Metafen

Leaflet accompanying the packaging: information for the user

Metafen, 200 mg + 325 mg, tablets

Ibuprofen + Paracetamol

It is necessary to carefully read the contents of the leaflet 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 doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any 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 Metafen and what is it used for
• 2. Important information before using Metafen
• 3. How to use Metafen
• 4. Possible side effects
• 5. How to store Metafen
• 6. Contents of the packaging and other information

1. What is Metafen and what is it used for

Metafen is a medicine in the form of oral tablets. It contains two active substances, ibuprofen and paracetamol, which have analgesic, antipyretic, and anti-inflammatory effects.

Indications for use:

• pains of various origins, including:
• headaches
• migraines
• menstrual pains
• toothaches
• muscle pains
• bone and joint pains
• lower back pains
• post-traumatic pains
• neuralgias
• fever.

The medicine is intended for adults and adolescents over 12 years of age.

2. Important information before using Metafen

When not to use Metafen

If the patient is allergic to paracetamol, ibuprofen, or any of the other ingredients of this medicine (listed in section 6).

If there is an allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid; a history of aspirin-induced asthma, angioedema (a skin and mucous membrane disease characterized by swelling), bronchospasm, rhinitis, or urticaria associated with acetylsalicylic acid or other NSAIDs.

In severe renal and/or hepatic impairment.

In the case of gastric and/or duodenal ulcer disease (active or in the past); perforation or bleeding, also occurring after the use of NSAIDs.

In severe hypertension.

In severe cardiovascular disease, tachycardia (rapid heart rate), angina pectoris.

In severe heart failure.

During pregnancy and breastfeeding.

During concurrent use of anticoagulant medications and in bleeding disorders (tendency to bleed in the skin and mucous membranes, nose, gastrointestinal tract).

In the case of urinary retention.

In patients with a congenital deficiency of glucose-6-phosphate dehydrogenase.

In children under 12 years of age.

In the case of alcoholism.

Warnings and precautions

Before starting Metafen, the patient should discuss it with their doctor or pharmacist.

The pharmacist or doctor should be informed if the patient has an infection - see below, section "Infections".

Concurrent use of Metafen with other NSAIDs, including COX-2 inhibitors and acetylsalicylic acid at a daily dose greater than 75 mg, increases the risk of adverse reactions.

Metafen contains paracetamol. To avoid overdose, the patient should check if other medications they are taking contain paracetamol. Concurrent use of other paracetamol-containing medications with Metafen may lead to overdose and increase the risk of serious adverse reactions.

Long-term concurrent use of various pain-relieving medications may lead to kidney damage with a risk of kidney failure.

There is a risk of kidney function disorders in dehydrated adolescents.

Care should be taken when using the medicine in patients with:

liver and/or kidney function disorders and cardiovascular disease; in patients with kidney function disorders, the smallest effective dose should be used.

systemic lupus erythematosus and mixed connective tissue disease - there is an increased risk of developing aseptic meningitis.

gastrointestinal diseases (ulcerative colitis, Crohn's disease) - symptoms may worsen.

heart rhythm disorders, hypertension, heart attack, or heart failure in the past - fluid retention may occur due to worsening kidney function.

bleeding disorders or concurrent use of anticoagulant medications - ibuprofen may prolong bleeding time.

The medicine should be used with caution in patients with asthma and in those who have had other allergic reactions, due to the risk of bronchospasm.

In patients over 65 years of age, there is a greater risk of adverse reactions than in younger patients.

During long-term use of the medicine, especially in patients with a history of gastrointestinal diseases, particularly in 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 and a doctor consulted.

Care should be taken when using the medicine in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications like warfarin (acenocoumarol) or antiplatelet agents like acetylsalicylic acid.

Skin reactions

Severe skin reactions have been reported with the use of Metafen. If any skin rash, mucous membrane changes, blisters, or other signs of allergy occur, the medicine should be discontinued and medical help sought immediately, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Metafen may mask the symptoms of infection, such as fever and pain. Therefore, Metafen 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 the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

During paracetamol use, the patient should not drink alcohol due to the risk of liver damage.

There is a special risk of liver damage in fasting individuals and those who regularly drink alcohol.

Taking the medicine may cause false results in some laboratory tests performed using oxidation-reduction methods (e.g., blood glucose measurement).

Taking anti-inflammatory and pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of use should be as short as possible.

The patient should consult their doctor or pharmacist before using Metafen if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• they have hypertension, diabetes, high cholesterol, a family history of heart disease or stroke, or smoke.

During Metafen use, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have reported a severe disease called metabolic acidosis (blood and body fluid disorder), which requires emergency treatment (see section 2).

Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions.

The patient should consult their doctor or pharmacist if they experience new or worsening symptoms.

Metafen 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.

As with any other paracetamol-containing medicine, the patient should avoid using Metafen in combination with other paracetamol-containing medicines due to the increased risk of serious adverse reactions.

Metafen may interact with other medicines, and some medicines may interact with Metafen. The patient should inform their doctor or pharmacist if they are taking:

• acetylsalicylic acid (except for small doses up to 75 mg per day, as prescribed by a doctor), its derivatives, and other NSAIDs and/or corticosteroids (e.g., prednisone) - increased risk of adverse reactions;
• diuretics - decreased effectiveness of these medicines;
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• methotrexate (a medicine used in cancer) and lithium salts (medicines used in psychiatry) - may increase the risk of adverse reactions due to increased blood levels;
• digitalis glycosides (medicines used in heart failure) - may increase digoxin blood levels and worsen heart failure;
• anticoagulant medications (e.g., aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• rifampicin, antiepileptic medications, and barbiturates (medicines with anticonvulsant and sedative effects) - may increase the risk of liver damage;
• monoamine oxidase inhibitors (MAOIs - medicines used in depression, e.g., phenelzine) - may cause excitement and high fever;
• zydovudine (an antiviral medicine) - may increase the toxic effect of zidovudine on the bone marrow and prolong bleeding time in HIV-positive patients with hemophilia (a hereditary blood disease);
• chloramphenicol - increased toxicity due to increased blood levels;
• metoclopramide and other prokinetic agents (enhancing gastrointestinal motility) - accelerated paracetamol absorption;
• selective serotonin reuptake inhibitors - increased risk of gastrointestinal bleeding;
• cholestyramine - decreased paracetamol absorption rate;
• cyclosporine, tacrolimus (medicines used after transplantation, e.g., kidney) - increased risk of kidney toxicity;
• mifepristone - NSAIDs may reduce its effectiveness;
• quinolone antibiotics used with NSAIDs may increase the risk of seizures;
• propantheline and other anti-motility agents - delayed paracetamol absorption;
• flucloxacillin (an antibiotic) - due to the serious risk of blood and body fluid disorders (metabolic acidosis), which require emergency treatment (see section 2).

Other medicines may also be affected by or affect Metafen treatment. Therefore, before using Metafen with other medicines, the patient should consult their doctor or pharmacist.

Metafen with food, drink, and alcohol

Drinking alcohol while using Metafen may lead to toxic liver damage and liver failure.

Metafen should be taken after a meal (see section 3).

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 using this medicine.

Metafen is contraindicated during the entire pregnancy and breastfeeding period.

The medicine should not be used during pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart function disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor.

Using Metafen for more than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart.

This medicine belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped. Ibuprofen may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

After taking NSAIDs, side effects such as dizziness, drowsiness, fatigue, and vision disturbances may occur. Patients experiencing these symptoms should not drive or operate machinery.

3. How to use Metafen

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

The medicine is intended for oral use.

The smallest effective dose should be used for the shortest duration necessary to relieve symptoms and reduce the risk of adverse reactions. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

Recommended dose:

Adults: 1 or 2 tablets at a time.

The dose can be repeated up to three times a day if necessary.

Do not take more than 6 tablets per day.

Use in adolescents

Adolescents over 12 years of age: 1 tablet at a time. The dose can be repeated up to three times a day if necessary. Do not take more than 3 tablets per day.

Metafen should be taken after a meal.

For short-term use.

The patient should consult their doctor if symptoms persist or worsen, or if the medicine needs to be used for more than 3 days.

Elderly patients: dose modification is not required.

In elderly patients, there is an increased risk of serious adverse reactions - see section "Warnings and precautions".

Taking a higher dose of Metafen than recommended

If the patient has taken a higher dose of Metafen than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess the potential health risk and receive advice on what to do.

Ibuprofen overdose

Overdose symptoms may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, and disorientation. They may also include excitement, drowsiness, disorientation, or coma. Seizures have been reported occasionally. 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, likely due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, asthma symptoms may worsen. Additionally, hypotension and breathing difficulties may occur.

