Nurofen Pediatric 40 mg/ml oral suspension strawberry flavor

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nurofen Pediatric 40 mg/ml oral suspension, strawberry flavor

Ibuprofen

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Always follow exactly the instructions for administration contained in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms or your child's symptoms worsen or do not improve:
• after 24 hours in infants aged 3 to 5 months weighing more than 5 kg
• after 3 days in children over 6 months of age and adolescents.

Leaflet contents:

1. What Nurofen Pediatric is and what it is used for
2. What you need to know before taking Nurofen Pediatric
3. How to take Nurofen Pediatric
4. Possible side effects
5. How to store Nurofen Pediatric

Pack contents and additional information

1. What Nurofen paediatric is and what it is used for

Nurofen paediatric contains ibuprofen and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain, inflammation, and elevated body temperature.

This medicine is used in children from 3 months of age for the symptomatic treatment of:

• fever,
• mild to moderate occasional pain

2. What you need to know before starting to take Nurofen pediatric

Allergic reaction symptoms have been reported with ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Immediately stop using ibuprofen and contact your doctor or seek emergency medical help right away if you notice any of these signs.

Do not administer this medicine to children who:

? Are allergic (hypersensitive) to ibuprofen, to other NSAIDs (e.g., acetylsalicylic acid, naproxen, etc.) or to any of the other components of this medicine (listed in section 6). Reactions indicating allergy may include: difficulty breathing or asthma, nasal discharge, swelling of the face, lips, tongue or hands, or itchy skin rash after taking acetylsalicylic acid or other similar painkillers (NSAIDs).

? Have you suffered from a stomach or duodenal ulcer or bleeding, or have you experienced perforation of the digestive tract?

? Do they have vomiting with blood?

? Present black stools or diarrhea with blood.

? Suffer from a serious liver or kidney disease.

? Suffer from bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood), since ibuprofen may increase the duration of bleeding.

The input is empty. Please provide text to translate.

? Suffer from severe heart failure.

? If you are a woman, you should not use this medicine if you are in the last trimester of pregnancy.

Warnings and precautions:

You should consult your doctor or pharmacist before starting to administer this medicine to your child:

? If you have edema (fluid retention).

? If you suffer from asthma or any other respiratory disorder.

The input provided is empty. Please provide the text you would like translated.

? If you have or have had any heart disorder or have high blood pressure.

? If you have a kidney or liver disease, or need to take the medicine long-term (more than 1 to 2 weeks), your doctor may need to carry out regular check-ups.

? If you experience symptoms of dehydration, such as severe diarrhea or vomiting, you should drink plenty of fluids and contact your doctor immediately, as in this particular case, ibuprofen could lead to kidney failure as a consequence of dehydration. There is a risk of renal failure in dehydrated children and adolescents.

? Have you had or developed a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without previous warning symptoms?

? This risk is greater when high doses are used and in prolonged treatments, in patients with a history of peptic ulcer, and in elderly patients.

? If you are taking medications that affect blood coagulation simultaneously, such as oral anticoagulants (like warfarin) or antiplatelet agents of the acetylsalicylic acid type. You should also inform your doctor about the use of other medications that could increase the risk of such bleeding, such as corticosteroids (like prednisolone) and selective serotonin reuptake inhibitor antidepressants.

? If you suffer from Crohn's disease (a condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, medicines of the pediatric Nurofen type may worsen these conditions.

? If you have lupus erythematosus (a chronic disease affecting the immune system that can involve various vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.

? If you suffer from acute intermittent porphyria (a metabolic disorder affecting your blood that may cause symptoms such as reddish discoloration of urine, blood in urine, or liver disease), so that the appropriateness or not of treatment with ibuprofen can be assessed.

? Treatment with ibuprofen may mask fever, an important sign of infection, making diagnosis more difficult.

? If you suffer from headaches after prolonged treatment, you should not take higher doses of the medication.

? Allergic reactions may occur with this medication.

? If you have an infection; see the section “Infections” below.

? During chickenpox, the use of this medicine is not recommended.

? The physician will perform more stringent monitoring if you receive ibuprofen after undergoing major surgery.

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 this medicine if:

• have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (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"),

• have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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

Consult a doctor before using this medicine if your child has any of the above conditions.

Skin reactions

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

Infections

Nurofen Pediatric may mask the signs of an infection, such as fever and pain. Therefore, Nurofen Pediatric might delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

In case of administration of this medication in adults:

Elderly patients have a higher risk of adverse events when taking NSAIDs, particularly those affecting the stomach and intestine. 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 (particularly gastrointestinal bleeding), especially in the early stages of treatment.

Precautions during pregnancy and in women of childbearing age

Since the administration of drugs of the type Nurofen pediatric has been associated with an increased risk of congenital anomalies/abortion, administration during the first and second trimesters of pregnancy is not recommended unless considered strictly necessary. In such cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated. For female patients of childbearing potential, it should be considered that medications of the Nurofen pediatric type have been associated with a decreased ability to conceive.

Interferences with analytical tests

The use of ibuprofen may alter the following laboratory tests:

- Bleeding time (may be prolonged for 1 day after discontinuing treatment)

• Blood glucose concentration (may decrease)

- Creatinine clearance (may decrease)

• Hematocrit or hemoglobin (may decrease)

- Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)

• With liver function tests: increased transaminase levels.

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

Use of pediatric Nurofen with other medicines

Inform your doctor or pharmacist if your child is using or has recently used any other medicines, including those obtained without a prescription.

Nurofen Pediatric can affect or be affected by other medications. For example:

? Corticosteroids (such as cortisone or prednisolone), as they may increase the risk of gastrointestinal bleeding or ulcer.

The input is empty. Please provide text to translate.

? Other NSAIDs such as aspirin and other NSAID-type medications (including COX-2 inhibitors such as celecoxib or etoricoxib).

? Anticoagulant medications (e.g., to treat clotting disorders/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).

The provided input is empty. Please provide the content you would like translated.

? Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels), such as ticlopidine.

? Selective serotonin reuptake inhibitors (used in depression).

? Medications that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, and angiotensin II receptor antagonists such as losartan).

? Diuretics (medications used to increase urine elimination).

? Lithium (a medication for depression), your doctor may adjust the dose of this medication.

? Methotrexate (a medication for cancer and inflammatory diseases); possibly your doctor will adjust the dose of this medication.

? Mifepristone (abortion-inducing agent): NSAIDs should not be taken during the 8-12 days following the use of mifepristone.

The input provided is empty. Please provide the content you'd like translated.

? Hydantoins such as phenytoin (used in the treatment of epilepsy).

? Sulfonamides such as sulfamethoxazole and cotrimoxazole.

? Pentoxifylline (to treat intermittent claudication).

? Cyclosporine and tacrolimus (used in organ transplantation to prevent rejection).

? Zidovudine (a medication for treating AIDS).

? Sulfonylureas (for diabetes).

? Probenecid (for gout or in combination with penicillin in infections) and sulfinpyrazone (for gout).

? Digoxin and other cardiac glycosides (used in the treatment of heart disorders): ibuprofen may increase plasma concentrations of these drugs.

? Thrombolytics (medicines that dissolve blood clots).

? Aminoglycoside antibiotics such as neomycin.

? Antibiotics of the quinolone group, such as norfloxacin.

? Herbal extracts (from the Ginkgo biloba tree).

? Cholestyramine (to reduce cholesterol levels), since the administration of NSAIDs with cholestyramine may delay and reduce the reabsorption of NSAIDs.

? Baclofen (used to treat involuntary and persistent muscle contractions).

? CYP2C9 inhibitors such as voriconazole and fluconazole (for fungal infections), since these medications may increase exposure to NSAIDs.

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

Use of pediatric Nurofen with food, drinks, and alcohol

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

Alcohol consumption is not recommended during treatment, as it increases the risk of gastrointestinal adverse effects.

The input is empty. Please provide text to translate.

Pregnancy, lactation, and fertility

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

Pregnancy

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may cause kidney and heart problems in the fetus. It may affect your tendency and your baby's tendency to bleed, and may delay or prolong labor beyond what is expected. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor specifically advises it. In such cases, the dose and duration will be limited to the minimum possible. Starting from week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which could 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 you require treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

The input is empty. Please provide the text you would like translated.

Female Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) that can affect female fertility. This effect is reversible upon discontinuation of the medication. Avoid taking this medicine if you are trying to become pregnant.

Driving and operating machinery

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

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

The input is empty. Please provide text to translate.

Nurofen Pediatric contains liquid maltitol, propylene glycol, and sodium.

This medicine contains liquid maltitol (E-965). If your doctor has advised you that you have an intolerance to certain sugars, consult with him before taking this medicine. It may cause a mild laxative effect because it contains 2.226 g of liquid maltitol (E-965) per 5 ml.

Caloric value: 2.3 kcal/g of maltitol.

This medicine contains 3.29 mg of propylene glycol (E-1520) in each 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.

This medicine contains less than 23 mg of sodium (1 mmol) per ml, which is essentially "sodium-free".

3. How to take Nurofen for children

Follow exactly the dosing instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For oral use.

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

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of the child's body weight, divided into three or four individual doses every 6–8 hours. It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofen per kg of body weight. The interval between each dose will depend on the progression of symptoms, but must never be less than 4 hours.

The recommended dose for pain and fever is:

Body weight/Age (approx)	Frequency	Dosage	Maximum daily dose
5 - 7.6 kg 3 - 6 months*	3 times a day, if necessary	50 mg (1.25 ml) per dose	1.25 ml 3 times a day (equivalent to 150 mg of ibuprofen/day)
7.7 - 9 kg 6 - 12 months*	3 to 4 times a day, if necessary	50 mg (1.25 ml) per dose	1.25 ml 3 to 4 times a day (equivalent to 150-200 mg of ibuprofen/day)
10 - 15 kg 1 - 3 years*	3 to 4 times a day, if necessary	100 mg (2.5 ml) per dose	2.5 ml 3 to 4 times a day (equivalent to 300-400 mg of ibuprofen/day)
16 - 20 kg 4 - 6 years	3 to 4 times a day, if necessary	150 mg (3.75 ml) per dose	3.75 ml 3 to 4 times a day (equivalent to 450-600 mg of ibuprofen/day)
21 - 29 kg 7 - 9 years	3 to 4 times a day, if necessary	200 mg (5 ml) per dose	5 ml 3 to 4 times a day (equivalent to 600-800 mg of ibuprofen/day)
30 - 40 kg 10 - 12 years	3 to 4 times a day, if necessary	300 mg (7.5 ml) per dose	7.5 ml 3 to 4 times a day (equivalent to 900-1,200 mg of ibuprofen/day)

*The use of this medicine in children under 2 years of age must always be under medical prescription.

Its use is not recommended in children under 3 months of age or weighing less than 5 kg.

Adolescents (over 12 years of age and weighing more than 40 kg):

Take a dose of 5–10 ml (equivalent to 200–400 mg of ibuprofen) every 4 or 6 hours, as needed. The maximum daily dose for adolescents must not exceed 1,200 mg of ibuprofen within 24 hours.

Due to the amount of ibuprofen contained in this medicine, other formulations more suitable for treatment in adults and adolescents over 12 years of age are recommended.

Patients with kidney and/or liver disease:

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

In infants between 3 and 5 months of age weighing more than 5 kg:

Medical attention should be sought if symptoms worsen or, if symptoms persist, within no more than 24 hours.

In children between 6 months and 12 years of age and in adolescents (under 18 years of age):

In children from 6 months of age and in adolescents, consult a doctor if it is necessary to administer the medicine for more than 3 days or if symptoms worsen.

In patients with a sensitive stomach, it is recommended to take the medicine during meals.

Administration method using the syringe

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

If you take more Nurofen paediatric than you should:

If you accidentally take or administer more medicine than prescribed, or if a child has accidentally ingested the medicine, consult a doctor immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and amount taken, or go to the nearest hospital to assess the risk and receive advice on the measures to be taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, blurred vision, tinnitus, confusion, and involuntary eye movements. At high doses, gastrointestinal bleeding, hypotension, changes in blood composition, 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 have been reported.

If you forget to take or give your child Nurofen paediatric:

Do not take or administer a double dose to make up for missed doses. If you forget to take or administer a dose, take it as soon as you remember, and then take the next dose at the previously indicated dosing interval.

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 can cause adverse effects, although not everyone will experience them.

Adverse effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. You or your child may experience one of the known adverse effects of NSAIDs. In such a case, or if you have any concerns, stop administering/taking this medicine and consult your doctor as soon as possible. Elderly patients using this product are at increased risk of developing problems related to adverse effects.

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

STOP administering or taking this medicine and seek immediate medical help if you or your child experience:

• signs of gastrointestinal bleeding, such as severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee
• signs of a rare but serious allergic reaction, such as worsening asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or decreased blood pressure leading to shock. These may occur even with the first use of this medicine
• Non-elevated red, target-shaped or circular rashes on the trunk, often with blisters in the center, 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).
• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).

Widespread 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).

Inform your doctor if you experience the following adverse effects:

Common: (may affect up to 1 in 10 people)

• stomach problems such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestine, which may exceptionally lead to anemia.

Uncommon: (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 bowel disease (ulcerative colitis or Crohn's disease), gastritis
• disorders of the central nervous system such as headache, dizziness, insomnia, restlessness, irritability, and fatigue
• visual disturbances
• various skin rashes
• hypersensitivity reactions with hives and itching.

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

• tinnitus (ringing in the ears)
• increased blood urea levels, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis)
• decreased hemoglobin levels.

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

• esophagitis, pancreatitis, and development of diaphragm-type intestinal strictures
• heart failure, heart attack, and swelling of the face and hands (edema)
• reduced urine output and inflammation (especially in patients with hypertension or reduced kidney function), swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) which may lead to acute renal failure. If you experience any of the symptoms listed above or feel sadness, stop taking this medicine immediately and consult your doctor, as these may be early signs of kidney damage or failure
• psychotic-type reactions, depression
• elevated blood pressure, vasculitis
• palpitations
• liver dysfunction, liver damage (early signs may include skin discoloration), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in blood cell production. Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of infections-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of some painkillers (NSAIDs). If signs of infection appear or worsen, seek medical help immediately. Antibiotic therapy should be evaluated
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed during treatment with ibuprofen. This is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
• severe forms of skin reactions such as skin rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell's syndrome) or hair loss (alopecia).

Frequency not known: (cannot be estimated from available data)

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• respiratory tract reactivity including asthma, bronchospasm, or dyspnea
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell)
• widespread 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 generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See also section 2
• skin becomes sensitive to light.

Medicines of this type may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an 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 Nurofen Pediatric

Keep out of sight and reach of children.

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.

Do not store above 25 °C.

Validity period after opening the bottle: 6 months.

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

6. Package contents and other information

Composition of Nurofen paediatric:

The active substance is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.

The other components (excipients) are: monohydrate citric acid, sodium citrate, sodium chloride, sodium saccharin, polysorbate 80, domiphen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavour (containing propylene glycol), and purified water.

Appearance of the medicine and contents of the pack

White or almost white oral suspension with a strawberry flavour.

It is presented in amber-coloured PET bottles of 150 or 200 ml, equipped with child-resistant closures. The package includes a 5 ml dosing syringe, graduated at 1.25, 2.5, 3.75 and 5.0 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Reckitt Benckiser Healthcare S.A.

Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer:

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the most recent revision 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 Health Products (AEMPS): http://www.aemps.gob.es/