IBUPROFEN FAIRMED 600 mg FILM-COATED TABLETS

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

Ibuprofen Fairmed contains the active ingredient ibuprofen. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen relieves pain and has an anti-inflammatory effect.

In adults and adolescents from 15 years of age (≥50 kg body weight), it is used for the symptomatic treatment of pain and inflammation in arthritic diseases (e.g., rheumatoid arthritis), degenerative arthritic conditions (e.g., osteoarthritis), and painful swelling and inflammation after soft tissue injuries.

2. What you need to know before taking Ibuprofen Fairmed

Do not take Ibuprofeno Fairmed:

• if you are allergic to ibuprofen or any of the other ingredients of this medication (listed in section 6),
• if you have ever had an allergic reaction (such as bronchospasm [contraction of lung muscles that can cause asthma and difficulty breathing], asthma attacks, nasal discharge, inflammation of the nasal passages, skin rash, or sudden swelling of the face) after taking acetylsalicylic acid or other similar analgesics (NSAIDs),
• if you have severe liver, kidney, or heart failure,
• if you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility"),
• if you have a history of ulcers (peptic ulcers) or recurrent gastrointestinal bleeding or currently have one (at least 2 distinct episodes with confirmed ulcers or bleeding),
• if you have a history of gastrointestinal bleeding or perforation associated with previous NSAID treatment,
• if you have cerebral bleeding (cerebrovascular hemorrhage) or other bleeding,
• if you are severely dehydrated (e.g., due to vomiting, diarrhea, or insufficient fluid intake),
• if you have unexplained blood formation disorders,
• if you have a disease that increases the tendency to bleeding.

Warnings and precautions

Anti-inflammatory/analgesic medications like ibuprofen may slightly increase the risk of myocardial infarction or stroke, especially if used in high doses. Do not exceed the recommended dose or treatment duration.

With ibuprofen, signs of allergic reactions, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and consult your doctor or emergency services immediately if you notice any of these signs.

Pay special attention with this medication:

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 treatment. Stop using ibuprofen and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

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

• if you have heart problems, such as heart failure, angina pectoris (chest pain), or if you have had a myocardial infarction, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA"),
• • if you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker,
  • if you have liver or kidney problems. With prolonged use, it is necessary to monitor renal function, liver values, and blood count. In general, the habitual use of (various types of) analgesics can cause lasting kidney problems. This risk may increase with physical exertion and loss of salt and dehydration (e.g., caused by vomiting, diarrhea, or insufficient fluid intake),
  • if you have or have had digestive problems or chronic intestinal inflammation, i.e., colon inflammation (ulcerative colitis) or Crohn's disease,
  • if you need to be cautious when taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood-thinning medications (e.g., warfarin), selective serotonin reuptake inhibitors (a medication for depression), or antiplatelet agents (e.g., acetylsalicylic acid),
  • if you are taking another NSAID (e.g., COX-2 inhibitors like celecoxib or etoricoxib), as they should be avoided together (see section "Other medications and Ibuprofen Fairmed"),
  • if you have a mixed connective tissue disease (an autoimmune disease) or systemic lupus erythematosus (an autoimmune disease),
  • if you have a certain hereditary blood formation disorder (e.g., acute intermittent porphyria),
  • if you have coagulation disorders,
  • if you have recently undergone major surgery,
  • if you have or have had asthma or any allergic disease, as it may cause breathing difficulties,
  • if you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called analgesic asthma), Quincke's edema, or hives,
  • if you are dehydrated, as there is a risk of kidney failure, especially in adolescents and elderly patients who are dehydrated,
  • if you have an infection; see the section "Infections" below,
  • if the prolonged use of any type of pain relievers for headaches may worsen it. If you experience or suspect this situation, you should seek medical advice and discontinue treatment.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. You should stop taking ibuprofen and seek immediate medical attention if you develop skin rashes, mucosal lesions, blisters, and other signs of allergy, as they can be the first signs of a severe skin reaction. See section 4.

The risk of side effects is minimized by using the minimum effective dose for the shortest possible time. Elderly patients are at a higher risk of side effects from NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Do not use different pain relievers at the same time unless your doctor has instructed you to do so.

Gastrointestinal bleeding, ulcers, or perforation, potentially with a fatal outcome, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. If gastrointestinal bleeding or an ulcer occurs, treatment should be discontinued immediately. The risk of bleeding, ulcers, or perforation of the gastrointestinal tract is higher with higher doses of NSAIDs in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 2 "Do not take Ibuprofeno Fairmed"), and in elderly patients. These patients should start treatment with the minimum available dose. For these patients, combination treatment with gastric protectors (e.g., misoprostol or proton pump inhibitors) should be considered, as well as for patients who require concomitant low-dose acetylsalicylic acid or other medications that may increase the gastrointestinal risk.

Patients with a history of gastrointestinal toxicity, and particularly elderly patients, should report the occurrence of any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of treatment.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia 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. During chickenpox, it is recommended to avoid using this medication.

Consult a doctor if you are concerned about any of the conditions mentioned.

Children and adolescents

There is a risk of kidney failure in dehydrated adolescents.

Other medications and Ibuprofen Fairmed:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• anticoagulants (i.e., medications to thin the blood/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• medications to reduce high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan).

Other medications may also affect or be affected by ibuprofen treatment.

Therefore, you should always consult your doctor or pharmacist before using ibuprofen tablets with other medications.

Especially if it is one of the following medications:

Taking Ibuprofeno Fairmed with food, drinks, and alcohol

You should limit or avoid alcohol consumption while taking ibuprofen, as it may increase gastrointestinal side effects.

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 medication.

Pregnancy

Do not take ibuprofen 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 the fetus. It may affect your tendency to bleed and that of your baby and delay or prolong delivery more than expected.

Do not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, you should use the minimum dose for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus, which may reduce the amniotic fluid level surrounding the baby (oligohydramnios) or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen is excreted in breast milk, but it is unlikely to have effects on the breastfed child if used for short-term treatment. However, consult a doctor if you need to use ibuprofen more than occasionally during breastfeeding.

Fertility

The use of ibuprofen may affect fertility. It is not recommended to use ibuprofen while trying to conceive or during infertility investigation.

Driving and using machines

In general, the influence of this medication on the ability to drive and use machines is zero or insignificant. However, since higher doses may cause adverse central nervous system effects such as fatigue and dizziness, the ability to react and actively participate in road traffic and operate machines may be impaired in individual cases. This applies to a greater extent in combination with alcohol.

Ibuprofeno Fairmed contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Ibuprofeno Fairmed contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Ibuprofeno Fairmed

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rheumatic diseases and painful swelling and inflammation after soft tissue injuries

Ibuprofeno Fairmed 600mg tablets

Adults

The single dose is 300-600 mg of ibuprofen. The recommended daily dose is 1,200-1,800 mg in divided doses. An interval of at least 6 hours should be left between doses. Some patients can be maintained with 600-1,200 mg daily. In severe or acute conditions, it may be advantageous to increase the dose until the acute phase is controlled, as long as the daily dose does not exceed 2,400 mg in divided doses.

Adolescents from 15 years old (≥50 kg body weight):

The single dose is 300-600 mg of ibuprofen. The recommended daily dose is 1,200-1,800 mg in divided doses. An interval of at least 6 hours should be left between doses. Some patients can be maintained with 600-1,200 mg daily. In severe or acute conditions, it may be advantageous to increase the dose until the acute phase is controlled, as long as the daily dose does not exceed 2,400 mg in divided doses.

Children and adolescents

Ibuprofen 600 mg film-coated tablets are not indicated in adolescents with a body weight of less than 50 kg or in children or adolescents under 15 years of age.

Elderly patients

If you are an elderly patient, you will be more prone to adverse effects, especially bleeding, ulcers, and perforations in the gastrointestinal tract, which can be fatal. Your doctor will indicate the correct dose you should take, which will be the minimum possible.

Hepatic or renal impairment

If your renal or hepatic function is reduced, your doctor will indicate the correct dose you should take, which will be the minimum possible dose. Do not take this medication if you have severe hepatic or renal impairment.

Method of administration

This medication is for oral use.

Take the tablets with a glass of water.

The tablet can be divided into equal doses.

It is recommended that patients with sensitive stomachs take ibuprofen with food.

Duration of treatment

The duration of treatment is decided by the responsible doctor.

In rheumatic diseases, it may be necessary to use ibuprofen for a longer period.

If you take more Ibuprofeno Fairmed than you should

If you take more ibuprofen than you should, or if a child has taken this medication by accident, consult your doctor immediately or go to the nearest hospital for information on the risk and advice on the necessary measures to take.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see section 4 later), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, blurred vision.

Additionally, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling of cold in the body, and respiratory problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, hypotension and decreased breathing may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ibuprofeno Fairmed

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

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

Cases of fluid accumulation in the tissues (edema), arterial hypertension, and heart failure associated with NSAID treatment have been reported. Medications like ibuprofen may slightly increase the risk of suffering myocardial infarction or stroke.

The most frequently observed adverse effects affect the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforation, or bleeding, sometimes fatal, especially in elderly patients (see section 2 "Warnings and precautions"), may occur. After use, nausea, vomiting, diarrhea, flatulence, constipation, digestive discomfort, abdominal pain, tarry stools, bloody vomiting, mouth and throat ulcers (ulcerative stomatitis), worsening of existing intestinal disease (colitis or Crohn's disease), and gastritis have been reported. Less frequently, stomach mucosa inflammation (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose and duration of treatment.

• Stop taking Ibuprofeno Fairmed and consult a doctor immediatelyif you present one of the following symptoms

• severe hypersensitivity reactions (very rare: may affect up to 1 in 10,000 people). These can manifest as: swelling of the face, tongue, and throat, difficulty breathing, rapid heartbeat, decreased blood pressure, up to potentially fatal shock. If any of these symptoms occur, which can happen even during the first use, immediate medical attention is required.
• severe stomach pain, especially when starting to take ibuprofen (uncommon: may affect up to 1 in 100 people);
• black stools, bloody diarrhea, or vomiting blood (uncommon: may affect up to 1 in 100 people);
• fever, sore throat and mouth, pseudo-flu symptoms, feeling of fatigue, nosebleeds, and skin bleeding. These symptoms may be due to a reduction in the white blood cells in the body (agranulocytosis) (very rare: may affect up to 1 in 10,000 people);
• severe or persistent headache (very rare: may affect up to 1 in 10,000 people).

• red patches that are not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and pseudo-flu symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (very rare: may affect up to 1 in 10,000 people).
• generalized skin rash, elevated body temperature, enlarged lymph nodes, and increased eosinophils (a type of white blood cell) (DRESS syndrome). (Frequency not known: cannot be estimated from available data).
• Severe skin and mucous membrane disorders such as necrotic and/or erythema multiforme (very rare: may affect up to 1 in 10,000 people).
• if you have a skin rash or mucosal lesions. Severe rashes can include blisters on the skin, especially on the legs, arms, hands, and feet, which can also affect the face and lips. This can worsen, as the blisters increase in size, spread, and parts of the skin may peel off (toxic epidermal necrolysis). A severe infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscles (very rare: may affect up to 1 in 10,000 people) may also occur.
• Red, scaly, and generalized rash with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Frequency not known (cannot be estimated from available data). See also section 2.

Other possible adverse effectsthat may occur

• Very common: may affect up to 1 in 10 people

• gastrointestinal symptoms such as heartburn, abdominal pain, and nausea, diarrhea, vomiting, flatulence (gas), and constipation,
• mild gastrointestinal bleeding that, in exceptional cases, can cause anemia.

• Common: may affect up to 1 in 10 people

• central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, and fatigue,
• gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, worsening of existing intestinal disease (colitis or Crohn's disease), gastritis.

• 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),
• reduced urine output and swelling (especially in patients with arterial hypertension or reduced renal function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that can cause acute renal failure. If any of these symptoms occur or if you feel unwell, stop taking ibuprofen and consult your doctor immediately, as they could be the first signs of kidney damage or failure,
• visual disturbances.

• Rare: may affect up to 1 in 1,000 people

• tinnitus, hearing loss,
• kidney pain and/or abdominal pain, blood in the urine, and fever can be signs of kidney damage (papillary necrosis). Elevated uric acid levels in the blood, elevated urea levels in the blood.

• Very rare: may affect up to 1 in 10,000 people

• If signs of infection or worsening of infection occur during the use of ibuprofen, you should go to the doctor without delay. It should be investigated if there is an indication for anti-infective/antibiotic therapy. With ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or confusion have been observed. Patients with autoimmune disorders (systemic lupus erythematosus [SLE], mixed connective tissue disease) seem to be predisposed to these adverse effects,
• problems with blood cell production (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) eosinophilia, coagulopathy (coagulation disorders), aplastic anemia, hemolytic anemia, neutropenia - the first signs are: fever, sore throat, superficial mouth ulcers, pseudo-flu symptoms, intense exhaustion, nosebleeds, and skin bleeding. In these cases, treatment should be stopped immediately and a doctor consulted. Do not use any self-treatment with pain relievers or fever-reducing medications (antipyretics),
• hypoglycemia, hyponatremia,
• signs of severe generalized allergic reactions (hypersensitivity reactions) can be: swelling of the face, tongue, and throat, difficulty breathing, rapid heartbeat, decreased blood pressure, up to potentially fatal shock. If any of these symptoms occur, which can happen even during the first use, immediate medical attention is required,
• psychotic reactions, hallucinations, confusion, depression,
• tingling (paresthesia) and inflammation of the optic nerve (optic neuritis),
• palpitations, heart failure, myocardial infarction, edema, hypertension, and heart failure associated with NSAID treatment at high doses have been reported,
• arterial hypertension, vasculitis,
• asthma, dyspnea, bronchospasm,
• esophagitis, pancreatitis, formation of intestinal strictures of the diaphragm type. In case of relatively intense pain in the upper abdomen, vomiting blood, or black stools, treatment should be stopped and a doctor consulted.
• liver damage (the first signs can be skin discoloration), especially in prolonged treatments, liver failure, acute hepatitis, altered liver function.
• Severe skin reactions such as rashes with redness and blisters, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell syndrome), hair loss (alopecia),
• in exceptional cases, severe skin and soft tissue infections can occur during chickenpox.

• Frequency not known (cannot be estimated from available data)
  • the skin becomes sensitive to light (photosensitivity),
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome),
  • acute generalized exanthematous pustulosis (AGEP),
  • inflammation of the nasal mucosa (rhinitis),
  • Kounis syndrome,
  • renal function disorders.

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibuprofeno Fairmed

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

Do not use this medication after the expiration date shown on the blister or carton after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Fairmed

The active ingredient is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.

The other ingredients (excipients) are:

Core of the tablet:

Anhydrous colloidal silica, microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethylcellulose, talc, magnesium stearate.

Coating material:

Hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol, sodium citrate.

Appearance of the product and package contents

White, oval, biconvex film-coated tablets with the inscription "6" on one side and a score line on the other, approximately 17.7 mm long and 10.6 mm wide.

The tablet can be divided into equal doses.

Available package sizes with 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 film-coated tablets in PVC-aluminum blisters.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fairmed Healthcare GmbH

Dorotheenstrasse 48

22301 Hamburg

Germany

Manufacturer:

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:December 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).