Laboratoria Polfavudi Zatoki

Leaflet attached to the packaging: patient information

Polfa Łódź Laboratories ZATOKI,200 mg + 30 mg, 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, 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 any possible side effects not listed in this leaflet, they should inform 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 Polfa Łódź Laboratories ZATOKI and what is it used for
• 2. Important information before taking Polfa Łódź Laboratories ZATOKI
• 3. How to take Polfa Łódź Laboratories ZATOKI
• 4. Possible side effects
• 5. How to store Polfa Łódź Laboratories ZATOKI
• 6. Package contents and other information

1. What is Polfa Łódź Laboratories ZATOKI and what is it used for

Polfa Łódź Laboratories ZATOKI is a combination medicine containing ibuprofen and pseudoephedrine, in the form of tablets for oral use.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), with therapeutic effects: anti-inflammatory, analgesic, and antipyretic.
Pseudoephedrine is a medicine that reduces congestion of the mucous membranes of the upper respiratory tract. When taken orally, it causes vasoconstriction, reduces swelling and congestion of the nasal mucosa and sinuses, thereby improving nasal patency and sinus drainage.
It is used to relieve symptoms of nasal congestion and sinusitis with accompanying headache, sinus-related pain, and fever in the course of flu or cold.

2. Important information before taking Polfa Łódź Laboratories ZATOKI

When not to take Polfa Łódź Laboratories ZATOKI

if the patient is allergic to ibuprofen, pseudoephedrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
if the patient is allergic to NSAIDs, including acetylsalicylic acid;
if the patient has a history of aspirin-induced asthma, angioedema (a skin and mucous membrane disease characterized by swelling), bronchospasm, rhinitis, or urticaria associated with the use of acetylsalicylic acid or other NSAIDs,
if the patient has severe renal and/or hepatic impairment,
in the case of stomach and/or duodenal ulcer (active or in history), perforation, or bleeding, also occurring after the use of NSAIDs,
if the patient has severe hypertension,
if the patient has glaucoma (an eye disease that can lead to vision impairment or loss),
if the patient has hyperthyroidism,
if the patient has prostatic hyperplasia,
if the patient has a pheochromocytoma,
if the patient has nasal polyps,
in the case of severe cardiovascular disease, tachycardia, angina pectoris,
in severe heart failure,
in the case of a history of hemorrhagic stroke or the presence of risk factors that may increase the likelihood of hemorrhagic stroke, for example, taking vasoconstrictor medications or other decongestant medications used orally or intranasally,
during pregnancy and breastfeeding,
in the case of bleeding disorders (tendency to bleed in the skin and mucous membranes, nose, gastrointestinal tract) and the use of anticoagulant medications,
in the case of urinary retention,
in the case of concurrent use of other NSAIDs, including COX-2 inhibitors.

Warnings and precautions

Particular caution should be exercised:
in patients with impaired liver and/or kidney function and cardiovascular system; in patients with impaired kidney function, the lowest effective dose should be used, with simultaneous monitoring of their function,
in patients with asthma or allergies - taking the medicine may cause bronchospasm,
in patients with systemic lupus erythematosus and mixed connective tissue disease

• there is an increased risk of developing aseptic meningitis, in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) - symptoms may worsen, in patients with cardiac arrhythmias, hypertension, myocardial infarction, or heart failure in their history - fluid retention may occur due to impaired kidney function, in patients taking anticoagulant medications and having bleeding disorders
• ibuprofen may prolong bleeding time, in patients with symptoms of neurological disorders (nausea, headaches), in patients with diabetes, in patients with cervical urethral stricture, in patients with pyloric stenosis, in patients with benign prostatic hyperplasia.

