risk of gastrointestinal bleeding.

Weaken their action:

• Diuretics and blood pressure medications (antihypertensives): may increase the risk of kidney damage.
• ACE inhibitors (to treat heart failure and high blood pressure). Additionally, there may be an increased risk of renal dysfunction.
• Acetylsalicylic acid in low doses: may alter the antithrombotic effect of low-dose acetylsalicylic acid.
• Mifepristone (used to induce abortion): the use of NSAIDs during the 8 to 12 days after mifepristone administration may reduce the effect of mifepristone.

Other possible interactions:

• Diuretics that spare potassium: may increase potassium levels in the blood.
• Probenecid and sulfinpyrazone (to treat gout): may delay the excretion of ibuprofen. This may cause ibuprofen to accumulate in the body and increase its adverse effects.
• Quinolones: may increase the risk of seizures.
• Voriconazole, fluconazole (CYP2C9 inhibitors; used to treat fungal infections): may increase ibuprofen levels in the blood. Consider reducing the ibuprofen dose, especially if high doses are used, when administered with voriconazole or fluconazole.
• Sulfonilureas (to treat diabetes): NSAIDs may potentiate the hypoglycemic effect of sulfonilureas. It is recommended to monitor blood glucose levels as a precaution during concurrent use.
• Tacrolimus: if both medications are administered simultaneously, renal damage may occur.
• Ciclosporin (to reduce immune reactions): may cause renal damage.
• Colestiramine (to lower cholesterol): prolongs and reduces (25%) the absorption of ibuprofen. Medications should be administered with an interval of at least 2 hours between them.
• Zidovudine (to treat HIV/AIDS): may increase the risk of joint effusion and hematomas in HIV-positive hemophiliacs.
• Aminoglycosides (antibiotics): may reduce their elimination and increase toxicity.
• Herbal medicines: Ginkgo biloba (used to treat dementia) may increase the risk of bleeding.

Ibuprofen may alter the results of some laboratory tests:

Consult your doctor if you are to undergo clinical analysis and are taking or have recently taken ibuprofen, as it may alter the results.

Taking Ibuprofeno Farmalider with alcohol:

Consumption of alcoholic beverages during ibuprofen treatment should be avoided, as it may potentiate its adverse effects, especially those affecting the stomach, intestines, and brain.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

If you become pregnant while taking ibuprofen, inform your doctor.

Do not take Ibuprofeno Farmalider 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 Ibuprofeno Farmalider during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Farmalider 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 monitoring.

Breastfeeding

The active ingredient, ibuprofen, and its degradation products pass into breast milk in small amounts. Since, to date, no adverse consequences for the infant have been reported, it is not necessary to interrupt breastfeeding during short-term treatments at the recommended doses for treating mild or moderate pain and fever.

Fertility

Ibuprofen belongs to a group of medications (NSAIDs) that may reduce fertility in women. The effects are reversible upon discontinuing treatment.

Driving and operating machinery

In isolated cases, patients taking ibuprofen may experience an adverse reaction characterized by fatigue, dizziness, and visual disturbances, which may affect their reaction time and ability to drive and operate machinery. These effects are potentiated by concurrent alcohol consumption.

Ibuprofeno Farmalider contains lactose monohydrate,if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

For short-term use only.

You may reduce the appearance of adverse effects by taking the most effective dose possible at the lowest dose for the shortest time necessary to control symptoms.

The recommended dose is:

The recommended doses are detailed in the table below.

The respective dosing intervals should be chosen according to the symptomatology and the maximum daily dose. The interval between doses will not be less than 6 hours. Do not exceed the recommended maximum daily dose.

If an adolescent over 12 years needs to take this medication for more than 3 days, or if symptoms worsen, consult a doctor.

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

If an adult needs to take this medication for more than 3 days in case of fever or 4 days in pain treatment, or if symptoms worsen, consult a doctor.

Use in children

This medication is not intended for use in adolescents weighing less than 40 kg or in children under 12 years.

Administration form

For oral administration. Tablets should be swallowed whole, with a glass of water..

It is recommended that patients with stomach problems take the tablets during meals.

If you take more Ibuprofeno Farmalider than you should

If the intake exceeds the recommended dose by a large margin, seek immediate medical assistance.

If you have taken more Ibuprofeno Farmalider than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained 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 people with asthma, it may cause worsening of asthma.

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 the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forgot to take Ibuprofeno Farmalider

Do not take a double dose to compensate for the missed dose.

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.

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

- Flat red spots, in the shape of a target or circular, on the trunk, often with blisters in the center, peeling of the skin, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

- Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

- Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Side effects can be reduced by using the lowest effective dose for the shortest possible time to relieve symptoms. The following list of side effects includes all those known to be associated with ibuprofen treatment, including those that occurred during prolonged treatment with high doses in rheumatic patients. Frequency data, apart from very rare reports, are based on short-term administration of daily doses up to a maximum of 1200 mg of ibuprofen for oral presentations and a maximum of 1800 mg for suppositories.

Regarding the following side effects, it should be noted that they are largely dose-dependent and vary between different patients..

