Ibuprom Zatoki Sprint

Leaflet accompanying the packaging: patient information

IBUPROM SPRINT SINUS

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 advised 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

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

1. What is Ibuprom Sprint Sinus and what is it used for

Ibuprom Sprint Sinus is used to relieve symptoms associated with nasal congestion or sinus headache, fever, and joint and muscle pain associated with colds and flu.
This medicine contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), which has analgesic and antipyretic effects. The capsules also contain pseudoephedrine hydrochloride, a decongestant that helps 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.
Ibuprom Sprint Sinus should be used in adults and adolescents over 12 years of age.

2. Important information before taking Ibuprom Sprint Sinus

When not to take Ibuprom Sprint Sinus:

• if you are allergic to ibuprofen, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs) or have had skin rashes, hives, itching, difficulty breathing, chest tightness, swelling of the face, lips, tongue, or throat when taking these medicines or if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• if you have active or have had stomach ulcers, bleeding from the stomach, or perforation of the stomach;
• if you have diabetes, prostate enlargement, thyroid disease, glaucoma, or a pheochromocytoma (a tumor of the adrenal gland);
• if you have severe liver disease, heart disease, severe heart failure, or circulatory disorders;
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you are taking medicines for depression called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (or have taken them in the last 14 days);
• if you have other bleeding problems;
• if you have had a stroke;
• if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), painkillers, or other decongestants taken orally;
• in children under 12 years of age;
• during pregnancy or breastfeeding;
• if you have been diagnosed with hereditary fructose intolerance.

Warnings and precautions

Taking anti-inflammatory and pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Ibuprom Sprint Sinus, you should discuss your treatment with a doctor or pharmacist if:

• you have heart disease, such as heart failure, angina (chest pain), have had a heart attack, have had a bypass operation, have peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of the arteries) or have had a stroke (including a mini-stroke or transient ischemic attack - TIA).
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you smoke. The risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.
• you have bleeding disorders.
• you have stomach ulcers or inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease).
• while taking Ibuprom Sprint Sinus, you may experience sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis). If you experience such gastrointestinal symptoms, stop taking Ibuprom Sprint Sinus and seek medical attention immediately. See section 4.
• you have asthma or allergies.
• you have heart, kidney, liver, or prostate disease.
• elderly people - are more prone to side effects, such as stomach bleeding and perforation, which can be fatal.
• in case of systemic lupus erythematosus (SLE) - a disease that affects the immune system, causing joint pain, skin changes, and other problems.
• in case of attempting to conceive.

If you are between 12 and 17 years old, have recently not taken fluids or have been diagnosed with dehydration due to diarrhea or vomiting, consult a doctor or pharmacist before taking the medicine. There is a higher risk of kidney problems in case of dehydration.
While taking Ibuprom Sprint Sinus, you may experience a decrease in blood flow to the optic nerve. If you experience sudden vision loss, stop taking Ibuprom Sprint Sinus and seek medical attention immediately. See section 4.
While taking ibuprofen, allergic reactions to this medicine have been reported, including difficulty breathing, face and neck swelling (angioedema), chest pain.
If you notice these symptoms, stop taking Ibuprom Sprint Sinus and seek medical attention immediately.

Skin reactions

Severe skin reactions have been reported with the use of Ibuprom Sprint Sinus. If you experience: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, stop taking Ibuprom Sprint Sinus and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
If you experience fever with generalized redness of the skin and a pustular rash, stop taking Ibuprom Sprint Sinus and seek medical attention immediately. See section 4.

Infections

Ibuprom Sprint Sinus may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprom Sprint Sinus may delay the use of appropriate infection treatment and lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.
If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, consult a doctor immediately.
After taking pseudoephedrine-containing medicines, 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 you experience symptoms that may be signs of PRES or RCVS, stop taking Ibuprom Sprint Sinus immediately and seek medical attention (symptoms, see section 4 "Possible side effects").

Children and adolescents

Do not give this medicine to children under 12 years of age.
Ibuprom Sprint Sinus should be used in adults and adolescents over 12 years of age.

Ibuprom Sprint Sinus 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 nonsteroidal anti-inflammatory drugs (NSAIDs);
• decongestant medicines (nasal or oral);
• in the past or in the last two weeks, antidepressant medicines known as monoamine oxidase inhibitors (MAOIs);
• tricyclic antidepressants (used to treat depression).

Tell your doctor if you are taking:

• blood-thinning medicines (e.g., warfarin, ticlopidine, aspirin/acetylsalicylic acid);
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan) or any diuretic;
• digitalis glycosides, such as digoxin, or quinidine used to treat heart conditions;
• phenytoin (a medicine used to treat epilepsy);
• lithium (used to treat mood disorders);
• methotrexate (used to treat arthritis);
• antacids (medicines 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 medicine used after a transplant);
• medicines known as sulfonylureas, such as glibenclamide (used to treat diabetes);
• corticosteroids (a type of anti-inflammatory medicine, e.g., hydrocortisone);
• selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine) (medicines used to treat depression);
• aminoglycosides (e.g., gentamicin or amikacin) (medicines used to treat infections);
• the antibacterial medicine furazolidone (used to treat infections);
• zidovudine (used to treat HIV infections);
• guanethidine, reserpine, or methyldopa (medicines used to treat heart and circulatory diseases);
• sulfinpyrazone and probenecid (medicines used to treat gout);
• potassium-sparing diuretics (medicines used to treat heart conditions);
• ergot-derived medicines (used to treat migraines);
• dopamine receptor agonists (medicines used to treat Parkinson's disease symptoms);
• heparin, Ginkgo biloba (used to treat blood clots).

In case of need for anesthesia, stop the medicine and inform the anesthesiologist.
Some other medicines may also be affected by or have an effect on the treatment with Ibuprom Sprint Sinus. Therefore, always consult a doctor or pharmacist before taking Ibuprom Sprint Sinus with other medicines.

Pregnancy and breastfeeding

Ibuprom Sprint Sinus should not be taken during pregnancy or breastfeeding.
If you are pregnant or think you may be pregnant or are planning to have a baby, consult a doctor or pharmacist before taking this medicine.

Fertility

Ibuprofen belongs to a group of medicines, NSAIDs, which may have a negative effect on female fertility.
This effect is reversible after stopping the medicine. It is unlikely that occasional use of ibuprofen will affect fertility. However, if you have problems conceiving, tell your doctor that you are taking this medicine.

Driving and using machines

After taking the medicine, you may feel dizzy, have unusual headaches, vision or hearing disturbances, including visual or auditory hallucinations. In such a case, do not drive vehicles, do not ride a bicycle, or operate any other machines or tools.

Ibuprom Sprint Sinus contains sorbitol and potassium.

The medicine contains 63 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, consult a doctor before taking or administering the medicine.
One capsule of Ibuprom Sprint Sinus contains 21 mg of potassium. This should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take Ibuprom Sprint Sinus

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The medicine should be taken orally and for a short period only.
Adults, elderly, and adolescents over 12 years of age: Use the lowest effective dose to minimize the risk of side effects.
The recommended dose is 1 or 2 capsules every 4 to 6 hours. The capsules should be swallowed whole, with a large glass of water. Take as many capsules as needed, remembering to leave a 4 to 6-hour interval between doses. Do not take more than 6 capsules in 24 hours. If after 3 days there is no improvement or you feel worse, consult a doctor.
Do not use in children under 12 years of age.
Do not exceed the recommended dose.
Use the lowest 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).

Taking a higher dose of Ibuprom Sprint Sinus than recommended

If you have taken more than the recommended dose of Ibuprom Sprint Sinus or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do. Take the capsules with you to show the doctor.
Symptoms may include nausea, stomach pain, feeling sick (nausea), vomiting, headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred.
In case of accidental overdose, stop taking the medicine.

Missing a dose of Ibuprom Sprint Sinus

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, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The risk of side effects can be minimized by using the lowest effective doses.
Stop taking Ibuprom Sprint Sinus and seek medical attention immediately if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

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

If you experience any of the following side effects, stop taking Ibuprom Sprint Sinus and consult a doctor or pharmacist.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 Ibuprom Sprint Sinus

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". 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 packaging and other information

What Ibuprom Sprint Sinus contains

• The active substances of the medicine are ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.
• The other ingredients are: macrogol 600, potassium hydroxide, purified water. Capsule composition: gelatin, sorbitol, liquid, partially dehydrated, purified water, natural beta-carotene 10% CWD, powder, consisting of: natural beta-carotene (E160), modified food starch (E1450), dl-alpha-tocopherol (E307). Printing ink consisting of: shellac, iron oxide black (E172), n-butyl alcohol, propylene glycol, ammonia hydroxide 28%.

What Ibuprom Sprint Sinus looks like and what the packaging contains

Soft, gelatin capsule, transparent, light yellow to light orange in color, oval, with black printing "IZS". The capsule contents are a clear, light orange liquid.
Blister pack with PVC/PVDC/Aluminum in a cardboard box.
Pack sizes:
10 pieces - 1 blister of 10 capsules.
20 pieces - 2 blisters of 10 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

US Pharmacia Sp. z o.o.
Ziębicka 40,
50-507 Wrocław
To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: May 2024