IBUPROFENO PHARMEX 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofeno Pharmex 20 mg/ml Oral Suspension

Ibuprofeno

Contents of the Package Leaflet:

1. What is Ibuprofeno Pharmex 20 mg/ml Oral Suspension and what is it used for.
2. What you need to know before taking Ibuprofeno Pharmex 20 mg/ml Oral Suspension.
3. How to take Ibuprofeno Pharmex 20 mg/ml Oral Suspension.
4. Possible side effects.
5. Storage of Ibuprofeno Pharmex 20 mg/ml Oral Suspension.
6. Package Contents and Additional Information.

1. What is Ibuprofeno Pharmex 20 mg/ml Oral Suspension and what is it used for

Ibuprofeno Pharmex 20 mg/ml Oral Suspension 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 infants over 3 months and children up to 12 years for the symptomatic relief of mild or moderate occasional pain, as well as in febrile conditions.

2. What you need to know before taking Ibuprofeno Pharmex 20 mg/ml Oral Suspension

Do not take Ibuprofeno Pharmex 20 mg/ml Oral Suspension:

• If you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. Allergic reactions may be: 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 (medicines 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

Tell your doctor:

• 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 medicine, 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 medicine 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.
• 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 higher 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-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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 type Ibuprofeno Pharmex 20 mg/ml Oral Suspension may worsen these conditions.
• If you are being treated with diuretics (medicines used 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 (inflammation of the meninges 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 important that you use the smallest dose that relieves-controls the pain and do not take this medication for longer than necessary to control your symptoms.

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 this medication 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).

Children and Adolescents

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

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

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

Other Medications and Ibuprofeno Pharmex 20 mg/ml Oral Suspension

Tell your doctor or pharmacist if you are using or have recently used any other medication, even those purchased without a prescription.

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

• Other non-steroidal anti-inflammatory drugs like aspirin, as the risk of ulcer and gastrointestinal bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications, e.g., to treat coagulation problems/prevent coagulation, (e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Colestyramine (medication used to treat high cholesterol)
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production), as the risk of kidney toxicity may increase.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as hypoglycemia may occur.
• 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 (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat 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 Ibuprofeno Pharmex 20 mg/ml Oral Suspension with other medications.

Taking ibuprofen may alter the following laboratory tests:

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

Tell your doctor if you are going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Pharmex 20 mg/ml Oral Suspension with Food, Drinks, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility

The use of this medication 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 medication. You should not take ibuprofen during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

This applies to a greater extent to the combination with alcohol.

Ibuprofeno Pharmex 20 mg/ml Oral Suspension contains sodium benzoate (E-211),liquid maltitol (E-965),and sodium.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may have a slight laxative effect because it contains 0.25 g of liquid maltitol per ml of oral suspension. Caloric value: 0.575 Kcal per ml of oral suspension.

It contains 1.84 mg (0.8 mmol) of sodium per milliliter, which should be taken into account in the treatment of patients with low-sodium diets.

This medication contains 200 mg of sodium benzoate per ml of oral suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Infections

Ibuprofeno Pharmex 20 mg/ml Oral Suspension may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Pharmex 20 mg/ml Oral Suspension may delay 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 your doctor without delay.

3. How to take Ibuprofeno Pharmex 20 mg/ml oral suspension

Follow the administration instructions of this medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Only for occasional use and for limited periods.

Adverse effects can be minimized by using the smallest dose that relieves symptoms for the shortest necessary time.

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

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the child's age and weight.

As a general rule, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the intensity of symptoms, and is divided into three doses.

The use of this medication in children under 2 years of age should always be done under medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a schedule of 4 daily doses. In this case, the maximum daily doses (see last column of the previous table) should not be exceeded in 24 hours. The dose to be administered at each dose, every 6 hours, will be recalculated/reduced proportionally.

The use of this medication is not recommended in children under 3 months or with a weight below 5 kg.

Patients with kidney, liver, or heart disease: should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe cardiac, renal, or hepatic failure.

If this medication needs to be used for more than 3 days or if symptoms worsen in children from 6 months to 12 years, a doctor should be consulted.

In children aged 3 to 5 months, a doctor should be consulted if symptoms worsen or persist after 24 hours.

Method of administration

Ibuprofeno Pharmex 20 mg/ml oral suspension is an oral suspension for administration by mouth. It can be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the perforated cap opening
3. Invert the bottle and withdraw the necessary dose
4. Administer the contents of the syringe directly into the mouth or into a spoon.
5. The syringe should be washed after each dose and can be sterilized by boiling in water or soaking in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur when taking the oral suspension of ibuprofen; make sure the bottle has been shaken well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals.

Administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

If you take more Ibuprofeno Pharmex 20 mg/ml oral suspension than you should

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

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate).

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

If you forget to take Ibuprofeno Pharmex 20 mg/ml oral suspension

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

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them. The incidence of adverse 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 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 with blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon adverse effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), hypersensitivity, paresthesia (sensation of numbness, tingling, or prickling, more frequent in hands, feet, arms, or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body), and renal failure (sudden loss of kidney function) have also been reported.

• Rare adverse effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, 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, 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, decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which 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, pseudo-flu symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• 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 at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation-related infections has been observed with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Frequency not known(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 usually produces bloody diarrhea).

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).

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 material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. 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 medication.

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5. Conservation of Ibuprofeno Pharmex 20 mg/ml oral suspension

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Do not use this medication if you observe that the medication is not white in color, has no orange odor, or, after shaking, its appearance is not uniform.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 Pharmex 20 mg/ml oral suspension

• The active ingredient is ibuprofen. Each 1 ml of suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: glycerol (E-422), liquid maltitol (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate (E-331), sodium benzoate (E-211), polysorbate 80, sodium saccharin (E-954), orange flavor, and purified water.

Appearance of the product and package contents

White oral suspension with an orange odor. It is presented in a topaz-colored bottle containing 200 ml of oral suspension. Each package includes a 5-milliliter dosing syringe graduated in milliliters.

Marketing authorization holder

PHARMEX ADVANCED LABORATORIES S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Manufacturer

BASI-INDUSTRIA FARMACEUTICA, S.A.

Rua Do Padrao nº 98 (Coimbra) – 3000-312 – Portugal.

Date of the last revision of this prospectus:October 2018

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