JUNIPRO 40 mg/ml ORAL SUSPENSION STRAWBERRY FLAVOR

Introduction

Package Leaflet: Information for the User

Junipro 40 mg/ml Oral Suspension Strawberry 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. It may harm them, even if their symptoms are the same as your child's.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Junipro 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. Junipro 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 use Junipro

Do not give Junipro to children who:

• are allergic to ibuprofen or other similar painkillers (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6).
• have had breathing problems, asthma, runny nose, swollen face or hands, or urticaria (hives) after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• have had gastrointestinal bleeding or perforation related to previous NSAID use.
• have had recurrent peptic ulcers or gastrointestinal bleeding (two or more episodes of ulcers or bleeding confirmed).
• have severe liver or kidney failure.
• have severe heart failure.
• have had a stroke 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 blood cell disorder (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 Junipro for a long time, liver, kidney, and blood tests should be performed regularly.
• caution is advised if other medicines are given 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 headache medication.
  • has or has had asthma or an allergic disease, as breathing difficulties may occur.
  • suffers from allergic rhinitis, nasal polyps, or chronic obstructive respiratory disease, as there is a higher risk of allergic reactions. The allergic reaction can present as an asthma attack, angioedema, or urticaria.

• 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. Therefore, this medicine may delay 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 Junipro 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 gastrointestinal bleeding, ulceration, or perforation, which can be fatal, with all NSAIDs at any time during treatment, with or without previous symptoms or history of gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is higher when increasing NSAID doses in patients with a history of ulcers, especially complicated ulcers with bleeding or perforation (see section 2 'Do not give Junipro...'), and in the elderly. In these patients, treatment should be started 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 use of low-dose acetylsalicylic acid or other drugs that may increase the gastrointestinal risk.

Anti-inflammatory/pain-relieving 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 Junipro 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 ischaemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, have 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 problems, swelling of the face and neck (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you notice any of these signs.

Consult your doctor before using Junipro 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 Junipro

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

Junipro 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 (e.g., 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 Junipro. Therefore, you should always consult your doctor or pharmacist before using Junipro with other medicines.

In particular, tell them if your child is taking:

Taking Junipro with alcohol

Do not drink alcohol while using Junipro. The risk of experiencing some side effects, such as those affecting the gastrointestinal tract or central nervous system, may be increased when drinking alcohol during treatment with Junipro.

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 3 months of pregnancy, as it may cause problems with the baby's kidneys and heart, increase the risk of bleeding in the mother and the baby, and prolong labor. Avoid using 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 can lead to low levels of amniotic 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.

Junipro can be taken during breastfeeding if used at the recommended dose for the shortest possible time.

Fertility

Junipro 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 Junipro

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 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) 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 that contain propylene glycol or alcohol.

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

3. How to use Junipro

Always use this medicine 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 weighing less than 5 kg.

In patients with stomach sensitivity, it is recommended to take Junipro 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.

1. Remove the cap from the bottle by pressing it down and turning it counterclockwise.

1. Insert the syringe firmly into the port (hole) located on the neck of the bottle.

1. 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.

1. Return the bottle to its normal position and remove the syringe from the port by gently turning it.

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

In infants from 3-5 months (who weigh from 5 kg) you should seek medical attention after 24 hours of use if symptoms persist.

Consult your doctor if symptoms worsen.

If you use more Junipro than you should:

If you or your child accidentally take or administer more Junifen than you should, or if a child has ingested the medicine accidentally, always consult a doctor or call the toxicology information service, phone 91 562 04 20, indicating the medicine 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 medicine to the healthcare professional.

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 Junipro:

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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Junipro can cause side effects, although not everyone gets 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. In such a case, or if you have any concerns about this, stop administering this medicine 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 medicine 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 look like 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 medicine 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 trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These serious 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 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, trunk, 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.

Common(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 strictures 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 renal 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 Junipro 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 mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin and mucous membrane 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 conditions (e.g., necrotizing fasciitis) associated with the use of some pain relievers (NSAIDs) has been described. If signs of infection or worsening appear, you should consult a doctor immediately. It should be evaluated whether antibiotic therapy is necessary
• Symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever, or altered consciousness during ibuprofen treatment have been observed. 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 may 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.

Medicines of this type 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 side effect not listed in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Junipro

Keep this medicine out of sight and reach of children.

Do not use Junipro after the expiration date shown on the packaging. 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.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Junipro:

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, brominated domiphen, liquid maltitol, glycerol, xanthan gum, strawberry flavor (which contains propylene glycol), and purified water.

Appearance of the product and package contents

Viscous white suspension with strawberry flavor.

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

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