Metafen Zatoki

Package Leaflet: Information for the User

Metafen ZATOKI, 200 mg + 30 mg, tablets

Ibuprofen + Pseudoephedrine hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Package Leaflet Contents

• 1. What is Metafen ZATOKI and what is it used for
• 2. Important information before taking Metafen ZATOKI
• 3. How to take Metafen ZATOKI
• 4. Possible side effects
• 5. How to store Metafen ZATOKI
• 6. Package contents and other information

1. What is Metafen ZATOKI and what is it used for

Metafen 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 non-steroidal anti-inflammatory drugs (NSAIDs). It is a derivative of propionic acid with therapeutic effects: anti-inflammatory, analgesic, and antipyretic.
Pseudoephedrine is a sympathomimetic amine that reduces congestion of the upper respiratory tract mucosa. When taken orally, it causes vasoconstriction, reduces swelling and congestion of the nasal mucosa and sinuses, thereby improving nasal patency and sinus drainage.
Metafen ZATOKI is recommended for the symptomatic treatment of sinusitis-related disorders, such as fever, headache, sinus and nasal congestion, accompanied by pain and symptoms of congestion and swelling of the mucous membrane.

2. Important information before taking Metafen ZATOKI

When not to take Metafen ZATOKI

If you are allergic to ibuprofen, pseudoephedrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
If you have been diagnosed with an allergy to NSAIDs, including acetylsalicylic acid; have a history of aspirin 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.
In case of severe liver failure.
If you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.
In case of stomach and/or duodenal ulcer (active or in history), perforation, or bleeding, also occurring after the use of NSAIDs.
In case of glaucoma (an eye disease leading to vision impairment or loss), hyperthyroidism, prostate enlargement, pheochromocytoma, nasal polyps.
If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
In case of severe cardiovascular disease, tachycardia, angina pectoris.
In case of severe heart failure.
In case of a history of hemorrhagic stroke or risk factors that may increase the likelihood of hemorrhagic stroke, such as taking vasoconstrictor medications or other medications that reduce congestion, used orally or intranasally.
During pregnancy and breastfeeding.
In case of bleeding tendency (tendency to bleed in the skin and mucous membranes, nose, gastrointestinal tract) and taking anticoagulant medications.
In case of urinary retention.
In case of concurrent use of other NSAIDs, including COX-2 inhibitors.

Warnings and precautions

Before starting treatment with Metafen ZATOKI, discuss it with your doctor or pharmacist.
During the use of ibuprofen, allergic reactions to this medicine have been reported, including respiratory disorders, facial and neck edema (angioedema), chest pain. If you experience these symptoms, stop taking Metafen ZATOKI and seek medical attention immediately.
When to exercise particular caution when taking Metafen ZATOKI:
in patients with impaired liver and/or kidney function and cardiovascular system; in patients with impaired kidney function, use effective doses, as small as possible, with simultaneous monitoring of kidney function;
in patients with asthma or allergy - 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) - may exacerbate symptoms;
in patients with rhythm disorders, hypertension, myocardial infarction, or heart failure in history - may lead to fluid retention in the body due to impaired kidney function;
in patients taking anticoagulant medications and having bleeding disorders - ibuprofen may prolong bleeding time;
in patients with neurological symptoms (nausea, headaches);
in patients with diabetes;
in patients with urinary tract obstruction;
in patients with esophageal stricture;
in patients with benign prostatic hyperplasia;
in patients with existing infections - see below, section "Infections".
Patients over 65 years of age have a higher risk of side effects than younger patients.
During the use of Metafen ZATOKI, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, stop taking Metafen ZATOKI and seek medical attention immediately. See section 4.
During long-term use, especially in patients with a history of gastrointestinal disease, particularly in patients over 65 years of age, there is a risk of gastrointestinal bleeding, ulceration, or perforation. If any unusual gastrointestinal symptoms occur, especially during the initial treatment period, stop taking the medicine and consult a doctor.
Caution should be exercised when taking Metafen ZATOKI in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications like warfarin (acenocumarol) or antiplatelet agents like acetylsalicylic acid.
Concomitant, long-term use of various painkillers may lead to kidney damage with a risk of kidney failure. There is a risk of impaired kidney function in dehydrated children and adolescents.
Skin reactions
Severe skin reactions have been reported with the use of Metafen ZATOKI. If you experience: any skin rash, changes in mucous membranes, blisters, or other symptoms of allergy, stop taking Metafen ZATOKI and seek medical attention immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
Infections
Metafen ZATOKI may mask the symptoms of an infection, such as fever and pain. Therefore, Metafen ZATOKI 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 associated with chickenpox.
If you are taking this medicine during an existing infection, and the symptoms of the infection persist or worsen, consult a doctor immediately.
Like other medicines with a stimulating effect on the central nervous system, pseudoephedrine may have a risk of abuse. When taking higher 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.
The medicine should not be given to children under 12 years of age without a doctor's recommendation.
This medicine belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.
Taking anti-inflammatory/pain-relieving 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.
Before taking Metafen ZATOKI, the patient should discuss the treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial 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.

