IBUPROFENO DERMOGEN 400 mg ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Dermogen 400 mg Oral Suspension

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days (3 days in adolescents) or if you have a fever for more than 3 days.

Contents of the Package Leaflet:

1. What is Ibuprofen Dermogen and what is it used for
2. What you need to know before taking Ibuprofen Dermogen
3. How to take Ibuprofen Dermogen
4. Possible side effects
5. Storage of Ibuprofen Dermogen
6. Package Contents and Additional Information

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

This medication is used for the symptomatic relief of occasional mild or moderate pain, as well as febrile states in adults and adolescents from 12 years of age.

2. What you need to know before taking Ibuprofen Dermogen

Do not take Ibuprofeno Dermogen:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6) or to other medications of the non-steroidal anti-inflammatory drug (NSAID) group or aspirin. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.

• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
  • If you vomit blood.
  • If you have black stools or bloody diarrhea.
  • If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
  • If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
  • If you have severe heart failure.
  • If you are in the third trimester of pregnancy.

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 disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medication, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks. In case of dehydration, ensure sufficient fluid intake.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication. If a gastrointestinal bleeding or ulcer occurs, treatment should be suspended immediately.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• The concomitant administration of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 (Cox-2) inhibitors, should be avoided due to the increased risk of ulcers and bleeding.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications of the ibuprofen type may worsen these conditions.
• If you are undergoing treatment with diuretics (medications to urinate), 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 (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" section below.

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

With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno Dermogen immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Dermogen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or if you are a smoker.

Similarly, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin Reactions

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay the appropriate treatment of the infection, which may 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.

Children and Adolescents:

There is a risk of kidney damage in dehydrated children and adolescents.

Other Medications and Ibuprofeno Dermogen:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may interfere and should not be taken with ibuprofen without consulting your doctor first:

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlodipine.
• Colestyramine (used to treat high cholesterol levels).
• Selective serotonin reuptake inhibitors (used in depression).
• Other NSAIDs, including selective cyclooxygenase-2 (Cox-2) inhibitors.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone, may increase the risk of bleeding.
• Diuretics, as they may increase renal toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Ginkgo biloba tree extracts.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver, such as voriconazole and fluticonazole for treating fungal infections).

Other medications may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using this medication with other medications.

Interference with Analytical Tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Ibuprofeno Dermogen with Food, Drinks, and Alcohol:

You can take it alone or with food. In general, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Consuming alcohol during treatment may increase the risk of adverse gastrointestinal reactions.

Pregnancy, Breastfeeding, and Fertility:

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 your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. Do not take this medication during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, this medication may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or 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 checks.

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, their administration is not recommended during the first and second trimester of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible. The risk is believed to increase with the dose and duration of treatment.

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

Driving and Using Machines:

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery.

If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofeno Dermogen contains maltitol liquid (E-965), azorubine (E-122), sodium, and sodium benzoate (E-211).

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

Due to the presence of azorubine (E-122), it may cause allergic reactions.

This medication contains 58 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 2.9% of the maximum recommended daily sodium intake for an adult.

This medication contains 10 mg of sodium benzoate per sachet. Sodium benzoate may increase the risk of jaundice (yellowish skin and eye color) in newborns (up to 4 weeks of age).

3. How to Take Ibuprofeno Dermogen

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

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

For occasional use, during limited periods. The administration of the medication is subject to the appearance of pain or fever; as these disappear, the medication should be suspended.

Adults and Adolescents from 12 years of age:The recommended dose is one sachet (400 mg of ibuprofen) every 6 to 8 hours, if necessary. Do not take more than 3 sachets (1200 mg of ibuprofen) in 24 hours.

Children and Adolescents:The use of this medication is not recommended in children or adolescents weighing less than 40 kg, as the dose of ibuprofen it contains is not suitable for the recommended posology in these patients.

Elderly Patients:The posology should be established by the doctor, as it may be necessary to reduce the usual dose.

Patients with Kidney, Liver, or Heart Disease:Your doctor will indicate the dose you should take, as you may need a reduction in the usual dose.

If the pain persists for more than 5 days (3 days in adolescents) or the fever for more than 3 days, consult your doctor. If the pain or fever worsens or other symptoms appear, interrupt treatment and consult your doctor.

Method of Administration

This medication is administered orally.

Ibuprofeno Dermogen is a suspension. It should be homogenized before taking by pressing the top and bottom of the sachet with your fingers several times. The contents of the sachet can be taken directly or diluted in water or juice.

In case of gastrointestinal discomfort, it is recommended to take the medication with meals.

If you take more Ibuprofeno Dermogen than you should:

If you have taken more oral suspension than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the package leaflet of the medication to the healthcare professional.

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If a severe overdose has occurred, the doctor will take the necessary measures.

If you forget to take Ibuprofeno Dermogen:

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects of medicines like Ibuprofeno Dermogen are more common in people over 65 years of age.

The incidence of adverse effects is lower in short 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.

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

The following adverse effects have been observed:

• Frequent Adverse Effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting blood, dizziness or feeling of instability, headache, fatigue.

• Infrequent Adverse Effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs), and somnolence, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, difficulty breathing. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and 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 sounds in the ear), reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue and larynx swelling, dyspnea, tachycardia, hypotension), 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 suffered from 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 adverse effects are decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow 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, pseudogripal symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• Very Rare Adverse Effects(may affect up to 1 in 10,000 people): Pancreatitis, very severe bullous reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and detachment of the epidermis), 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.

If signs of infection or worsening of infection occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Unknown Frequency(cannot be estimated from available data):

Colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea)

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

Generalized red scaly rash, with bumps under the skin and localized blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Dermogen if you experience these symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

If any of the following adverse effects occur, discontinue treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe blisters or peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ibuprofeno Dermogen

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

Keep it in its original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno Dermogen

• The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen.
• The other excipients are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), thaumatin (E-957), strawberry flavor, azorubine (E-122), glycerol (E-422), and purified water.

Appearance of the Product and Package Contents

Rosa-colored oral suspension with characteristic strawberry odor and flavor. It is packaged in thermosealed sachets made of polyethylene, satin-finish cellulose, aluminum, and thermosensitive resin, containing 10 ml of oral suspension.

Each package contains 12 or 24 sachets. Only some package sizes may be marketed.

Marketing Authorization Holder

Dermogen Farma, S.A.

San Rafael, 3.

28108 – Alcobendas (Madrid)

Manufacturer

FARMALIDER, S.A.

La Vega, nº 6. Carriches

45532 (Toledo) Spain

Date of the Last Revision of this Leaflet:February 2025

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