Metafen ibuprofen

Package leaflet: Information for the patient

Metafen Ibuprofen, 200 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before using 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 3 days, medical advice should be sought.

Table of contents

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

Metafen Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has analgesic, antipyretic, and anti-inflammatory properties. The mechanism of action of ibuprofen is based on inhibition of prostaglandin synthesis.
It exerts an analgesic effect within 0.5 hour and an antipyretic effect within 2 to 4 hours after administration. The analgesic effect lasts for 4 to 6 hours, and the antipyretic effect for 6 to 8 hours.
Metafen Ibuprofen is indicated for:

• mild to moderate pain of various origins, e.g. dysmenorrhea, headache, toothache, muscle pain, post-traumatic pain, neuralgia,
• fever of various causes,
• relief of symptoms associated with colds and influenza.

2. Important information before using Metafen Ibuprofen

When not to use Metafen Ibuprofen:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), manifested as bronchial asthma, rhinitis, or 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, liver, or kidney failure;
• if the patient has a bleeding tendency (haemorrhagic diathesis);
• if the patient is concurrently using other NSAIDs, including COX-2 inhibitors.

Warnings and precautions
Before starting treatment with Metafen Ibuprofen, discuss this with your doctor or pharmacist.
Allergic reactions to ibuprofen have occurred, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Metafen Ibuprofen immediately and contact your doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection – see below, section titled “Infections”.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Metafen Ibuprofen, the patient should discuss treatment with a doctor or pharmacist:

• if the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked 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, a family history of heart disease or stroke, or if the patient smokes;
• if the patient has impaired liver function, special caution is required;
• if the patient has systemic lupus erythematosus or mixed connective tissue disease, there is an increased risk of developing aseptic meningitis;
• if the patient has impaired kidney function, special caution is required, as there is a risk of further deterioration;
• if the patient has a history of gastrointestinal disorders such as ulcerative colitis or Crohn’s disease, the condition may worsen;
• if the patient has bleeding disorders (e.g. haemophilia), ibuprofen may prolong bleeding time;
• if the patient has active or past bronchial asthma or allergic conditions, ibuprofen increases the risk of bronchospasm;
• in elderly patients, the risk of adverse effects increases;
• if visual disturbances occur (e.g. blurred vision, colour vision disturbances), discontinue the medicine and consult an ophthalmologist;
• if during treatment the patient develops bronchospasm, anaphylactic reaction, nosebleed, chest pain, seizures, or fainting, the medicine should be discontinued and medical advice sought;
• if the patient has chickenpox – see below, section titled “Infections”.

Special caution is required before using Metafen Ibuprofen, as ibuprofen use carries a risk of gastrointestinal ulceration, perforation, or bleeding. These adverse effects, which may be fatal, may occur without warning symptoms. Ibuprofen treatment should be discontinued if gastrointestinal bleeding or ulceration occurs. Patients with a history of gastrointestinal disorders, particularly elderly patients, should be informed of the need to report any unusual gastrointestinal symptoms, especially bleeding, to their doctor. This is particularly important during the initial treatment period. The lowest effective dose should be used in such patients.
Concurrent use of ibuprofen with anticoagulants (e.g. warfarin, acenocoumarol), antiplatelet agents (e.g. salicylic acid), or corticosteroids increases the risk of gastrointestinal bleeding or disturbances.
Exercise caution when co-administering with cyclosporine, methotrexate, digoxin, lithium, probenecid, or valproic acid.
Alcohol consumption 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 fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Taking medicines such 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. Do not use higher doses or longer treatment duration than recommended.
Long-term, concurrent use of ibuprofen and other painkillers increases the risk of kidney damage and kidney failure (analgesic nephropathy).
There is a risk of kidney dysfunction in dehydrated adolescents.

Serious skin reactions
Serious skin reactions have occurred with the use of ibuprofen, including 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 develops any symptoms related to these serious skin reactions described in section 4, discontinue Metafen Ibuprofen immediately and seek medical help.

Infections
Metafen Ibuprofen may mask symptoms of infection such as fever and pain. Therefore, Metafen Ibuprofen 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 takes this medicine during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.

Interaction of Metafen Ibuprofen with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Metafen Ibuprofen may affect the action of other medicines, or other medicines may affect the action of Metafen Ibuprofen. For example:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine;
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan);
• other NSAIDs: increased risk of adverse effects;
• diuretics: there is limited evidence of reduced diuretic effectiveness;
• zidovudine: evidence of prolonged bleeding time in patients treated concomitantly with ibuprofen and zidovudine;
• methotrexate and lithium: NSAIDs have been shown to increase serum concentrations of both lithium and methotrexate; monitoring of serum lithium and methotrexate levels is recommended;
• corticosteroids: concomitant use of NSAIDs and corticosteroids may increase the risk of adverse effects, particularly gastrointestinal;
• cardiac glycosides: NSAIDs may exacerbate symptoms of heart failure and increase serum levels of cardiac glycosides;
• 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 nephrotoxic effects;
• quinolone antibiotics: concomitant use of NSAIDs with quinolone antibiotics increases the risk of seizures.

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

Metafen Ibuprofen with food and drink
Take the medicine immediately after meals, with a large amount of liquid. In cases of gastrointestinal disturbances, it is recommended to take the medicine during meals or with milk.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use Metafen Ibuprofen during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Metafen Ibuprofen may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child and may delay or prolong labour.
Do not take Metafen Ibuprofen during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. Prolonged use of Metafen Ibuprofen for more than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child’s heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
There are no reports of harmful effects of ibuprofen on infants. Ibuprofen and its metabolites pass into breast milk in small amounts. Therefore, during short-term use of ibuprofen at recommended doses for mild to moderate pain and fever, discontinuation of breastfeeding is not required.

Effect on fertility
This medicine belongs to the group of nonsteroidal anti-inflammatory drugs, which may negatively affect fertility in women. This effect is reversible after discontinuation of treatment.

Driving and operating machinery
There is no data on harmful effects of the medicine on the ability to drive or operate machinery. In rare cases, mainly during use of high doses, visual disturbances (blurred or double vision) may occur. Consult a doctor regarding the ability to drive.

Metafen Ibuprofen contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Metafen Ibuprofen

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms and reduce the risk of adverse effects.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
If it is necessary to use this medicine for longer than 3 days or if symptoms worsen, consult a doctor.
This medicine is not intended for children under 12 years of age.

Adults and adolescents over 12 years of age:
Mild to moderate pain, painful menstruation, fever, relief of cold and flu symptoms
200 mg to 400 mg as a single dose, or 3 to 4 times daily as needed. A single dose higher than 400 mg does not provide stronger analgesic effect.
Without medical advice, the daily dose should not exceed 1200 mg.

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

Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, confusion, or coma may also occur. Seizures may occur rarely. 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 have been reported. Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood clotting factor function. Acute kidney 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.

In adult patients, the single dose of ibuprofen that may cause overdose symptoms is not precisely defined. In children, overdose symptoms may occur after ingestion of more than 400 mg. The half-life in such cases is between 1.5 and 3 hours.

Symptomatic and supportive treatment is recommended. The doctor will monitor vital signs. Treatment may include gastric lavage and administration of activated charcoal (if less than 1 hour has passed since ingestion of the medicine). In cases of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. In patients with asthma, bronchodilators will be administered.

If you forget to take Metafen Ibuprofen
Do not take a double dose to make up for a missed dose.

Stopping Metafen Ibuprofen
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs 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 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 reactions are listed according to their frequency of occurrence, starting with the most common.

Not very common (occurring in fewer than 1 in 100 patients):
dyspepsia, abdominal pain and discomfort, heartburn, nausea, dizziness, rash, urticaria, itching.

Rare (occurring in fewer than 1 in 1,000 patients):
diarrhea, bloating, constipation, vomiting, gastritis, headache, skin itching, edema.

Very rare (occurring in fewer than 1 in 10,000 patients):
ulcerative stomatitis, exacerbation of colitis, Crohn's disease, tarry stools, vomiting blood, duodenitis, esophagitis, depression, insomnia, disorientation, mood swings, restlessness, somnolence, irritability and fatigue, convulsions, aseptic meningitis with fever or coma, tinnitus, reduced urine output, renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention), liver function disorders, particularly during long-term use: hepatitis, pancreatitis, jaundice, increased liver enzyme activity, anaemia (hemolytic and aplastic), agranulocytosis (absence in blood of white blood cells called granulocytes), leukopenia (decreased number of white blood cells), thrombocytopenia with or without purpura (decreased number of platelets), pancytopenia (decreased number of blood cells), facial swelling, laryngeal and lingual edema, dyspnea, tachycardia – cardiac arrhythmia, hypotension – sudden drop in arterial blood pressure, shock, anaphylactic shock, worsening of asthma, bronchospasm, arterial hypotension, arterial hypertension, heart failure associated with use of NSAIDs at high doses.

Gastric and (or) duodenal ulceration, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients.

Initial symptoms of blood and lymphatic system disorders: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruises, petechiae, purpura, nosebleeds).

Cases of hypersensitivity reactions to ibuprofen have been observed: allergic reactions, neutropenia, eosinophilia, decreased hematocrit, hearing loss, visual disturbances.

In patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease, who are taking ibuprofen, single cases of aseptic meningitis have been observed: neck stiffness, headache, nausea, vomiting, fever, disorientation.

In isolated cases, acute hypersensitivity reactions manifested as hypotension have occurred.

Edema, arterial hypertension and heart failure have been reported in connection with NSAID therapy. Use of drugs such as Metafen Ibuprofen may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

Frequency unknown (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metafen Ibuprofen

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Metafen Ibuprofen contains

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

• Other ingredients are: maize starch, sodium croscarmellose, povidone, hypromellose, talc.
  Coating: hypromellose, monohydrate lactose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Metafen Ibuprofen looks like and contents of the pack
Yellow-brown, round, biconvex coated tablets with a diameter of 10 mm.
Each pack contains: 2, 6, 10 or 20 coated tablets.

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

Manufacturer
Polfarmex S.A.
Józefów 9
99-300 Kutno

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Branch in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba