Package Leaflet: Information for the User

Geloprofen 400 mg Film-Coated Tablets

ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

- Keep this leaflet. You may need to read it again.

- If you need more information or advice, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

-You should consult a doctor if you get worse or do not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

1. What is Geloprofen and what it is used for

2. What you need to know before starting to take Geloprofen

3. How to take Geloprofen

4. Possible side effects

5. Storage of Geloprofen

6. Contents of the pack and additional information

Geloprofen contains ibuprofen as the active ingredient and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in adults and adolescents over 12 years old (weight above 40 kg) for the symptomatic relief of occasional mild or moderate pain, such as headache, toothache, menstrual pain, muscle cramps, or back pain (lumbago), and in febrile states.

Do not take Geloprofen

•if you are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other components of this medication (listed in section 6). Allergic reactions may include:

skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.

•if you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract

• If you vomit blood.

• If you have black stools or bloody diarrhea.

• if you have severe heart failure

• if you have a severe liver or kidney disease.

•if you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.

• if you are in the third trimester of pregnancy

•if you have severe dehydration (caused by vomiting, diarrhea or inadequate fluid intake).

Warnings and precautions

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

• if you have edema (fluid retention)

• if you have or have had any heart problems or high blood pressure.

• if you have asthma or any other respiratory problems.

•if you have kidney or liver disease, are over 60 years old or need to take the medication for a prolonged period (more than 1-2 weeks), your doctor may need to perform regular checks.

•if you present symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case may cause kidney failure as a consequence of dehydration. In dehydrated adolescents, there is a risk of renal function deterioration.

•if you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may manifest by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease and in elderly patients.

•if you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents (e.g. acetylsalicylic acid), corticosteroids and selective serotonin reuptake inhibitors (SSRIs). You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and SSRIs.

•if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.

•if you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.

•if you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis.

•if you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the advisability of treatment with ibuprofen.

•inform your doctor if you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult.

•if you experience headaches after prolonged treatment, do not take higher doses of the medication.

• it is possible that you may experience allergic reactions with this medication.With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Geloprofen 400mg film-coated tablets immediately and contact your doctor or emergency medical services if you observe any of these signs.

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•Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.

• it is not recommended to take this medication if you have chickenpox.

• if you have an infection; see the "Infections" heading below.

It is essential to use the smallest dose that relieves/controls pain and not to take this medication for longer than necessary to control your symptoms.

Severe skin reactions

Severe skin reactions have been reported in association with this medication. Stop taking this medication and see your doctor immediately if you experience any skin rash, membrane lesions, blisters or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking this medication if:

•you have heart problems, including heart failure, angina (chest pain) or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

•you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

Children and adolescents

There is a risk of kidney damage and adolescents who are dehydrated

Pregnancy and lactation

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Infections

This medication may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in 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.

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

This medication is administered orally.

Only for occasional use and for limited periods.

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

Patients with stomach discomfort should take the medication with milk or during meals. The tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

The recommended dose is:

Adults and adolescents over 12 years (over 40 kg of weight):1 tablet of 400 mg will be taken every 6-8 hours, if necessary. No more than 3 tablets (1200 mg of ibuprofen) should be taken in 24 hours.

Patients over 65 years:Your doctor will indicate the dose you should take, as you may need a reduction in the usual dose.

Patients with kidney, liver, or heart insufficiency:Your doctor will indicate the dose you should take, as you may need a reduction in the usual dose.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days (3 days in adolescents), you should consult a doctor.

Medication administration is subject to the appearance of pain or fever. As soon as these appear, medication should be suspended.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medication is not recommended for use in children (under 12 years) or adolescents with a weight of less than 40 kg.

If you take more Geloprofen than you should

If you have taken more medication than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Normally, symptoms of overdose occur 4 to 6 hours after ibuprofen intake.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, headache, rapid involuntary eye movements, ringing in the ears, and confusion. It may also cause agitation or disorientation. At high doses, intestinal hemorrhage, hypotension, metabolic acidosis, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), coma, weakness, and dizziness have been reported. Additionally, blood in urine, low potassium levels in the blood, chills, and breathing problems have been reported. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. In rare cases, cases of metabolic acidosis, decreased body temperature, alteration of kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe overdose has occurred, kidney insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forget to take Geloprofen

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

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at your usual time.

If you interrupt treatment with Geloprofen

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

•Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or sensation of instability, fatigue.

•Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms or legs) and somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure and papillary necrosis (especially in prolonged use) associated with increased urea.

•Rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis,

anaphylactic reaction (in case of severe generalized hypersensitivity reaction may appear facial swelling, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever or disorientation. Other side effects are thrombocytopenia, leukopenia (decrease in white blood cells, may manifest as frequent infections with fever, chills or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils) and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding and bruises.

•Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

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Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

•Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

A generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See section 2.

The skin becomes sensitive to light.

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

If any of the following side effects appear, interrupt treatment andseek medical attention immediately:

•Allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing.

•Vomiting blood or coffee ground-like material.

•Bloody stools or diarrhea with blood.

•Severe stomach pain.

•Significant blisters or peeling of the skin.

•Intense or persistent headache.

•Yellow discoloration of the skin (jaundice).

•Signs of severe hypersensitivity (see above in this section).

•Swelling of the limbs or accumulation of fluid in the arms or legs.

•Flat, red, circular patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

•Generalized skin rash, elevated 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 pustular exanthema).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30 °C

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Geloprofen

- The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.

- The other excipients are:

Tablet core: croscarmelose sodium, hypromellose, lactose, microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate, and purified water.

Coating: hypromellose, titanium dioxide (E-171), purified talc, purified water, and propylene glycol (E-1520).

Appearance of Geloprofen and content of the packaging

Oval, biconvex, scored on both sides, and white tablets. It is presented in aluminum-PVC/PVDC blisters of 12 or 20 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Responsible for manufacturing

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid (Spain)

Last review date of this leaflet:November 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/