Ibunoven Zatoki

Leaflet accompanying the packaging: patient information

Ibunoven NASAL, 200 mg + 30 mg, soft capsules

Ibuprofen + Pseudoephedrine hydrochloride

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Ibunoven and what is it used for

Ibunoven is used to relieve symptoms associated with nasal congestion, as well as sinus headache, fever, and pain associated with colds and flu.
This medicine contains ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), which also has analgesic and antipyretic effects. The capsules also contain pseudoephedrine hydrochloride, a substance that facilitates breathing, helping to clear the nasal passages and reduce nasal congestion.
This medicine should only be used if there is nasal congestion with headache, pain, and/or fever at the same time. It should not be used if only one of these symptoms is present.

2. Important information before taking Ibunoven

When not to take Ibunoven:

• if the patient is allergic to ibuprofen, acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (NSAIDs), or if they have had skin rashes, hives, itching, difficulty breathing, chest tightness, swelling of the lips, face, or tongue when taking these medicines, or if they are allergic to any of the other ingredients of this medicine (listed in section 6),
• if the patient has active or past stomach ulcers, stomach bleeding, or perforation,
• if the patient has diabetes, prostate problems, thyroid disease, glaucoma, or a pheochromocytoma (a tumor of the adrenal gland),
• if the patient has severe kidney disease (kidney failure), severe liver disease, heart disease, severe heart failure, high blood pressure (hypertension) that cannot be controlled with medication, or circulation disorders,
• if the patient is taking medications for depression called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (or if they have taken them in the last 14 days),
• if the patient has other bleeding problems,
• if the patient has had a stroke,
• if the patient is taking other non-steroidal anti-inflammatory drugs (NSAIDs), painkillers, or other nasal decongestants taken orally,
• in children under 12 years of age,
• during pregnancy or breastfeeding.

Warnings and precautions

Taking anti-inflammatory/pain-relieving medications like 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.
There have been reports of serious effects on the blood vessels of the brain, known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
If any of the following symptoms occur, stop taking the medicine and contact a doctor immediately: sudden, severe headache, feeling unwell, vomiting, confusion, seizures, vision disturbances (see section 4).

Important information before taking Ibunoven

While taking ibuprofen, there have been reports of allergic reactions to this medicine, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain.
If any of these symptoms are noticed, stop taking Ibunoven immediately and contact a doctor or emergency medical services.

While taking Ibunoven, be especially careful:

There have been reports of severe skin reactions, 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 experiences any of the symptoms associated with these severe skin reactions (described in section 4), stop taking Ibunoven and contact a doctor.

Before starting Ibunoven, discuss with your doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), has had a heart attack, bypass surgery, or has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes. Any risk is more likely after high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment;
• the patient has bleeding disorders;
• the patient has stomach ulcers or inflammatory bowel disease (such as ulcerative colitis and Crohn's disease);
• while taking Ibunoven, there may be a sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis). If such gastrointestinal symptoms occur, stop taking Ibunoven and seek medical attention immediately. See section 4;
• if the patient has asthma or allergies;
• if the patient has heart, kidney, liver, or prostate disease;
• in the case of the elderly - they are more prone to side effects such as stomach bleeding and perforation, which can be fatal;
• in the case of systemic lupus erythematosus (SLE) - a disease that affects the immune system, causing joint pain, skin changes, and other disorders;
• in the case of trying to conceive;
• in the case of dehydrated youth aged 12-17, as there is a risk of kidney disease. If youth aged 12-17 do not drink fluids or lose fluids due to persistent vomiting or diarrhea, they should consult a doctor before taking this medicine;
• if the patient has an infection - see below, section entitled "Infections".

Stop taking this medicinal product and contact a doctor immediately if:

• Sudden chest pain or discomfort accompanied by shortness of breath.
• Sudden abdominal pain or blood in the stool.
• Sudden and severe headache, accompanied by vomiting or vision disturbances.

Pseudoephedrine can cause blood vessel constriction (vasoconstriction). This effect may be associated with the occurrence of the following sudden conditions. These conditions require immediate medical attention:

• Acute coronary syndrome (ACS): includes conditions such as myocardial infarction or unstable angina, which is a type of severe chest pain caused by blockage of blood flow to part of the heart. Sudden chest pain or discomfort (feeling of pressure or tightness) may radiate from the chest to the arms, jaw, neck, back, or abdomen. You may also feel dizzy, sweat, or have difficulty breathing. Stop taking this medicine and contact a doctor immediately if symptoms occur that may be signs of ACS.
• After taking pseudoephedrine-containing medications, there have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain. If symptoms occur that may be signs of PRES or RCVS, stop taking this medicine and contact a doctor immediately (see section 4).

When to be especially careful when taking Ibunoven
Skin reactions
Severe skin reactions have been reported with Ibunoven.
If any of the following occur: any skin rash, mucosal lesions, blisters, or other signs of allergy, stop taking Ibunoven and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4.
While taking Ibunoven, there may be a decrease in blood flow to the optic nerve. If sudden vision loss occurs, stop taking Ibunoven and contact a doctor or seek medical attention immediately. See section 4.
While taking Ibunoven, avoid drinking alcohol.
Pseudoephedrine may result in a positive doping test result.
Ibunoven should be avoided in the case of chickenpox.
Infections
Ibunoven may mask the symptoms of an infection, such as fever and pain. Therefore, Ibunoven may delay the use of appropriate infection treatment and lead 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 while an infection is present, and the infection symptoms persist or worsen, they should consult a doctor immediately.

Children and adolescents

Ibunoven can be used in adults and adolescents over 12 years of age.
Ibunoven should not be used in children under 12 years of age.

Ibunoven and other medicines

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

Do not take this medicine if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs),
• nasal decongestants (nasal or oral),
• in the past or in the last two weeks, antidepressant medications known as monoamine oxidase inhibitors (MAOIs),
• tricyclic antidepressants (used to treat depression).

Tell your doctor if you are taking:

• blood-thinning medications (such as warfarin, ticlopidine, acetylsalicylic acid (aspirin)),
• blood pressure-lowering medications (such as ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan) or any diuretic,
• digitalis glycosides, such as digoxin, or quinidine used to treat heart conditions,
• phenytoin (a medication used to treat epilepsy),
• lithium (used to treat mood disorders),
• methotrexate (used to treat arthritis),
• antacids (medications used to treat stomach ulcer symptoms, such as heartburn),
• cyclosporin (used to weaken the immune system, e.g., after a transplant),
• mifepristone (used to terminate pregnancy),
• quinolone antibiotics (used to treat a wide range of infections),
• tacrolimus (a medication used after a transplant),
• sulfonylurea derivatives, such as glibenclamide (used to treat diabetes),
• corticosteroids (a type of anti-inflammatory medication, e.g., hydrocortisone),
• selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine) (medications used to treat depression),
• aminoglycosides (e.g., gentamicin or amikacin) (medications used to treat infections),
• the antibacterial agent furazolidone (a medication used to treat infections),
• zidovudine (a medication used to treat HIV infections),
• guanethidine, reserpine, or methyldopa (medications used to treat heart and circulatory conditions),
• sulfinpyrazone and probenecid (medications used to treat gout),
• potassium-sparing diuretics (medications used to treat heart conditions),
• ergot derivatives (medications used to treat migraines),
• dopamine receptor agonists (medications used to treat Parkinson's disease symptoms),
• heparin, Ginkgo biloba(used to treat blood clots).

In case of need for anesthesia, stop taking the medicine and inform the anesthesiologist.
Also, some other medications may be affected by or have an effect on Ibunoven treatment. Therefore, before taking Ibunoven with other medications, always consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Taking Ibunoven in the last 3 months of pregnancy may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and her baby and cause delayed or prolonged labor.
Taking Ibunoven for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn baby, leading to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart .
If treatment is necessary during attempts to conceive, the smallest dose should be used for the shortest possible time.

Ibunoven should not be used in pregnant or breastfeeding women.

Ibuprofen belongs to a group of medications called NSAIDs, which may have a negative effect on female fertility. This effect is reversible after stopping the medication. It is unlikely that occasional use of ibuprofen will affect fertility. However, if there are difficulties in conceiving, the doctor should be informed about taking this medicine.

Driving and using machines

The medicine has no effect on the ability to drive and use machines. Ibunoven may cause side effects such as dizziness, hallucinations, unusual headaches, and vision or hearing disturbances. If any of these side effects occur, driving should be avoided.

Ibunoven contains sorbitol

Liquid sorbitol, partially dehydrated

The medicine contains 63 mg of liquid sorbitol, partially dehydrated, in each capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to adolescents.

3. How to take Ibunoven

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
This combination medicinal product should only be used when the action of pseudoephedrine hydrochloride to reduce nasal congestion and the analgesic and/or anti-inflammatory action of ibuprofen is necessary. If one symptom predominates (occurs alone, either nasal congestion, or headache, and/or fever), it is more beneficial to treat with a single substance.

The medicine should be taken orally and for a short period only.

Adults, elderly, and adolescents over 12 years of age

Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose is 1 or 2 capsules every 4 to 6 hours. The capsules should be taken with water. Take as many capsules as needed, remembering to leave a 4- to 6-hour interval between doses. Do not exceed 6 capsules per day. If symptoms persist for more than 3 days, consult a doctor.

Do not use in children under 12 years of age.

Do not exceed the recommended dose.

Taking a higher dose of Ibunoven than recommended

If the patient has taken a higher dose of Ibunoven than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do. Take the capsules with you to show the doctor.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion. There may also be restlessness, excitement, disorientation, and coma. Occasionally, patients have experienced seizures. At high doses, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and difficulty breathing may occur.

Missing a dose of Ibunoven

Ibunoven is taken as needed. If a dose is missed and symptoms persist, take the next dose of the medicine. Do not take a double dose to make up for a missed dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention:

• Red, flat, target-like, or circular rashes on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 not known.
• Red, peeling rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

If any of the following symptoms occur:

• sudden, severe headache,
• feeling unwell, vomiting,
• confusion (altered consciousness),
• seizures,
• vision disturbances, stop taking the medicine and contact a doctor immediately, as these may be symptoms of an effect on the blood vessels of the brain and serious disorders such as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which are reported after taking pseudoephedrine-containing products.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The risk of side effects can be reduced by taking the smallest effective dose for the shortest duration necessary to relieve symptoms.

If any of the following side effects occur, stop taking the medicine and contact a doctor or pharmacist:

In addition to the above-mentioned symptoms, the following side effects may occur during treatment:

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ibunoven

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the blister and carton after: EXP.
The expiration date refers to the last day of the month stated.
Do not store above 25°C.
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 Ibunoven contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride. Each capsule contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• Other ingredients are: Capsule filling: macrogol 600 (E 1521), potassium hydroxide, purified water. Capsule shell: gelatin, liquid sorbitol, partially dehydrated, purified water, natural beta-carotene 10% CWD, consisting of: natural carotene (E 160a), modified starch, all-rac-α-tocopherol (E 307). Opacode Black Ink (S-1-17823): shellac, isopropyl alcohol, iron oxide, black (E 172), n-butyl alcohol, propylene glycol, ammonium hydroxide.

What Ibunoven looks like and contents of the pack

Ibunoven has the form of light orange, transparent, oval, soft gelatin capsules filled with a liquid of a color from transparent to light orange, with the imprint "IBP" with a length of 16.00 mm ± 1.00 mm and a width of 9.5 mm ± 1.00 mm.
The capsules are packaged in PVC/PVDC/Aluminum blisters, in a cardboard box.
The packaging contains 12 capsules or 24 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231

Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Date of last revision of the leaflet: