IBUM 400 mg/60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ibum Zatoki Max
3. 400 mg + 60 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Ibum Zatoki Max and what is it used for
   1. Indications for Use
5. Important Information Before Taking Ibum Zatoki Max
   1. When Not to Take Ibum Zatoki Max
   2. Warnings and Precautions
   3. Ibum Zatoki Max and Other Medicines
   4. Taking Ibum Zatoki Max with Food
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Using Machines
   7. Ibum Zatoki Max Contains Lactose
6. How to Take Ibum Zatoki Max
   1. Use in Children
   2. Overdose of Ibum Zatoki Max
   3. Missed Dose of Ibum Zatoki Max
7. Possible Side Effects
   1. If You Experience Any of the Following Symptoms, Stop Taking Ibuprofen and Seek Medical Attention:
   2. Side Effects Due to Pseudoephedrine in the Medicine:
   3. Reporting Side Effects
8. How to Store Ibum Zatoki Max
9. Contents of the Package and Other Information
   1. What Ibum Zatoki Max Contains
   2. What Ibum Zatoki Max Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. Information About the Medicine
   5. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Ibum Zatoki Max

400 mg + 60 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package 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 those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Ibum Zatoki Max and what is it used for
• 2. Important information before taking Ibum Zatoki Max
• 3. How to take Ibum Zatoki Max
• 4. Possible side effects
• 5. How to store Ibum Zatoki Max
• 6. Contents of the package and other information

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

Ibum Zatoki Max has a combined effect of two components: ibuprofen, belonging to non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic drug.

Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract. It clears the nose and paranasal sinuses, reducing the amount of discharge.

Indications for Use

The drug is intended for temporary use to relieve symptoms of nasal congestion and paranasal sinuses with accompanying headache, pain related to sinus congestion, and fever in the course of flu or cold.

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important Information Before Taking Ibum Zatoki Max

When Not to Take Ibum Zatoki Max

• 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 had allergic symptoms after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as nasal congestion, urticaria, or bronchial asthma,
• in patients with active or recurrent peptic ulcer disease, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients with bleeding disorders (tendency to bleed),
• in patients with severe liver or heart failure,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• in pregnancy,
• during breastfeeding,
• in patients with severe cardiovascular disorders, tachycardia (rapid heart rate), angina pectoris,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in patients who have had urinary retention,
• in patients with hyperthyroidism,
• in patients with narrow-angle glaucoma,
• in patients who have had a hemorrhagic stroke or have risk factors that may increase the risk of a hemorrhagic stroke, such as taking vasoconstrictor medications or other decongestants used orally or nasally (see "Ibum Zatoki Max and other medicines").

Warnings and Precautions

Before starting treatment with Ibum Zatoki Max, you should discuss it with your doctor or pharmacist.

Particular caution should be exercised when taking Ibum Zatoki Max in patients:

• with systemic lupus erythematosus and mixed connective tissue disease - due to the increased risk of developing aseptic meningitis,
• with gastrointestinal diseases (ulcerative colitis, Crohn's disease) - due to the possibility of exacerbating the disease,
• with kidney function disorders - due to the risk of further deterioration of kidney function,
• with liver function disorders,
• with rhythm disorders, hypertension, myocardial infarction, or heart failure in their history,
• with active or previously diagnosed bronchial asthma and allergic diseases - due to the possibility of bronchospasm,
• in the elderly - due to the risk of increased side effects,
• taking other medications listed in the "Ibum Zatoki Max and other medicines" section,
• with diabetes,
• with benign prostatic hyperplasia,
• with glaucoma,
• with pyloric stenosis,
• with urethral stricture,
• taking other NSAIDs, including COX-2 inhibitors (increased risk of side effects).

During treatment with Ibum Zatoki Max, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, you should stop taking Ibum Zatoki Max and immediately consult a doctor or seek medical attention. See section 4.

Patients who have had hypertension and/or heart failure should be particularly cautious and consult their doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and edema.

Taking anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.

Before taking Ibum Zatoki Max, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• they have hypertension, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or if they smoke,
• they have an infection - see below, the section entitled "Infections".

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients who have had such warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately and a doctor consulted.

Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Such patients should use the smallest effective dose.

During treatment with Ibum Zatoki Max, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, you should stop taking Ibum Zatoki Max and seek medical attention immediately. See section 4.

During treatment with ibuprofen, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain. If any of these symptoms are noticed, you should stop taking Ibum Zatoki Max immediately and seek medical attention or call emergency services.

Caution should be exercised when taking the medicine in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications, such as warfarin (acenocoumarol) or antiplatelet agents, such as acetylsalicylic acid.

Prolonged use of analgesic medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Infections

Ibum Zatoki Max may mask the symptoms of infection, such as fever and pain. Therefore, Ibum Zatoki Max may delay the use of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

Skin Reactions

Severe skin reactions have been reported with the use of Ibum Zatoki Max. If a skin rash, mucosal lesions, blisters, or other signs of hypersensitivity occur, you should stop taking Ibum Zatoki Max and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.

With the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should stop taking Ibum Zatoki Max and seek medical attention immediately.

After taking pseudoephedrine-containing medications, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that can be associated with reduced blood flow to the brain.

If symptoms occur that may be signs of PRES or RCVS, you should stop taking Ibum Zatoki Max immediately and seek medical attention immediately (symptoms, see section 4 "Possible side effects").

As with other centrally acting sympathomimetic medications, there is a risk of pseudoephedrine abuse. With increased doses, toxic effects may occur. Long-term use can lead to the development of tachyphylaxis (loss of drug effect) with an increased risk of overdose. After sudden withdrawal of the medicine, depression may occur.

The medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic medications (medications that constrict blood vessels in mucous membranes), appetite suppressants, amphetamine-like psychostimulants.

Effect on Fertility in Women

Ibum Zatoki Max belongs to a group of medications that may adversely affect fertility in women. There is evidence that cyclooxygenase inhibitors (prostaglandin synthesis), to which ibuprofen belongs, may cause fertility disorders in women by affecting ovulation. This effect is temporary and reverses after treatment is stopped.

Children and Adolescents

Do not give to children under 12 years of age.

In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.

Elderly Patients

In elderly patients, there is an increased risk of side effects.

To minimize the risk of side effects, the medicine should be taken for the shortest period necessary to relieve symptoms.

Athletes should note that after taking pseudoephedrine, a positive result may occur in doping tests.

Consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Ibum Zatoki Max and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Ibum Zatoki Max may affect the action of other medicines or other medicines may affect the action of Ibum Zatoki Max. For example:

• anticoagulant medications (i.e., blood thinners that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or corticosteroids (e.g., prednisolone or dexamethasone); taking these medications in combination with ibuprofen may increase the risk of gastrointestinal side effects;
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• antihypertensive and diuretic medications: ibuprofen (like other NSAIDs) may reduce the effect of these medications;
• lithium (an antidepressant medication): there is evidence of a potential increase in lithium levels in the blood when taking ibuprofen (like other non-steroidal anti-inflammatory medications);
• methotrexate (an anticancer medication): there is a risk of increased methotrexate levels in the blood when taking ibuprofen (like other non-steroidal anti-inflammatory medications);
• zydovudine (an antiviral medication): there is evidence of an increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zidovudine and ibuprofen;
• medications that reduce stomach acid, increase the absorption rate of pseudoephedrine, and kaolin decreases the absorption rate of pseudoephedrine.

Before taking ibuprofen, tell your doctor about taking any of the above medications.

Also, some other medications may be affected or have an effect on Ibum Zatoki Max treatment. Therefore, before taking Ibum Zatoki Max with other medications, always consult your doctor or pharmacist.

Ibum Zatoki Max should not be taken with the following medications:

• monoamine oxidase inhibitors and for up to 14 days after stopping these inhibitors. Taking monoamine oxidase inhibitors and sympathomimetic medications at the same time may cause hypertensive crises.
• due to the increased risk of vasoconstriction and increased blood pressure, it is not recommended to take Ibum Zatoki Max (due to pseudoephedrine content) with the following medications:

Do not recommend taking the following medications with pseudoephedrine:

• appetite suppressants (pseudoephedrine may increase their effect);
• psychostimulant medications of the amphetamine type (pseudoephedrine may increase their effect);
• antihypertensive medications, alpha-methyldopa, mecamylamine, reserpine, ergot alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
• tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and arrhythmias).

When taking halogenated anesthetics, inhaled general anesthetics, in combination with pseudoephedrine, a severe hypertensive reaction may occur during the perioperative period, similar to when these medications are taken with other indirectly acting sympathomimetic medications. Therefore, it is recommended to discontinue Ibum Zatoki Max 24 hours before scheduled general anesthesia.

Taking Ibum Zatoki Max with Food

The medicine should be taken after meals.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Taking Ibum Zatoki Max during pregnancy 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 risk of bleeding in the mother and her child and cause delayed or prolonged labor. Ibum Zatoki Max may also cause a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart.

Breastfeeding

Taking Ibum Zatoki Max during breastfeeding is contraindicated.

Fertility

Taking Ibum Zatoki Max may adversely affect fertility in women. See "Warnings and Precautions".

Driving and Using Machines

While taking Ibum Zatoki Max, be cautious when driving vehicles and operating machinery.

Ibum Zatoki Max Contains Lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to Take Ibum Zatoki Max

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The medicine is taken orally. The recommended dose is:

Adults and Adolescents Over 12 Years: 1 tablet every 4 hours after meals. Do not take more than 3 tablets per day (maximum daily dose of 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses).

The single dose should be reduced to ½ tablet if it is sufficient to relieve symptoms.

Elderly Patients: dose adjustment is not required unless there is impaired kidney or liver function. If there are kidney or liver function disorders, the doctor should determine the dose individually.

Use the smallest effective dose for the shortest period necessary to relieve symptoms. This will minimize the risk of side effects. If the symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Consult a doctor if it is necessary to take the medicine for more than 3 days or if symptoms worsen.

Use in Children

Do not give the medicine to children under 12 years of age.

Overdose of Ibum Zatoki Max

If you have taken more than the recommended dose of Ibum Zatoki Max or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital for advice on the possible risk to your health and the actions to be taken.

Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as increased blood pressure and increased heart rate.

The doctor will provide symptomatic and supportive treatment. Within one hour of taking the medicine, it is recommended to administer activated charcoal (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, check the electrolyte levels and perform an electrocardiogram.

Missed Dose of Ibum Zatoki Max

Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Ibum Zatoki Max can cause side effects, although not everybody gets them.

If You Experience Any of the Following Symptoms, Stop Taking Ibuprofen and Seek Medical Attention:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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 body temperature, and swollen lymph nodes (DRESS syndrome),
• red, scaly rash with nodules under the skin and blisters, usually accompanied by fever, occurring at the beginning of treatment (acute generalized exanthematous pustulosis).

Stop taking Ibum Zatoki Max and seek medical attention immediately if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.

Uncommon(affects 1 to 10 users in 1,000):

headache, indigestion, stomach pain, nausea, urticaria, and itching.

Rare(affects 1 to 10 users in 10,000):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
• edema resulting from kidney and urinary disorders.

Very Rare(affects less than 1 user in 10,000):

• black stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, and perforation, sometimes with a fatal outcome, especially in the elderly,
• in single cases, depression, psychotic reactions, and tinnitus have been reported, aseptic meningitis,
• dysuria (difficulty urinating), decreased urine output, kidney failure, renal papillary necrosis, increased urea levels in the blood,
• liver function disorders, especially during long-term use,
• blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial mouth 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 edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), single cases of symptoms of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Frequency Not Known:

• Chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome.
• Severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• Red, scaly rash with nodules under the skin and blisters, usually occurring at the beginning of treatment, mainly in skin folds, on the torso, and upper limbs, with fever (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Ibum Zatoki Max and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.
• Ischemic colitis (inflammatory bowel disease caused by insufficient blood flow).
• Decreased blood flow in the optic nerve (ischemic optic neuropathy).

Treatment with NSAIDs in high doses has been associated with edema, hypertension, and heart failure.

Taking medications like Ibum Zatoki Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Side Effects Due to Pseudoephedrine in the Medicine:

posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), indigestion, gastrointestinal disorders, redness, and rash, nausea, vomiting, excessive sweating, dizziness, rapid heart rate, arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia, ischemic optic neuropathy.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

tel.: +48 22 49 21 301, fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Ibum Zatoki Max

Keep the medicine out of the sight and reach of children.

Store in the original package. 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 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 Package and Other Information

What Ibum Zatoki Max Contains

• The active substances are ibuprofen and pseudoephedrine hydrochloride: 1 tablet contains 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, siliconized microcrystalline cellulose (a mixture of microcrystalline cellulose and anhydrous colloidal silica), sodium carboxymethylcellulose (type A), anhydrous colloidal silica, magnesium stearate, Opadry II White 85F18422: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Ibum Zatoki Max Looks Like and Contents of the Package

Ibum Zatoki Max coated tablets are white, oval, and biconvex with a dividing line on both sides.

One package of the medicine contains 6 or 12 coated tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Information About the Medicine

tel.: (22) 742 00 22

e-mail: [email protected]

Date of Last Revision of the Package Leaflet: