Infex Zatoki

Leaflet accompanying the packaging: patient information

Infex Zatoki, 200 mg + 30 mg, coated tablets

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, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in adolescents and after 5 days of use in adults, there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Infex Zatoki contains the active substance ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which has a decongestant effect on the nasal mucosa.

• Ibuprofen reduces pain and swelling and lowers high body temperature.
• Pseudoephedrine acts on the blood vessels in the nose to reduce nasal congestion.

Infex Zatoki is indicated for the relief of nasal congestion with accompanying headache, fever, and/or pain in the course of a cold or flu. Infex Zatoki is indicated for use in adults and adolescents from 15 years of age. The combination drug should only be used if the patient has a blocked nose in combination with pain or fever. Do not use the medicine if only one of these symptoms is present. If there is no improvement or worsening after 3 days in adolescents and after 5 days of taking the medicine in adults, consult a doctor.

2. Important information before taking Infex Zatoki

When not to take Infex Zatoki:

• if the patient is allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6),
• in patients under 15 years of age,
• during pregnancy and breastfeeding,

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• if the patient has ever had allergic reactions (such as wheezing, asthma exacerbation, rhinitis with itching, facial swelling, or hives) after taking acetylsalicylic acid (aspirin) or other painkillers, antipyretics, or anti-inflammatory drugs,
• if the patient has stomach ulcers or has had stomach ulcers in the past,
• if the patient has had perforation or bleeding due to the use of NSAIDs in the past,
• if the patient has severe liver failure,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• if the patient has severe heart failure,
• if the patient has severe heart or circulatory diseases (heart disease, high blood pressure, angina pectoris, rapid heartbeat), hyperthyroidism, diabetes, pheochromocytoma (adrenal gland tumor),
• if the patient has had a heart attack,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if the patient has had a stroke or is at risk of stroke,
• if the patient has had seizures,
• if the patient has unexplained blood disorders,
• if the patient has glaucoma (eye pressure disorders),
• if the patient has difficulty urinating due to prostate disease,
• if the patient has systemic lupus erythematosus, a disease affecting the immune system, e.g., causing joint pain and skin changes,
• if the patient is taking:
• acetylsalicylic acid (aspirin) (more than 75 mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs) or other painkillers,
• other decongestant nasal medications, such as phenylpropanolamine, phenylephrine, or ephedrine or methylphenidate,
• non-selective monoamine oxidase inhibitors (MAOIs used to treat Parkinson's disease or depression) or have taken them within the last 2 weeks.

Warnings and precautions

Before startingto take Infex Zatoki, consult a doctor or pharmacist:

• if the patient has asthma; risk of asthma attack,
• if the doctor has diagnosed blood clotting disorders,
• if the patient is taking blood thinners, such as warfarin, low-dose acetylsalicylic acid,
• if the patient is taking medications that may increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants from the selective serotonin reuptake inhibitor (SSRI) group (e.g., fluoxetine, paroxetine) or NSAIDs, including acetylsalicylic acid,
• if the patient has psychosis or diabetes,
• if the patient has a history of gastrointestinal diseases (e.g., ulcerative colitis or Crohn's disease),
• if the patient has kidney or liver disease,
• if the patient is taking anti-migraine medications,
• if the patient has an infection - see below, section titled "Infections".

Infex Zatoki may mask the symptoms of an infection, such as fever and pain. Therefore, Infex Zatoki may delay the use of appropriate infection treatment and consequently 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 during an infection, and the symptoms of the infection persist or worsen, consult a doctor immediately.

• if the patient has heart disease, including heart failure, angina pectoris (chest pain), or has had a heart attack, coronary artery bypass grafting (bypass surgery), peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or has had any type of stroke (including "mini-stroke" or transient ischemic attack "TIA")
• if the patient has high blood pressure, diabetes, high cholesterol, or has a family history of heart disease or stroke, or if the patient smokes

During treatment, avoid consuming alcohol. There is a risk of kidney problems in dehydrated adolescents. If symptoms persist or worsen, consult a doctor.

Children and adolescents

Infex Zatoki should not be used in children under 15 years of age.

Infex Zatoki and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Infex Zatoki with:

• acetylsalicylic acid (aspirin) (more than 75 mg per day);
• other non-steroidal anti-inflammatory drugs (NSAIDs),
• other painkillers or antipyretics;
• within 14 days after stopping monoamine oxidase inhibitors (MAOIs used to treat Parkinson's disease or depression);
• other decongestant nasal medications used to unblock the nose (e.g., phenylpropanolamine, phenylephrine, and ephedrine given orally or intranasally).

