Ibuprofen Farmalider 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Farmalider 200 mg film-coated tablets

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of the leaflet

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

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

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

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

2. What you need to know before taking Ibuprofeno Farmalider

Do not take Ibuprofeno Farmalider:

• If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• If you have previously experienced any reaction such as bronchospasm, asthma attacks, inflammation of the nasal mucosa, angioedema, or skin rashes after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have unexplained blood clotting disorders.
• If you suffer from severe liver or kidney disease.
• If you have experienced gastrointestinal bleeding or perforation (i.e., of the digestive tract) related to treatment with NSAIDs.
• If you currently have or have had recurrent stomach or duodenal ulcers (peptic ulcer) or gastrointestinal bleeding (two or more confirmed episodes of ulcer 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 any 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 medicine.

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

• Certain hereditary blood disorders (e.g., acute intermittent porphyria);
• Certain disorders of the immune system (systemic lupus erythematosus and mixed connective tissue disease).

Careful medical monitoring is required in cases of:

• Gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• Impaired kidney or liver function;
• Dehydration;
• High blood pressure or heart failure;
• Allergies (e.g., skin reactions to other substances, asthma, seasonal allergies), nasal polyps, chronic inflammation of nasal mucosa, or chronic obstructive respiratory disease, as the risk of hypersensitivity reactions is higher;
• Recent major surgical intervention.
• If you have an infection; see the heading "Infections" below.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms.

Other NSAIDs

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

Elderly population

Elderly patients are more likely to experience adverse effects of NSAIDs, particularly gastrointestinal perforations and bleeding, which may be fatal in some cases. They are also at higher risk of suffering consequences from adverse effects.

Gastrointestinal ulcers, bleeding, and perforations

Gastrointestinal ulcers, perforations, and bleeding, sometimes 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 serious gastrointestinal events.

The risk of gastrointestinal ulcer, perforation, or bleeding is higher with higher NSAID doses, if you have previously had an ulcer, especially if complicated by bleeding or perforation, and if you are elderly. Treatment should be initiated with the lowest possible dose. Consult your doctor, as they may prescribe a combination treatment with protective agents (e.g., misoprostol or proton pump inhibitors). The same applies if you are taking low-dose acetylsalicylic acid (aspirin) or other medications that may increase gastrointestinal risk.

If you have previously experienced gastrointestinal adverse effects, especially if you are elderly, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment. Exercise extreme caution if you are simultaneously taking other medications that could increase the risk of ulcer or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents like acetylsalicylic acid (see section 2, Other medicines and Ibuprofeno Farmalider).

If gastrointestinal ulcer or bleeding occurs during treatment with ibuprofen, treatment must be discontinued and you should consult your doctor.

If you have had or currently have gastrointestinal disorders (ulcerative colitis, Crohn's disease), be cautious when taking NSAIDs, as they may worsen your condition (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 Farmalider and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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

Consult your doctor or pharmacist before taking ibuprofen if you:

• Have heart problems such as heart failure or angina (chest pain), or if you have had a myocardial infarction, 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 transient ischemic attack or TIA).
• Have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

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 lead to 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 include those with renal, cardiac, or hepatic insufficiency, those taking diuretics and ACE inhibitors, and the elderly.

Discontinuation of NSAID treatment generally leads to recovery to the pre-treatment state.

Hypersensitivity reactions

Very rare cases of severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. Treatment must be discontinued at the first signs of hypersensitivity following the intake/administration of ibuprofen. Depending on symptoms, medical professionals should apply the necessary medical procedures.

Other information

Ibuprofen, the active substance in this medicine, may temporarily inhibit platelet function in the blood (platelet aggregation). Careful monitoring of patients with coagulation disorders is required.

During long-term ibuprofen treatment, liver enzymes and renal function should be regularly checked, and a complete blood count should be performed if necessary.

Sufficient fluids should be consumed during treatment, especially in cases of fever, diarrhea, or vomiting.

NSAIDs such as ibuprofen may mask symptoms of infection or fever.

Alcohol consumption while using NSAIDs may worsen adverse effects related to the active substance, particularly those affecting the digestive tract and central nervous system.

Prolonged use of any type of analgesic to treat headaches may worsen them. If this occurs or is suspected, consult your doctor and discontinue treatment. Medication-overuse headache should be suspected in patients who experience daily or very frequent headaches despite (or because of) regular use of headache medications.

In general, habitual use of analgesics, especially a combination of various analgesic substances, may cause permanent kidney damage with risk of renal failure (analgesic nephropathy).

Children and adolescents

There is a risk of renal failure in dehydrated adolescents.

This medicine should not be administered to adolescents weighing less than 40 kg or to children under 12 years of age.

Other medicines and Ibuprofeno Farmalider

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

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

• Anticoagulant medicines (i.e., to prevent blood clot formation; e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medicines to lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing products, and angiotensin II receptor antagonists such as losartan).

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

Potentiate its action, with possible increase in adverse effects:

• Acetylsalicylic acid and other non-steroidal anti-inflammatory analgesics, as well as corticosteroids (medicines containing cortisone and cortisone-like substances), may increase the risk of gastrointestinal bleeding.
• Methotrexate (for treating cancer and certain rheumatic diseases): administration of ibuprofen within 24 hours before or after methotrexate may increase methotrexate concentrations and increase its adverse effects.
• Anticoagulants (to prevent blood clot formation) such as warfarin.
• Digoxin (to strengthen the heart), phenytoin (to treat seizures), or lithium (to treat certain psychiatric disorders); ibuprofen may increase blood concentrations of these medicines. If ibuprofen is taken as recommended (for a maximum of 3 or 4 days), monitoring of blood concentrations of these medicines is not necessary.
• Antiplatelet agents, as well as selective serotonin reuptake inhibitors (for treating depression), may also increase the risk of gastric and intestinal bleeding.

Weaken its action:

• Diuretics and blood pressure-lowering medicines (antihypertensives): there may be an increased risk to the kidneys.
• ACE inhibitors (for treating heart failure and high blood pressure). Additionally, there may be an increased risk of renal dysfunction.
• Low-dose acetylsalicylic acid: the antithrombotic effect of low-dose acetylsalicylic acid may be altered.
• Mifepristone (used to induce abortion): the use of NSAIDs during the 8 to 12 days following mifepristone administration may reduce the effect of mifepristone.

Other possible interactions:

• Potassium-sparing diuretics: may increase blood potassium levels.
• Probenecid and sulfinpyrazone (for treating gout): may delay ibuprofen excretion. 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 blood levels of ibuprofen. Consideration should be given to reducing the ibuprofen dose, especially if high doses are used, when administered together with voriconazole or fluconazole.
• Sulfonylureas (for diabetes): NSAIDs may enhance the hypoglycemic effect of sulfonylureas. As a precaution, blood glucose levels should be monitored during concomitant use.
• Tacrolimus: if both medicines are administered simultaneously, kidney damage may occur.
• Cyclosporine (to reduce immune reactions): kidney damage may occur.
• Cholestyramine (to lower cholesterol): prolongs and reduces (by 25%) ibuprofen absorption. Medicines should be administered with at least a 2-hour interval between them.
• Zidovudine (for treating HIV/AIDS): increased risk of joint hemorrhage and bruising in HIV-positive hemophiliacs.
• Aminoglycosides (antibiotics): their elimination may be reduced and toxicity increased.
• Herbal medicines: Ginkgo biloba (used to treat dementia) may increase the risk of bleeding.

Ibuprofen may alter the results of certain laboratory tests:

Consult your doctor if you are scheduled for clinical tests and are taking or have recently taken ibuprofen, as it may alter test results.

Taking Ibuprofeno Farmalider with alcohol:

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

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

If you become pregnant while being treated with ibuprofen, inform your doctor.

Do not take Ibuprofeno Farmalider during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected. Do not take Ibuprofeno Farmalider 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 Farmalider 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.

Breastfeeding

The active substance, ibuprofen, and its metabolites pass into breast milk only in small amounts. Since, to date, no negative consequences for the infant are known, it is generally not necessary to interrupt breastfeeding during short-term treatment at recommended doses for mild to moderate pain and fever.

Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) that may reduce fertility in women. These effects are reversible upon discontinuation of treatment.

Driving and use of machinery

In isolated cases, patients taking ibuprofen may experience adverse reactions characterized by fatigue, dizziness, and visual disturbances, which may affect reaction time and the ability to drive and operate machinery. These effects are enhanced by the simultaneous consumption of alcohol.

Ibuprofeno Farmalider contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ibuprofeno Farmalider

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

For short-term use only.

You can reduce the occurrence of adverse effects by taking the lowest effective dose for the shortest duration necessary to control symptoms.

The recommended dose is:

The recommended doses are detailed in the following table.

Body weight (age)	Single dose	Maximum daily dose
40 kg or more (adults and adolescents over 12 years of age)	200-400 mg of ibuprofen (1-2 tablets)	1200 mg of ibuprofen (6 tablets)

The respective dosing intervals should be selected according to the symptom pattern and the maximum daily dose. The interval between doses must not be less than 6 hours. The recommended maximum daily dose must not be exceeded.

If an adolescent over 12 years of age needs to take this medicine for more than 3 days, or if symptoms worsen, a doctor should be consulted.

The lowest effective dose should be used for the shortest duration 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 medicine for more than 3 days for fever or 4 days for pain treatment, or if symptoms worsen, a doctor should be consulted.

Use in children

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

Method of administration

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

Patients with stomach problems are advised to take the tablets during meals.

If you take more Ibuprofeno Farmalider than you should

If the amount ingested greatly exceeds the recommended dose, seek immediate medical attention.

If you have taken more Ibuprofeno Farmalider than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk 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 such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In asthmatic patients, worsening of asthma may occur.

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

If you forget to take Ibuprofeno Farmalider

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

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.

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

• Flat, red, target-shaped or circular 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].
• Widespread rash, high body temperature, and swollen 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).

Adverse effects can be reduced by using the lowest effective dose for the shortest possible time needed to relieve symptoms. The following list includes all known adverse effects associated with ibuprofen treatment, including those occurring 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 formulations and up to 1800 mg for suppositories.

The following adverse effects should be considered largely dose-dependent and may vary between individual patients.

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

Less frequently, inflammation of the stomach (gastritis) has been observed.

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

Medicines such as ibuprofen have been associated with a small increased risk of myocardial infarction and cerebrovascular events.

STOP TAKING AND IMMEDIATELY CONSULT A DOCTOR IF YOU EXPERIENCE:

• Signs of gastrointestinal bleeding such as: relatively severe abdominal pain, blood in stools or bloody diarrhea, vomiting blood or dark particles resembling coffee grounds.
• Signs of serious allergic reactions such as skin rash, swelling of the face, tongue or throat, wheezing or shortness of breath, worsening of asthma, difficulty breathing, palpitations, or decreased blood pressure that may lead to shock.
• Severe skin reactions such as rashes covering the entire body, skin peeling, widespread blisters, or skin detachment.

Other adverse effects

Common (may affect up to 1 in 10 people)

• Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with decreased blood pressure). In such cases, inform your doctor immediately and stop taking ibuprofen.
• Central nervous system disturbances such as headache, drowsiness, agitation, irritability, or fatigue.
• Visual disturbances. In such cases, inform your doctor immediately and stop taking ibuprofen.
• Inflammation of the mucosa lining the stomach (gastritis).
• Gastrointestinal ulcers, in some cases with bleeding and perforation.
• Ulcerative stomatitis, worsening of colitis and Crohn's disease.
• Skin rash, urticaria, itching, purpura (including allergic purpura).

Rare (may affect up to 1 in 1,000 people)

• Ringing in the ears (tinnitus), hearing disturbances.
• Kidney tissue damage (papillary necrosis), particularly with long-term treatment, and increased blood uric acid concentration.

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 appear or worsen during ibuprofen treatment (e.g., redness, swelling, warmth, pain, fever), the patient should seek medical attention immediately.
• Signs of inflammation of the meninges (aseptic meningitis) such as headache, nausea, vomiting, fever, neck stiffness, or disorientation. Patients at higher risk include those with a history of certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease).
• Blood disorders (anemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, and nosebleeds or skin bleeding. In such cases, stop taking the medication immediately and consult a doctor. DO NOT self-medicate with any painkillers or fever-reducing medicines.
• Severe generalized hypersensitivity reactions. These may manifest as: facial swelling, swelling of the tongue and larynx with airway constriction, shortness of breath, palpitations, decreased blood pressure, and even potentially fatal shock.
• Psychotic reactions, depression.
• Reversible toxic amblyopia.
• Palpitations, heart failure, myocardial infarction.
• Increased blood pressure.
• Inflammation of the esophagus and pancreas.
• Formation of intestinal strictures.
• Liver dysfunction or acute liver inflammation. Liver injury or failure, particularly with prolonged use, may present as yellowing of the skin and eyes (jaundice), pale stools, and dark urine.
• Alopecia (hair loss).
• Photosensitivity reactions, allergic vasculitis.
• Severe skin reactions with redness and widespread blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome). In isolated cases, severe skin infections with complications in soft tissues may occur during chickenpox.
• Decreased urine output and fluid accumulation in tissues (edema), particularly in patients with high blood pressure or impaired kidney function; nephrotic syndrome (fluid accumulation in the body (edema) and excess protein in urine); inflammatory kidney disease (interstitial nephritis), which may lead to acute renal failure. Reduced urine production, fluid accumulation in the body (edema), and general malaise may be signs of kidney disease or even renal failure.

Frequency unknown (cannot be estimated from available data)

• A severe skin reaction known as DRESS syndrome 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 affecting 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 serious allergic reaction called Kounis syndrome.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, 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: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno Farmalider

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

Do not store above 25 °C.

Do not use this medicine after the expiry date stated on the blister or packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Ibuprofeno Farmalider

• The active substance is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other excipients are:

Core

Hypromellose, sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.

Coating

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

Appearance of the medicinal product and contents of the pack

Ibuprofeno Farmalider are white, oblong, biconvex coated tablets, with one side scored and the other side smooth. The dimensions of the coated tablets are: 6 mm wide, 12 mm long and 4.2 mm thick.

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

Each box contains 20 coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, S.A.

La Granja, 1, 3.º 28108

Alcobendas, Madrid

(Spain)

Manufacturer

Toll Manufacturing Services, S.L.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Farmalider, S.A.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Date of the most recent revision of this package leaflet: December 2024