Ibuprofen Cinfa 20 mg/ml oral suspension EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

ibuprofen cinfa 20 mg/ml oral suspension EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ibuprofen cinfa is and what it is used for

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

This medicine is used in infants over 3 months and children up to 12 years of age for the treatment of:

• Symptomatic relief of mild to moderate occasional pain.
• Feverish conditions.

2. What you need to know before taking ibuprofeno cinfa

Do not take ibuprofeno cinfa

• If you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding disorders or blood coagulation problems, or if you are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines at the same time, your doctor will perform blood coagulation tests.
• If you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofeno cinfa.

• If you have oedema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation. This may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. The risk is higher when high doses or long-term treatments are used, 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 are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• 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 (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) 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 suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection: see the “Infections” section below.
• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Stop using ibuprofeno cinfa immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

It is important that you use the lowest effective dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.

Skin reactions

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

Stop taking ibuprofen and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

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 ibuprofen:

• If you have heart problems, including heart failure, angina (chest pain), have had a 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").
• If you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and that of your baby to bleed and may delay or prolong labour beyond the expected time. You should not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

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

Infections

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

Other medicines and ibuprofeno cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
• Anticoagulant medicines, e.g. to treat coagulation problems/avoid clotting (e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
• Mifepristone (an abortion-inducing agent).
• Digoxin and cardiac glycosides (for treating heart disorders).
• Hydantoins such as phenytoin (for treating epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (for treating certain bacterial infections).
• Corticosteroids such as cortisone and prednisone.
• Diuretics (medicines used to increase urine output), as this may increase the risk of kidney toxicity.
  • Pentoxifylline (for treating intermittent claudication).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for treating gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
• Tacrolimus or cyclosporine (used to prevent organ transplant rejection).
• Zidovudine (an anti-HIV medicine).
• 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).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

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 levels of urea nitrogen and serum levels of creatinine and potassium (may increase).
• Liver function tests: increased transaminase values.

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

Taking ibuprofeno cinfa with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

The use of this medicine is not recommended in women trying to become pregnant.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section "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.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are not usually necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities requiring increased vigilance, such as driving and operating machinery.

This is especially relevant when combined with alcohol.

ibuprofeno cinfa contains maltitol liquid (E-965)

This medicine 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 produce a mild laxative effect because it contains 212.5 mg of maltitol per millilitre.

Calorific value: 2.3 kcal/g maltitol/isomalt.

ibuprofeno cinfa contains sodium benzoate (E-211)

This medicine contains 2 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).

ibuprofeno cinfa contains sodium

This medicine contains 34.2 mg of sodium (main component of table/cooking salt) in 20 ml. This corresponds to 1.71% of the maximum daily sodium intake recommended for an adult.

ibuprofeno cinfa contains ethanol (alcohol)

This medicine contains 1.43 mg of alcohol (ethanol) per ml, equivalent to 0.14% (w/v). The amount in 20 ml of this medicine is equivalent to less than 1 ml of beer or wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

ibuprofeno cinfa contains propylene glycol (E-1520)

This medicine contains 4.77 mg of propylene glycol per ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to take ibuprofen cinfa

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

For occasional use only and for limited periods.

The lowest effective dose should be used for the shortest duration necessary 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).

Use in children

The recommended dose of ibuprofen depends on the child's age and weight. For children from 3 months up to 12 years of age, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the intensity of symptoms, divided into three doses (see table).

This medicine should always be used in children under 2 years of age only on medical prescription.

The suspension can also be dosed according to a schedule of 4 doses per day. In that case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours should be recalculated/reduced proportionally.

The use of ibuprofen is not recommended in children under three months of age or weighing less than 5 kg.

Patients with kidney, liver, or heart disease

Dose reduction and medical advice are required. Ibuprofen must not be used in patients with severe heart, renal, or hepatic failure.

If this medicine needs to be used for more than 3 days, or if symptoms worsen in children aged 6 months to 12 years, consult a doctor.

In children aged 3 to 5 months, consult a doctor if symptoms worsen or persist beyond 24 hours.

Method of administration

ibuprofeno cinfa is an oral suspension.

For accurate dosing, the packaging contains a 5 ml graduated oral syringe. Follow these steps:

• Shake the bottle before use.
• Insert the syringe into the bottle.
• Invert the bottle and withdraw the prescribed dose.
• Administer directly from the syringe or transfer the contents to a spoon.
• The syringe must be cleaned and dried after each use.

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

A burning sensation in the mouth or throat may occur with oral ibuprofen suspension; therefore, patients are advised to ensure the bottle has been shaken well before use.

Administration of the medicine should be based on the presence of pain or fever. As these symptoms subside, medication should be discontinued.

If you take more ibuprofeno cinfa than you should

If you have taken more ibuprofen than recommended, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and receive advice on necessary measures.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhea, headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may be reported. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors.

Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also occurred.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatic patients.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ibuprofeno cinfa

Do not take a double dose to make up for missed 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 your usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

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

The frequencies shown below refer to short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen.

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), photosensitivity reactions, hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterised by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, oedema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock)), 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 and other collagen diseases), which was a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising.

• Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, severe skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation associated with infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to consult a doctor as soon as possible.

• Frequency not known (cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea). A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cells). Generalised red, scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). The skin becomes sensitive to light. Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2. Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• Severe stomach pain.
• Blisters or extensive peeling of the skin.
• 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 arms or legs.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalised skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Generalised, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 ibuprofen cinfa

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

This medicine does not require any special storage conditions.

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of ibuprofen cinfa

• The active substance is ibuprofen. Each millilitre of oral suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: glycerol (E-422), liquid maltitol (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate, sodium benzoate (E-211), polysorbate 80, sodium saccharin, orange flavour (containing ethanol and propylene glycol (E-1520)) and purified water.

Appearance of the product and contents of the pack

White or practically white, homogeneous suspension after shaking.

Each pack contains a 200 ml amber-coloured polyethylene terephthalate (PET) bottle with a white high-density polyethylene (HDPE) cap and translucent closure, together with a 5 ml oral dosing syringe.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66020/P_66020.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66020/P_66020.html