Infex zatoki

Package leaflet: Information for the user

Infex Zatoki, 200 mg + 30 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days in adolescents or after 5 days of treatment in adults, or if symptoms worsen, consult a doctor.

Table of contents

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

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

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

Infex Zatoki is indicated for the relief of nasal congestion associated with headache, fever and/or pain occurring in colds or influenza.
Infex Zatoki is indicated for use in adults and adolescents aged 15 years and older.
This combination medicine should be used only if the patient has a blocked nose together with pain or fever. Do not use the medicine if only one of these symptoms is present.
If there is no improvement or if the condition worsens after 3 days in adolescents or after 5 days of treatment in adults, consult a doctor.

2. Important information before using Infex Zatoki

When MUST NOT use 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,
• if the patient has ever experienced allergic reactions (such as wheezing, worsening of asthma, runny itchy nose) after taking acetylsalicylic acid (aspirin) or another painkiller, antipyretic or anti-inflammatory medicine,
• if the patient has gastric ulcers or a history of gastric ulcers,
• if the patient has previously experienced perforation or bleeding due to use of nonsteroidal anti-inflammatory drugs (NSAIDs),
• 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),
• if the patient has hyperthyroidism, diabetes, or a chromaffinoma (a tumour of the adrenal gland),
• if the patient has had a myocardial infarction,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if the patient has previously had a stroke or is at risk of stroke,
• if the patient has previously experienced seizures,
• if the patient has unexplained blood disorders,
• if the patient has glaucoma (increased pressure in the eye),
• if the patient has difficulty urinating due to prostate gland disease,
• if the patient has systemic lupus erythematosus, an autoimmune disease causing joint pain and skin changes,
• if the patient is taking:
• acetylsalicylic acid (aspirin) (more than 75 mg per day) or other nonsteroidal anti-inflammatory drugs (NSAIDs) or other painkillers,
• other medicines causing vasoconstriction of the nasal mucosa, such as phenylpropanolamine, phenylephrine or ephedrine, or methylphenidate,
• non-selective monoamine oxidase inhibitors (MAO inhibitors used in the treatment of Parkinson's disease or depression) or has taken them within the last 2 weeks.

Warnings and precautions
Before starting treatment with Infex Zatoki, consult a doctor or pharmacist:

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

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, treatment with Infex Zatoki must be stopped immediately and medical help must be sought immediately (symptoms, see section 4 "Possible side effects").

During treatment with ibuprofen, allergic reactions to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), chest pain. If these symptoms occur, Infex Zatoki must be discontinued immediately and medical advice must be sought from a doctor or emergency department.

Use with caution in case of excessive stimulation. If hallucinations, restlessness or sleep disturbances occur during treatment, the medicine should be discontinued.

Taking anti-inflammatory or pain-relieving medicines such as Infex Zatoki may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

During treatment with Infex Zatoki, sudden abdominal pain or rectal bleeding due to colitis (ischaemic colitis) may occur. If these gastrointestinal symptoms occur, discontinue use of Infex Zatoki and contact a doctor or seek immediate medical help. See section 4.

During treatment with Infex Zatoki, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of Infex Zatoki and contact a doctor or seek immediate medical help. See section 4.

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

If the patient develops generalized feverish rash with blisters, discontinue use of the medicine and contact a doctor or seek immediate medical help. See section 4.

Infections
Infex Zatoki may mask symptoms of infection such as fever and pain. Therefore, Infex Zatoki may delay appropriate treatment of infection, thereby increasing the 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 ongoing infection and symptoms of infection persist or worsen, immediate medical advice must be sought.

Discuss treatment with a doctor or pharmacist before using Infex Zatoki if:

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

Avoid alcohol during treatment with this medicine.
There is a risk of kidney problems in adolescents who are dehydrated.
If symptoms persist or worsen, consult a doctor.

Children and adolescents
Infex Zatoki must not be used in children and adolescents under 15 years of age.

Infex Zatoki and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Do not use Infex Zatoki with:

• acetylsalicylic acid (aspirin) (more than 75 mg per day),
• other nonsteroidal anti-inflammatory drugs (NSAIDs),
• other painkillers or antipyretics,
• within 14 days after stopping treatment with monoamine oxidase inhibitors (MAO inhibitors used in the treatment of Parkinson's disease or depression),
• other vasoconstrictor medicines used to relieve nasal congestion (e.g. phenylpropanolamine, phenylephrine, ephedrine) administered 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 preventing blood clots, such as acetylsalicylic acid (aspirin), warfarin, ticlopidine),
• medicines lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• medicines that may increase the risk of gastric ulcers or bleeding, e.g. 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), because Infex Zatoki may reduce their effectiveness or increase the risk of irregular heartbeat, high blood pressure or kidney function disorders,
• cyclosporine (an immunosuppressive medicine) due to possible increased risk of kidney function disorders,
• medicines for depression (lithium, tricyclic antidepressants) which may increase the risk of adverse effects,
• concomitant use of phenytoin may increase the serum concentration of this medicine. Monitoring of phenytoin blood levels is not generally required for proper use of the medicine (up to 5 days maximum),
• other medicines causing vasoconstriction or suppressing appetite, antimigraine medicines, oxytocin, as they may increase the risk of adverse effects,
• probenecid and sulfinpyrazone may delay excretion of ibuprofen,
• sulfonylurea derivatives (antidiabetic medicines): although interactions between ibuprofen and sulfonylureas have not been described so far, blood glucose levels should be checked as a precaution during concomitant use,
• diuretics (medicines increasing urine output),
• high-dose methotrexate (over 20 mg per week), as it may enhance methotrexate effects,
• quinolone antibiotics due to increased risk of seizures,
• cyclosporine, tacrolimus and trimethoprim,
• zidovudine (in HIV infection treatment),
• heparin injections and (or) products containing Gingko biloba due to increased risk of bleeding,
• mifepristone: nonsteroidal anti-inflammatory drugs (NSAIDs) must not be administered within 8–12 days after mifepristone administration, as NSAIDs may reduce its effectiveness.

Also, some other medicines may be affected by or may affect the action of Infex Zatoki. Therefore, always consult a doctor or pharmacist before using Infex Zatoki with other medicines, including those available without a prescription.

During the perioperative period, acute hypertensive reaction may occur due to pseudoephedrine. Therefore, Infex Zatoki should be discontinued several days before planned surgery and the anaesthesiologist 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, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Infex Zatoki must not be used during pregnancy. The active substances, ibuprofen and pseudoephedrine, may cause severe disorders in unborn children.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause kidney and heart dysfunction in the unborn child. They may increase the tendency to bleed in both mother and child and may delay or prolong labour.

From the 20th week of pregnancy, nonsteroidal anti-inflammatory drugs (NSAIDs) may cause kidney dysfunction in the unborn child, leading to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart.

Breastfeeding
Infex Zatoki must not be used during breastfeeding. The active substances, ibuprofen and pseudoephedrine, have been detected in breastfed infants of women taking these medicines.

Effect on fertility
Infex Zatoki contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
No effect of Infex Zatoki on the ability to drive or operate machinery has been observed. However, the possibility of dizziness or hallucinations occurring in exceptional cases should be considered.

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

3. How to use Infex Zatoki

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Infex Zatoki is intended for oral use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If signs of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

Recommended dose:
Adults and adolescents aged 15 years and above: 1 tablet every 4–6 hours, as needed. In cases 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 whole with water, preferably after food. Do not break or crush the tablets.

Use in children and adolescents
Do not use in children and adolescents under 15 years of age.

Duration of treatment
This medicine is intended for short-term use only. Use the lowest 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 (aged 15–18 years).
If symptoms persist or worsen, consult your doctor.

Use of a higher than recommended dose of Infex Zatoki
If a patient takes more ibuprofen and pseudoephedrine hydrochloride than recommended, or if a child accidentally ingests the medicine, always contact a doctor or the nearest hospital immediately for assessment of potential health risks and advice on appropriate actions.

Symptoms of overdose may include nausea, abdominal pain, vomiting (including vomiting with blood), diarrhoea, dry mouth, headache, tinnitus, confusion, blurred vision and nystagmus. Following large doses, drowsiness, restlessness, confusion, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Prothrombin time/INR may be prolonged. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.

Additionally, insomnia, fever, sweating, restlessness, anxiety and tremor may occur.

Missed dose of Infex Zatoki
Do not take a double dose to make up for a missed dose.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking Infex Zatoki immediately and seek immediate medical help

• if any of the following symptoms occur, 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 subcutaneous blisters
  • rapid heartbeat with low blood pressure
• if signs of gastrointestinal bleeding occur:
  • bright red stools, black tarry stools, vomiting blood or dark particles resembling coffee grounds
• if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:
  • sudden, severe headache
  • nausea
  • vomiting
  • confusion
  • seizures
  • visual disturbances

Other adverse effects:
Not common (may occur in up to 1 in 100 patients):

• headache, dizziness, difficulty sleeping, restlessness, irritability or fatigue
• stroke, seizures, aseptic meningitis
• visual disturbances
• dry mouth, thirst
• abdominal discomfort, indigestion, nausea, vomiting, diarrhoea, loss of appetite

Rare (may occur in up to 1 in 1,000 patients):

• tinnitus (ringing in the ears)
• nervousness, tremor, anxiety, restlessness, hallucinations, insomnia
• worsening of asthma
• abdominal pain, bloating, constipation
• oedema, high blood pressure, palpitations, awareness of heartbeat, heart attack, shortness of breath
• cardiac arrhythmias, chest pain
• kidney tissue damage, increased blood uric acid levels
• skin rashes, urticaria, itching, redness, excessive sweating

Very rare (may occur in up to 1 in 10,000 patients):

• infections, signs of meningitis (headache, fever, neck stiffness)
• blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include fever, sore throat, mouth ulcers, flu-like symptoms, exhaustion, unexplained nosebleeds or bruising
• severe allergic reactions
• psychotic reactions, depression
• kidney failure and other kidney disorders
• liver disorders
• gastric ulcers, sometimes with bleeding or perforation (blood in vomit or stools), gastritis, oral ulceration, exacerbation of colitis and Crohn’s disease, intestinal strictures
• oesophagitis (heartburn), pancreatitis
• severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis
• hair loss
• severe skin infections, soft tissue complications in chickenpox
• decreased haemoglobin concentration in blood

Frequency unknown (frequency cannot be estimated from available data)

• severe conditions affecting brain blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS symptoms include: skin rash, fever, lymphadenopathy and increased eosinophil count (a type of white blood cell)
• red, scaly rash with subcutaneous nodules and pustules, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis, AGEP). If such symptoms occur, treatment with Infex Zatoki must be discontinued and immediate medical help sought. See also section 2.
• colitis of the large intestine caused by inadequate blood supply (ischaemic colitis)
• skin becomes sensitive to light
• hallucinations, abnormal behaviour
• muscle weakness
• difficulty urinating in men with benign prostatic hyperplasia
• reduced blood flow in the optic nerve (ischaemic optic neuropathy)
• chest pain, which may be a symptom of a severe allergic reaction known as Kounis syndrome

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Infex Zatoki

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the blister and carton following "EXP:" and
"Expiry date (EXP):". 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Infex Zatoki contains

• The active substances are ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine).
• Other ingredients are: microcrystalline cellulose, pregelatinized corn starch, povidone K-30, anhydrous colloidal silicon dioxide, stearic acid, sodium croscarmellose, sodium lauryl sulfate, polyvinyl alcohol – partially hydrolysed, talc, macrogol 3350, colouring “MICA-Based Pearlescent Pigment” (a mixture of aluminium-potassium silicate (E 555) and titanium dioxide (E 171)), 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). (For further information regarding sodium, see the end of section 2.)

What Infex Zatoki looks like and contents of the pack
Infex Zatoki is a yellow, oval, biconvex film-coated tablet (dimensions: approximately 15.6 mm x 7.7 mm).
Infex Zatoki is available in PVC/PCTFE/Aluminium blisters containing 12, 20 or 24 tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
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.
Mogilska 80
31-546 Kraków

This medicinal product is authorised in the European Economic Area under the following names:
Italy: AISLAR 200 mg/30 mg compresse rivestite con film
Romania: Tedolfen 200 mg/30 mg comprimate filmate
Poland: Infex Zatoki