In patients over 65 years of age, there is a higher risk of adverse reactions than in younger patients.
During the use of Polfa Łódź Laboratories ZATOKI, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, the use of Polfa Łódź Laboratories ZATOKI should be discontinued and medical advice should be sought immediately. See section 4.
During long-term use of the medicine, especially in patients with a history of gastrointestinal diseases, particularly in patients over 65 years of age, there is a risk of gastrointestinal bleeding, ulceration, or perforation. In the event of any unusual gastrointestinal symptoms, especially in the initial treatment period, the medication should be discontinued immediately and a doctor should be consulted.
Caution should be exercised when using Polfa Łódź Laboratories ZATOKI in patients taking other medications that may increase the risk of gastrointestinal disorders or may increase the risk of bleeding, such as corticosteroids or anticoagulant medications like warfarin (acenocoumarol) or antiplatelet agents like acetylsalicylic acid.
Concomitant, long-term use of various painkillers may lead to kidney damage with a risk of kidney failure.
Skin reactions
Severe skin reactions have been reported with the use of Polfa Łódź Laboratories ZATOKI. If the following occur: any skin rash, changes in mucous membranes, blisters, or other symptoms of allergy, the use of Polfa Łódź Laboratories ZATOKI should be discontinued and medical help should be sought immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
As with other medicines with a stimulating effect on the central nervous system, there is a risk of drug abuse during the use of pseudoephedrine. When taking increased doses, toxic effects may occur. Sudden withdrawal of the medicine may lead to depression.
During the use of pseudoephedrine, athletes may test positive for doping substances.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs, NSAIDs) that may adversely affect female fertility. This effect is transient and disappears after the end of therapy.
Taking anti-inflammatory/analgesic medications, such as 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.
During the use of Polfa Łódź Laboratories ZATOKI, a decrease in blood flow in the optic nerve may occur. In case of sudden vision loss, the use of Polfa Łódź Laboratories ZATOKI should be discontinued and medical help should be sought immediately. See section 4.
Before taking Polfa Łódź Laboratories ZATOKI, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, 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 hypertension, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes,
• the patient has an infection - see below, section titled "Infections".

Infections
Polfa Łódź Laboratories ZATOKI may mask the symptoms of infection, such as fever and pain. Therefore, Polfa Łódź Laboratories ZATOKI may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
Taking the medicine in the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of adverse reactions.
In the event of new or worsening symptoms, the patient should consult their doctor or pharmacist.

Children

The medicine should not be given to children under 12 years of age.

Polfa Łódź Laboratories ZATOKI and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Polfa Łódź Laboratories ZATOKI may affect the action of other medicines or other medicines may affect the action of Polfa Łódź Laboratories ZATOKI.
Polfa Łódź Laboratories ZATOKI should not be used in combination with:

• monoamine oxidase inhibitors and for up to 14 days after stopping the inhibitor. When taking a monoamine oxidase inhibitor and sympathomimetic medicines (stimulating the sympathetic nervous system) at the same time, hypertensive crises may occur.

It is not recommended to use Polfa Łódź Laboratories ZATOKI with the following medicines due to the increased risk of vasoconstriction and increased blood pressure when taken with pseudoephedrine:

• dopamine receptor agonists, ergot alkaloids - bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor medicines - dihydroergotamine, ergotamine, methylergometrine;
• linezolid;
• decongestant medicines (used orally or intranasally) - phenylephrine, ephedrine, phenylpropanolamine.

Polfa Łódź Laboratories ZATOKI should be used with caution in combination with:

• acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs, or glucocorticosteroids; using these medicines at the same time as ibuprofen may increase the risk of adverse reactions related to the gastrointestinal tract.
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• anticoagulant medicines (e.g., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• lithium: there is evidence of a potential increase in lithium plasma concentrations during concomitant use of ibuprofen (like other nonsteroidal anti-inflammatory drugs);
• methotrexate: there is a risk of increased methotrexate plasma concentration during concomitant use of ibuprofen (like other nonsteroidal anti-inflammatory drugs);
• zydovudine: there is evidence of an increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zidovudine and ibuprofen at the same time.

It is not recommended to use the following medicines with pseudoephedrine:

• appetite suppressants (pseudoephedrine may enhance their effect);
• psychostimulant medicines of the amphetamine type (pseudoephedrine may enhance their effect);
• antihypertensive medicines, 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).

Antacids increase the absorption rate of pseudoephedrine, while kaolin decreases it.
When using general anesthetics in combination with pseudoephedrine, a sudden hypertensive reaction may occur during the perioperative period, similar to the use of these medicines with other sympathomimetic agents (stimulating the sympathetic nervous system). Therefore, it is recommended to discontinue Polfa Łódź Laboratories ZATOKI before planned general anesthesia.
Some other medicines may also be affected or have an effect on the treatment with Polfa Łódź Laboratories ZATOKI. Therefore, before using Polfa Łódź Laboratories ZATOKI with other medicines, the patient should always consult their doctor or pharmacist.

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 their doctor or pharmacist before taking this medicine.
Polfa Łódź Laboratories ZATOKI should not be used during pregnancy and breastfeeding.
Polfa Łódź Laboratories ZATOKI should not be used during pregnancy, as it may harm the unborn child or cause complications during delivery. Taking ibuprofen during pregnancy may cause kidney and heart problems in the unborn child. Ibuprofen may increase the risk of bleeding in the mother and child and cause prolonged or delayed labor.
From the 20th week of pregnancy, ibuprofen may cause kidney problems in the unborn child, which can lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios). There may also be a narrowing of the blood vessel (ductus arteriosus) in the child's heart.
Effect on fertility
See section 2.

Driving and using machines

Patients who experience side effects with Polfa Łódź Laboratories ZATOKI that affect their physical and mental abilities should not drive vehicles or operate machinery.

3. How to take Polfa Łódź Laboratories ZATOKI

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
In adults and children over 12 years of age, the usual dose is:
initial dose - 2 tablets, then if necessary 1-2 tablets every 4-6 hours during the day.
Maximum daily dose - 6 tablets.
Patients over 65 years of age: dose modification is not necessary unless kidney or liver function is impaired; in such cases, the dose should be determined individually.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Overdose of Polfa Łódź Laboratories ZATOKI

Observations of varying degrees of severity of adverse reactions have been made. The earliest symptoms of pseudoephedrine overdose may occur: headache, nausea, vomiting, thirst, anxiety, restlessness, fever, tachycardia (rapid heart rate), insomnia, dilated pupils, vision disturbances, hallucinations, delusions, muscle weakness, difficulty urinating, tremors, anxiety, disorientation,
In case of overdose, the patient should seek medical help immediately. The doctor will perform gastric lavage and, if necessary, administer medications to correct electrolyte disturbances and other symptoms of overdose.

Missed dose of Polfa Łódź Laboratories ZATOKI

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sudden fever, skin redness, or numerous small blisters (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Polfa Łódź Laboratories ZATOKI.
See section 2.
If such symptoms occur, the use of Polfa Łódź Laboratories ZATOKI should be discontinued and medical help should be sought immediately.
Adverse reactions due to the presence of ibuprofen
NSAIDs have been associated with reports of edema, hypertension, and heart failure.
Taking ibuprofen-containing medications may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when used in high doses.
Adverse reactions occurring not very often (in less than 1 in 100 people)

• indigestion, abdominal pain, nausea
• headaches
• urticaria and itching.

Adverse reactions occurring rarely (in less than 1 in 1,000 people)

• diarrhea, bloating, constipation, vomiting, gastritis
• dizziness, insomnia, excitement, irritability, and fatigue
• edema.

Adverse reactions occurring very rarely (in less than 1 in 10,000 people)

• blood count disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis),
• liver function disorders, especially during long-term use,
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastric and/or duodenal ulcer, gastrointestinal bleeding, and perforation, especially in patients over 65 years of age.
• dysuria - discomfort during urination, decreased urine output, kidney failure, renal papillary necrosis, increased urea concentration in the blood, increased sodium concentration in the blood (sodium retention),
• severe hypersensitivity reactions such as facial edema, tongue and laryngeal edema, dyspnea, tachycardia - arrhythmias, hypotension - sudden decrease in blood pressure, shock. Exacerbation of asthma and bronchospasm.
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, single cases of symptoms have been reported, such as stiffness in the neck, headache, nausea, vomiting, fever, disorientation,
• edema, hypertension, heart failure associated with the use of NSAIDs in high doses.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)
Red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the use of Polfa Łódź Laboratories ZATOKI should be discontinued and medical help should be sought immediately. See also section 2.
In individual cases, depression, psychotic reactions, and tinnitus have been reported.
Adverse reactions due to the presence of pseudoephedrine
Ischemic colitis - frequency unknown (cannot be determined from available data),
indigestion, gastrointestinal disorders, redness, and rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, arrhythmias, anxiety, insomnia, uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, hallucinations, thrombocytopenia, decreased blood flow in the optic nerve (ischemic optic neuropathy) - frequency unknown (cannot be determined from available data).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Polfa Łódź Laboratories ZATOKI

Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
Do not use this medicine if the patient notices a change in the appearance of the tablets.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Polfa Łódź Laboratories ZATOKI contains

• The active substances of the medicine are: ibuprofen (Ibuprofenum)- 200 mg pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum) - 30 mg
• The other ingredients (excipients) are: mannitol, microcrystalline cellulose silanized with a composition of microcrystalline cellulose and anhydrous colloidal silica, sodium carboxymethylcellulose (type A), maize starch paste, magnesium stearate, povidone K-90.

What Polfa Łódź Laboratories ZATOKI looks like and what the pack contains

The medicine is in the form of white, oblong tablets, packaged in blisters. One blister contains 6 or 10 tablets.
The outer packaging - a cardboard box, contains 6, 10, or 20 tablets in blisters and a patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
tel/fax: 22 616 33 48 / 22 617 69 21

Manufacturer

SENSILAB Polska Spółka z ograniczoną odpowiedzialnością – Spółka komandytowo-akcyjna
ul. gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
Detailed information about this medicine is available from the marketing authorization holder, including for the visually impaired and blind (audio version, CD) at phone number: 22 616 33 48.

Date of last revision of the leaflet: