Apirofen 40 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

APIROFENO 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 must not be given 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.

Contents of the leaflet

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

1. What Apirofeno is and what it is used for

Apirofeno belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before taking Apirofeno

Do not take Apirofeno

• 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 ingredients of Apirofeno. Signs of allergy 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 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 concomitant use of anticoagulants is necessary, your doctor will perform blood coagulation tests.

Warnings and precautions

Special caution is recommended with Apirofeno.

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 or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing 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 perform 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 case could lead to kidney failure due to dehydration.
• If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as medicines like Apirofeno may worsen these conditions.
• If you are taking diuretics (medicines to increase urine production), because kidney function should be monitored.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect 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, which 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 monitor you more closely if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• It is important to use the lowest effective dose that relieves/controls pain and not to take this medicine longer than necessary to control your symptoms.

Allergic reactions

Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop taking Apirofeno immediately and contact your doctor or emergency medical services without delay 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 Apirofeno if:

• You have heart problems, including heart failure, angina (chest pain), a previous heart attack, coronary 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 smoke.

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

Infections

Apirofeno may mask signs of infection such as fever and pain. Therefore, Apirofeno 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 infection symptoms persist or worsen, consult a doctor immediately.

Skin reactions

Serious skin reactions have been reported with ibuprofen, 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 Apirofeno 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 potential

Because administration of medicines like Apirofeno 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 limited to the minimum possible.

Administration of Apirofeno is contraindicated during the third trimester.

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

Use of Apirofeno with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Apirofeno may interact with or be affected by other medicines. For example:

• Anticoagulants (e.g. medicines used to treat or prevent blood clotting, such as acetylsalicylic acid and warfarin).
• Antiplatelet agents such as ticlopidine (which prevent blood clots in blood vessels).
• Corticosteroids such as cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (used for depression).
• Other NSAIDs such as aspirin.
• Lithium (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 (used to induce abortion).
• Digoxin and other 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 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, 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).

Other medicines may also interact with or be affected by Apirofeno. Therefore, always consult your doctor or pharmacist before using Apirofeno with other medicines.

Interference with laboratory tests:

Taking ibuprofen may affect 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 levels (may increase)
• Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for clinical laboratory testing and are taking or have recently taken ibuprofen.

Taking Apirofeno with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended. Breastfeeding does not need to be interrupted 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 take only a single dose of Apirofeno or use it for a short period, no special precautions are needed.

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

Apirofeno contains Ponceau 4R (E-122), maltitol liquid (E-965), sodium benzoate (E-211) and sodium

This medicine:

Contains Ponceau 4R (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; hence, it is essentially "sodium-free".

3. How to take Apirofeno

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

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

For accurate dosing, the packaging contains a graduated oral syringe. Insert the syringe into the perforated cap, invert the bottle, and pull the plunger until the liquid reaches the mark in ml or the equivalent in kg of the child's weight. Then return the bottle to its upright position and remove the syringe.

The syringe should be cleaned and dried after each use.

The syringe may be either 3 ml or 5 ml, depending on the presentation. The 3 ml syringe is included in presentations intended for children under 4 years of age (approximately under 16 kg body weight), and the 5 ml syringe is included in presentations intended for children aged 4 years and older (approximately over 16 kg body weight).

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

Children:

The dose of ibuprofen to be administered depends on the child's age and body weight. As a general rule, 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.

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

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

However, as a general guide, the following dosage regimen is recommended:

Adults and adolescents over 12 years of age:

The recommended dose is 10 ml three 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 you a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

Elderly:

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

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor immediately 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 Apirofeno than you should

If you have taken more Apirofeno than you should, or if a child has accidentally ingested the medicine, consult 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), diarrhoea, 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 and 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 hepatic damage may occur. Asthma exacerbation is possible in asthmatic patients. Low blood pressure and reduced respiration 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 following 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 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, Apirofeno may cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as Apirofeno 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 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 (in fewer than 1 in 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 Apirofeno are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Also observed are nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting of blood, oral ulcers, 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). Less frequently, gastritis has been observed.

Other adverse effects: 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 Apirofeno may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

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

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

Dermatological:

Medicines such as Apirofeno 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 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), photosensitivity reactions, inflammation of blood vessels in the skin. Rarely, 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. 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 Apirofeno immediately if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system:

Uncommon: transient swelling of the skin, mucous membranes, or sometimes internal organs (angioedema), nasal mucosal inflammation, bronchospasm (spasm of the bronchi preventing 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 sensation of instability. Rare: paresthesia (numbness, tingling, "pins and needles," more commonly 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 some form of 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 predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (failure of the bone marrow to produce various types of 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 Apirofeno may, rarely, be associated with liver injury. Other rare adverse effects include: hepatitis (liver inflammation), abnormalities in liver function, and jaundice (yellowing of the skin and eyes). Frequency not known: liver failure (severe deterioration of liver function).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Apirofeno, 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:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. 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, high body temperature, and enlarged 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 can 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 Apirofeno

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

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Apirofeno 40 mg/ml oral suspension

• The active substance is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen as the active substance.
• The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate (E-331), sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), thaumatin (E-957), strawberry flavour, cochineal red A (E-122), glycerol (E-422) and purified water.

Appearance of the product and pack contents

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

The 30 ml and 50 ml containers are supplied with a 3 ml graduated syringe with 1 ml markings and 0.10 ml subdivisions.

The 100, 150 and 200 ml containers are supplied with a 5 ml graduated syringe with 1 ml markings and 0.20 ml subdivisions.

Only certain pack 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 Barberà del Vallès, Barcelona. Spain.

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/