JUNIFEN 40 mg/ml ORAL SUSPENSION ORANGE FLAVOR

Introduction

Package Leaflet: Information for the User

Junifen 40 mg/ml Oral Suspension Orange Flavor

Ibuprofen

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as your child's.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Junifen and what is it used for
2. What you need to know before you start using Junifen
3. How to use Junifen
4. Possible side effects
5. Storage of Junifen
6. Contents of the pack and further information

1. What is Junifen and what is it used for

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

• fever,
• mild or moderate pain.

You should consult a doctor if your child's condition worsens or does not improve after 24 hours (in infants from 3 to 5 months and over 5 kg body weight) or after 3 days (in children over 6 months).

2. What you need to know before you start using Junifen

Do not give Junifen to children who:

• are allergic to ibuprofen or other similar painkillers (NSAIDs) or to any of the other ingredients of the medicine (listed in section 6).
• have had breathing difficulties, asthma, runny nose, swelling of the face and/or hands, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• have had stomach or intestinal bleeding or perforation related to previous use of NSAIDs.
• have had recurrent stomach or duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of ulcers or bleeding confirmed).
• have severe liver or kidney failure.
• have severe heart failure.
• have had a brain hemorrhage (cerebrovascular hemorrhage) or other active bleeding.
• have blood coagulation disorders, as ibuprofen may increase the risk of bleeding.
• have indeterminate blood cell formation disorders.
• are severely dehydrated (due to vomiting, diarrhea, or insufficient 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 using this product if your child:

• has an infection; see the heading "Infections" below.
• has a hereditary disorder of blood cell production (e.g., acute intermittent porphyria).
• has blood coagulation disorders.
• has certain skin diseases (systemic lupus erythematosus [SLE] or mixed connective tissue disease).
• has or has had intestinal disease (ulcerative colitis or Crohn's disease), as these conditions may worsen.
• has or has had high blood pressure or heart failure.
• has reduced kidney function.
• has liver disorders. When taking Junifen for a long time, liver, kidney, and blood tests should be performed regularly.
• It is recommended to exercise caution if other medicines are administered 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 medicine for depression), or antiplatelet agents (e.g., acetylsalicylic acid).
• is taking another NSAID (including COX-2 inhibitors like celecoxib or etoricoxib), as they should not be taken together.
• • Undesirable effects can be minimized by using the minimum effective dose for the shortest possible time.
  • In general, the habitual use of (various classes of) painkillers can cause serious and prolonged kidney problems. This risk may increase under physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
  • The prolonged use of any type of painkiller for headaches can worsen them. If this situation is experienced or 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) the regular use of painkillers.
  • has or has had asthma or an allergic disease, as breathing difficulties may occur.

• has 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 hives.

• should not use Junifen during chickenpox.
• has recently undergone major surgery, as close medical monitoring is required.
• is dehydrated, as there is a higher risk of kidney problems in dehydrated children.

Infections

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

Skin Reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Junifen treatment and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

There have been reports of bleeding, ulceration, or perforation of the gastrointestinal tract, which can be fatal, with all NSAIDs at any time during treatment, with or without previous symptoms or history of serious gastrointestinal events. In the event of gastrointestinal bleeding or ulceration, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is higher when increasing the dose of NSAIDs in patients with a history of ulcers, especially complicated ulcers with bleeding or perforation (see section 2 'Do not give Junifen...'), and in the elderly. In these patients, treatment should be initiated at the lowest available dose. Combination treatment with protective drugs (e.g., misoprostol or proton pump inhibitors) should be considered in these patients and also in those who require concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the gastrointestinal risk.

Pain-relieving/anti-inflammatory medicines like ibuprofen may be associated with a small increased risk of having a 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 Junifen if:

• you 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 your legs or feet due to narrowed or blocked 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.

Ibuprofen has been associated with signs of allergic reaction to this medicine, such as breathing difficulties, swelling of the face and neck (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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

Elderly

Elderly patients have a higher risk of adverse events when taking NSAIDs, especially gastrointestinal and intestinal events.

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

Other medicines and Junifen

Tell your doctor or pharmacist if your child is using, has recently used, or might use any other medicines.

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

• anticoagulant medicines (e.g., to treat blood clotting problems/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan)

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

In particular, inform them if your child is taking:

Taking Junifen with alcohol

Do not consume alcohol during the use of Junifen. The risk of experiencing some side effects, such as those affecting the gastrointestinal tract or the central nervous system, may be increased when alcohol is consumed during treatment with Junifen.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use this medicine if you are in the last trimester of pregnancy, as it may cause kidney and heart problems in the fetus, increase the risk of bleeding in the pregnant mother and the fetus, and prolong labor. Avoid taking this medicine during the first 6 months of pregnancy unless your doctor advises you to do so. In these cases, the dose and duration will be limited to the minimum possible. Ibuprofen may cause kidney problems in the fetus, which may lead to low levels of the fluid surrounding the fetus (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the fetus's heart, if taken for a few days from the 20th week of pregnancy. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of ibuprofen and its breakdown products pass into breast milk. Junifen can be taken during breastfeeding if used at the recommended dose for the shortest possible time.

Fertility

Junifen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is stopped.

Driving and using machines

When used for a short period, this medicine has a negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Junifen

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

It may have a slight 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 less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free" and is very unlikely to cause problems if you have celiac disease.

5 ml does not contain more than 0.315 micrograms of gluten.

Patients with diseases other than celiac disease should not take this medicine.

3. How to use Junifen

Always use this medication exactly as your doctor has indicated.Consult your doctor or pharmacist if you have any doubts.

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

Usual dose in case of pain and fever:

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

It is not recommended to use in children under 3 months or with a weight of less than 5 kg.

In patients with stomach sensitivity, it is recommended to take Junifen 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 on 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 normal position and remove the syringe from the port by gently turning it.
6. Place the end 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. Keep it out of reach and sight of children.

Duration of treatment

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

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

Consult your doctor if symptoms worsen.

If you use more Junifen than you should:

If you or your child accidentally take or administer more Junifen than you should, or if a child has ingested the medication accidentally, always consult a doctor or call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount used, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

The symptoms of overdose may include: nausea, abdominal pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding, headache, ringing in the ears, confusion, involuntary eye movements (nystagmus) or more rarely diarrhea. Additionally, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated potassium levels in the blood), increased prothrombin time / INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, somnolence, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in the blood, chills, and respiratory problems.

If you or your child forget to take Junifen:

Do not take or administer a double dose to make up for forgotten doses. If you forget to take or administer a dose, do so as soon as you remember and then take the next dose according to the previously indicated administration interval.

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

4. Possible side effects

Like all medications, Junifen can cause side effects, although not everyone will experience them. Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Your child may suffer from one of the known side effects of NSAIDs. If this is the case, or if you have any concerns, stop administering this medication and consult your doctor as soon as possible. Elderly people who use this product are at a higher risk of developing problems associated with side effects.

STOP TAKING this medication and seek immediate medical attention if your child develops:

• Signs of intestinal bleedingsuch as: severe abdominal pain, black stools, vomiting blood or dark particles that resemble coffee grounds.
• Signs of a rare but serious allergic reactionsuch as worsening of asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, low blood pressure that causes shock. These disorders can occur even when using this medication for the first time. If you observe any of these symptoms, consult a doctor immediately.
• Reddish, non-raised, target-like or circular patches on the torso, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare - may affect up to 1 in 10,000 patients)].
• Widespread skin rash, high body temperature, swollen lymph nodes, and elevated eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known (cannot be estimated from available data)].
• Widespread, red, and scaly rash, with bumps under the skin and blisters, mainly located in skin folds, torso, and upper limbs, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) [Frequency not known (cannot be estimated from available data)].

If your child has any of the following side effects, they worsen, or you notice any side effect not mentioned, inform 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 constipation, and mild bleeding in the stomach and/or intestine that can cause anemia in exceptional cases.

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 intestinal disease (colitis or Crohn's disease), gastritis.
• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue.
• Visual disturbances.
• Various skin rashes.
• Hypersensitivity reactions with urticaria and itching.

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

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

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

• Esophagitis, pancreatitis, and formation of intestinal stenosis of the diaphragm type.
• Heart failure, heart attack, and swelling of the face and hands (edema).
• Decreased 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) that can lead to acute kidney failure. If you experience any of the above symptoms or if you have a feeling of sadness, stop taking Junifen and consult your doctor immediately, as it may be the first signs 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 failure, 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, nosebleeds, and skin bleeding, and unexplained bruising. In these cases, you should stop treatment immediately and consult your doctor. Do not self-medicate with pain relievers or antipyretic medications.
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of inflammation-related infections (e.g., necrotizing fasciitis) associated with the use of some pain relievers (NSAIDs). If signs of infection or worsening appear, you should consult a doctor immediately. It should be evaluated if antibiotic therapy is necessary.
• Symptoms of aseptic meningitis such as stiff neck, 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 happens, contact your doctor immediately.
• Hair loss (alopecia).

Frequency not known(cannot be estimated from available data)

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Respiratory tract reactivity including asthma, bronchospasm, or shortness of breath.
• The skin becomes sensitive to light.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Junifen

Keep this medication out of sight and reach of children.

Do not use Junifen after the expiration date shown on the package. The expiration date is the last day of the month indicated. Do not store above 25 °C.

Validity period after opening the bottle: 6 months.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Junifen:

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

The other components are; citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin, polysorbate 80, bromodiphenhydramine, liquid maltitol, glycerol, xanthan gum, orange flavor (which contains wheat starch), and purified water.

Appearance of the product and package contents

Junifen is a viscous white suspension with an orange flavor.

Each bottle contains 100 ml, 150 ml, or 200 ml.

The package contains a syringe (5 ml syringe, graduated in 1.25 ml, 2.5 ml, 3.75 ml, and 5.0 ml).

Only some package sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser Healthcare S.A.

C/ Mataró, 28, 08403 Granollers (Barcelona) Spain

Manufacturer:

Sia Elvim

Kurzemes prospekts 3-513

Riga LV 1067 Latvia

or

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: April 2025

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