IBUSINUS

IBUSINUS COLD AND FLU 20 FILM-COATED TABLETS

Ibusinus contains two active substances: ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.
Ibusinus is indicated as an anti-inflammatory, analgesic, antipyretic (reduces fever) and decongestant for the upper respiratory tract and sinuses in adults and children over 1512 years of age. Through its two active substances - ibuprofen and pseudoephedrine hydrochloride, Ibusinus decongests the nose and sinuses and relieves symptoms of sinusitis and respiratory conditions. It is recommended for the treatment of sinusitis, rhinosinusitis, respiratory conditions and for the symptomatic treatment of flu.

Precautions:
Do not take Ibusinus:

• if you are allergic to ibuprofen and pseudoephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have had bronchospasm (shortness of breath, wheezing and shortness of breath), rhinitis, urticaria or angioedema (swelling of the face, tongue or throat - larynx - which can cause difficulty breathing) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if you have had an ulcer or bleeding in the stomach or small intestine (duodenum) related to previous use of pain and inflammation medications (NSAIDs);
• if you have an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more such episodes in the past;
• if you have severe impairment (severe insufficiency) of the liver, kidneys or heart;
• if you have coronary heart disease;
• if you have any active bleeding (including in the brain);
• if you have a condition of unknown origin resulting in abnormal formation of blood cells;
• if you have high blood pressure well above normal limits or uncontrolled with appropriate treatment;
• if you have angina pectoris (chest pain);
• if you have diabetes;
• if you have pheochromocytoma;
• if you have increased thyroid gland activity (hyperthyroidism);
• if you have a form of glaucoma with angle closure;
• if you have prostatic hyperplasia;
• if you have epilepsy;
• if you are taking certain antidepressants (called tricyclic antidepressants and monoamine oxidase inhibitors) or if you have stopped taking these medicines for less than 2 weeks;
• if you are under 1512 years of age and weigh less than 40 kg;
• if you are pregnant or breastfeeding.

Before taking Ibusinus, talk to your doctor or pharmacist if:

• you have systemic lupus erythematosus (SLE) or other autoimmune conditions (mixed connective tissue disease);
• there is a family history of a disorder in the production of the red pigment in the blood (porphyria);
• you suffer from alcoholism;
• you have pyloro-duodenal obstruction (narrowing to blockage of the connection between the stomach and small intestine);
• you have chronic inflammatory bowel disease, such as ulcerative colitis (ulcerative colitis), a condition that affects the digestive tract (Crohn's disease) or other conditions of the stomach or intestine;
• you have heart failure and high blood pressure;
• you have liver and kidney disorders;
• you have blood cell formation disorders;
• you have problems with blood clotting;
• you have allergies, allergic rhinitis, seasonal (hay fever), bronchial asthma, chronic inflammation of the nasal mucosa and sinuses, nasal polyps or chronic obstructive conditions of the respiratory tract, as the risk of urticaria, angioedema and bronchospasm is higher;- you have recently had major surgery.

Children and adolescents
There is a risk of renal failure in children and adolescents who suffer from dehydration.
Elderly
If you are elderly you will be more exposed to adverse reactions, especially bleeding and perforation of the digestive tract which can lead to death.
Ulcers, perforation and bleeding in the stomach or intestines

• If you have previously had an ulcer in the stomach or intestines, especially if it was complicated by perforation or was accompanied by bleeding, you should be aware of any unusual abdominal symptoms and tell your doctor immediately, especially if these symptoms occur at the beginning of treatment. This is necessary because the risk of bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, treatment should be discontinued. Bleeding, ulceration or perforation of the stomach or intestines can occur without other warning signs, even in patients who have never had such problems. They can also lead to death.
• The risk of ulcers, perforation or bleeding in the stomach or intestines increases with high doses of ibuprofen. The risk is increased in the elderly, in people with multiple conditions, in those with low body weight or who consume alcoholic beverages. The risk also increases if certain medicines are taken at the same time as ibuprofen (see below, Ibusinus with other medicines).

Effects on the heart and brain
Anti-inflammatory/pain medications, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially if used in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Ibusinus if:

• you have heart problems, including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (reduced blood circulation to the legs or feet, due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or transient ischemic attack “TIA”).
• you have high blood pressure, diabetes, high blood cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Skin reactions

You should stop taking ibuprofen at the first sign of a transient skin rash, mucosal lesions or other signs of allergy as these may be the first sign of serious adverse skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome) which can sometimes lead to death. The highest risk of these reactions is in the first month of treatment.
During chickenpox, it is recommended to avoid using this medicine.

Effects on the kidneys

Ibusinus can cause kidney problems, even in patients who have not had such conditions before. These problems can lead to swelling of the legs and can even lead to severe heart disease or persistently high blood pressure values in predisposed people. Ibusinus can cause kidney damage, especially in patients who already have kidney, heart or liver problems, are taking certain medications (diuretics or ACE inhibitors), and in the elderly. Your doctor needs to monitor your kidney function. In general, discontinuing ibuprofen treatment leads to healing.

Other precautions:

• In long-term treatment, with the use of high doses of analgesics, headaches may occur which should not be treated by increasing the doses of this medicine.
• Regular use over long periods of time of analgesics can lead to permanent kidney damage and risk of renal failure. This risk may increase in conditions of physical exertion, associated with loss of salts and dehydration.
• Ibusinus can mask the symptoms or signs of an infection (fever, pain and inflammation); it can also temporarily prolong bleeding time. Your doctor will monitor your liver function and blood tests.
• During treatment with Ibusinus, certain cases with symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed in patients with certain autoimmune diseases (such as systemic lupus erythematosus, mixed connective tissue disease).
• Alcohol consumption should be avoided as it can accentuate the adverse reactions of ibuprofen and other anti-inflammatory drugs, especially if they affect the gastrointestinal tract or brain.
• In the event of visual disturbances (including if you have glaucoma), you should consult your doctor, discontinue treatment with ibuprofen and an ophthalmological examination is recommended.
• Ibusinus may reduce the possibility of becoming pregnant. You should discuss with your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
• High-performance athletes should be warned that pseudoephedrine can lead to positive test results.
• Reduced blood flow to the optic nerve may occur during Ibusinus administration. If sudden loss of vision occurs, discontinue Ibusinus and contact your doctor or seek medical attention immediately. See section 4.

Ibusinus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Ibusinus can influence or be influenced by other medicines. For example:

• other non-steroidal anti-inflammatory drugs (NSAIDs)
• acetylsalicylic acid
• anticoagulants (against blood clotting), such as warfarin or heparin
• antiplatelet agents (against blood clotting), such as ticlopidine or clopidogrel
• methotrexate (used in the treatment of cancer and autoimmune diseases)
• quinidine, digitalis glycosides, for example digoxin (for the treatment of various heart conditions)
• phenytoin (used to prevent the onset of epileptic seizures)
• lithium (used in the treatment of depression and mania)
• diuretics (for the elimination of water), including those that save potassium
• antihypertensives (for the treatment of persistently high blood pressure values), such as:
• • ACE inhibitors, for example, captopril
• • beta-blockers
• • angiotensin II antagonists
• colestiramine (used in the treatment of high cholesterol values)
• aminoglycosides (medicines against certain types of bacteria)
• SSRIs (medicines against depression), such as paroxetine, sertraline, citalopram
• moclobemide (selective and reversible MAOI – a medicine used in the treatment of depressive illnesses or social phobias)
• ciclosporin, tacrolimus (for the inhibition of the immune system after organ transplantation)
• zidovudine or ritonavir (used in the treatment of HIV infections)
• mifepristone
• probenecid or sulfinpyrazone (for the treatment of gout)
• antibiotic quinolones
• sulfonylureas (for the treatment of type 2 diabetes)
• corticosteroids (used against inflammation)
• bisphosphonates (used in osteoporosis, Paget's disease and to reduce high blood calcium levels)
• pentoxifylline (used in the treatment of circulatory disorders of the arteries of the legs or arms)
• baclofen (a muscle relaxant)
• trimethoprim
• sympathomimetics, for example decongestants or medicines that reduce appetite.
• sympatholytics, for example bretilium, betanidine, guanethidine, debrisoquine, methyldopa, reserpine
• α- and β-adrenergic blocking medicines
• tricyclic antidepressants and those called MAOIs
• some general anesthetics (volatile halogenated).

Ibusinus with food, drinks and alcohol

• Take Ibusinus with a glass of water during or after a meal.
• Avoid ethyl alcohol, as it accentuates the adverse reactions to Ibusinus, especially those that affect the stomach, intestines or brain.
• 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 taking this medicine.
• Do not take Ibusinus if you are pregnant or breastfeeding.
• Ibusinus contains ibuprofen which belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

In general, Ibusinus has no adverse reactions on the ability to drive vehicles or operate machinery.
However, at high doses, in individual cases, adverse reactions may occur, such as fatigue, drowsiness, vertigo and visual disturbances (reported as less common); therefore, activities that require increased attention, motor coordination and quick decisions (for example, working at heights, the ability to drive vehicles and operate machinery) could be negatively affected. This effect is potentiated in the case of concomitant alcohol consumption.

Possible adverse reactions:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicines such as Ibusinus can be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke.
The possibility of adverse reactions increases at higher doses and with longer duration of treatment.
The following adverse reactions are important and require immediate intervention, if they occur. You should stop taking Ibusinus and contact your doctor immediately if the following symptoms occur:
Common (affecting less than 1 in 10 patients ):

• tarry stools or vomiting blood (ulcer in the digestive tract with bleeding)

Very rare (affecting less than 1 in 10000 patients ):

• swelling of the face, tongue or throat (larynx) which can cause difficulty breathing (angioedema), rapid heartbeat, severe drop in blood pressure or shock with potential fatality
• sudden allergic reaction with shortness of breath, wheezing and drop in blood pressure
• severe skin rash with blisters, especially on the legs, arms, palms and soles which may also involve the face and lips (erythema multiforme, Stevens-Johnson syndrome). These can worsen further, the blisters can enlarge and spread and parts of the skin can peel (Lyell's syndrome). There may also be severe infection with destruction of the skin (necrosis), subcutaneous tissue and muscles.

You should stop taking the medicine and contact your doctor as soon as possible if you experience the following adverse reactions:
Very common (affecting more than 1 in 10 patients ):

• burning sensation in the head of the chest, abdominal pain, indigestion

Less common (affecting less than 1 in 100 patients ):

• blurred vision or other vision problems, such as sensitivity to light
• hypersensitivity reactions, such as transient skin rash, itching, asthma attack (sometimes with low blood pressure)

Rare (affecting less than 1 in 1000 patients ):

• loss of vision

Very rare (affecting less than 1 in 10000 patients ):

• sudden filling of the lungs with water resulting in difficulty breathing, high blood pressure, water retention and weight gain

Other possible adverse reactions to Ibusinus are:

Very common (affecting more than 1 in 10 patients ):

• gastrointestinal disorders, such as diarrhea, nausea, vomiting, bloating, constipation

Common (affecting less than 1 in 10 patients ):

• ulcer in the digestive tract with or without perforation
• inflammation of the intestine and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease) and complications of diverticulitis of the large intestine (perforation or fistula)
• microscopic intestinal bleeding which can lead to anemia
• ulcers in the mouth and inflammation
• headache, drowsiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability