Ibufen mini junior

Package leaflet: Information for the user

Ibufen mini Junior, 100 mg, soft capsules
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

1. What Ibufen mini Junior is and what it is used for
2. Important information before taking Ibufen mini Junior
3. How to take Ibufen mini Junior
4. Possible side effects
5. How to store Ibufen mini Junior
6. Contents of the pack and other information

1. What Ibufen mini Junior is and what it is used for

Ibufen mini Junior belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic and anti-inflammatory properties and is intended for children aged 4 to 12 years weighing between 16 and 40 kilograms.

What Ibufen mini Junior is used for
The medicine is indicated for the following conditions:

• mild to moderate pain of various origins:
• headaches (including migraine);
• toothache;
• muscle, joint and bone pain;
• pain following injuries;
• neuralgia;
• pain associated with colds and influenza;
• ear pain occurring in middle ear inflammation.
• fever of various origins (e.g. associated with influenza, colds or other infectious diseases).

2. Information before using Ibufen mini Junior

When not to use Ibufen mini Junior:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has previously had asthma, difficulty breathing, nasal inflammation, swelling or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs);
• if the patient has or has previously had stomach ulcer or gastrointestinal bleeding (or has had two or more such episodes in the past);
• if the patient has or has previously had gastrointestinal bleeding or perforation related to previous use of NSAIDs;
• if the patient has severe liver, kidney, or heart failure;
• in children under 4 years of age or weighing less than 16 kg;
• if the patient has cerebral haemorrhage or any other active bleeding;
• if the patient has blood clotting disorders;
• if the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).
• Ibuprofen is contraindicated during the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting treatment with Ibufen mini Junior, discuss this with your doctor or pharmacist.
Allergic reactions to ibuprofen have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Ibufen mini Junior immediately and contact your doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection – see below, section titled "Infections".
Use of anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibufen mini Junior, the patient should discuss treatment with a doctor or pharmacist:

• if the patient has heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• if the patient has skin disorders (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if the patient has inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• if the patient has impaired kidney function;
• if the patient has impaired liver function;
• immediately after major surgical procedures;
• if the patient has asthma or allergic conditions, as breathing difficulties may occur;
• if the patient has nasal mucosal inflammation, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema, or urticaria;
• if chickenpox has been diagnosed – see below, section titled "Infections".
• if the patient is taking medicines such as Ibufen mini Junior, as this may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not exceed the recommended dose or duration of treatment (see section 3 of the leaflet);
• if the patient has blood clotting disorders;
• if long-term use of Ibufen mini Junior is required – regular monitoring of liver and kidney function tests and blood counts is necessary.

Severe skin reactions
Severe skin reactions have been reported with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient develops any symptoms related to these severe skin reactions described in section 4, Ibufen mini Junior must be discontinued immediately and medical help should be sought.

Infections
Ibufen mini Junior may mask symptoms of infection such as fever and pain. Therefore, Ibufen mini Junior may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an existing infection and symptoms persist or worsen, consult a doctor immediately.
Avoid concomitant use with other NSAIDs, including selective COX-2 inhibitors, due to increased risk of adverse effects (see section "Ibufen mini Junior with other medicines").
Use of the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects. Elderly patients are more susceptible to adverse effects.
Chronic use of (various) pain-relieving medicines may lead to kidney damage with risk of renal failure (analgesic nephropathy). This risk may be increased by physical exertion associated with loss of salt and dehydration. Therefore, such use should be avoided. There is a risk of impaired kidney function in dehydrated children.
Headaches may occur after prolonged use of pain-relieving medicines and should not be treated with increased doses of the medicine.

Children
Use of Ibufen mini Junior is contraindicated in children under 4 years of age or weighing less than 16 kg.

Ibufen mini Junior with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, or which are planned to be taken.
Ibufen mini Junior may affect the action of other medicines or other medicines may affect the action of Ibufen mini Junior. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan);
• pain-relieving medicines;
• other non-steroidal anti-inflammatory drugs (NSAIDs);
• diuretics;
• zidovudine;
• lithium and methotrexate;
• corticosteroids;
• cyclosporine;
• digoxin;
• selective serotonin reuptake inhibitors (SSRIs);
• phenytoin;
• tacrolimus;
• mifepristone;
• quinolone antibiotics;
• antidiabetic medicines (sulfonylurea derivatives).
  Other medicines may also interact with or be affected by treatment with Ibufen mini Junior. Therefore, always consult a doctor or pharmacist before using Ibufen mini Junior with other medicines.

Ibufen mini Junior with food, drink and alcohol
Take the medicine during or after meals, with plenty of fluids.
Do not drink alcohol while taking this medicine, as it may worsen gastrointestinal and central nervous system adverse effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Ibufen mini Junior is intended for children (see section 1 of the leaflet). The data below refer to the active substance – ibuprofen.

Pregnancy
Do not use Ibufen mini Junior during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the mother and the child and may delay or prolong labour.
Do not take Ibufen mini Junior during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. Use of Ibufen mini Junior for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
The medicine passes into breast milk but may be used during breastfeeding if administered at the recommended doses and for the shortest possible duration.

Fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and using machines
Ibufen mini Junior has no effect or negligible effect on the ability to drive and operate machinery when used short-term and at recommended doses.

Ibufen mini Junior contains sorbitol (E 420) and liquid maltitol (E 965)
The medicine contains 19.6 mg of sorbitol (E 420) per capsule.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child) or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.
The medicine contains 10.2 mg of liquid maltitol (E 965) per capsule.
If intolerance to certain sugars has previously been diagnosed in the patient, the patient should consult a doctor before taking the medicine.

3. How to use Ibufen mini Junior

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms and reduce the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine is intended for use in children aged 4 to 12 years with a body weight of 16 to 40 kilograms.
Use of Ibufen mini Junior in children under 4 years of age or with body weight below 16 kilograms is contraindicated.
The medicine should be taken orally.
Children – the maximum daily dose of ibuprofen is 20–30 mg per kg of body weight, divided into 3 to 4 individual doses. Do not exceed the maximum daily dose.
Recommended dose

The medicine should be taken during or after a meal. The capsules should be swallowed whole with a glass of water. The capsules must not be chewed, sucked or crushed.
This medicine is intended for short-term use.
If it is necessary to use this medicine for longer than 3 days or if symptoms worsen, consult a doctor.

Use of Ibufen mini Junior in patients with renal and/or hepatic impairment
In patients with mild to moderate renal and/or hepatic impairment, there is no need to reduce the dose.

Use of a higher than recommended dose of Ibufen mini Junior
If a patient has taken a higher than recommended dose of Ibufen mini Junior or if a child has accidentally ingested the medicine, medical advice should always be sought from a doctor or the nearest hospital to assess any potential health risk and to receive guidance on appropriate actions to take.

Symptoms of overdose may include nausea, epigastric pain, vomiting (blood traces may be present), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. Agitation, drowsiness, confusion or coma may also occur. Seizures have been reported occasionally in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur.

Additionally, prothrombin time (INR) may be prolonged, probably due to impaired blood coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. In addition, hypotension and breathing difficulties may occur.

Overdose cases are rare. There is no specific antidote. Treatment is symptomatic and supportive. The doctor may consider administering activated charcoal if less than one hour has passed since the overdose.

Missed dose of Ibufen mini Junior
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling of the skin, and ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) – very rare.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome) – frequency not known.
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) – frequency not known.

Ibufen mini Junior is generally well tolerated, but adverse effects may occur during its use.
Adverse effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses. Other adverse effects may occur when ibuprofen is used for other indications or for prolonged periods.

Common adverse effects (occur less frequently than in 1 in 10 patients)

• Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, diarrhoea, vomiting, flatulence and constipation, as well as minor bleeding from the stomach and/or intestines, which may exceptionally lead to anaemia.

Uncommon adverse effects (occur less frequently than in 1 in 100 patients)

• Hypersensitivity reactions with skin rashes and itching, as well as episodes of breathlessness. You should stop taking Ibufen mini Junior and contact your doctor immediately.
• Headache, dizziness, insomnia, restlessness, irritability, fatigue.
• Visual disturbances.
• Perforation or bleeding from the gastrointestinal tract, tarry stools and vomiting blood, exacerbation of pre-existing inflammatory bowel disease (ulcerative colitis or Crohn's disease), inflammation of the stomach lining (gastritis).

Rare adverse effects (occur less frequently than in 1 in 1,000 patients)

• Tinnitus (ringing in the ears).
• Flank and/or abdominal pain, blood in the urine, and fever may be symptoms of kidney damage (renal papillary necrosis). Rarely, increased blood uric acid levels may also occur.

Very rare adverse effects (occur less frequently than in 1 in 10,000 patients)

• Exceptionally, skin infections during chickenpox. Exacerbation of infection-related inflammatory conditions (e.g. necrotising fasciitis) has been reported during treatment with certain painkillers (NSAIDs). If signs of infection appear or worsen during treatment with Ibufen mini Junior, you should immediately consult a doctor. The doctor will assess whether anti-infective treatment (antibiotic therapy) is indicated. During ibuprofen use, symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or altered consciousness have been observed. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be at higher risk of this complication.
• Problems with blood cell production. Initial symptoms include: fever, sore throat, oral mucosal ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. Do not self-medicate with painkillers or antipyretics.
• Severe hypersensitivity reactions, which may present as: facial, tongue and throat swelling, breathlessness, rapid heartbeat, low blood pressure, shock. If any of the above symptoms occur, which may happen even after the first dose, immediate medical assistance is required.
• Psychotic reactions, depression.
• Cases of palpitations, heart failure, heart attack and stroke have been reported. Taking ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
• Hypertension.
• Oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures. If severe upper abdominal pain, vomiting blood or tarry stools occur, treatment should be stopped and a doctor consulted.
• Liver damage (first sign may be abnormal skin discolouration) – associated with long-term treatment; liver failure, acute hepatitis.
• Reduced urine output and development of oedema (especially in patients with hypertension or impaired kidney function); oedema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms or general malaise occur, Ibufen mini Junior should be discontinued and immediate medical advice sought, as these may be the first signs of kidney damage or kidney failure.

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

• skin becomes sensitive to light;
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ibufen mini Junior

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ibufen mini Junior contains

• The active substance is ibuprofen. Each capsule contains 100 mg of ibuprofen.
• The other ingredients are: macrogol 600, potassium hydroxide, purified water; capsule shell: gelatin, non-crystallizing liquid sorbitol (E 420), liquid maltitol (E 965), purified water.

What Ibufen mini Junior looks like and contents of the pack
The medicine is in the form of light yellow, soft, gelatin capsules with a central band, filled with a sticky liquid.
The cardboard box contains a PVDC/PVC/Aluminium blister pack with 15 capsules.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz