Metafen sinus

Package leaflet: Information for the user

Metafen ZATOKI, 200 mg + 30 mg, tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read this leaflet carefully before taking the medicine, as 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
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of contents

1. What Metafen ZATOKI is and what it is 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. Contents of the pack and other information

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

Metafen ZATOKI is a combination medicine containing ibuprofen and pseudoephedrine,
in the form of tablets for oral administration.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is a propionic acid derivative with therapeutic effects: anti-inflammatory, analgesic,
and antipyretic.
Pseudoephedrine is a sympathomimetic amine that reduces congestion of the mucous membranes of the upper respiratory tract. When administered orally, it causes vasoconstriction, reduces swelling and congestion of the nasal and sinus mucosa, thereby improving nasal patency and drainage of secretions from the sinuses.
Metafen ZATOKI is recommended for symptomatic treatment of conditions associated with sinus disorders, such as fever, headache, sinus and nasal obstruction accompanied by pain, and symptoms of mucosal congestion and swelling.

2. Important information before using Metafen ZATOKI

When not to use Metafen 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 has a known allergy to NSAIDs, including acetylsalicylic acid; or has previously experienced
aspirin-induced asthma, angioedema (a skin and mucous membrane disorder characterized by swelling),
bronchospasm, rhinitis, or urticaria associated with the use of acetylsalicylic acid or other NSAIDs.
In case of severe liver failure.
If the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal failure.
In case of active or past peptic ulcer disease of the stomach and/or duodenum, perforation, or bleeding,
including those occurring after use of NSAIDs.
In case of glaucoma (an eye disease leading to worsening or loss of vision), hyperthyroidism,
prostatic hyperplasia, pheochromocytoma, or nasal polyps.
If the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension.
In case of severe cardiovascular disease, tachycardia, or angina pectoris.
In case of severe heart failure.
In case of a history of hemorrhagic stroke or presence of risk factors increasing the likelihood of
hemorrhagic stroke, such as use of vasoconstrictive drugs or other drugs reducing blood flow, taken orally or intranasally.
During pregnancy and breastfeeding.
In case of bleeding tendency (inclination to bleed in areas such as skin, mucous membranes, nose, or gastrointestinal tract) and when taking anticoagulant medications.
In case of urinary retention.
When concurrently taking other NSAIDs, including COX-2 inhibitors.

Warnings and precautions
Before starting treatment with Metafen ZATOKI, consult a doctor or pharmacist.
Allergic reactions to ibuprofen have been reported, including respiratory disturbances, facial and neck swelling (angioedema), and chest pain. If these symptoms occur, discontinue Metafen ZATOKI immediately and seek medical attention from a doctor or emergency department.

When to exercise particular caution when using Metafen ZATOKI:

• in patients with impaired liver and/or kidney or circulatory system function; in patients with kidney dysfunction, the lowest effective dose should be used, with regular monitoring of kidney function;
• in patients with bronchial asthma or allergies – taking the medicine may cause bronchospasm;
• in patients with systemic lupus erythematosus or mixed connective tissue disease – increased risk of aseptic meningitis;
• in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease) – symptoms may worsen;
• in patients with a history of cardiac arrhythmias, hypertension, myocardial infarction, or heart failure – fluid retention may occur due to worsening kidney function;
• in patients concurrently taking anticoagulants or with coagulation disorders – ibuprofen may prolong bleeding time;
• in patients with neurological symptoms (nausea, headaches);
• in diabetic patients;
• in patients with urinary bladder outlet obstruction;
• in patients with pyloric stenosis;
• in patients with mild prostatic hyperplasia;
• in patients with existing infection – see below, section titled "Infections".

Patients over 65 years of age have a higher risk of adverse effects compared to younger patients.
During treatment with Metafen ZATOKI, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue Metafen ZATOKI immediately and seek medical advice without delay. See section 4.
With long-term use, especially in patients with a history of gastrointestinal disorders, particularly those 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, the medicine should be discontinued immediately and a doctor should be informed.
Exercise caution when using Metafen ZATOKI in patients concurrently taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like warfarin (acenocoumarol), or antiplatelet agents like acetylsalicylic acid.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure. There is a risk of impaired kidney function in dehydrated children and adolescents.

Skin reactions
Severe skin reactions associated with the use of Metafen ZATOKI have been reported. If any skin rash, mucosal changes, blisters, or other allergic symptoms appear, discontinue Metafen ZATOKI immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.

Infections
Metafen ZATOKI may mask objective signs of infection, such as fever and pain. Therefore, Metafen ZATOKI may delay appropriate treatment of infection and consequently increase 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 persist or worsen, immediate consultation with a doctor is required.

Like other centrally acting nervous system stimulants, there is a risk of abuse with pseudoephedrine. Toxic effects may occur with increased doses. Sudden discontinuation may lead to depression.
During use of pseudoephedrine, athletes may test positive in doping tests.

Do not administer to children under 12 years of age without medical advice.
This medicine belongs to the group of NSAIDs, which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Before using Metafen ZATOKI, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker.

During treatment with Metafen ZATOKI, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue Metafen ZATOKI immediately and contact a doctor or seek medical help without delay. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of 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, discontinue Metafen ZATOKI immediately and seek urgent medical attention (symptoms, see section 4 "Possible side effects").
If new symptoms occur or existing symptoms worsen, contact a doctor or pharmacist.

Metafen ZATOKI and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
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 adverse effects;
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
• diuretics – NSAIDs may reduce their effectiveness;
• anticoagulant medicines (i.e., blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• lithium (a psychiatric medicine) and methotrexate (a medicine used in cancer diseases) – clinical data indicate that NSAIDs may increase serum concentrations of both lithium and methotrexate;
• zidovudine (an antiviral medicine) – clinical data indicate prolonged bleeding time in patients treated concomitantly with ibuprofen and zidovudine;
• corticosteroids – increased risk of gastrointestinal adverse effects.

Pseudoephedrine, an ingredient of Metafen ZATOKI:

• may enhance the effect of sympathomimetic medicines, e.g., decongestants and appetite suppressants;
• should not be given to patients receiving monoamine oxidase inhibitors (MAOIs, used in depression treatment) or within 14 days of their discontinuation;
• may reduce the effect of guanethidine and increase the risk of cardiac arrhythmias in patients taking cardiac glycosides, quinidine, or tricyclic antidepressants.

The effect of pseudoephedrine:

• may be increased or decreased by tricyclic antidepressants (e.g., imipramine, opipramol);
• may be reduced by antihypertensive medicines (guanethidine, reserpine, and methyldopa).
  Antacids increase the absorption rate of pseudoephedrine, while kaolin decreases it.

During use of halogenated gases and inhaled general anesthetics, acute hypertensive reactions may occur in the perioperative period when used in combination with pseudoephedrine, similar to reactions seen with other indirectly acting sympathomimetic agents. Therefore, it is recommended to discontinue the medicine 24 hours before planned general anesthesia.

Other medicines may also interact with or be affected by treatment with Metafen ZATOKI. Therefore, always consult a doctor or pharmacist before combining Metafen ZATOKI with other medicines.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Metafen ZATOKI is contraindicated during pregnancy and breastfeeding.
Do not use Metafen ZATOKI during pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor.
Metafen ZATOKI, if 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 levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

Effect on fertility – see section "Warnings and precautions".

Driving and operating machinery
Patients in whom Metafen ZATOKI causes adverse effects affecting psycho-physical performance should not drive or operate machinery.

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

3. How to take Metafen ZATOKI

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use.
The lowest effective dose for the shortest necessary duration should be used in order to relieve symptoms and minimize the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).

Recommended dose:
For adults and adolescents over 12 years of age, the usual dose is:
Initial dose – 2 tablets, followed if necessary by 1 to 2 tablets every 4 hours as needed. Maximum daily dose – 6 tablets.

For patients over 65 years of age: dose adjustment is not usually required, unless renal or hepatic function is impaired; in such cases, dosing should be individually adjusted.