Paracetamol overdose

Symptoms such as pallor, nausea, vomiting, anorexia, abdominal pain may occur within a few to several hours after paracetamol overdose. These symptoms may resolve the next day, despite the onset of liver damage, which may then manifest as abdominal tenderness, nausea, and jaundice. Severe abdominal pain, hematuria, cardiac arrhythmias, and pancreatitis may also occur.

Early overdose symptoms are related to ibuprofen, while later symptoms are related to paracetamol. Treatment of poisoning should be carried out in a hospital, under intensive medical care.

Missing a dose of Metafen

If a dose is missed and symptoms persist, the next dose should be taken. A double dose should not be taken to make up for the missed dose.

Stopping Metafen use

In case of further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metafen can cause side effects, although not everybody gets them.

Common side effects (occurring in 1 to 10 patients per 100):

• abdominal pain, diarrhea, indigestion, nausea, gastrointestinal disorders, and vomiting;
• increased activity of alanine aminotransferase and gamma-glutamyltransferase enzymes, as well as changed liver function test parameters after paracetamol use; increased creatinine and urea levels in the blood.

Uncommon side effects (occurring in 1 to 10 patients per 1,000):

• bloating, constipation; gastric ulcer, perforation, or gastrointestinal bleeding, with symptoms such as melena and hematemesis, sometimes with a fatal outcome, especially in the elderly;
• ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease; pancreatitis has been reported rarely;
• headache, dizziness;
• various types of rashes, including urticaria and itching; angioedema and facial edema;
• increased aspartate aminotransferase activity, increased alkaline phosphatase, creatine phosphokinase, and creatinine levels in the blood, decreased hemoglobin levels, and increased platelet count.

Rare side effects (occurring in 1 to 10 patients per 10,000):

• insomnia;
• gastritis;
• edema.

Very rare side effects (occurring in less than 1 patient per 10,000):

• blood cell count disorders; the first symptoms are: fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and nosebleeds;
• abnormal liver function, hepatitis, and jaundice, liver enlargement; after paracetamol overdose, acute liver failure, liver failure, liver necrosis, and liver damage may occur;
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (skin reactions characterized by rash, redness, and blisters; peeling of the skin; oral, throat, nose, genital, and conjunctival ulcers). Very rare cases of severe skin reactions have been reported. The medicine should be discontinued, and medical help sought immediately if the first signs of a skin reaction occur (see section 2).
• severe allergic reactions with symptoms such as: facial edema, tongue and laryngeal edema, dyspnea, tachycardia, arrhythmias, hypotension, shock, asthma exacerbation, bronchospasm;
• paresthesia (tingling sensation), optic neuritis, and drowsiness, excitement, irritability; in individual cases, psychotic reactions and tinnitus have been reported;
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) treated with ibuprofen, isolated cases of aseptic meningitis have been reported, with symptoms such as: neck stiffness, headache, nausea, vomiting, fever, disorientation;
• confusion, depression, and hallucinations;
• vision disturbances;
• tinnitus and vertigo of labyrinthine origin;
• excessive sweating, purpura;
• edema, hypertension, and heart failure - reported in association with NSAID treatment in high doses;
• toxic effects on the kidneys, including interstitial nephritis, nephrotic syndrome, and acute and chronic kidney failure, pain and burning during urination, decreased urine output, renal papillary necrosis, elevated serum sodium levels (sodium retention);
• fatigue and malaise.

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

• severe skin reactions known as DRESS syndrome. DRESS syndrome symptoms include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell);
• 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 patient should discontinue Metafen and seek medical help immediately. See also section 2;
• skin becomes sensitive to light;
• a serious condition that can cause blood acidification (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Taking ibuprofen-containing medications may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient 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 gather more information on the safety of the medicine.

5. How to store Metafen

The medicine should be stored out of sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiration date stated on the blister, container, and carton after: EXP.

The expiration date is the last day of the specified month.

Do not use this medicine if the appearance of the tablets has changed.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Metafen contains

• The active substances of the medicine are ibuprofen and paracetamol. Each tablet contains 200 mg of ibuprofen and 325 mg of paracetamol.
• Other ingredients are: povidone, starch, microcrystalline cellulose, magnesium stearate.

What Metafen looks like and what the packaging contains

The medicine is in the form of white or almost white, oval, uncoated tablets with the inscription "Metafen" on one side.

The outer packaging - a cardboard box - contains:

2, 6, 10, 20, 60 tablets in aluminum/PVC blisters or 50 tablets in a polyethylene container.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet: