Metafen Ibuprofen

Leaflet attached to the packaging: patient information

Metafen Ibuprofen, 200 mg, coated tablets

Ibuprofen

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 advised 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.

Table of contents of the leaflet

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

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

Metafen Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs), it has analgesic, antipyretic, and anti-inflammatory effects. The mechanism of action of ibuprofen is based on the inhibition of prostaglandin synthesis.
It shows analgesic effect after 0.5 hours, and antipyretic effect after 2 to 4 hours after taking the medicine. The analgesic effect lasts for 4 to 6 hours, and the antipyretic effect lasts for 6 to 8 hours.
Metafen Ibuprofen is indicated for use in:

• pains of various origins with mild to moderate intensity, e.g. painful menstruation, headaches, toothaches, muscle pains, post-traumatic pains, neuralgia,
• fever of various origins,
• relieving symptoms of colds and flu.

2. Important information before taking Metafen Ibuprofen

When not to take Metafen Ibuprofen:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, manifested by asthma, rhinitis, urticaria;
• if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum with perforation or bleeding;
• if the patient is in the third trimester of pregnancy;
• if the patient has severe heart failure, liver, or kidney failure;
• if the patient has a bleeding disorder;
• if the patient is taking other NSAIDs, including COX-2 inhibitors.

Warnings and precautions

Before starting treatment with Metafen Ibuprofen, the patient should discuss it with their doctor or pharmacist.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If the patient notices any of these symptoms, they should stop taking Metafen Ibuprofen immediately and seek medical help immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, the section entitled "Infections".
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 Ibuprofen, the patient should discuss their treatment with their doctor or pharmacist:

• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, bypass surgery, 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);
• if the patient has high blood pressure, diabetes, high cholesterol levels, has a history of heart disease or stroke in their family, or smokes;
• if the patient has liver function disorders, they should be cautious;
• if the patient has systemic lupus erythematosus and mixed connective tissue disease, there is a greater risk of developing aseptic meningitis;
• if the patient has impaired kidney function, they should be cautious, as there is a risk of further deterioration of their function;
• if the patient has a history of gastrointestinal diseases, such as ulcerative colitis, Crohn's disease, the disease may worsen;
• if the patient has bleeding disorders (e.g. hemophilia), ibuprofen may prolong bleeding time;
• if the patient has active or a history of asthma and allergic diseases, ibuprofen increases the risk of bronchospasm;
• if the medicine is used in elderly patients, the risk of side effects increases;
• if the patient experiences vision disturbances (blind spots, color vision disturbances), they should stop taking the medicine and consult an ophthalmologist;
• if the patient experiences bronchospasm, anaphylactic reaction, nosebleeds, chest pain, seizures, fainting while taking the medicine, it is recommended to stop taking the medicine and consult a doctor;
• if the patient has chickenpox - see below, the section entitled "Infections".

Before taking Metafen Ibuprofen, the patient should be cautious, as taking ibuprofen carries the risk of developing ulcers, perforation, or bleeding in the gastrointestinal tract. These side effects, which can be fatal, may be preceded by warning signs, but do not have to be. Treatment with ibuprofen should be discontinued in case of gastrointestinal bleeding or ulcers. Patients with a history of gastrointestinal diseases, especially the elderly, should be informed about the need to report any unusual gastrointestinal symptoms to their doctor, especially bleeding. This is especially important during the initial treatment period. In such patients, the use of the smallest possible dose of the medicine is recommended.
Taking ibuprofen and anticoagulant medications (e.g. warfarin, acenocoumarol), antiplatelet agents (e.g. salicylic acid), or corticosteroids increases the risk of bleeding or gastrointestinal disorders.
Cautious use is recommended when combined with cyclosporine, methotrexate, digoxin, lithium, probenecid, valproic acid.
Concomitant consumption of alcohol increases the risk of gastrointestinal bleeding.
Ibuprofen may cause a sudden decrease in blood glucose levels.
Metafen Ibuprofen belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.
Taking such medicines as Metafen Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended.
Long-term, concomitant use of ibuprofen and other pain-relieving medications increases the risk of kidney damage, kidney failure (analgesic nephropathy).
There is a risk of kidney function disorders in dehydrated adolescents.
Severe skin reactions
In connection with the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should stop taking Metafen Ibuprofen immediately and seek medical help.
Infections
Metafen Ibuprofen may mask the symptoms of an infection, such as fever and pain. Therefore, Metafen Ibuprofen may delay the use of appropriate infection treatment, which can lead to an 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, they should consult their doctor immediately.

Metafen Ibuprofen and other medicines

Tell the doctor about all medicines the patient is taking or has recently taken, as well as about medicines they plan to take.
Metafen Ibuprofen may affect the action of other medicines or other medicines may affect the action of Metafen Ibuprofen. For example:

• medicines with anticoagulant action (i.e. blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• other NSAIDs: the risk of side effects increases;
• diuretics: there is limited evidence of reduced efficacy of diuretics;
• zydovudine: there is evidence of prolonged bleeding time in patients treated with ibuprofen and zidovudine;
• methotrexate and lithium: it has been proven that NSAIDs can cause an increase in plasma levels of both lithium and methotrexate; monitoring of lithium and methotrexate levels in serum is recommended;
• corticosteroids: concomitant use of NSAIDs and corticosteroids may increase the risk of side effects, especially those related to the gastrointestinal tract;
• cardiac glycosides: NSAIDs may exacerbate heart failure and increase the levels of cardiac glycosides in the blood;
• mifepristone: NSAIDs used between 8 and 12 days after mifepristone administration may reduce its effectiveness;
• cyclosporine: concomitant use of NSAIDs and cyclosporine increases the risk of nephrotoxicity;
• quinolone antibiotics: concomitant use of NSAIDs with quinolone antibiotics increases the risk of seizures.

Also, some other medicines may be affected by or have an effect on treatment with Metafen Ibuprofen. Therefore, before taking Metafen Ibuprofen with other medicines, the patient should always consult their doctor or pharmacist.

Metafen Ibuprofen with food and drink

The medicine should be taken immediately after meals, with a large amount of liquid; in cases of gastrointestinal disorders, it is recommended to take the medicine during meals or with milk.

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.
Pregnancy
Do not take Metafen Ibuprofen during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Metafen Ibuprofen may cause kidney and heart disorders in the unborn child. This may affect the patient's and their child's tendency to bleed and may cause delayed or prolonged labor.
Do not take Metafen Ibuprofen during the first 6 months of pregnancy, unless it is absolutely necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Metafen Ibuprofen taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
There are no reports of harmful effects of ibuprofen on infants. In small amounts, ibuprofen and its metabolites pass into the breast milk of nursing mothers. Therefore, during short-term use of ibuprofen in recommended doses for pain relief and fever, it is not necessary to stop breastfeeding.
Fertility
The medicine belongs to a group of nonsteroidal anti-inflammatory drugs that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.

Driving and using machines

There is no data on the harmful effects of the medicine on the ability to drive vehicles and operate machinery. In rare cases, especially when using high doses, vision disturbances (blurred or double vision) may occur. The patient should consult their doctor about the possibility of driving vehicles.

Metafen Ibuprofen contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
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 Ibuprofen

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.
The patient should use the smallest effective dose for the shortest necessary period to alleviate symptoms and minimize the risk of side effects. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
If it is necessary to use this medicine for more than 3 days or if the symptoms worsen, the patient should consult their doctor.
The medicine is not indicated for children under 12 years of age.

Adults and adolescents over 12 years of age:

Mild to moderate pain, painful menstruation, fever, relieving symptoms of colds and flu
From 200 mg to 400 mg at a time or 3 to 4 times a day, as needed. A single dose greater than 400 mg does not cause stronger analgesic effects.
Without a doctor's recommendation, do not use a dose greater than 1200 mg per day.

Taking a higher dose of Metafen Ibuprofen than recommended

If the patient has taken a higher dose of Metafen Ibuprofen than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what actions to take in such a case.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which 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 some 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, worsening of asthma symptoms may occur.
Furthermore, low blood pressure and difficulty breathing may occur.
In adult patients, a single dose of ibuprofen that can cause symptoms of overdose is not precisely determined. In children, symptoms of overdose may occur after taking a dose greater than 400 mg. The half-life is then between 1.5 and 3 hours.
Symptomatic and supportive treatment is recommended. The doctor will monitor vital signs.
The treatment includes gastric lavage, administration of activated charcoal (if the medicine has been taken within the last hour). In case of frequent or prolonged seizures, the doctor may recommend intravenous administration of diazepam or lorazepam. In patients with asthma, the doctor will administer bronchodilators.

Missing a dose of Metafen Ibuprofen

Do not take a double dose to make up for a missed dose.

Stopping treatment with Metafen Ibuprofen

In case of any further doubts about taking 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.
The patient should stop taking ibuprofen and seek medical help immediately if they experience any of the following symptoms:

• 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 swollen lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with nodules under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Side effects are listed according to their frequency, starting from the most common.
Uncommon (occur less frequently than in 1 in 100 patients):
indigestion, abdominal pain and discomfort, heartburn, nausea, dizziness, rash, urticaria, itching.
Rare (occur less frequently than in 1 in 1,000 patients):
diarrhea, bloating, constipation, vomiting, gastritis, headaches, skin itching, edema.
Very rare (occur less frequently than in 1 in 10,000 patients):
ulcerative stomatitis, exacerbation of ulcerative colitis, Crohn's disease, tarry stools, gastrointestinal bleeding (see also section 4 below), depression, insomnia, disorientation, mood changes, agitation, drowsiness, irritability, and fatigue, seizures, aseptic meningitis with fever or coma, tinnitus, decreased urine output, kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention), liver function disorders, especially during long-term use: hepatitis, pancreatitis, jaundice, increased liver enzyme activity, anemia (hemolytic and aplastic), agranulocytosis (lack of white blood cells called granulocytes in the blood), leukopenia (decreased white blood cell count), thrombocytopenia with or without purpura (decreased platelet count), pancytopenia (decreased blood cell count), facial edema, laryngeal edema, tongue edema, dyspnea, tachycardia - arrhythmia, hypotension - sudden decrease in blood pressure, shock, anaphylactic shock, bronchospasm, hypotension, hypertension, heart failure associated with the use of NSAIDs in high doses.
It may cause peptic ulcer disease and/or duodenal ulcer, perforation, or bleeding of the gastrointestinal tract, sometimes with a fatal outcome, especially in the elderly.
The first symptoms of blood and lymphatic system disorders: fever, sore throat, superficial oral ulcers, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds).
Observed cases of hypersensitivity reactions to ibuprofen: allergic reactions, neutropenia, eosinophilia, decreased hematocrit, hearing loss, vision disturbances.
In patients with autoimmune diseases, such as systemic lupus erythematosus, mixed connective tissue disease, taking ibuprofen, single cases of symptoms of aseptic meningitis have been observed: neck stiffness, headache, nausea, vomiting, fever, disorientation.
In single cases, acute hypersensitivity reactions have occurred, manifested by hypotension.
In connection with the treatment of NSAIDs, edema, hypertension, and heart failure have been reported. Taking such medicines as Metafen Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Frequency not known (frequency cannot be estimated from the available data):

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Metafen Ibuprofen

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Contents of the pack and other information

What Metafen Ibuprofen contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.

ibuprofen.

• The other ingredients of the medicine are: corn starch, sodium carmellose, povidone, hypromellose, talc. Coating: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Metafen Ibuprofen looks like and contents of the pack

Coated tablets of yellow-brown color, round, biconvex, with a diameter of 10 mm.
One pack contains: 2, 6, 10, or 20 coated tablets.

Marketing authorization holder

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

Manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: