Ibum zatoki

Package leaflet: Information for the patient

Ibum Zatoki
200 mg + 30 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any possible side effects 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 Ibum Zatoki is and what it is used for
2. Important information before taking Ibum Zatoki
3. How to take Ibum Zatoki
4. Possible side effects
5. How to store Ibum Zatoki
6. Contents of the pack and other information

1. What Ibum Zatoki is and what it is used for

The medicine exerts a combined effect of two active substances: ibuprofen, belonging to non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic agent.
Ibuprofen has analgesic, antipyretic, and anti-inflammatory properties. Pseudoephedrine is a medicine that reduces congestion of the mucous membranes of the upper respiratory tract. It clears nasal passages and sinuses and reduces mucus secretion.
Indications
The medicine is intended for short-term use to relieve symptoms of nasal and paranasal sinus congestion accompanied by headache, pain associated with sinus congestion, and fever occurring during influenza or common cold.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibum Zatoki

When not to use Ibum Zatoki:
if the patient is allergic to ibuprofen, pseudoephedrine or any of the other
ingredients of this medicine (listed in section 6),
in patients who have ever experienced allergic reactions such as rhinitis,
urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal
anti-inflammatory drugs (NSAIDs),
in patients with active or a history of peptic ulceration of the stomach and/or duodenum, perforation
(hole in the wall) or gastrointestinal bleeding, including cases occurring after use of NSAIDs,
in patients with bleeding disorders (tendency to bleed),
in patients with severe liver failure or severe heart failure,
if the patient has severe acute (sudden) or chronic (long-term) kidney disease or
kidney failure,
during pregnancy,
during breastfeeding,
in patients taking other NSAIDs, including COX-2 inhibitors (increased
risk of adverse effects),
in patients with severe cardiovascular disorders, tachycardia (rapid heartbeat), or angina pectoris,
if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication,
in patients who have experienced urinary retention,
in patients with hyperthyroidism,
in patients with narrow-angle glaucoma,
in patients with a history of haemorrhagic stroke or risk factors
that may increase the risk of haemorrhagic stroke, for example due to taking
vasoconstrictive drugs or other medications reducing nasal congestion,
taken orally or applied to the nose (see section “Ibum Zatoki and other medicines”).

Warnings and precautions
Before starting treatment with Ibum Zatoki, consult your doctor or pharmacist.
Exercise particular caution when using Ibum Zatoki in patients:
with systemic lupus erythematosus or mixed connective tissue disease – due to increased risk of aseptic meningitis,
with gastrointestinal disorders (ulcerative colitis, Crohn's disease) – due to possible worsening of the disease,
with impaired kidney function – due to risk of further deterioration of kidney function,
with impaired liver function,
with cardiac arrhythmias, hypertension, myocardial infarction or
heart failure in medical history,
with active or past history of bronchial asthma and allergic diseases – due to possible occurrence of bronchospasm,
in elderly patients – due to increased risk of adverse effects,
taking medications listed in the section “Ibum Zatoki and other medicines”,
with diabetes,
with mild benign prostatic hyperplasia,
with glaucoma,
with pyloric stenosis,
with bladder outlet obstruction.

During treatment with Ibum Zatoki, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of Ibum Zatoki immediately and contact your doctor or seek medical help without delay. See section 4.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, discontinue Ibum Zatoki immediately and seek immediate medical attention (symptoms, see section 4 “Possible side effects”).

Patients with a history of hypertension and/or heart failure should exercise particular caution and consult a doctor or pharmacist before using Ibum Zatoki, as fluid retention, hypertension and oedema have been reported with NSAID treatment.

Taking 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 Ibum Zatoki, the patient should discuss treatment with a doctor or pharmacist if:
the patient has heart disease 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 has had any stroke (including mini-stroke or transient ischaemic 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”.

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or in patients who previously experienced such warning symptoms. If bleeding or ulceration of the gastrointestinal tract occurs, discontinue the medicine immediately and contact a doctor. Patients with a history of gastrointestinal disorders, especially elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period. Such patients should use the lowest effective dose of the medicine.

During treatment with Ibum Zatoki, sudden abdominal pain or rectal bleeding may occur due to inflammatory condition of the large intestine (ischaemic colitis). If such gastrointestinal symptoms occur, discontinue Ibum Zatoki and seek immediate medical advice. See section 4.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), chest pain, have been reported. If any of these symptoms occur, discontinue Ibum Zatoki immediately and contact a doctor or emergency medical services without delay.

Exercise caution when using Ibum Zatoki in patients taking other medicines that may increase the risk of stomach or intestinal disorders or bleeding, such as corticosteroids or anticoagulants such as warfarin (acenocoumarol), or antiplatelet agents such as acetylsalicylic acid.

Long-term, simultaneous use of painkillers may lead to kidney damage with risk of kidney failure (analgesic nephropathy).

Infections
Ibum Zatoki may mask symptoms of infection such as fever and pain. Therefore, Ibum Zatoki 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.

Skin reactions
Severe skin reactions associated with use of Ibum Zatoki have been reported.
If any skin rash, mucosal changes, blisters or other allergic symptoms appear, discontinue use of Ibum Zatoki and seek immediate medical help, as these may be early signs of a very serious skin reaction. See section 4.

Serious 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 occurred with ibuprofen. If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, discontinue Ibum Zatoki immediately and seek medical help.

As with other medicines acting on the central nervous system, there is a risk of abuse with pseudoephedrine. Toxic effects may occur with increased doses. Long-term use may lead to tachyphylaxis (loss of sensitivity to the drug’s effect), increasing the risk of overdose. Depression may occur after abrupt discontinuation of the medicine.

Ibum Zatoki should be used cautiously in patients taking tricyclic antidepressants and other sympathomimetic medicines (medicines causing vasoconstriction of mucosal blood vessels), appetite suppressants, or psychotropic amphetamine-like medicines.

Effect on female fertility
Ibum Zatoki belongs to a group of medicines that may adversely affect fertility in women.
There is evidence that substances inhibiting cyclooxygenase (prostaglandin synthesis), such as ibuprofen, may cause fertility disorders in women by affecting ovulation.
This effect is transient and resolves after discontinuation of treatment.

Children and adolescents
Do not give to children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired kidney function.

Elderly patients
Elderly patients have an increased risk of adverse effects.
To minimize the risk of adverse effects, the medicine should be taken for the shortest duration necessary to relieve symptoms.

Note for athletes: After using pseudoephedrine, doping tests may yield positive results.

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

Ibum Zatoki and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Ibum Zatoki may affect the action of other medicines or other medicines may affect the action of Ibum Zatoki. For example:
anticoagulants (i.e. blood thinners/preventing clot formation), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine;
acetylsalicylic acid, other non-steroidal anti-inflammatory drugs or corticosteroids (e.g.
prednisolone or dexamethasone); using these medicines in combination with ibuprofen may increase the risk of gastrointestinal adverse effects;
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
antihypertensive and diuretic medicines: ibuprofen (like other NSAIDs) may reduce the effectiveness of these medicines;
lithium (antidepressant): evidence suggests potential increase in serum lithium levels during concomitant use of ibuprofen (similar to other NSAIDs);
methotrexate (anticancer medicine): risk of increased methotrexate serum levels during concomitant use of ibuprofen (similar to other NSAIDs);
zidovudine (antiviral medicine): evidence suggests increased risk of joint bleeding and haematomas in haemophilic, HIV-positive patients taking zidovudine and ibuprofen simultaneously;
antacids increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate of pseudoephedrine.

Before taking ibuprofen, inform your doctor if you are taking any of the above-mentioned medicines.

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

Do not use Ibum Zatoki simultaneously with the following medicines:
monoamine oxidase inhibitors (MAOIs) or within 14 days after stopping such treatment. Concomitant use of MAOIs and sympathomimetic medicines may cause hypertensive crisis.

Due to increased risk of vasoconstriction and elevated blood pressure, simultaneous use of Ibum Zatoki (due to pseudoephedrine content) with the following medicines is not recommended:
dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide;
vasoconstrictive dopaminergic medicines – dihydroergotamine, ergotamine, methylergonovine;
linezolid;
nasal decongestants (taken orally or applied nasally) – phenylephrine, ephedrine, phenylpropanolamine.

Concomitant use of the following medicines with pseudoephedrine is not recommended:
appetite suppressants (pseudoephedrine may enhance their effect);
psychostimulants of amphetamine-type (pseudoephedrine may enhance their effect);
antihypertensive medicines, alpha-methyldopa, mecamylamine, reserpine, ergot alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and cardiac arrhythmias).

During use of halogenated gases and inhalational general anaesthetics, concomitant use with pseudoephedrine may cause acute hypertensive reaction in the perioperative period, similar to reactions seen with other sympathomimetic agents. Therefore, it is recommended to discontinue Ibum Zatoki 24 hours before planned general anaesthesia.

Taking Ibum Zatoki with food
Take the medicine after meals.

Pregnancy, breastfeeding and effect on 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
Use of Ibum Zatoki in pregnant women is contraindicated, 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 increase the tendency to bleeding in the mother and her child and may delay or prolong labour. Ibum Zatoki may also cause reduced amniotic fluid volume surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child’s heart.

Breastfeeding
Use of Ibum Zatoki in women during breastfeeding is contraindicated.

Fertility
Use of Ibum Zatoki may adversely affect female fertility. See section “Warnings and precautions”.

Driving and operating machinery
Exercise caution when driving or operating machinery during treatment with Ibum Zatoki.

Ibum Zatoki contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Ibum Zatoki

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.
The medicine is taken orally. The recommended dose is:
Adults and adolescents aged over 12 years: 1 to 2 tablets every 4 hours after meals. Do not exceed a dose of more than 6 tablets per day (maximum daily dose 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride in divided doses).
Elderly patients: dose adjustment is not required unless renal or hepatic function is impaired. If renal or hepatic impairment is present, the doctor should determine the dosage individually.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. This reduces the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Consult a doctor if treatment with this medicine is required for more than 3 days or if symptoms worsen.
Use in children
This medicine should not be given to children under 12 years of age.
Overdose of Ibum Zatoki
If a patient has taken more than the recommended dose of Ibum Zatoki, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for assessment of possible health risks and advice on the necessary actions to take.
Symptoms may include nausea, stomach pain (epigastric pain), vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, breathing difficulties, increased blood pressure, and increased heart rate may occur.
The doctor will provide symptomatic and supportive treatment. Within one hour of ingestion, activated charcoal is recommended (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, electrolyte levels should be checked and an electrocardiogram should be performed.
Missed dose of Ibum Zatoki
Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

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

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling of the 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).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Immediately discontinue use of Ibum Zatoki and seek immediate medical attention if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur, including:
severe headache with sudden onset,
nausea,
vomiting,
confusion,
seizures,
visual disturbances.

Not very common (in 1 to 10 patients per 1,000):
headache, dyspepsia, abdominal pain, nausea, urticaria, and itching.

Rare (in 1 to 10 patients per 10,000):
diarrhea, bloating, constipation, vomiting, gastric mucosal inflammation,
dizziness,
insomnia, restlessness, irritability, and fatigue,
edema due to kidney and urinary tract disorders.

Very rare (occurring in less than 1 patient per 10,000):
tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation 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,
dysuria (difficulty urinating), reduced urine output, renal failure, renal papillary necrosis, increased serum urea concentration,
liver function disorders, particularly during prolonged use,
blood morphology abnormalities (anemia, leukopenia – reduced white blood cell count, thrombocytopenia – reduced platelet count, agranulocytosis – reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds),
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
severe hypersensitivity reactions such as: facial, tongue, and laryngeal swelling, shortness of breath, tachycardia (rapid heartbeat), hypotension (sudden drop in blood pressure), shock,
exacerbation 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.

Frequency not known:

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Severe conditions affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Severe skin reactions may occur, known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, primarily located in skin folds, on the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue use of Ibum Zatoki immediately and seek urgent medical help. See also section 2.
• Skin becomes sensitive to light.
• Inflammation of the large intestine due to inadequate blood supply (ischemic colitis).
• Reduced blood flow in the optic nerve (ischemic optic neuropathy).

Treatment with high-dose NSAIDs has been associated with the occurrence of edema, hypertension, and heart failure.
Use of medicines such as Ibum Zatoki may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Adverse effects due to the presence of pseudoephedrine in the medicine:
posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), dyspepsia, gastrointestinal disturbances, skin redness and rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia (rapid heartbeat), cardiac arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia, ischemic optic neuropathy.

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

5. How to store Ibum Zatoki

Keep the medicine out of sight and reach of children.
Store in the original packaging. Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton. 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 help protect the environment.

6. Contents of the pack and other information

What Ibum Zatoki contains

• The active substances are ibuprofen and pseudoephedrine hydrochloride: one tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• Other components (excipients) are: monohydrate lactose, microcrystalline cellulose, silicified microcrystalline cellulose (a mixture of microcrystalline cellulose and colloidal anhydrous silica), sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate, and Opadry II 85 F1 84 22 White coating. Composition of the coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Ibum Zatoki looks like and contents of the pack
Ibum Zatoki coated tablets are round, 11 mm in diameter, white in colour, and have an engraved
(symbol-logo) on one side.
One pack contains 10 or 20 coated tablets in a cardboard box.
Marketing authorisation holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]