Leaflet: information for the user

ibuprofen cinfa 40 mg/ml oral suspension EFG

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).These medicines act by modifying the body's response to pain and elevated body temperature. Ibuprofen cinfa is used for the short-term symptomatic treatment of:

• fever,
• mild or moderate pain.

Do not takeibuprofen cinfa

• if you are allergic to ibuprofen, other similar pain-relieving medicines (NSAIDs), or any of the other ingredients of this medicine (listed in section 6).
• if you have had breathing difficulties, asthma, runny nose, swelling of the face and/or hands, or urticaria after taking aspirin or other similar pain-relieving medicines (NSAIDs).
• if you have had gastrointestinal bleeding or perforation related to previous use of NSAIDs.
• if you have a history of recurrent stomach ulcers/duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of ulcer or bleeding confirmed).
• if you have severe liver or kidney disease.
• if you have severe heart failure.
• if you have had a cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding.
• if you have bleeding disorders, as ibuprofen may increase the duration of bleeding.
• if you have unexplained blood clotting disorders.
• if you are severely dehydrated (caused by vomiting, diarrhea, or inadequate fluid intake).

Do not take this medicine if you are in the last trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeibuprofen cinfa

• if you have a hereditary disorder of blood cell production (e.g. acute intermittent porphyria).
• if you have bleeding disorders.
• if you have certain skin diseases (systemic lupus erythematosus [SLE] or mixed connective tissue disease).
• if you have or have had inflammatory bowel disease (ulcerative colitis or Crohn's disease), as these conditions may worsen (see section 4 ‘Possible side effects’).
• if you have had or have high blood pressure or heart failure.
• if you have reduced kidney function.
• if you have liver problems. When taking ibuprofen for a prolonged period, regular liver function tests, renal function tests, and blood tests should be performed.
• Caution is advised when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (a depression medicine), or antiplatelet agents (e.g. aspirin).
• if you are taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as they should not be taken together (see section “Use of other medicines”).
• the undesirable effects may be minimized by using the minimum effective dose for the shortest possible time.
• in general, the habitual use of (various classes of) analgesics can cause severe and prolonged kidney problems. This risk may increase under physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• the prolonged use of any type of analgesic for headaches may worsen them. If this situation occurs or is suspected, medical advice should be sought and treatment should be discontinued. The diagnosis of medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medicines.
• if you have or have had asthma or an allergic disease, as difficulty breathing may occur.
• if you have allergic rhinitis, nasal polyps, or chronic obstructive respiratory disease, as there is a higher risk of allergic reactions. The allergic reaction may present as an asthma attack, angioedema, or urticaria.
• severe skin reactions (such as Stevens-Johnson syndrome) have been rarely described in connection with the use of NSAIDs. Ibuprofen use should be discontinued immediately upon noticing the first signs of skin rash, mucous membrane lesions, or any other signs of allergic reactions.
• do not use ibuprofen during chickenpox.
• if you have recently undergone major surgery, as special medical supervision is required.
• if you are dehydrated, as there is a higher risk of kidney problems in dehydrated children.
• NSAIDs may mask the symptoms of infections and fever.
• if you have an infection; see the heading “Infections” below.
• Signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofen cinfa immediately and contact your doctor or emergency medical services if you notice any of these signs.

Special caution is recommended with ibuprofen cinfa.

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been associated with ibuprofen treatment.Discontinue treatment with Ibuprofen cinfa and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking ibuprofen and see your doctor immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Severe gastrointestinal bleeding, ulcers, or perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without previous symptoms or a history of severe gastrointestinal episodes. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulcers, or perforation is higher with increasing doses of NSAIDs in patients with a history of ulcers, especially complicated ulcers or perforation (see section 2 ‘Do not take ibuprofen cinfa’), and in elderly patients. In these patients, treatment should be initiated at the lowest available dose. Consideration should be given to combined treatment with protective medications (e.g. misoprostol or proton pump inhibitors) in these patients and also those who require simultaneous administration of low-dose aspirin, or other medications that are likely to increase the gastrointestinal risk.

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or if you are a smoker.

Consult your doctor before using ibuprofen if your child has any of the above conditions.

Elderly patients

Elderly patients are at a higher risk of adverse events when taking NSAIDs, especially gastrointestinal and intestinal problems. See section 4 ‘Possible side effects’ for more information.

Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.

Use ofibuprofen cinfa with other medicines

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

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

• anticoagulant medicines (e.g. for treating blood clotting problems or preventing clotting, e.g. aspirin, warfarin, ticlopidine)
• blood pressure-lowering medicines (e.g. ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan)

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

Please inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those purchased without a prescription. In particular, inform them if you are taking:

Use of ibuprofen cinfa with alcohol

Do not consume alcohol during ibuprofen treatment. The risk of experiencing some adverse effects, such as those affecting the gastrointestinal tract or the central nervous system, may be increased when alcohol is taken during ibuprofen treatment.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Breastfeeding

Only small amounts of ibuprofen and its metabolites reach breast milk. Ibuprofen may be taken during breastfeeding if used at the recommended dose for the shortest possible time.

Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuing the medication.

Driving and operating machines

At short-term use, this medicine has no or insignificant influence on the ability to drive and operate machines.

ibuprofen cinfa contains sodium benzoate (E-211).This medicine contains 1 mg of sodium benzoate per ml.

ibuprofen cinfa contains maltitol (E-965).This medicine contains maltitol liquid. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

ibuprofen cinfa contains sodium.This medicine contains 5.79 mg of sodium (main component of table salt/for cooking) per ml. This is equivalent to 0.28% of the maximum daily sodium intake recommended for an adult.

ibuprofen cinfa contains benzyl alcohol.

This medicine contains0.00016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("choking syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless recommended by your doctor.

This medicine should not be used for more than a week in children under 3 years old unless advised by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

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

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

Recommended dose for pain and fever:

*Doses should be administered approximately every 6 to 8 hours.

Do not recommend use in children under 3 months or with a weight less than 5 kg.

In patients with stomach sensitivity, it is recommended to take ibuprofen during meals.

WARNING:Do not administer a dose higher than indicated.

Method of administration with the syringe

For oral use.

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and turning it counterclockwise.
3. Insert the syringe firmly into the port (hole) located at the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, pull the plunger down slowly until the suspension reaches the appropriate mark on the syringe.
5. Replace the bottle in its normal position and remove the syringe from the port by turning it gently.
6. Place the tip of the syringe in the child's mouth. Press the plunger slowly to release the suspension gently. Replace the cap after use. Wash the syringe with warm water and let it dry. Store it out of reach and sight of children.

Duration of treatment

This medication should only be used for a short period. If in children over 6 months of age, this medication is required for more than 3 days or if symptoms worsen, you should consult a doctor.

If symptoms persist in infants 3-5 months old (who weigh from 5 kg), you should consult a doctor before 24 hours of use.

Consult your doctor if symptoms worsen.

If you take more ibuprofen cinfa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call theToxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, disorientation, or coma. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may occur.

Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.

Acute renal failure and liver damage may occur.

Exacerbation of asthma is possible in asthmatics. Additionally, low blood pressure and reduced breathing may occur.

If you forgot to take ibuprofen cinfa

Do not take a double dose to compensate for the missed doses.If you forget to takeor administer a dose, do it as soon as you remember and then take the next dose according to the previous administration interval.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. You or your child may experience one of the known side effects of NSAIDs. In this case, or if you have any concerns, stop administering this medicine and consult your doctor as soon as possible. Patients of advanced age who use this medicine are at a higher risk of developing problems associated with side effects.

STOP TAKING this medicine and seek immediate medical attention if you or your child develops:

• Signs of intestinal bleedingsuch as: severe abdominal pain, black stools, vomiting with blood or dark particles that resemble coffee grounds.
• Signs of a rare but severe allergic reactionsuch as worsening of asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, reduced blood pressure leading to shock. These disorders can occur even when using this medicine for the first time. If you notice any of these symptoms, consult a doctor immediately.
• Severe skin reactionssuch as a skin rash that covers the entire body, peeling, blisters or skin shedding.
• Flat, red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin reactions can be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature and enlarged lymph nodes (DRESS syndrome).
• Generalized, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

If you or your child experiences any of the following side effects, they worsen or you notice any other side effect not mentioned, report it to your doctor.

Frequent (may affect up to 1 in 10 people)

• Stomach and intestinal problems such as heartburn, stomach pain and nausea, indigestion, diarrhea, vomiting, flatulence (gas) and mild bleeding in the stomach and/or intestine that may cause anemia in exceptional cases

Rare (may affect up to 1 in 100 people)

• Gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing intestinal disease (colitis or Crohn's disease), gastritis
• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or fatigue
• Visual disturbances
• Diverse skin eruptions
• Hypersensitivity reactions with urticaria and itching

Rare (may affect up to 1 in 1,000 people)

• Tinnitus (ringing in the ears)
• Increased urea concentrations in the blood, side pain and/or abdomen, blood in the urine and fever may be signs of kidney damage (papillary necrosis)
• Increased uric acid concentrations in the blood
• Decreased hemoglobin levels

Very rare (may affect up to 1 in 10,000 people)

• Oesophagitis, pancreatitis and formation of diaphragmatic intestinal stenosis
• Heart failure, myocardial infarction and facial and hand swelling (edema)
• Decreased urine output and inflammation (especially in patients with hypertension or reduced renal function), swelling (edema) and cloudy urine (nephrotic syndrome), interstitial nephritis that can lead to acute renal failure. If you experience any of the mentioned symptoms or feel sad, stop taking ibuprofen and consult your doctor immediately, as it may be the first sign of kidney damage or failure.
• Psychotic reactions, depression
• High blood pressure, vasculitis
• Palpitations.
• Liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver insufficiency, acute liver inflammation (hepatitis)
• Blood cell production problems – the first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, excessive fatigue, nasal and skin bleeding, and unknown origin hematomas. In these cases, you must stop treatment immediately and consult your doctor. Do not self-medicate with painkillers or antipyretic medications.
• Severe skin infections and complications of soft tissue during varicella infection.
• There has been a description of the worsening of inflammatory conditions related to an infection (e.g. necrotizing fasciitis) associated with the use of some analgesics (NSAIDs). If signs of infection appear or worsen, seek medical attention immediately. Antibiotic therapy may be necessary.
• Asymptomatic meningitis has been observed as neck stiffness, headache, nausea, vomiting, fever or altered consciousness during ibuprofen treatment. It is more likely to affect patients with autoimmune disorders (e.g. SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately.
• Severe skin reactions such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell syndrome), hair loss (alopecia)

Unknown frequency (cannot be estimated from available data)

• Respiratory tract reactivity including asthma, bronchospasm or shortness of breath.
• A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation and elevated eosinophils (a type of white blood cell).
• Generalized, red and scaly rash, with bumps under the skin and blisters, located mainly in skin folds, the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofen Cinfa if you experience these symptoms and seek medical attention immediately.See also section 2.
• The skin becomes sensitive to light.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

This type of medication may be associated with a slight increase in the risk of myocardial infarction or stroke.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directlythrough theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Once the packaging is opened, store below 30°C for a maximum of 6 months..

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.of the pharmacy.In case of doubt, please ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofibuprofen cinfa

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, xanthan gum, liquid maltitol (E-965), taumatine (E-957), strawberry flavor (natural flavorings, cornstarch maltodextrin, triethyl citrate (E-1505), propylene glycol (E-1520) and benzyl alcohol), glycerol (E-422) and purified water.

Appearance of the product and contents of the package

Ibuprofen Cinfa is an oral suspension, viscous, white or almost white in color and with a strawberry flavor. It is presented in a PET amber-colored bottle with a child-resistant safety closure, made of polyethylene. It contains a 5 ml graduated syringe with a polypropylene cylinder and a polyethylene piston.

It is presented in 30, 100, 150 and 200 ml packaging sizes.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorios Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes (Madrid)

Spain

FARMALIDER, S.A.

c/ Aragoneses 2

28108- Alcobendas Madrid

Spain

ZINEREO PHARMA, S.L.U

A Relva, S.N

O Porriño 36410 Pontevedra (Spain)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

Netherlands

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191, Spain

LABORATORIOS BASI INDUSTRIA FARMACEUTICA S.A.

Parque Industrial Manuel Lourenco Ferreira Lote 8 15 E 16,

Mortagua, 3450-232, Portugal

Last review date of this leaflet: November 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77857/P_77857.html

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