Leaflet: information for the user

Pirexin 40 mg/ml oral suspension

Ibuprofen

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Pirexin is and for what it is used

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

3. How to take Pirexin

4. Possible side effects

5. Storage of Pirexin

6. Contents of the pack and additional information

Pirexin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic treatment of fever and mild to moderate pain.

Do not take Pirexin

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, naproxen, etc., or any other component of Pirexin. These reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach 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 are in the third trimester of pregnancy.
• If you have a severe liver or kidney disease.
• If you have bleeding or clotting disorders or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirexin.

Special caution is recommended with Pirexin.

Inform your doctor:

• If you have had or develop a stomach ulcer, bleeding, or perforation in the stomach or duodenum, which may manifest as intense or persistent abdominal pain and/or black stools, even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider adding a stomach protector medication.

• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart condition or high blood pressure.
• 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. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.
• If you are taking anticoagulants (blood thinners) or have bleeding or clotting disorders, or are taking medications that affect blood clotting, such as aspirin, warfarin, or ticlopidine. If necessary, your doctor will perform blood clotting tests.
• If you have Crohn's disease or ulcerative colitis, as Pirexin-type medications may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor will need to 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 meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the need for ibuprofen treatment.
• If you have an infection; see the "Infections" section below.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• It is recommended to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Allergic reactions

Signs of allergic reaction to ibuprofen have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Pirexin immediately and contact your doctor or emergency medical services if you observe any of these signs.

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 Pirexin if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Infections

Pirexin may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Pirexin 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 skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Skin Reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Stop Pirexin treatment and seek medical attention immediately if you notice any of these severe skin reaction symptoms.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer Pirexin 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, the administration of Pirexin is contraindicated.

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

Use of Pirexin with other medications

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

• Pirexin may affect or be affected by other medications. For example:Anticoagulants (e.g., for blood clotting problems, e.g., aspirin, warfarin, ticlopidine).
• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
• Corticosteroids such as prednisone and prednisolone.
• Selective serotonin reuptake inhibitors (used in depression).
• Other NSAIDs such as aspirin.
• 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 conditions).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Diuretics (medications used to increase urine production).
• 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 cyclosporine (used in organ transplants to prevent rejection).
• 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).
• Zidovudine (medication used to treat HIV/AIDS).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts (from the Ginkgo biloba tree).

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

Interference with laboratory tests

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).
• With liver function tests: increased values of transaminases.

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

Taking Pirexin with food and beverages

It is recommended to take Pirexin with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pirexin should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women).

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during lactation.No interruption of breastfeeding is necessary for a short treatment with the recommended dose for pain and fever.

Driving and operating machinery

If you only take one dose of Pirexin or take it for a short period, no special precautions are necessary.

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

Pirexin contains azorubine (E-122), maltitol liquid (E-965), sodium benzoate (E-211), and sodium (as sodium benzoate, sodium citrate, sodium chloride, and sodium saccharin).

This medication:

Contains azorubine (E-122), which may cause allergic reactions. It may cause asthma, especially in patients allergic to aspirin.

Contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 2.5 g of maltitol liquid (E-965) per 5 ml dose. Caloric value: 2.3 kcal/g of maltitol.

Contains 1 mg of sodium benzoate (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

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

Pirexin is an oral suspension for administration. It can be administered directly or diluted in water.

For an exact dosage, the containers contain a 5-milliliter oral syringe. The syringe is inserted into the perforated cap, the bottle is turned upside down, and the plunger is pulled until the liquid reaches the corresponding milliliter (ml) mark, the bottle is returned to its initial position, and the syringe is removed.

The syringe must be cleaned and dried after each use.

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

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four doses.

It is recommended not to exceed the maximum daily dose of 40 mg/kg of body weight of ibuprofen.

The use of this medication is not recommended in children under 3 months.

The interval between doses will depend on the evolution of symptoms, but it will never be less than 4 hours.

However, as a guideline, the following dosing schedule is recommended:

Adults and adolescents (over 12 years):

The recommended dose is 5 to 10 ml 3 times a day (up to 1,200 mg of ibuprofen in 24 hours).

Patients with kidney and/or liver diseases:

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

Older patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, you can only increase the dose once your doctor has confirmed that you tolerate the medication well.

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

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

If you take more Pirexin than you should

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

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody mucus), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures.At high doses, symptoms of numbness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, bloody urine, low potassium levels in the blood, chills, and breathing problems may occur. Furthermore, the prothrombin time with INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. Low blood pressure and reduced respiration may also occur.

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

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying may be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Pirexin

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

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

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

The side effects of medicines like Pirexin are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (in more than 1 in 10 patients); common (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (less than 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with medicines like Pirexin are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, vomiting blood, mouth ulcers, worsening of ulcerative colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation that usually produces diarrhea with blood) have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Uncommon: mucosal inflammation of the mouth with the formation of ulcers. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis that presents with diarrhea with blood). Very rare: pancreatitis.

Cardiovascular:

Medicines like Pirexin may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines of the type Pirexin.

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

Cutaneous:

Medicines like Pirexin may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome(widespread erosions that affect the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk)and toxic epidermal necrolysis(erosions on mucous membranes and painful lesions with necrosis and skin detachment).Other side effects are: Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), skin reactions influenced by light, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur. Frequency not known: skin becomes sensitive to light, a severe skin reaction called DRESS syndrome may also occur. DRESS syndrome symptoms 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 on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Pirexin if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness or feeling of instability. Rare:paresthesia (numbness, tingling, aching, etc. more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges that 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 some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor.The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: vision disturbances. Rare: abnormal or blurred vision.

Haematological:

Rare: thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin),granulocytopenia (decrease in a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (bone marrow insufficiency to produce different types of cells) or 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, nasal bleeding, and skin bleeding.Very rare: prolonged bleeding time.

Renal::

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder) nephrotic syndrome (characterized by protein in the urine and body swelling) and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Heptatic::

Medicines like Pirexin may be associated, in rare cases, with liver damage.Other rare side effectsare: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Frequency not known: liver insufficiency (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

Until now, severe allergic reactions have not been reported with Pirexin, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension(lower than usual blood pressure)or shock.

If any of the side effects listed below appear, stop treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, swelling of the face, chest tightness, or difficulty breathing.
• Red spots not elevated, in the shape of a target or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• Vomiting blood or coffee ground-like vomit.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Severe headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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.

Store in a dry and cool place.

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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Pirexin

- The active ingredient is ibuprofen, each ml of suspension contains 40 mg of ibuprofen.

- The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate (E-331), sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), strawberry flavor, taumatine (E-957), azorubine (E-122) and purified water.

Appearance of the product and contents of the packaging

Bottle made of topaz-colored polyethylene terephthalate (PET) containing an oral suspension of pink color, with a strawberry smell and taste.

Includes a 5 ml oral graduated syringe.

It is presented in packaging of 30, 100 and 150 ml.

Only some sizes of packaging may be commercially marketed.

Other available presentations

Pirexin 20 mg/ml in a 200 ml packaging.

Holder of the marketing authorization and responsible for manufacturing.Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona. Spain.

Responsible for manufacturing:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) - Spain

O

Laboratorios ERN, S.A.

C/Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain.

Last review date of this leaflet: October 2024.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.