Other medicines may affect the action of Infex Zatoki or Infex Zatoki may affect the action of other medicines, for example:

• anticoagulant medicines (i.e., blood thinners or anti-clotting agents, such as acetylsalicylic acid (aspirin), warfarin, ticlopidine),
• antihypertensive medicines (ACE inhibitors, such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• medicines that may increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants from the SSRI group (e.g., fluoxetine, paroxetine) or NSAIDs, including aspirin and selective cyclooxygenase (COX)-2 inhibitors;
• medicines for irregular heartbeat, angina pectoris, heart failure, or fluid retention (e.g., cardiac glycosides), as Infex Zatoki may reduce their effect or increase the risk of irregular heartbeat, high blood pressure, or kidney disorders;
• cyclosporine (an immunosuppressive drug) due to the possible increased risk of kidney disorders;
• antidepressant medicines (lithium, tricyclic antidepressants) may increase the risk of side effects;
• concomitant use of phenytoin may increase the level of this medicine in the blood. Monitoring of phenytoin blood levels is not usually required for proper use of the medicine (up to 5 days);
• other decongestant or appetite suppressant medicines, as they may increase the risk of side effects;
• probenecid and sulfinpyrazone may delay the excretion of ibuprofen;
• sulfonylureas (antidiabetic medicines): although interactions between ibuprofen and sulfonylureas have not been reported, it is recommended to check blood sugar levels as a precaution when using them together;
• diuretic medicines;
• high-dose methotrexate (more than 20 mg per week), as it may increase the effect of methotrexate;
• quinolone antibiotics due to increased risk of seizures;
• cyclosporine, tacrolimus, and trimethoprim;
• anti-migraine medicines;
• zidovudine (for HIV infection treatment);
• heparin injections or (and) medicines containing Ginkgo bilobadue to increased risk of bleeding;
• mifepristone: non-steroidal anti-inflammatory drugs (NSAIDs) should not be administered for 8-12 days after mifepristone administration, as NSAIDs may weaken its effect.

Also, some other medicines may be affected by or have an effect on Infex Zatoki. Therefore, always consult a doctor or pharmacist before taking Infex Zatoki with other medicines, including those available without a prescription.

During the perioperative period, a severe hypertensive reaction may occur due to the use of pseudoephedrine. Therefore, Infex Zatoki should be discontinued a few days before scheduled surgery and the anesthesiologist should be informed.

Infex Zatoki with food and drink

Tablets should be swallowed with water, preferably after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Infex Zatoki should not be used during pregnancy. The active substances: ibuprofen and pseudoephedrine may cause serious disorders in unborn babies.

Non-steroidal anti-inflammatory drugs (NSAIDs) may cause kidney and heart disorders in the unborn baby. They may increase the risk of bleeding in the mother and the baby and cause delayed or prolonged labor.

From the 20th week of pregnancy, non-steroidal anti-inflammatory drugs (NSAIDs) may cause kidney disorders in the unborn baby, leading to low amniotic fluid levels around the baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart.

Breastfeeding

Infex Zatoki should not be used during breastfeeding. The active substances: ibuprofen and pseudoephedrine were present in breastfed infants of mothers taking them.

Fertility

Infex Zatoki contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

No effect of Infex Zatoki on the ability to drive and use machines has been observed. However, consider the possibility of dizziness or drowsiness in exceptional situations.

Infex Zatoki contains sodium:

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free". This should be taken into account for patients on a controlled sodium diet.

3. How to take Infex Zatoki

This medicine should always be taken exactly as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Infex Zatoki is intended for oral use only.

Use the smallest effective dose for the shortest duration necessary to relieve symptoms.

If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Recommended dose:

Adults and adolescents from 15 years of age: 1 tablet every 4-6 hours, as needed. In case of more severe symptoms, 2 tablets every 6-8 hours, as needed.

Do not exceed the maximum daily dose of 6 tablets.

Tablets should be swallowed with water, preferably after a meal. Tablets should not be broken or crushed.

Use in children and adolescents

Do not use in children under 15 years of age.

Duration of treatment

The medicine is intended for short-term use. Use the smallest effective dose for the shortest duration necessary to relieve symptoms.

Do not exceed 5 days of treatment in adults.

Do not exceed 3 days of treatment in adolescents (15-18 years of age).

If symptoms persist or worsen, consult a doctor.

Overdose of Infex Zatoki

In case of overdose of ibuprofen and pseudoephedrine hydrochloride, or if a child has accidentally taken the medicine, always consult a doctor or the nearest hospital to assess the risk to health and for advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (including vomiting with blood), 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, blood in the urine, feeling cold, and breathing difficulties have occurred.

Missed dose of Infex Zatoki

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, Infex Zatoki can cause side effects, although not everybody gets them.

Stop taking Infex Zatoki and seek medical help immediately

• in case of the following symptoms, which may indicate severe allergic reactions:
• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe skin itching with hives
• severe skin reactions, including blisters under the skin
• rapid heartbeat with low blood pressure
• in case of signs of bleeding from the gastrointestinal tract:
• bright red stools, black tarry stools, vomiting blood or dark particles resembling coffee grounds
• if symptoms occur that may indicate posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:
• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• vision changes

Other side effects:

Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, difficulty sleeping, restlessness, irritability, or fatigue
• stroke, seizures, aseptic meningitis
• vision disorders
• dry mouth, thirst

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• discomfort in the abdominal cavity, indigestion, nausea, vomiting, diarrhea, loss of appetite

Rare (may affect up to 1 in 1,000 people):

• tinnitus (ringing in the ears)
• nervousness, tremors, anxiety, restlessness, hallucinations, insomnia
• exacerbation of asthma
• abdominal pain, bloating, constipation
• edema, high blood pressure, rapid heartbeat, feeling of heartbeat, heart attack, shortness of breath
• arrhythmias, chest pain
• kidney tissue damage, elevated uric acid levels in the blood
• skin rashes, hives, itching, redness, excessive sweating

Very rare (may affect up to 1 in 10,000 people):

• infections with inflammatory reactions, symptoms of meningitis (headache, fever, stiff neck)
• blood diseases (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms: fever, sore throat, mouth ulcers, flu-like symptoms, fatigue, unexplained bleeding from the nose or bruising
• severe allergic reactions
• psychotic reactions, depression
• kidney failure and other kidney disorders
• liver disorders
• stomach ulcers, sometimes with bleeding or perforation (blood in vomit or stool), gastritis, mouth ulcers, exacerbation of ulcerative colitis and Crohn's disease, intestinal strictures
• esophagitis (heartburn), pancreatitis
• severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
• hair loss
• severe skin infections, complications of soft tissue in chickenpox

Frequency not known (frequency cannot be estimated from the available data)

• severe vascular disorders of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• drug reaction with eosinophilia and systemic symptoms (DRESS). Severe skin reactions called DRESS can include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). If such symptoms occur, stop taking Infex Zatoki and seek medical help immediately. See also section 2.
• ischemic colitis (inflammation of the colon due to insufficient blood flow)
• skin sensitivity to light
• hallucinations, abnormal behavior
• difficulty urinating in men with prostate enlargement
• reduced blood flow in the optic nerve (ischemic optic neuropathy)
• chest pain, which may be a symptom of a severe allergic reaction called Kounis syndrome

Reporting side effects

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If you experience any side effects, including any side effects not listed in the 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Infex Zatoki

Keep the medicine out of sight and reach of children.

There are no special precautions for storing the medicine.

Do not use this medicine after the expiry date stated on the blister and carton after "EXP:" and "Expiry date (EXP):". The expiry date refers to the last day of the month stated.

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 pack and other information

What Infex Zatoki contains

• Active substancesare ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine).
• Other ingredientsare microcrystalline cellulose, cornstarch, povidone K-30, colloidal anhydrous silica, stearic acid, sodium croscarmellose, sodium lauryl sulfate, polyvinyl alcohol - partially hydrolyzed, talc, macrogol 3350, polysorbate 80, hypromellose 3 mPas, hypromellose 5 mPas, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Infex Zatoki looks like and contents of the pack

Infex Zatoki is a yellow, oval, biconvex coated tablet (approximately 15.6 mm x 7.7 mm).

Infex Zatoki is available in blisters of PVC/PCTFE/Aluminum foil, containing 12, 20, and 24 tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
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tel.: (22) 345 93 00

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy:
AISLAR 200 mg/30 mg film-coated tablets
Romania:
Tedolfen 200 mg/30 mg film-coated tablets
Poland:
Infex Zatoki

Date of last revision of the leaflet: February 2025

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