Ibuprofen Farmalider

Leaflet accompanying the packaging: patient information

Ibuprofen Farmalider, 200 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after:
• 3 days in adolescents,
• 3 days of fever treatment and 4 days of pain treatment in adults, no improvement occurs or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet:

• 1. What is Ibuprofen Farmalider and what is it used for
• 2. Important information before taking Ibuprofen Farmalider
• 3. How to take Ibuprofen Farmalider
• 4. Possible side effects
• 5. How to store Ibuprofen Farmalider
• 6. Contents of the packaging and other information

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

Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). This medicine is intended for short-term, symptomatic treatment of mild or moderate pain, such as toothache, headache, or pain associated with minor injuries and/or fever in adolescents with a body weight of over 40 kg (over 12 years of age) and adults.

2. Important information before taking Ibuprofen Farmalider

When not to take Ibuprofen Farmalider:

• If the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced bronchospasm, asthma, nasal polyps, angioedema, or skin reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If the patient has unexplained blood formation disorders.
• If the patient has severe liver or kidney dysfunction.
• If the patient has a history of gastrointestinal bleeding or perforation associated with previous NSAID use.
• If the patient has active or a history of recurrent peptic ulcer (gastric or duodenal ulcer) or gastrointestinal bleeding (two or more separate episodes of confirmed peptic ulcer or bleeding).
• If the patient has severe heart failure.
• If the patient is in the last three months of pregnancy (see section 2 "Pregnancy, breastfeeding, and fertility").
• If the patient has a history of cerebrovascular bleeding or other active bleeding.
• If the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

Before starting treatment with Ibuprofen Farmalider, the patient should discuss it with their doctor or pharmacist. Ibuprofen Farmalider should be used only after careful consideration of the benefit-risk ratio:

• in cases of certain hereditary blood disorders (e.g., acute intermittent porphyria);
• in cases of certain immune system diseases (systemic lupus erythematosus or mixed connective tissue disease).

Particular caution is required when treating patients with:

• gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• liver or kidney dysfunction;
• dehydration;
• high blood pressure or heart failure;
• allergies (such as skin reactions to other medications, asthma, hay fever), chronic nasal polyps, or chronic obstructive respiratory disease - these individuals are at increased risk of hypersensitivity reactions;
• recent major surgical procedures.
• if the patient has an infection - see below, section titled "Infections".

Side effects can be minimized by administering the smallest effective dose for the shortest duration necessary to control symptoms. Other NSAIDs should be avoided during treatment with ibuprofen, including selective COX-2 inhibitors. Elderly patients are at increased risk of side effects, especially gastrointestinal bleeding and perforation, which can be fatal. Elderly patients are also at risk of consequences of side effects.

Gastrointestinal bleeding, ulcers, and perforation have been reported with the use of all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs and is higher in patients with a history of gastrointestinal ulcers, especially if complicated by bleeding or perforation, as well as in elderly patients. Such patients should start treatment with the lowest available dose. Consultation with a doctor is recommended, as the use of protective therapy (e.g., misoprostol or proton pump inhibitors) should be considered. This applies to patients taking low-dose acetylsalicylic acid (aspirin) or other substances that may increase the risk associated with the gastrointestinal tract.

Patient monitoring is recommended, especially in patients with a history of gastrointestinal side effects, particularly the elderly, who should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment. Caution is advised in patients taking medications that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (e.g., acetylsalicylic acid) (see section 2, "Other medications and Ibuprofen Farmalider"). If gastrointestinal bleeding or ulcers occur during ibuprofen treatment, treatment must be discontinued and a doctor consulted.

In patients with gastrointestinal disease (ulcerative colitis, Crohn's disease), NSAIDs should be used with caution, as these conditions 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), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, Ibuprofen Farmalider should be discontinued immediately and medical help sought.

Caution is advised against using ibuprofen in patients with chickenpox.

Cardiovascular precautions

Taking anti-inflammatory or pain-relieving medications like ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and treatment duration should be as short as possible.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, Ibuprofen Farmalider should be discontinued immediately and medical help sought.

Ibuprofen Farmalider and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or plan to take. Ibuprofen Farmalider may affect the action of other medications or other medications may affect the action of Ibuprofen Farmalider. For example:

• anticoagulant medications (e.g., aspirin, warfarin, ticlopidine);
• blood pressure-lowering medications (e.g., ACE inhibitors, beta blockers, angiotensin II receptor antagonists).

Other medications may also interact with Ibuprofen Farmalider. Therefore, before taking Ibuprofen Farmalider with other medications, the patient should always consult their doctor or pharmacist.

Increased intensity of action with possible increased risk of side effects:

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs with analgesic action, as well as corticosteroids (containing cortisone or similar substances), may increase the risk of gastrointestinal bleeding.
• Methotrexate (used to treat cancer and certain types of rheumatic diseases): administering ibuprofen within 24 hours before or after methotrexate administration may lead to increased methotrexate levels and intensified side effects.
• Anticoagulant medications (e.g., warfarin).
• Digoxin (used to strengthen the heart), phenytoin (used to treat seizures), or lithium (used to treat certain mental illnesses): ibuprofen may increase the levels of these medications in the blood. Monitoring of blood levels is not usually required, unless the medication is used according to the recommendations (not longer than 3 or 4 days).
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) (medications used to treat depression) may also increase the risk of gastrointestinal bleeding.

Reduced action:

• Diuretics and blood pressure-lowering medications: increased risk of kidney problems may occur.
• ACE inhibitors (used to treat heart failure and high blood pressure): increased risk of kidney failure may also occur.
• Low-dose acetylsalicylic acid: the antiplatelet effect of low-dose acetylsalicylic acid may be disrupted.
• Mifepristone (used for medical termination of pregnancy): if NSAIDs are used within 8-12 days after mifepristone administration, they may reduce the effectiveness of mifepristone.

Other possible interactions:

• Potassium-sparing diuretics: may lead to increased potassium levels in the blood.
• Probenecid and sulfinpyrazone (used to treat gout): may delay ibuprofen elimination, leading to its accumulation in the body and increased side effects.
• Quinolone antibiotics: may increase the risk of seizures.
• Voriconazole, fluconazole (CYP2C9 inhibitors) (used to treat fungal infections): may increase ibuprofen levels in the blood. Reducing the ibuprofen dose should be considered, especially when using high doses of ibuprofen with voriconazole or fluconazole.
• Sulfonylurea derivatives (used to treat diabetes): NSAIDs may enhance the hypoglycemic effect of sulfonylurea derivatives. As a precaution, blood glucose levels should be monitored during combination therapy.
• Tacrolimus: concurrent use of these medications may lead to kidney damage.
• Cyclosporine (an immunosuppressive medication): may lead to kidney damage.
• Cholestyramine (used to lower cholesterol): prolonged and reduced (25%) absorption of ibuprofen. These medications should be administered at least 2 hours apart.
• Zidovudine (used to treat HIV/AIDS): increased risk of bleeding into the joints and ecchymosis in HIV-positive patients with hemophilia.
• Aminoglycosides (antibiotics): may slow down aminoglycoside elimination and increase their toxicity.
• Herbal extracts: Ginkgo biloba (used to treat dementia) may increase the risk of bleeding.

Ibuprofen may affect the results of certain laboratory tests: the doctor should be informed if the patient is undergoing clinical analyses and is taking or has recently taken ibuprofen, as it may affect the results.

Ibuprofen Farmalider and alcohol

Alcohol should be avoided during treatment with ibuprofen, as it may increase the side effects of ibuprofen, especially those related to the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

Pregnancy

If the patient becomes pregnant during ibuprofen treatment, they should inform their doctor. Ibuprofen Farmalider should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney or heart problems in the unborn child. It may also affect the patient's and child's tendency to bleed and cause longer or more difficult delivery than expected. Ibuprofen Farmalider should not be taken during the first six months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest time possible. If Ibuprofen Farmalider is used for more than a few days from the 20th week of pregnancy, it may cause the unborn child's arterial duct to narrow (constriction of the ductus arteriosus) or kidney problems, leading to low amniotic fluid levels (oligohydramnios). If the patient requires treatment for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

The active substance ibuprofen and its metabolites pass into breast milk in small amounts. Since negative consequences for the infant are not yet known, during short-term use in the recommended dose for mild or moderate pain or fever, there is no need to interrupt breastfeeding.

Fertility

The medication belongs to a group of medications (NSAIDs) that may cause fertility problems in women. This effect is reversible and disappears after discontinuation of the medication.

Driving and operating machinery

During treatment with ibuprofen, side effects such as fatigue or dizziness may occur. As a result, some individuals may experience impaired reaction ability, ability to participate in traffic, or ability to operate machinery. This is especially true when interacting with alcohol, as it increases these effects.

Ibuprofen Farmalider contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medication.

3. How to take Ibuprofen Farmalider

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor, pharmacist, or nurse should be consulted. For short-term use only. Side effects can be minimized by administering the smallest effective dose for the shortest duration necessary to control symptoms.

The recommended dose is:

In accordance with the detailed information provided in the table below.

The interval between consecutive doses should be determined based on symptoms and considering the maximum daily dose. The interval between consecutive doses should not be less than 6 hours. The maximum recommended daily dose should not be exceeded. If the adolescent over 12 years of age needs to use this medication for more than 3 days or if symptoms worsen, they should consult a doctor. If the adult needs to use this medication for more than 3 days for fever or more than 4 days for pain treatment or if symptoms worsen, they should consult a doctor.

Use in children

Ibuprofen Farmalider should not be used in adolescents with a body weight below 40 kg or in children under 12 years of age. Administration: oral. Tablets should be swallowed whole with a glass of water. Patients with sensitive stomachs should take Ibuprofen Farmalider during meals.

Overdose of Ibuprofen Farmalider

If the patient has taken more than the recommended dose of Ibuprofen Farmalider or if a child has accidentally taken the medication, they should always consult a doctor or go to the nearest hospital to assess the potential risk to their health and receive advice on what to do. Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, feeling cold, and breathing difficulties. In case of significant overdose, medical help should be sought immediately. Symptoms of acute ibuprofen overdose are usually limited to stomach pain, nausea, vomiting, and diarrhea. Tinnitus, headache, dizziness of central origin, dizziness of labyrinthine origin, and gastrointestinal bleeding may also occur. Severe poisoning may lead to feelings of emptiness in the head, excitement, disorientation, coma, seizures, myoclonic contractions in children, decreased blood pressure, respiratory depression, cyanosis, metabolic acidosis, increased tendency to bleed, acute kidney failure, and liver damage. In asthmatics, asthma may worsen.

Missed dose of Ibuprofen Farmalider

A double dose should not be taken to make up for a missed dose. In case of further doubts about taking this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Ibuprofen Farmalider can cause side effects, although not everyone will experience them.

If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical help immediately:

• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with nodules under the skin and blisters, usually occurring at the start of treatment, accompanied by fever (acute generalized exanthematous pustulosis).

Side effects can be minimized by taking the smallest effective dose for the shortest duration necessary to alleviate symptoms. The following list of side effects includes all known side effects associated with ibuprofen treatment, including those occurring in patients with rheumatism undergoing long-term, high-dose therapy. The frequency of side effects, except for very rare reports, refers to short-term use of maximum daily doses of 1200 mg ibuprofen in oral forms and 1800 mg in suppositories.

Regarding the following side effects, it should be noted that they are largely dose-dependent, and their severity varies among individual patients. The most common side effects are related to the gastrointestinal system. Gastrointestinal ulcers or perforation may occur, which can be fatal, especially in elderly patients (see section 2). After taking ibuprofen, nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, and minor gastrointestinal bleeding, which can rarely lead to anemia, have been reported. Less frequently, stomach inflammation has been reported. Gastrointestinal side effects are the most common. They may include ulcers or perforation of the stomach or intestines, which can be fatal, especially in elderly patients (see section 2). After taking ibuprofen, nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, and minor gastrointestinal bleeding, which can rarely lead to anemia, have been reported. Less frequently, stomach inflammation has been reported.

The patient should stop taking Ibuprofen Farmalider and seek medical help immediately if they experience:

• symptoms of gastrointestinal bleeding: relatively severe stomach pain, black stools, blood in the stool, vomiting blood or coffee grounds-like vomit.
• symptoms of a severe allergic reaction, such as skin rash, facial swelling, tongue or throat swelling, wheezing, shortness of breath, asthma worsening, difficulty breathing, palpitations, blood pressure drop leading to shock.
• severe skin reactions, such as widespread skin rash with redness and blistering.

Other side effects

Frequent (may occur in 1 in 10 patients)

• gastrointestinal symptoms, such as heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which can rarely lead to anemia.

Uncommon (may occur in 1 in 100 patients)

• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with blood pressure drop). In such cases, the doctor should be informed immediately, and ibuprofen should be discontinued.
• central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• visual disturbances. In such cases, the doctor should be informed immediately, and ibuprofen should be discontinued.
• stomach inflammation.
• gastric or intestinal ulcers, sometimes with bleeding and perforation.
• mouth ulcers, worsening of ulcerative colitis or Crohn's disease.
• skin rash, hives, itching, urticaria (including allergic urticaria).

Rare (may occur in 1 in 1,000 patients)

• tinnitus (ringing in the ears), hearing impairment.
• kidney tissue damage (renal papillary necrosis), especially after long-term use, increased uric acid levels in the blood.

Very rare (may occur in 1 in 10,000 patients)

• worsening of infectious inflammation (e.g., development of necrotizing fasciitis). If symptoms of infection occur or worsen during ibuprofen treatment, such as redness, swelling, high temperature, pain, and fever, medical help should be sought immediately.
• symptoms of meningitis (aseptic meningitis), such as severe headache, nausea, vomiting, fever, neck stiffness, or changes in consciousness. Patients who have previously had certain immune system diseases (systemic lupus erythematosus and mixed connective tissue disease) seem to be at higher risk.
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, the medication should be discontinued immediately, and a doctor should be consulted. Patients should not attempt to take pain-relieving or antipyretic medications on their own.
• severe general hypersensitivity reactions. Symptoms may include facial swelling, tongue or throat swelling, narrowing of the airways, shortness of breath, palpitations, blood pressure drop, or life-threatening shock.
• psychotic reactions, depression.
• reversible toxic vision loss.
• heart palpitations, heart failure, heart attack.
• high blood pressure.
• esophageal or pancreatic inflammation.
• formation of diaphragm-like constrictions in the intestine.
• liver dysfunction or acute liver inflammation. Liver failure or damage, especially with long-term use, may manifest as yellowing of the skin and eyes or pale stools and dark urine.
• hair loss (alopecia).
• hypersensitivity reactions to light, allergic vasculitis.
• severe skin reactions, such as skin rash with redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome). In individual cases, during chickenpox infection, severe skin infections with soft tissue complications may occur.

Frequency not known (frequency cannot be estimated from available data)

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).
• A red, scaly rash with nodules under the skin and blisters, usually occurring at the start of treatment, accompanied by fever (acute generalized exanthematous pustulosis). If such symptoms occur, Ibuprofen Farmalider should be discontinued, and medical help should be sought immediately. See also section 2.
• Skin sensitivity to light.
• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Reporting side effects

If side effects occur, including those not listed in the leaflet, the doctor should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl. Reporting side effects will help gather more information on the safety of the medication.

5. How to store Ibuprofen Farmalider

The medication should be stored out of sight and reach of children. It should not be stored at temperatures above 25°C. The medication should not be used after the expiration date stated on the blister pack or carton after: EXP. The expiration date refers to the last day of the specified month. Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Farmalider contains

• The active substance of the medication is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Excipients are: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), talc, propylene glycol.

What Ibuprofen Farmalider looks like and contents of the pack

Ibuprofen Farmalider is a white, oblong, biconvex, coated tablet with a score line on one side and a smooth surface on the other. The dimensions of the coated tablets are: 6 mm width, 12 mm length, and 4.2 mm thickness. The packaging material consists of PVC/PVDC/Aluminum blisters. Each pack contains 20 coated tablets.

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 Toll Manufacturing Services, S.L. C/Aragoneses, 2 28108 Alcobendas (Madrid) Spain

Date of last revision of the leaflet:

02/2024