APIROFENO 40 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

APIROFENE 40 mg/ml Oral Suspension

Ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Apirofene and what is it used for

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

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

2. What you need to know before you take Apirofene

Do not take Apirofene

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other ingredients of Apirofene. Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• 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 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 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.

Warnings and precautions

Special caution is recommended with Apirofene.

Tell your doctor:

• 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 prior warning symptoms.
• This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have had any heart disorder or have 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 to 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, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could cause kidney failure due to dehydration.
• 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 or ulcerative colitis, as medications of the Apirofene type may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production) because your kidney function should be monitored.
• 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.
• 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 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 stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• It is important to use the smallest dose that relieves/controls the pain and not to take this medication for longer than necessary to control your symptoms.

Allergic reactions

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 Apirofene 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 Apirofene 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).

Infections

Apirofene may hide the signs of an infection, such as fever and pain. Consequently, Apirofene 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.

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Apirofene treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because the administration of Apirofene-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 considered strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Apirofene is contraindicated.

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

Use of Apirofene with other medications

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

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

• Anticoagulant medications (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid and warfarin).
• Antiplatelet agents (prevent the 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 (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 other 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).
• Diuretics (medications used to increase urine production).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (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 against the AIDS virus).
• Aminoglycoside antibiotics such as neomycin.
• Ginkgo biloba herb extracts.

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

Interference with laboratory tests:

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after treatment is discontinued)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (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 Apirofene with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not take Apirofene 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. It is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

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

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

Apirofene contains azorubine (E-122), liquid maltitol (E-965), sodium benzoate (E-211), and sodium

This medication:

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

Contains liquid maltitol (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 have a slight laxative effect because it contains 2.5 g of liquid maltitol (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 of age).

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

3. How to take Apirofeno

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

Apirofeno is an oral suspension. It can be administered directly or diluted in water.

For exact dosing, the containers come with a graduated oral syringe. The syringe is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the mark in ml, or the equivalent in kg of the child's weight, the bottle is returned to its initial position, and the syringe is removed.

The syringe should be cleaned and dried after each use.

The syringe can be 3 or 5 ml, depending on the presentation. Including the 3 ml syringe in presentations adapted for children under 4 years (approximately less than 16 kg of weight) and the 5 ml syringe for presentations adapted for children over 4 years (approximately more than 16 kg of weight).

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

Children:

The dose of ibuprofen to be administered 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/kg of weight, divided into three or four doses.

It is recommended not to exceed the maximum daily dose of 40 mg per kg of 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 the 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 10 ml 3 times a day (equivalent to 1,200 mg of ibuprofen).

Patients with kidney and/or liver disease:

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

Elderly:

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 checked that you tolerate the medication well.

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

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you take more Apirofeno than you should

If you have taken more Apirofeno 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.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), 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, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. Additionally, the prothrombin time with INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. There may also be low blood pressure and reduced breathing.

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

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

If you forget to take Apirofeno

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 for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible side effects

Like all medications, Apirofeno can cause side effects, although not everyone will experience them.

The side effects of medications like Apirofeno are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (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 (in 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 frequent side effects that occur with medications like Apirofeno are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting blood, oral 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, the appearance of gastritis has been observed.

Other side effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal stricture, exacerbation of diverticular disease, hemorrhagic colitis. Very rare: pancreatitis.

Cardiovascular:

Medications like Apirofeno may be associated with a moderate increase in the risk of suffering a heart attack or stroke.

Edema, hypertension, and heart failure have also been observed in association with treatments with medications of the Apirofeno type.

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

Dermatological:

Medications like Apirofeno may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Other side effects are: Frequent: skin rash. Uncommon: skin redness, itching or skin swelling, purpura. Very rare: hair loss, erythema multiforme, skin reactions due to light influence, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Frequency not known: skin becomes sensitive to light, a severe skin reaction known as DRESS syndrome may also occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils. Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment. Stop taking Apirofeno 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 viscera, nasal mucosa inflammation, bronchospasm. Rare: severe allergic reactions. In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear. Very rare: joint pain and fever.

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability. Rare: paresthesia. Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease, 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:

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

Ocular:

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

Blood:

Rare: decreased platelets, decreased white blood cells, decreased red blood cells, decreased granulocytes, pancytopenia, agranulocytosis, aplastic anemia, or hemolytic anemia. The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

Based on experience with NSAIDs in general, cases of interstitial nephritis, nephrotic syndrome, and renal failure cannot be excluded.

Hepatic:

Medications like Apirofeno may be associated, in rare cases, with liver damage. Other rare side effects are: hepatitis, abnormal liver function, and jaundice. Frequency not known: liver failure.

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with Apirofeno, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, stop treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Red, non-elevated spots, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes [DRESS syndrome].
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment [acute generalized exanthematous pustulosis].
• Vomiting blood or coffee-ground-like material.
• 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 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Apirofeno

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 that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Apirofeno 40 mg/ml oral suspension

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen as the active ingredient.
• The other components (excipients) are: sodium benzoate, anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, thaumatin, strawberry flavor, azorubine, glycerol, and purified water.

Appearance of the product and package contents

Apirofeno 40 mg/ml oral suspension is a pink oral suspension. It is presented in 30, 50, 100, 150, and 200 ml containers.

The 30 and 50 ml containers come with a 3 ml graduated syringe with 1 ml divisions and 0.10 ml subdivisions.

The 100, 150, and 200 ml containers come with a 5 ml graduated syringe with 1 ml divisions and 0.20 ml subdivisions.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios ERN, S.A. C/Perú, 228 - 08020 Barcelona, Spain.

Manufacturer

Laboratorios ERN, S.A. C/Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona, Spain.

Date of the last revision of this leaflet: October 2024.

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