The most common side effects are those affecting the digestive tract. They may cause stomach/duodenal ulcers (peptic ulcers), perforation (hole in the stomach or intestine wall) or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see section 2). After ibuprofen use, the following have been reported: nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, blood in stools, inflammation of the buccal mucosa with ulcers (stomatitis ulcerosa) and worsening of colitis and Crohn's disease.

Less frequently, gastric inflammation (gastritis) has been observed.

Edema (fluid retention), increased blood pressure, and heart failure have been associated with NSAID treatment.

Medicines like ibuprofen have been linked to a small increase in myocardial infarction and stroke.

STOP TAKING and consult a doctor immediately if you notice:

- Signs of intestinal bleeding such as: relatively intense abdominal pain, blood in stools or diarrhea with blood, vomiting with blood and dark particles that resemble coffee grounds.

- Signs of severe allergic reactions such as skin eruption, facial swelling, tongue or throat swelling, wheezing or shortness of breath, worsening of asthma, difficulty breathing, palpitations or decreased blood pressure that can lead toshock.

- Severe skin reactions such as generalized eruptions, peeling, and blisters, or skin detachment.

Other side effects

Frequent (may affect up to 1 in 10 people)

- Gastrointestinal symptoms such as stomach burning, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and small gastrointestinal bleeding that may cause anemia in exceptional cases.

Rare (may affect up to 1 in 100 people)

- Allergic reactions with skin eruption and itching, as well as asthma attacks (possibly with decreased blood pressure). In that case, inform the doctor immediately and stop taking ibuprofen.

- Central nervous system alterations such as headache, drowsiness, agitation, irritability, or fatigue.

- Vision alterations. In that case, inform the doctor immediately and stop taking ibuprofen.

- Gastritis, stomach ulcers, in some cases with bleeding and perforation.

- Stomatitis ulcerosa, worsening of colitis and Crohn's disease.

- Skin eruption, urticaria, itching, purpura (including allergic purpura).

Rare (may affect up to 1 in 1000 people)

- Sensation of noise in the ears (tinnitus), hearing disorders.

- Renal tissue damage (papillary necrosis), especially with long-term treatment, and increased uric acid concentration in the blood.

Very rare (may affect up to 1 in 10,000 people)

- Worsening of inflammation related to infections (e.g., necrotizing fasciitis). If signs of infection or these worsen during ibuprofen treatment (e.g., redness, swelling, heat, pain, fever) the patient should seek medical attention immediately.

- Signs of inflammation of the meningeal membranes (aseptic meningitis) such as headache, nausea, vomiting, fever, neck stiffness, or disorientation. Patients who seem to be at higher risk are those who have experienced certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease).

- Blood disorders (anemia, leukopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, and nasal and cutaneous bleeding. In such cases, discontinue medication immediately and seek medical attention. DO NOT administer any type of medication to treat pain or reduce fever.

- Severe generalized hypersensitivity reactions. It may manifest as: facial edema, tongue and laryngeal swelling with constriction of the airways, shortness of breath, palpitations, decreased blood pressure, and potentially fatalshock.

- Psychotic reactions, depression.

- Reversible toxic amblyopia.

- Palpitations, heart failure, myocardial infarction.

- Increased blood pressure.

- Inflammation of the esophagus and pancreas.

- Intestinal stenosis formation.

- Liver dysfunction or acute liver inflammation. Liver damage or insufficiency, especially with prolonged use, is manifested by yellowing of the skin and eyes, as well as soft stools and dark urine.

- Alopecia (hair loss).

- Photosensitivity reactions, allergic vasculitis.

- Severe skin reactions, with generalized redness and formation of blisters (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome). In isolated cases, severe skin infections with complications in soft tissues may occur during varicella.

- Decreased urine excretion and increased fluid in tissues (edema), especially in patients with high blood pressure or kidney dysfunction; nephrotic syndrome (fluid accumulation in the body and excessive protein in the urine); interstitial nephritis, which may be accompanied by acute kidney insufficiency. Decreased urine production, fluid accumulation in the body, and general feeling of discomfort may be signs of kidney diseases and even kidney insufficiency.

Unknown frequency (cannot be estimated from available data)

- A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

- Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

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

Stop taking Ibuprofeno Farmalider if you experience these symptoms and seek medical attention immediately. See section 2. The skin becomes sensitive to light.

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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: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 25°C.

Do not use this medication after the expiration date that appears on the blister pack or the box 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 packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Farmalider

Core

Hydroxypropyl methylcellulose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating

Hydroxypropyl methylcellulose, titanium dioxide (E-171), talc, propylene glycol (E-1520).

Appearance of the product and contents of the packaging

Ibuprofeno Farmalider are coated tablets of white color, oblong shape, biconvex, with one face scored and the other face smooth. The dimensions of the coated tablets are: 6 mm in width, 12 mm in length, and 4.2 mm in thickness.

The packaging material consists of aluminum/PVC/PVDC laminate blisters.

Each boxcontains 20 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER, S.A.

The Granja, 1, 3rd floor 28108

Alcobendas, Madrid

(Spain)

Responsible for manufacturing

Toll Manufacturing Services, S.L.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Farmalider, S.A.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Last review date of this leaflet: December 2024