During the use of Metafen ZATOKI, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, stop taking Metafen ZATOKI and seek medical attention immediately. See section 4.
After taking pseudoephedrine-containing medications, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, stop taking Metafen ZATOKI immediately and seek medical attention (symptoms, see section 4 "Possible side effects").
If new or worsening symptoms occur, consult a doctor or pharmacist.

Metafen ZATOKI and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Metafen ZATOKI may affect the action of other medicines or other medicines may affect the action of Metafen ZATOKI. For example:
other NSAIDs - due to increased risk of side effects;
blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
diuretics - NSAIDs may reduce the effectiveness of their action;
anticoagulant medications (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
lithium (a medicine used in psychiatry) and methotrexate (a medicine used in cancer) - there are clinical data that NSAIDs may increase the levels of both lithium and methotrexate in the blood;
zydovudine (an antiviral medicine) - there are clinical data indicating prolonged bleeding time in patients treated with ibuprofen and zidovudine;
corticosteroids - the risk of gastrointestinal side effects increases.
Pseudoephedrine in Metafen ZATOKI:
may increase the effect of sympathomimetic medicines, e.g., decongestants and appetite suppressants;
should not be given to patients taking monoamine oxidase inhibitors (medicines used to treat depression) or within 14 days of their withdrawal;
may reduce the effect of guanethidine and increase the risk of arrhythmias in patients taking cardiac glycosides, quinidine, or tricyclic antidepressants.
Pseudoephedrine's effect:
may be increased or decreased by the use of tricyclic antidepressants (e.g., imipramine, opipramol);
may reduce the effect of blood pressure-lowering medicines (guanethidine, reserpine, and methyldopa).
Antacids increase the absorption rate of pseudoephedrine, and kaolin decreases the absorption rate of pseudoephedrine.
During the use of halogenated anesthetics, inhaled general anesthetics, in combination with pseudoephedrine, a sudden hypertensive crisis may occur during the perioperative period, similar to the use of these anesthetics in combination with other indirectly acting sympathomimetic medicines. Therefore, it is recommended to discontinue the medicine 24 hours before scheduled general anesthesia.
Also, some other medicines may be affected or have an effect on treatment with Metafen ZATOKI. Therefore, before taking Metafen ZATOKI with other medicines, always consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Metafen ZATOKI is contraindicated during pregnancy and breastfeeding.
Do not take Metafen ZATOKI during pregnancy, as it may harm the unborn child or cause difficulties during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolongation or delay of labor.
Metafen ZATOKI taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart.
Fertility - see "Warnings and precautions".

Driving and using machines

People who experience side effects with Metafen ZATOKI that affect their psychophysical fitness should not drive vehicles or operate machinery.

Metafen ZATOKI contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Metafen ZATOKI

Always take this medicine exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Oral use.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms and minimize side effects. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Recommended dose:
For adults and adolescents over 12 years of age, usually:
initial dose - 2 tablets, then if necessary 1 to 2 tablets every 4 hours during the day. Maximum daily dose - 6 tablets.
For patients over 65 years of age: no dose adjustment is necessary unless kidney or liver function is impaired; then the dose should be determined individually.
Use in children
Do not give the medicine to children under 12 years of age without a doctor's recommendation.
If it is necessary to take the medicine for more than 3 days or the patient's condition worsens, consult a doctor.

Overdose of Metafen ZATOKI

If you have taken more than the recommended dose of Metafen ZATOKI or a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to assess the risk to your health and for advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. They may also include agitation, drowsiness, disorientation, or coma. Seizures have been reported in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, exacerbation of asthma symptoms may occur. Additionally, low blood pressure and difficulty breathing may occur.
May occur: thirst, anxiety, restlessness, fever, tachycardia (rapid heart rate), dilated pupils, vision disturbances, hallucinations, delusions, muscle weakness, difficulty urinating, tremors, excessive sweating, arrhythmias, circulatory collapse.
Observed varying degrees of severity of side effects. The doctor will perform gastric lavage and, if necessary, administer medications to correct electrolyte disturbances and other medications to alleviate overdose symptoms.

Missed dose of Metafen ZATOKI

Metafen ZATOKI is used as needed. If you miss a dose and symptoms persist, take the next dose. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Metafen ZATOKI and seek medical attention immediately if you experience:

• symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:
• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes. These are symptoms of severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) - frequency not known (cannot be estimated from the available data).
• red, non-raised, target-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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 enlarged lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with bumps under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Side effects due to the presence of ibuprofen in the medicine
Uncommon side effects (less than 1 in 100 patients):

• indigestion, stomach pain, nausea;
• headaches;
• urticaria and itching.

Rare side effects (less than 1 in 1,000 patients):

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

Very rare side effects (less than 1 in 10,000 patients):

• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis);
• liver function disorders, especially during long-term use;
• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; stomach and/or duodenal ulcer, gastrointestinal bleeding, and perforation, especially in patients over 65 years of age;
• dysuria, reduced urine output, kidney failure, renal papillary necrosis, increased urea levels in the blood, increased sodium levels in the blood (sodium retention);
• severe allergic reactions such as facial, 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, isolated cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation;
• edema, hypertension, heart failure associated with the use of NSAIDs in high doses.

Side effects with a frequency not known (cannot be estimated from the available data):

• skin becomes sensitive to light;
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In individual cases, depression, psychotic reactions, and tinnitus have been reported.
In connection with the treatment of NSAIDs, reports of edema, hypertension, and heart failure have been made.
Taking medications containing ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Side effects due to the presence of pseudoephedrine in the medicine
Rare side effects (less than 1 in 1,000 patients):

• uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, hallucinations, thrombocytopenia.

Side effects with a frequency not known (cannot be estimated from the available data):

• ischemic colitis (colon inflammation due to insufficient blood flow);
• reduced blood flow in the optic nerve (ischemic optic neuropathy).

May occur: indigestion, gastrointestinal disorders, redness and rashes, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, arrhythmias, anxiety, insomnia.
The medicine is generally well-tolerated when used in recommended doses.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. 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
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metafen ZATOKI

Do not store above 25°C.
Store in the original package to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after: EXP. The expiry date refers to the last day of the month.
Do not use this medicine if you notice changes in the appearance of the tablets.
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. Package contents and other information

What Metafen ZATOKI contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride. Each tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• Other ingredients are: povidone, gelatinized starch, microcrystalline cellulose with anhydrous colloidal silica, sodium carboxymethylcellulose (type A), mannitol, magnesium stearate.

What Metafen ZATOKI looks like and contents of the pack

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

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Wörwag Pharma Operations spółka z ograniczoną odpowiedzialnością
ul. Gen. Mariana Langiewicza 58, 95-050 Konstantynów Łódzki

Date of last revision of the package leaflet: