Pirexin 40 mg/ml oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pirexin 40 mg/ml oral suspension

Ibuprofen

Read the entire 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Pirexin is and what it is used for
What you need to know before taking Pirexin
How to take Pirexin
Possible side effects
How to store Pirexin
Contents of the pack and other information

1. What Pirexin is and what it is used for

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.

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

Do not take Pirexin

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other components of Pirexin. Such reactions may include itchy skin rash, 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 diarrhoea with blood.
If you suffer from severe heart failure.
If you are in the third trimester of pregnancy.
If you have severe liver or kidney disease.
If you have bleeding disorders or blood coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines simultaneously, your doctor will perform blood coagulation tests.

Warnings and precautions

Talk to 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 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 higher when high doses are used, during prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
If you have oedema (fluid retention).
If you suffer from asthma or any other respiratory disorder.
If you have or have had heart problems or high blood pressure.
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 monitoring. Your doctor will advise you on the frequency of these 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 this specific case could lead to kidney failure due to dehydration.
If you are taking medicines that affect blood clotting, 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease or ulcerative colitis, as medicines like Pirexin may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), as kidney function should be monitored.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various 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 your doctor can assess whether treatment with ibuprofen is appropriate.
If you have an infection; see the section “Infections” below.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
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.
It is important to use the lowest dose that relieves/controls the pain and not to take this medicine longer than necessary to control your symptoms.

Allergic reactions

Signs of allergic reaction to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Pirexin immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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 Pirexin if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery 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 are a smoker.

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

Infections

Pirexin may mask signs of infection, such as fever and pain. Therefore, Pirexin may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment, 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). Discontinue treatment with Pirexin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like Pirexin has been associated with an increased risk of congenital abnormalities and 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 kept to a minimum.

Administration of Pirexin is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like Pirexin have been associated with reduced fertility.

Using Pirexin with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pirexin may affect or be affected by other medicines. For example: anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
Corticosteroids such as cortisone and prednisolone.
Selective serotonin reuptake inhibitors (used in depression).
Other NSAIDs such as aspirin.
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).
Diuretics (medicines used to increase urine output).
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).
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
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 blood clots).
Zidovudine (an anti-HIV medicine).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts (from Ginkgo biloba tree).

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

Interference with laboratory tests

Taking 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 a clinical laboratory test and are currently taking or have recently taken ibuprofen.

Taking Pirexin with food and drinks

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

Pregnancy, breastfeeding 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 medicine.

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

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended. It is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

Driving and using machines

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

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

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

This medicine:

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

Contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine. It may have a mild laxative effect because it contains 2.5 g of maltitol liquid (E-965) per 5 ml dose. Calorific 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 of age).

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

3. How to take Pirexin

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Pirexin is an oral suspension. It may be taken directly or diluted in water.

For accurate dosing, the packaging contains a 5-milliliter graduated oral syringe. The syringe is inserted into the pierced cap, the bottle is inverted, and the plunger is pulled until the liquid reaches the corresponding milliliter (ml) mark. Then, return the bottle to its upright position and remove the syringe.

The syringe should be cleaned and dried after each use.

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

Children:

The dose of ibuprofen administered depends on the child's age and weight. Generally, for children from 3 months to 12 years of age, 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 per kg of body weight of ibuprofen.

This medicine is not recommended for children under 3 months of age.

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

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

Age/Weight	Frequency	Dosage	Maximum daily dose
Children 3 to 6 months Approx. 5 to 7.6 kg	3 times a day	1.25 ml (50 mg) per dose	3.75 ml (150 mg)
Children 6 to 12 months Approx. 7.7 to 9 kg	3 to 4 times a day	1.25 ml (50 mg) per dose	3.75–5 ml (150–200 mg)
Children 1 to 3 years Approx. 10 to 15 kg	3 to 4 times a day	2.5 ml (100 mg) per dose	7.5–10 ml (300–400 mg)
Children 4 to 6 years Approx. 16 to 20 kg	3 to 4 times a day	3.75 ml (150 mg) per dose	11.25–15 ml (450–600 mg)
Children 7 to 9 years Approx. 21 to 29 kg	3 to 4 times a day	5 ml (200 mg) per dose	15–20 ml (600–800 mg)
Children 10 to 12 years Approx. 30 to 40 kg	3 to 4 times a day	7.5 ml (300 mg) per dose	22.5–30 ml (900–1200 mg)

Adults and adolescents (over 12 years of age):

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

Patients with kidney and/or liver disease:

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

Elderly patients:

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

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

If you think that the effect of this medicine 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 medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as numbness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time with INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. Low blood pressure and reduced breathing may also occur.

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

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

If you forget to take Pirexin

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

4. Possible adverse effects

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

Adverse effects of medicines such as Pirexin are more common in people over 65 years of age.

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

Frequencies are defined according to the following classification: very common (in more than 1 out of every 10 patients); common (in 1 to 10 out of every 100 patients); uncommon (in 1 to 10 out of every 1,000 patients); rare (in 1 to 10 out of every 10,000 patients); very rare (in fewer than 1 out of every 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as Pirexin are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting blood, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) have also been observed. Less frequently, gastritis has been reported.

Other adverse effects include: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophagitis, esophageal narrowing (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis presenting with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using Pirexin-type medicines.

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

Dermatological:

Medicines such as Pirexin may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis). Other adverse effects include: 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), photosensitivity reactions, inflammation of blood vessels in the skin. Severe skin infections and soft tissue complications during chickenpox may exceptionally occur. Frequency not known: skin becomes sensitive to light; a serious skin reaction known as DRESS syndrome may also 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, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue Pirexin immediately if you experience these symptoms and seek medical attention promptly. See also section 2.

Immune system:

Uncommon: transient swelling of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi restricting airflow to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the 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 unsteady. Rare: paresthesia (numbness, tingling, "pins and needles," more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had an underlying autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included 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: tinnitus (ringing or buzzing in the ears). Rare: hearing impairment.

Ocular:

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

Hematological:

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (failure of bone marrow to produce various blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medicines such as Pirexin may, rarely, be associated with liver injury. Other rare adverse effects include: hepatitis (liver inflammation), abnormal liver function tests, and jaundice (yellowing of the skin and eyes). Frequency not known: liver failure (severe liver impairment).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Pirexin, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
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 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 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. Storage of Pirexin

Keep this medicine out of sight and reach of children.

Store in a dry and cool place.

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

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

6. Contents of the pack and other information

Composition of Pirexin

The active substance 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 flavour, thaumatin (E-957), azorubine (E-122) and purified water.

Appearance of the product and contents of the pack

Brown PET polyethylene bottle containing a pink oral suspension with a strawberry odour and taste.

Includes a 5 ml graduated oral syringe.

Available in pack sizes of 30 ml, 100 ml and 150 ml.

Only some pack sizes may be commercially available.

Other presentations available

Pirexin 20 mg/ml in a 200 ml pack.

Marketing Authorization Holder and Manufacturer. Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain.

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) - Spain

Laboratorios ERN, S.A.

C/Gorgs Lladó, 188

08210 Barberà del Vallès, Barcelona, Spain.

Date of the most recent review of this leaflet: October 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/.