Ibufen junior

Patient Information Leaflet

Ibufen Junior, 200 mg, soft capsules
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 3 days, consult your doctor.

Contents of the leaflet

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

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

How the medicine works
Ibufen Junior belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic (pain-relieving), antipyretic (fever-reducing), and anti-inflammatory properties.
What Ibufen Junior is used for
The medicine is intended for use in children and adults in the following conditions:

• Mild to moderate pain of various origins:
  • headaches (including migraine);
  • toothache;
  • muscular, joint, and bone pain;
  • pain following injuries;
  • neuralgia;
  • pain associated with cold and flu;
  • painful menstruation;
  • ear pain occurring in middle ear inflammation.
• Fever of various causes (e.g. due to flu, cold, or other infectious diseases).

2. Important information before using Ibufen Junior

When not to use Ibufen 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 previously experienced allergic symptoms such as nasal congestion (rhinitis), angioedema, urticaria, bronchospasm, or bronchial asthma after taking acetylsalicylic acid or other non-steroidal painkillers (NSAIDs);
• if the patient has active or past peptic ulcer disease of the stomach and/or duodenum, or recurrent gastrointestinal ulceration or bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has experienced upper gastrointestinal bleeding or perforation following previous use of NSAIDs;
• if the patient has severe liver, kidney, or heart failure;
• do not administer to children with body weight below 20 kg;
• if the patient has experienced cerebral haemorrhage or other active bleeding;
• if the patient has unexplained blood disorders such as thrombocytopenia;
• if the patient has a bleeding tendency (haemorrhagic diathesis);
• during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Ibufen Junior, consult a 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 Junior immediately and contact a doctor or emergency medical services without delay.
Inform the pharmacist or doctor if the patient has an infection – see below, section titled "Infections".
Consult a doctor if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease;
• allergic reactions after taking acetylsalicylic acid;
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart function disorders;
• kidney function disorders;
• liver function disorders;
• blood coagulation disorders;
• active or past bronchial asthma or previous allergic reactions, as bronchospasm may occur after taking the medicine;
• chickenpox – see below, section titled "Infections".

Exercise caution when using the medicine immediately after major surgery.
Also consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids (see section "Ibufen Junior and other medicines").
Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with prior warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
The risk of adverse effects from ibuprofen use is higher in elderly patients than in younger patients.
Concomitant, long-term use of various painkillers may lead to kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion leading to salt loss and dehydration.
Therefore, avoid concomitant, long-term use of multiple painkillers.
There is a risk of kidney failure in dehydrated children and adolescents.
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 Junior, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (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 has experienced any stroke (including mini-stroke or transient ischaemic attack - TIA);
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

Severe skin reactions
Serious skin reactions have occurred with ibuprofen use, 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, discontinue Ibufen Junior immediately and seek medical help.

Infections
Ibufen Junior may mask symptoms of infection such as fever and pain. Therefore, Ibufen 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 the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately.
Cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use; therefore, any visual disturbances should be reported to a doctor.
Using the medicine for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Ibufen Junior and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take.
Ibufen Junior may affect the action of other medicines, or other medicines may affect the action of Ibufen 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 those containing atenolol, angiotensin II receptor antagonists such as losartan);
• painkillers;
• other non-steroidal anti-inflammatory drugs;
• diuretics;
• medicines used for depression (selective serotonin reuptake inhibitors - SSRIs), lithium;
• zidovudine, ritonavir (medicines used in HIV treatment);
• methotrexate (a medicine used in cancer or rheumatoid arthritis treatment);
• corticosteroids (such as prednisolone);
• phenytoin (an antiepileptic medicine);
• cyclosporine, tacrolimus (immunosuppressive medicines);
• mifepristone (a medicine used in gynaecology);
• quinolone antibiotics (such as ciprofloxacin);
• cardiac glycosides, including digoxin (medicines used in heart disease treatment);
• aminoglycosides (such as streptomycin);
• probenecid, sulfinpyrazone (medicines used in gout treatment);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in patients with high cholesterol levels).

Other medicines may also interact with or be affected by treatment with Ibufen Junior.
Therefore, always consult a doctor or pharmacist before using Ibufen Junior with other medicines.

Ibufen Junior with food and drink
The medicine can be taken during meals or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

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

Breastfeeding
Ibuprofen passes into breast milk in small amounts, but it is very unlikely to have a negative effect on the breastfed infant.

Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Ibufen Junior has no effect or negligible effect on the ability to drive and operate machinery when used short-term and according to recommendations.

Ibufen Junior contains sorbitol (E 420), liquid maltitol (E 965), and potassium

Sorbitol (E 420)
The medicine contains 28.8 mg of sorbitol in each capsule.

Maltitol (E 965)
The medicine contains 15 mg of liquid maltitol in each capsule. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Potassium
The medicine contains 0.27 mmol (10.5 mg) of potassium in each capsule, which should be considered in patients with reduced kidney function and in patients controlling potassium intake in their diet.

3. How to use Ibufen Junior

This medicine should always be taken exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use.
Use the lowest effective dose for the shortest necessary duration 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).
Do not exceed the maximum daily dose.
Children – the maximum daily dose of ibuprofen is 20–30 mg per kg body weight, divided into 3 to 4 single doses.
Recommended dose

The capsules should be swallowed whole with a glass of water. The capsules must not be chewed, sucked or crushed.
If it is necessary to use this medicine for longer than 3 days or if symptoms worsen, consult a doctor.
This medicine is intended for short-term use only.
This medicine must not be used in patients with body weight below 20 kg.
In patients with mild to moderate renal and (or) hepatic impairment, there is no need to reduce the dose.
Dosage adjustment is not required in elderly patients.
Use of a higher than recommended dose of Ibufen Junior
If a patient has used a higher than recommended dose of Ibufen Junior or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital to obtain advice on possible health risks and on actions to be taken in such a case.
Symptoms of overdose may include nausea, epigastric pain, vomiting (blood may be present), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. Excitation, drowsiness, confusion or coma may also occur. Seizures may occur rarely in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold and breathing difficulties have been reported.
In addition, prothrombin time (INR) may be prolonged, probably due to impaired function of blood clotting factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. In addition, low blood pressure and breathing difficulties may occur.
Cases of overdose 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 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 skin, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) – very rare.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) – frequency unknown.

Ibufen Junior is generally well tolerated, but adverse reactions may occur during its use.
The adverse reactions listed below have been observed during short-term use of ibuprofen at over-the-counter doses. The most commonly observed adverse reactions involve the gastrointestinal tract.

Uncommon (occurring in fewer than 1 in 100 patients):

• Indigestion, abdominal pain, nausea, bloating;
• Headache;
• Various types of skin rash, urticaria, and itching.

Rare (occurring in fewer than 1 in 1,000 patients):

• Diarrhoea, flatulence, constipation, and vomiting;
• Dizziness, insomnia, restlessness, and feeling tired.

Very rare (occurring in fewer than 1 in 10,000 patients):

• Aseptic meningitis, presenting as neck stiffness, headache, nausea, vomiting, fever, and disorientation – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease;
• Blood disorders: anaemia, leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), pancytopenia (haematological disorder characterised by deficiency of all normal blood cells: erythrocytes, leukocytes, and thrombocytes), agranulocytosis (reduced granulocyte count). Initial symptoms include fever, sore throat, superficial mucosal ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding;
• Severe hypersensitivity reactions presenting as facial, tongue, and laryngeal swelling; shortness of breath; rapid heartbeat; significant drop in blood pressure;
• Asthma, worsening of asthma, bronchospasm, dyspnoea, and wheezing;
• Nervousness;
• Visual disturbances;
• Tinnitus, dizziness;
• Oedema, hypertension, heart failure (reported in association with the use of NSAIDs);
• Gastric and duodenal ulcers, gastrointestinal perforation or bleeding, tarry stools, vomiting blood, sometimes with fatal outcome, particularly in elderly patients; ulcerative inflammation of the oral mucosa, gastritis, oral ulcers;
• Exacerbation of colitis and Crohn's disease;
• Liver function disorders, particularly during prolonged use of ibuprofen; hepatitis and jaundice;
• Acute kidney failure; renal papillary necrosis, particularly after prolonged use of ibuprofen, associated with increased serum urea levels and oedema, including peripheral oedema; presence of blood and/or protein in urine, interstitial nephritis, nephrotic syndrome;
• Decreased haematocrit and haemoglobin levels in laboratory tests.

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 known as Kounis syndrome.

Depression and psychotic reactions have been reported in isolated cases.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibufen Junior

Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Keep the medicine 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ibufen Junior contains

• The active substance is ibuprofen. Each capsule contains 200 mg of ibuprofen.
• Other ingredients are: macrogol 600, potassium hydroxide, purified water; capsule shell: gelatin, liquid non-crystallizing sorbitol (E 420), liquid maltitol (E 965), purified water.

What Ibufen Junior looks like and contents of the pack
Ibufen Junior is a yellowish transparent soft gelatin capsule filled with a sticky liquid.
Packaging: Alu/PVC/PVDC foil blister containing 6 or 10 capsules, in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceuticals Plants S.A.
Pelplinska Street 19, 83-200 Starogard Gdanski
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceuticals Plants S.A.
Medana Branch in Sieradz
Wladyslawa Lokietka Street 10, 98-200 Sieradz