Use in children
This medicine should not be given to children under 12 years of age without medical advice.

If it becomes necessary to use the medicine for longer than 3 days, or if the patient's condition worsens, a doctor should be consulted.

Taking more Metafen ZATOKI than recommended
If a patient has taken more than the recommended dose of Metafen ZATOKI, or if a child has accidentally ingested the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on appropriate actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures have been reported occasionally. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may be reported. In addition, prothrombin time (INR) may be prolonged, likely due to impaired blood coagulation factor function. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.

Additionally, low blood pressure and breathing difficulties may occur.
Other possible symptoms include: thirst, anxiety, restlessness, irritability, fever, tachycardia (rapid heartbeat), dilated pupils, visual disturbances, hallucinations, delusions, muscle weakness, difficulty urinating, tremor, excessive sweating, cardiac arrhythmias, and circulatory collapse.

The severity of adverse effects may vary. The physician may perform gastric lavage and, if necessary, administer medications to correct electrolyte imbalances and other agents to manage overdose symptoms.

If you miss a dose of Metafen ZATOKI
Metafen ZATOKI is taken on an as-needed basis. If a dose is missed and symptoms persist, take the next dose as soon as possible. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must immediately stop taking Metafen SINUS and seek urgent medical help if the following occur:

• symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:
  • sudden, severe headache,
  • nausea,
  • vomiting,
  • confusion,
  • seizures,
  • visual disturbances. These are symptoms of serious conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) – frequency unknown (frequency cannot be estimated from available data).
• red, flat, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) – very rare.
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

Adverse effects due to the presence of ibuprofen in the medicine
Adverse effects occurring not very frequently (less than 1 in 100 patients):

• indigestion, abdominal pain, nausea;
• headache;
• urticaria and itching.

Adverse effects occurring rarely (less than 1 in 1,000 patients):

• diarrhoea, bloating, constipation, vomiting, gastritis;
• dizziness, insomnia, restlessness, irritability, and feeling tired;
• oedema.

Adverse effects occurring very rarely (less than 1 in 10,000 patients):

• blood count abnormalities (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis);
• liver function disorders, particularly during long-term use;
• melaena, haematemesis, ulcerative inflammation of the oral mucosa, 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, reduced urine output, renal failure, renal papillary necrosis, increased serum urea concentration, increased plasma sodium concentration (sodium retention);
• severe hypersensitivity reactions such as facial, lingual, and laryngeal swelling, dyspnoea, tachycardia; cardiac arrhythmias, hypotension (sudden drop in blood pressure), shock; exacerbation of asthma and bronchospasm;
• in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation;
• oedema, hypertension, heart failure associated with the use of high-dose NSAIDs.

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

• skin becomes sensitive to light;
• chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

In isolated cases, depression, psychotic reactions, and tinnitus have been reported.
Treatment with NSAIDs has been associated with the occurrence of oedema, hypertension, and heart failure.
The use of medicines containing ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Adverse effects due to the presence of pseudoephedrine in the medicine
Adverse effects occurring rarely (less than 1 in 1,000 patients):

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

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

• inflammation of the large intestine due to inadequate blood supply (ischaemic colitis);
• reduced blood flow in the optic nerve (ischaemic optic neuropathy).

Other possible adverse effects include: indigestion, gastrointestinal disturbances, redness and rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, cardiac arrhythmias, restlessness, insomnia.
The medicine is generally well tolerated when used at the recommended doses.

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

5. How to store Metafen ZATOKI

Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Keep the medicine out of 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 stated month.
Do not use this medicine if you notice any changes in the appearance of the tablets.
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 packaging and other information

What the medicine Metafen ZATOKI contains

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

What the medicine Metafen ZATOKI looks like and contents of the pack
The medicine is in the form of elongated white tablets. One blister contains 6 or 10 tablets.
Outer packaging – cardboard box containing 6; 10; 20 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Wörwag Pharma Operations spółka z ograniczoną odpowiedzialnością
General Marian Langiewicza Street 58, 95-050 Konstantynów Łódzki