Geloprofen 400 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Geloprofen 400 mg film-coated tablets

ibuprofen

Read the entire leaflet carefully before starting to take this medicine because it contains important information for you.

Follow exactly the instructions for use of 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 additional information or advice, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet (see section 4).
• You must consult a doctor if you worsen or do not improve, if fever persists for more than 3 days, or pain for more than 3 days in adolescents or 5 days in adults.

Contents of the leaflet

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

1. What Geloprofen is and what it is used for

Geloprofen contains ibuprofen as the active substance 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 of age (weighing more than 40 kg) for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (muscle strains), or back pain (lumbago), and in febrile conditions.

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

Do not take Geloprofen

• if you are allergic to ibuprofen, to other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other components of this medicine (listed in section 6). Signs of allergy may include skin rash with itching,

  swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.

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

• if you are vomiting blood

• if you have black stools or bloody diarrhoea

• if you have severe heart failure

• if you suffer from serious liver or kidney disease

• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary

to use anticoagulant medicines at the same time, your doctor will perform blood coagulation tests.

• if you are in the third trimester of pregnancy
• if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

Warnings and precautions

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

• if you have oedema (fluid retention)
• if you have or have had heart problems or high blood pressure
• if you suffer from asthma or any other respiratory disorder
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular checks
• if you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to kidney failure due to dehydration. In dehydrated adolescents, there is a risk of impaired kidney function.
• if you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is greater when high doses or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients
• if you are taking concomitant medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs)
• if you suffer from Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions
• if you are taking diuretics (medicines to increase urine output), because your doctor should monitor your kidney function
• if you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur
• if you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so that your doctor can assess whether treatment with ibuprofen is appropriate
• inform your doctor if you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, thereby complicating diagnosis
• if you suffer from headaches after prolonged treatment, do not take higher doses of the medicine
• allergic reactions may occur with this medicine. Signs of allergic reaction to ibuprofen have been reported, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Stop using Geloprofen 400 mg film-coated tablets immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
  • Serious skin reactions have been reported with this medicine, including 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), associated with ibuprofen treatment. Discontinue treatment with Geloprofen 400 mg film-coated tablets and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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• your doctor will carry out stricter monitoring if you receive ibuprofen after major surgery
• it is advisable not to take this medicine if you have chickenpox
• if you have an infection; see the section "Infections" below

It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.

Skin reactions

Serious skin reactions have been reported with this medicine. Stop taking this medicine and see a doctor immediately if you develop any skin rash, lesions of mucous membranes, blisters or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic 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.

You should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA")
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke

Children and adolescents

There is a risk of kidney damage in dehydrated adolescents

Pregnancy and fertility precautions

Because administration of ibuprofen-type medicines has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that ibuprofen-type medicines have been associated with a reduced ability to conceive.

Infections

This medicine may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia

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and in bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Other medicines and Geloprofen

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

This medicine may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding
• Antiplatelet agents (prevent blood clots or thrombi in blood vessels) such as ticlopidine
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• Cholestyramine (a medicine used to treat high cholesterol)
• Selective serotonin reuptake inhibitors (used in depression)
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine
• Mifepristone (abortion-inducing agent)
• Digoxin and cardiac glycosides (used to treat heart disorders)
• Hydantoins such as phenytoin (used to treat epilepsy)
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
• Corticosteroids such as cortisone and prednisolone
• Diuretics (medicines used to increase urine output), as this may increase the risk of kidney toxicity
• Pentoxifylline (used to treat intermittent claudication)
• Probenecid (used in patients with gout or together with penicillin in infections)
• Quinolone antibiotics such as norfloxacin
• Sulfinpyrazone (for gout)
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
• Zidovudine (an anti-HIV medicine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan)
• Thrombolytics (medicines that dissolve clots)
• Aminoglycoside antibiotics such as neomycin
• Herbal extracts: Ginkgo biloba
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections)

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Other medicines may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medicines.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.

Taking Geloprofen with food, drinks and alcohol

It is recommended to take this medicine with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not drink alcohol, as this may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding and fertility

The use of this medicine is not recommended in women who are trying to become pregnant. 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.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section "Pregnancy and fertility precautions").

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not necessary.

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring heightened alertness, such as driving and operating machinery. This is particularly relevant when combined with alcohol.

Geloprofen contains lactose and sodium.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to use Geloprofen

Follow exactly the administration instructions for this medicine as stated in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

This medicine is administered orally.

For occasional use only and for limited periods.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

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

Recommended dose:

Adults and adolescents over 12 years of age (over 40 kg body weight): 1 tablet of 400 mg every 6–8 hours, if necessary. Do not take more than 3 tablets (1200 mg of ibuprofen) in 24 hours.

Elderly patients (>65 years): your doctor will indicate the dose you should take, as you may require a reduction from the usual dose.

Patients with kidney, liver, or heart impairment: your doctor will indicate the dose you should take, as you may require a reduction from the usual dose.

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

Administration of the medicine should only occur when pain or fever appear. Once these symptoms subside, treatment should be discontinued.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

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

If you take more Geloprofen than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhea, headache, rapid involuntary eye movements, tinnitus, and confusion. Agitation or disorientation may also occur. At high doses, gastrointestinal bleeding, hypotension, metabolic acidosis, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), coma, weakness, dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties may be reported. Additionally, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, bleeding from the stomach and intestine, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatic patients.

If you forget to take Geloprofen

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

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

If you stop taking Geloprofen

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 will experience them.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or skin tingling, urticaria, purpura (purple skin spots), hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), and somnolence, insomnia, anxiety, hearing disorders, vision disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, oedema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting 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. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as breathing difficulty and skin pallor), neutropenia (reduced neutrophils), agranulocytosis (severe reduction in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, pseudoinfluenza symptoms, extreme fatigue, bleeding and unexplained bruising.

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

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

• Frequency not known (cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea).

A serious skin reaction known as DRESS syndrome (an acronym in English) 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 located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

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

If any of the following adverse effects occur, stop treatment and seek immediate medical attention:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• Severe stomach pain.
• Blisters or extensive peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of limbs or fluid accumulation in arms or legs.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the centre, 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].
• Generalized skin rash, high body temperature, and enlarged 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).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Geloprofen

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

Do not store above 30 ºC.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Geloprofen

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.

• The other excipients are:

Tablet core: sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, corn starch, colloidal anhydrous 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 contents of the pack

White, oblong, biconvex tablets, scored on both sides. Packaged in aluminum-PVC/PVDC blisters containing 12 or 20 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Manufacturer

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid (Spain)

Local Representative:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona (Spain)

Date of latest revision of this package leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

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