Ibuprofen farmalider

Package leaflet: Information for the patient

Ibuprofen Farmalider, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If after:
  • 3 days in adolescents,
  • 3 days of treating fever and 4 days of treating pain in adults, there is no improvement or if you feel worse, you should contact your doctor.

Contents of the leaflet:

1. What Ibuprofen Farmalider is and what it is 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 pack and other information

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

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

2. Important information before using Ibuprofen Farmalider

When not to use Ibuprofen Farmalider:

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced bronchospasm, asthma attack, nasal mucosal swelling, angioedema, or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has blood disorders of unknown cause.
• If the patient has severe liver or kidney function disorders.
• If the patient has previously experienced gastrointestinal bleeding or perforation related to prior use of NSAIDs.
• If the patient has active or a history of recurrent gastric or duodenal ulcers (peptic ulcers) 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 effects on fertility").
• If the patient has cerebral haemorrhage or other active bleeding.
• If the patient has severe dehydration (caused by vomiting, diarrhoea, or inadequate fluid intake).

Warnings and precautions
Before starting Ibuprofen Farmalider, discuss this with your doctor or pharmacist.
Ibuprofen Farmalider should be used only after careful consideration of the benefit-risk ratio:

• In patients with certain inherited blood disorders (e.g. acute intermittent porphyria);
• In patients with certain immune system disorders (systemic lupus erythematosus or mixed connective tissue disease).

Particular caution and close monitoring by a physician are required in patients:

• With gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• With impaired liver or kidney function;
• With dehydration;
• With high blood pressure or heart failure;
• With allergies (such as skin reactions to other medicines, bronchial asthma, hay fever), chronic nasal mucosal swelling, or chronic obstructive respiratory disease – such individuals are at increased risk of hypersensitivity reactions;
• After recent major surgical procedures.
• If the patient has an infection – see below, section titled "Infections".

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Other NSAIDs
Concomitant use of ibuprofen and other NSAIDs, including COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided.
Elderly patients
Elderly patients are at increased risk of adverse effects during NSAID use, particularly gastrointestinal bleeding and gastrointestinal perforation, which may be fatal. Elderly patients are at risk of serious consequences of adverse reactions.
Gastrointestinal bleeding, ulcers and gastrointestinal perforation
Cases of gastrointestinal bleeding, ulcers or gastrointestinal perforation, which may be fatal, have been reported with the use of all NSAIDs at any time during treatment, with or without warning symptoms or previous serious gastrointestinal events in medical history.
The risk of gastrointestinal bleeding, peptic ulcers or gastrointestinal perforation increases with higher NSAID doses and is higher in patients with a history of gastrointestinal ulcers, especially if complicated by bleeding or perforation, and in elderly patients. Such patients should start treatment with the lowest available dose. Consult your doctor, as concomitant protective therapy (e.g. misoprostol or proton pump inhibitors) should be considered. This applies to patients also taking low-dose acetylsalicylic acid (aspirin) or other active substances that may increase gastrointestinal risk.
Patients with a history of gastrointestinal adverse effects, especially elderly patients, should report any unusual gastrointestinal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment. Caution is advised in patients taking concomitant medications that may increase the risk of gastrointestinal ulcers or bleeding, such as oral glucocorticoids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet drugs like acetylsalicylic acid (see section 2, "Other medicines and Ibuprofen Farmalider").
If gastrointestinal bleeding or a gastrointestinal ulcer occurs during ibuprofen treatment, treatment must be discontinued and medical advice sought.
NSAIDs should be used with caution in patients with gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4).
Severe skin reactions, including 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 any of the symptoms associated with these severe skin reactions described in section 4 occur, Ibuprofen Farmalider must be discontinued immediately and medical help sought.
Ibuprofen use is not recommended in patients with chickenpox.
Cardiovascular precautions
Taking anti-inflammatory or pain-relieving 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.
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 must be discontinued immediately and medical help sought without delay.
Before using Ibuprofen Farmalider, the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart disease, such as heart failure, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• The patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if the patient smokes.

Effect on kidneys
Ibuprofen may cause sodium, potassium and fluid retention in patients without prior kidney problems, due to its effect on renal perfusion. This may lead to oedema (fluid retention) or even heart failure or hypertension in predisposed patients. Cases of acute interstitial nephritis and nephrotoxic effects have been reported. Patients most at risk of these reactions include those with impaired kidney function, heart failure, impaired liver function, patients taking diuretics and ACE inhibitors, and elderly patients.
After discontinuation of NSAID therapy, renal function usually returns to the pre-treatment state.
Hypersensitivity reactions
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. Treatment must be discontinued at the first signs of hypersensitivity after taking or administering ibuprofen. Depending on symptoms, trained personnel should initiate appropriate medical procedures.
Infections
Ibuprofen Farmalider may mask signs of infection, such as fever and pain. Therefore, Ibuprofen Farmalider may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.
Other information
Ibuprofen, the active substance of this medicine, may cause transient inhibition of platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
During prolonged ibuprofen use, regular monitoring of liver enzyme activity, kidney function parameters, and peripheral blood morphology is necessary.
During treatment, adequate fluid intake should be maintained, especially in cases of fever, diarrhoea or vomiting.
NSAIDs such as ibuprofen may mask signs of infection and fever.
Concomitant use of NSAIDs with alcohol may intensify adverse effects caused by the active substance, especially gastrointestinal or central nervous system effects.
Long-term use of all types of painkillers for headache may lead to worsening headache. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache should be suspected in patients who frequently or daily experience headaches despite (or because of) regular use of painkillers.
Chronic use of painkillers, especially multiple painkillers simultaneously, may lead to permanent kidney damage and risk of kidney failure (analgesic nephropathy).
Children and adolescents
There is a risk of impaired kidney function in dehydrated adolescents.
This medicine should not be given to adolescents weighing less than 40 kg or to children under 12 years of age.
Ibuprofen Farmalider and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines planned for use.
Ibuprofen Farmalider may affect the action of other medicines or other medicines may affect the action of Ibuprofen Farmalider. For example:

• Anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• Blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Some other medicines may also be affected by or affect treatment with Ibufen for children with orange flavour. Therefore, always consult a doctor or pharmacist before using Ibuprofen Farmalider with other medicines.
Increased effect with possible increased risk of adverse effects:

• Acetylsalicylic acid and other non-steroidal anti-inflammatory pain-relieving medicines, as well as glucocorticoids (medicines containing cortisone or cortisone-like substances), may increase the risk of gastrointestinal bleeding.
• Methotrexate (used in cancer treatment and certain rheumatic diseases): administration of ibuprofen within 24 hours before or after methotrexate may increase methotrexate concentrations and intensify adverse effects.
• Anticoagulant medicines (blood thinners), e.g. warfarin.
• Digoxin (used to strengthen the heart), phenytoin (used to treat seizures), or lithium (used in the treatment of certain psychiatric disorders); ibuprofen may increase blood levels of these medicines. Blood level monitoring is usually not required if the medicine is used according to instructions (not longer than 3 or 4 days).
• Antiplatelet medicines and selective serotonin reuptake inhibitors/SSRIs (medicines used to treat depression) may also increase the risk of stomach and intestinal bleeding.

Reduced effect:

• Diuretics (water pills) and blood pressure-lowering medicines: increased risk to kidneys may occur.
• ACE inhibitors (medicines used to treat heart failure and high blood pressure). Additionally, there is an increased risk of kidney failure.
• Low-dose acetylsalicylic acid: the anticoagulant effect of low-dose acetylsalicylic acid may be impaired.
• 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 blood potassium levels.
• Probenecid and sulfinpyrazone (used in the treatment of gout): may delay ibuprofen elimination. This may lead to ibuprofen accumulation and intensification of adverse effects.
• Quinolone antibiotics: increased risk of seizures may occur.
• Voriconazole, fluconazole (CYP2C9 inhibitors) (used to treat fungal infections) may increase ibuprofen blood levels. Consideration should be given to reducing the ibuprofen dose, especially when high doses of ibuprofen are used with voriconazole or fluconazole.
• Sulfonylurea derivatives (medicines used to treat diabetes): NSAIDs may enhance the hypoglycaemic effect of sulfonylurea derivatives. As a precaution, blood glucose levels should be monitored during combination therapy.
• Tacrolimus: if these two medicines are used together, kidney damage may occur.
• Cyclosporine (an immunosuppressive medicine): kidney damage may occur.
• Cholestyramine (used to lower cholesterol levels): delayed and limited (25%) absorption of ibuprofen. These medicines should be administered at least two hours apart.
• Zidovudine (used to treat HIV/AIDS infection): increased risk of joint effusion and petechiae in HIV-positive patients with haemophilia.
• Aminoglycosides (antibiotics): may slow elimination of aminoglycosides and intensify their toxicity.
• Herbal extracts: Ginkgo biloba (used to treat dementia) may increase bleeding risk.

Ibuprofen may alter results of certain laboratory tests:
Inform your doctor if you are undergoing clinical tests and are taking or have recently taken ibuprofen, as it may affect test results.
Ibuprofen Farmalider and alcohol
Alcohol should be avoided during ibuprofen treatment, as it may intensify adverse effects of ibuprofen, especially on the stomach, intestines or brain.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
If a patient becomes pregnant during ibuprofen treatment, inform the doctor.
Do not take Ibuprofen Farmalider if you are in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may result in delivery occurring later or lasting longer than expected. Do not take Ibuprofen Farmalider during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest dose for the shortest possible time. If Ibuprofen Farmalider is used for longer than a few days beyond week 20 of pregnancy, it may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
The active substance ibuprofen and its metabolites pass into breast milk only in small amounts. Since adverse effects on the infant are not fully known, breastfeeding need not be interrupted during short-term use at the recommended dose for treatment of mild to moderate pain or fever.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may cause fertility disorders in women. This effect is reversible and resolves after discontinuation of the medicine.
Driving and operating machinery
During ibuprofen use, adverse effects such as fatigue or dizziness may occur. As a result, some individuals may experience impaired reaction ability, ability to actively participate in road traffic, and ability to operate machinery. This is especially true when combined with alcohol, which intensifies these effects.
Ibuprofen Farmalider contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Ibuprofen Farmalider

This medicine should always be taken according to the recommendations of a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist, or nurse.
For short-term use only.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary
to control symptoms.
Recommended dose:
The dose corresponds to the detailed information provided in the table below.

The interval between consecutive doses should be determined according to symptoms and taking into account the maximum daily dose. The interval between doses should not be shorter than 6 hours. The recommended maximum daily dose must not be exceeded.

If it is necessary to use this medicinal product for more than 3 days in adolescents over 12 years of age, or if symptoms worsen, consult a physician.

If it is necessary to use this medicinal product for more than 3 days in case of fever or more than 4 days in case of pain treatment in adults, or if symptoms worsen, consult a physician.

Use in children
Ibuprofen Farmalider must not be used in adolescents with body weight below 40 kg or in children under 12 years of age.

Method of administration
Oral use. Tablets should be swallowed whole with a glass of water.

Patients with sensitive stomach are advised to take Ibuprofen Farmalider during meals.

Use of a higher than recommended dose of Ibuprofen Farmalider
If a patient has used a higher than recommended dose of Ibuprofen Farmalider or if a child has accidentally ingested the medicinal product, seek immediate advice from a physician or go to the nearest hospital for assessment of potential health risks and guidance on necessary actions.

Symptoms may include nausea, stomach pain, vomiting (blood traces may be present), headache, tinnitus, confusion and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, feeling of cold and breathing difficulties may occur.

In case of significant overdose, seek immediate medical advice. Symptoms after acute ibuprofen overdose are usually limited to abdominal pain, nausea, vomiting and diarrhoea. Tinnitus, headache, centrally-mediated dizziness, labyrinthine dizziness and gastrointestinal bleeding may also occur.

Severe poisoning may lead to a sensation of emptiness in the head, agitation, disorientation, coma, seizures, myoclonic jerks in children, hypotension, respiratory depression, cyanosis, metabolic acidosis, increased tendency to bleeding, acute kidney failure and liver damage. In asthmatic patients, bronchial asthma may worsen.

Missed dose of Ibuprofen Farmalider
Do not take a double dose to make up for a missed dose.

If you have any further questions concerning the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen must be discontinued immediately
and medical help should be sought:

• Red, flat, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. The list below includes all known adverse effects associated with ibuprofen therapy, including those observed in patients with rheumatic conditions undergoing long-term, high-dose treatment. Frequency data, apart from very rare reports, refer to short-term use of maximum daily doses of 1200 mg of ibuprofen for oral formulations and 1800 mg for suppositories.
The following adverse effects should be noted as being largely dose-dependent, with severity varying among individual patients.
The most common adverse effects involve the gastrointestinal system. Gastric or duodenal ulcers (peptic ulcers), gastrointestinal perforation, or gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2). Cases of nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, tarry stools, blood in vomit, ulcerative inflammation of the oral mucosa, exacerbation of ulcerative colitis, and Crohn's disease have been reported after ibuprofen administration.
Gastritis (inflammation of the gastric mucosa) has been reported less frequently.
Treatment with NSAIDs has been associated with cases of edema (fluid retention), high blood pressure, and heart failure.
The use of drugs such as ibuprofen may be associated with a slightly increased risk of myocardial infarction (heart attack) or stroke.
THE MEDICINE SHOULD BE DISCONTINUED and medical advice sought immediately if the patient experiences:

• Symptoms of gastrointestinal bleeding: relatively severe abdominal pain, tarry stools, blood in stool, blood in vomit, or vomiting containing dark particles resembling coffee grounds.
• Symptoms of severe allergic reaction, e.g., skin rash, facial swelling, swelling of the tongue or throat, wheezing or shortness of breath, worsening of bronchial asthma, breathing difficulties, palpitations, drop in blood pressure leading to shock.
• Severe skin reactions, such as rashes covering the entire body; skin peeling or blister formation.

Other adverse effects
Common (may occur in 1 in 10 patients)

• Gastrointestinal symptoms, e.g., heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal blood loss, which may exceptionally lead to anemia.

Uncommon (may occur in 1 in 100 patients)

• Hypersensitivity reactions with skin rash and itching, as well as bronchial asthma attacks (possibly with a drop in blood pressure). In such cases, the physician should be informed immediately and ibuprofen discontinued.
• Central nervous system disorders, e.g., headache, dizziness, insomnia, psychomotor agitation, irritability, or fatigue.
• Visual disturbances. In such cases, the physician should be informed immediately and ibuprofen discontinued.
• Gastritis (inflammation of the gastric mucosa).
• Gastric or intestinal ulcers, sometimes with bleeding and perforation.
• Inflammation of the oral mucosa with ulcer formation, exacerbation of ulcerative colitis and Crohn's disease.
• Skin rash, urticaria, pruritus, purpura (including allergic purpura).

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

• Tinnitus (ringing in the ears), hearing disturbances.
• Kidney tissue damage (papillary necrosis), particularly after prolonged use, increased blood uric acid levels.

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

• Worsening of inflammatory conditions related to infection (e.g., necrotizing fasciitis). If signs or symptoms of infection appear or worsen during ibuprofen use (e.g., redness, swelling, high temperature, pain, and fever), immediate contact with a physician is required.
• Symptoms of meningitis (aseptic meningitis), e.g., severe headache, nausea, vomiting, fever, neck stiffness, or altered consciousness. Patients with previous autoimmune disorders (systemic lupus erythematosus and mixed connective tissue disease) appear to be at higher risk.
• Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, the drug should be discontinued immediately and medical attention sought. DO NOT attempt self-treatment with analgesics or antipyretics.
• Severe systemic hypersensitivity reactions. Symptoms may include facial swelling, swelling of the tongue or larynx with airway narrowing, shortness of breath, palpitations, drop in blood pressure, or even life-threatening shock.
• Psychotic reactions, depression.
• Reversible toxic amblyopia.
• Palpitations, heart failure, myocardial infarction.
• High blood pressure.
• Esophagitis and pancreatitis.
• Development of diaphragm-like strictures in the intestine.
• Liver function disorders or acute hepatitis. Liver failure or damage, especially with long-term use, may manifest as yellowing of the skin and eyes (jaundice), pale stools, and dark urine.
• Hair loss (alopecia).
• Photosensitivity reactions, allergic vasculitis.
• Severe skin reactions, e.g., skin rash with redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome). In isolated cases during varicella virus infection, severe skin infections with soft tissue complications may occur.
• Reduced urine output by the kidneys and fluid accumulation in the body (edema), particularly in patients with hypertension or impaired kidney function; nephrotic syndrome [fluid accumulation in the body (edema) and excessive protein in urine]; inflammatory kidney disease (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation in the body (edema), and general malaise may be signs of kidney disease or even kidney failure.

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, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, Ibuprofen Farmalider should be discontinued immediately and medical help sought without delay. See also section 2.
• Skin becomes sensitive to light
• Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
e-mail: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Farmalider

Keep this medicine out of 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 carton following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Farmalider contains

• The active substance is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Excipients: 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

What Ibuprofen Farmalider looks like and contents of the pack
Ibuprofen Farmalider is an elongated, biconvex, white coated tablet, with a division line on one side and smooth on the other. The dimensions of the coated tablets are as follows: 6 mm wide, 12 mm long and 4.2 mm thick.
The packaging material consists of blisters made of PVC/PVDC/Aluminium.
Each pack contains 20 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

02/2024