Ibumax 200 mg

Patient Information Leaflet

Ibumax 200 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve after 3 days or if you feel worse, consult a doctor.

Table of Contents

1. What Ibumax 200 mg is and what it is used for
2. Important information before taking Ibumax 200 mg
3. How to take Ibumax 200 mg
4. Possible side effects
5. How to store Ibumax 200 mg
6. Contents of the pack and other information

1. What Ibumax 200 mg is and what it is used for

Ibumax 200 mg contains ibuprofen – an active substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
Ibumax 200 mg is indicated for:

• Mild to moderate pain of various origins:
  • Headache (including migraine)
  • Toothache
  • Musculoskeletal and bone pain
  • Neuralgia
  • Pain associated with colds and flu
• Painful menstruation (dysmenorrhoea)
• Fever of various causes (e.g. associated with influenza, colds, or other infectious diseases)

2. Information before using Ibumax 200 mg

When not to use Ibumax 200 mg:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• with active or past peptic ulcer disease of the stomach and/or duodenum, gastrointestinal perforation or bleeding, including those occurring after use of NSAIDs,
• in whom symptoms of allergy such as rhinitis, urticaria or bronchial asthma occurred during treatment with acetylsalicylic acid or other NSAIDs,
• with severe liver failure, severe renal failure or severe heart failure,
• taking other non-steroidal anti-inflammatory drugs concurrently, including COX-2 inhibitors (increases the risk of adverse effects),
• during the last three months of pregnancy,
• with bleeding disorders.

Warnings and precautions
Before starting treatment with Ibumax 200 mg, discuss this with your doctor or pharmacist.

• if the patient has systemic lupus erythematosus or mixed connective tissue disease,
• history of allergic reactions after taking acetylsalicylic acid,
• if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has hypertension and/or heart function disorders,
• if the patient has kidney function disorders,
• if the patient has liver function disorders,
• if the patient has blood clotting disorders (ibuprofen may prolong bleeding time),
• if the patient has active or past bronchial asthma or history of allergic reactions; bronchospasm may occur after administration of the drug,
• patients taking other medicines (especially anticoagulants, diuretics, cardiac drugs or corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or may occur in patients who have previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, ibuprofen treatment should be discontinued. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment.

During use of ibuprofen, allergic reactions to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain. If any of these symptoms are observed, discontinue Ibumax 200 mg immediately and contact a doctor or emergency medical services without delay.

Concurrent, long-term use of painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).

Taking anti-inflammatory/pain-relieving 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.

Before using Ibumax 200 mg, 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 had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection – see below, section titled "Infections".

Skin reactions
Serious skin reactions have occurred with the use of ibuprofen, such as 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 serious skin reactions described in section 4, Ibumax 200 mg should be discontinued immediately and medical help should be sought.

Infections
Ibumax 200 mg may mask signs of infection such as fever and pain. Therefore, Ibumax 200 mg 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 existing infection and symptoms persist or worsen, immediate medical advice should be sought.

Elderly patients have an increased risk of adverse effects associated with ibuprofen use compared to younger patients.

The frequency and severity of adverse effects can be minimized by using the lowest therapeutic dose for the shortest possible duration.

Consult a doctor, even if the above warnings refer to conditions experienced in the past.

Children
This medicine is not indicated for use in children under 12 years of age.

There is a risk of renal failure in dehydrated adolescents.

Ibumax 200 mg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.

Do not take Ibumax 200 mg if you are taking other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other painkillers or acetylsalicylic acid (at analgesic doses).

Ibumax 200 mg may affect the action of other medicines or other medicines may affect the action of Ibumax 200 mg. 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 atenolol-containing medicines, angiotensin II receptor antagonists such as losartan),
• corticosteroids (such as prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant medicine),
• zidovudine (an antiviral medicine).

Some other medicines may also be affected by or may affect treatment with Ibumax 200 mg. Therefore, always consult your doctor or pharmacist before taking Ibumax 200 mg with other medicines.

Pregnancy, breastfeeding and fertility

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

Pregnancy
Do not take Ibumax 200 mg if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibumax 200 mg may lead to impaired kidney and heart function in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, Ibumax 200 mg should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest dose for the shortest possible duration should be used. If Ibumax 200 mg is taken by a woman from the 20th week of pregnancy for longer than a few days, it may cause impaired kidney function in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for longer than a few days, additional fetal monitoring should be recommended.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. As there are no reports of harmful effects of ibuprofen on infants, interruption of breastfeeding is not necessary during short-term use of ibuprofen at low doses.

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 disappears after discontinuation of treatment. In case of difficulty in becoming pregnant, consult a doctor before taking ibuprofen.

Driving and using machines
There are no data on the effect of Ibumax 200 mg on the ability to drive vehicles, operate machinery or psychomotor performance when used at recommended doses and for the recommended duration.

Ibumax 200 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibumax 200 mg

This medicine should always be taken 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. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine is intended for oral use only, in adults and adolescents aged 12 years and older.
Adults and adolescents aged 12 years and older: The initial dose is one or two tablets. Thereafter, if needed, one or two tablets every four hours. No more than six tablets should be taken within 24 hours (maximum daily dose 1200 mg in divided doses).
If the medicinal product is used for longer than 3 days in adolescents, or if symptoms worsen, consult a doctor.
Elderly patients: No dosage adjustment is required.
Do not exceed the recommended dose!
If you feel that the effect of Ibumax 200 mg is too strong or too weak, consult your doctor.
This medicine is intended for short-term use only.
Use the lowest effective dose for the shortest possible duration. This reduces the risk of adverse effects.
Do not take the medicine for more than 3 days unless otherwise directed by a doctor.

Overdose of Ibumax 200 mg
Cases of overdose are rare.
In severe poisoning, metabolic acidosis may occur, and prothrombin time (INR) may be prolonged.
Acute renal failure or liver damage may occur.
In patients with asthma, symptoms may worsen.
If a patient has taken more than the recommended dose of Ibumax 200 mg, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus (ringing in the ears), disorientation, and nystagmus. Agitation, drowsiness, disorientation, or coma may also occur. Seizures may occur sporadically in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Moreover, hypotension and breathing difficulties may occur.
There is no specific antidote. Symptomatic and supportive treatment should be administered, including removal of the drug from the body. The doctor should monitor vital signs and consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged convulsions, intravenous diazepam or lorazepam should be administered. In patients with asthma, bronchodilators should be administered.

Missed dose of Ibumax 200 mg
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following symptoms, ibuprofen use must be stopped immediately and medical help sought:

• Red, flat, target-like or round spots on the trunk, often with blisters in the center, skin peeling, and ulceration 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 fever, 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 generalized exanthematous pustulosis) – frequency unknown.

Adverse reactions occurring uncommonly (in 1 to 10 out of 1,000 patients using the medicine):

• Headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients using the medicine):

• Diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability, and feeling of fatigue,
• Edema due to kidney and urinary tract disorders.

Adverse reactions occurring very rarely (less than 1 in 10,000 patients using the medicine):

• Tarry stools, vomiting blood, ulcerative stomatitis, exacerbations of colitis and Crohn's disease,
• Peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
• In isolated cases: depression, psychotic reactions, tinnitus, aseptic meningitis,
• Reduced urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
• Liver function disorders, particularly during prolonged use,
• Abnormal blood morphology parameters (anemia, leukopenia – reduced white blood cell count, thrombocytopenia – reduced platelet count, pancytopenia – hematological disorder characterized by deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis – reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, hemorrhagic diathesis (e.g., bruising, petechiae, purpura, nosebleeds),
• Severe hypersensitivity reactions such as: facial, tongue, and laryngeal swelling, shortness of breath, tachycardia – heart rhythm disorder, hypotension – sudden drop in blood pressure, shock; worsening of asthma and bronchospasm,
• In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Skin becomes sensitive to light.
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome. When using medicines such as ibuprofen at high doses, cases of edema, hypertension, and heart failure have been reported.

Taking medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibumax 200 mg

No special storage instructions required.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Ibumax 200 mg contains
1 coated tablet contains:
active substance: ibuprofen, 200 mg
excipients: pregelatinized starch, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, stearic acid, colloidal anhydrous silica; coating:
hypromellose, polyethylene glycol 4000, polidextrose, titanium dioxide (E 171).

What Ibumax 200 mg looks like and contents of the pack
Ibumax 200 mg: 6, 10, 12, 20, 24, 30, 50 coated tablets (aluminum/PVC or aluminum/PVC/PVDC blisters) in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Tel: +358 3 615 600
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vitabalans Sp. z o.o.
ul. Narbutta 5 m 1
02-564 Warsaw
[email protected]