Metafen

Leaflet accompanying the packaging: patient information

Metafen, 200 mg + 325 mg, coated tablets

Ibuprofen + Paracetamol

It is essential 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 advised 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, 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 medicinal product in the form of coated tablets for oral administration.
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
• neuralgic pains
• 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 hypersensitive to paracetamol, ibuprofen, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a hypersensitivity to NSAIDs (non-steroidal anti-inflammatory drugs), including acetylsalicylic acid; has had asthma, angioedema (a disease of the skin and mucous membranes characterized by the occurrence of edema), bronchospasm, rhinitis, or urticaria associated with the use of acetylsalicylic acid or other NSAIDs;

edema), bronchospasm, rhinitis, or urticaria associated with the use of acetylsalicylic acid or other NSAIDs;

• if the patient has severe renal and/or hepatic impairment;
• if the patient has had gastric or duodenal ulcer, perforation, or bleeding, including those caused by the use of NSAIDs;
• if the patient has severe hypertension;
• if the patient has severe cardiovascular diseases, tachycardia (rapid heart rate), angina pectoris;
• if the patient has severe heart failure;
• if the patient has a bleeding disorder;
• if the patient is taking other NSAIDs, including COX-2 inhibitors and acetylsalicylic acid in a daily dose greater than 75 mg;
• if the patient is taking other medicines containing paracetamol;
• during pregnancy and breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Metafen, the patient should discuss it with their doctor or pharmacist.
Metafen contains paracetamol. To avoid overdose, the patient should check if other medicines being taken contain paracetamol (see section 2).
Concomitant, long-term use of different pain-relieving medicines may lead to kidney damage with a risk of kidney failure. There is a risk of impaired kidney function 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 lowest effective dose should be used;
with asthma and those who have had other allergic reactions, due to the risk of bronchospasm;
with systemic lupus erythematosus and mixed connective tissue disease - there is an increased risk of developing aseptic meningitis;
with gastrointestinal diseases in the past (ulcerative colitis, Crohn's disease) - may exacerbate symptoms; special care should be taken when using the medicine in patients over 65 years of age, as they are at increased risk of gastrointestinal bleeding, ulceration, or perforation, especially during long-term use. If any unusual gastrointestinal symptoms occur, especially during the initial treatment period, the medicine should be discontinued and medical advice sought immediately;
with heart rhythm disorders, hypertension, myocardial infarction, or heart failure - may lead to fluid retention in the body due to impaired kidney function;
with coagulation disorders and taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants, such as warfarin (acenocoumarol), certain antidepressants (see "Metafen and other medicines") or antiplatelet agents, such as acetylsalicylic acid;
with heart function disorders, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking)

• the treatment method should be discussed with a doctor or pharmacist; in patients over 65 years of age, there is a higher risk of side effects than in younger patients; if the patient has an infection - see below, section entitled "Infections".

Infections
Metafen may mask the symptoms of an infection, such as fever and pain. As a result, Metafen 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.
Skin reactions
Severe skin reactions have been reported with the use of Metafen. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of an allergic reaction, the patient should stop taking Metafen and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs, NSAIDs) that may adversely affect female fertility. This effect is reversible and disappears after the end of treatment.
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.
Taking the medicine in the smallest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects.
The use of the medicine may cause false results in some laboratory tests performed using oxidation-reduction methods (e.g., blood glucose measurement).
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the treatment duration should be as short as possible.
Before using Metafen, the patient should discuss their treatment with their doctor or pharmacist if:

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

During treatment with Metafen, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In such cases, patients have reported a severe condition called metabolic acidosis (a blood and body fluid disorder), which can occur when paracetamol is taken in regular doses for a longer period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

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 severe side effects.
Metafen may interact with other medicines, and some medicines may interact with Metafen.
The patient should not use Metafen concomitantly:

• with acetylsalicylic acid (except in a low dose of 75 mg per day on the advice of a doctor);
• with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as these medicines increase the risk of side effects.

Metafen can be used with caution with the following medicines. However, the patient should consult their doctor or pharmacist before taking:

• chloramphenicol (an antibiotic used in bacterial infections) - increases paracetamol absorption;
• cholestyramine (used to reduce cholesterol levels) - decreases paracetamol absorption rate;
• metoclopramide and other prokinetic agents (which enhance gastrointestinal motility) - increases paracetamol absorption;
• domperidone (an antiemetic) - increases paracetamol absorption;
• anticoagulant medicines (i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine) - may increase the risk of bleeding during regular paracetamol use;
• rifampicin (an antibiotic), antiepileptic drugs, and barbiturates (used as anticonvulsants and sedatives) - there is a risk of liver damage;
• monoamine oxidase inhibitor (MAOI) antidepressants - may cause excitement and high fever;
• selective serotonin reuptake inhibitors - increased risk of gastrointestinal bleeding;
• propantheline and other anti-peristaltic agents - delays paracetamol absorption;
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan) - NSAIDs may weaken the effect of these medicines;
• corticosteroids (anti-inflammatory medicines), antiplatelet agents - increased risk of gastrointestinal bleeding;
• cardiac glycosides (used, e.g., in heart failure) - NSAIDs may worsen heart failure;
• cyclosporin (used after transplants) - increased risk of kidney toxicity;
• diuretics - may increase the risk of toxic effects of NSAIDs on the kidneys; furthermore, NSAIDs may weaken the effect of diuretics;
• methotrexate (used in cancer) and lithium salts (used in psychiatry) - may increase the risk of side effects due to increased blood levels;
• mifepristone - NSAIDs weaken its effect;
• quinolone antibiotics (e.g., ciprofloxacin) - used with NSAIDs, may cause an increased risk of seizures;
• tacrolimus (used after transplants and in atopic dermatitis) - increased risk of nephrotoxicity;
• zidovudine (an antiviral medicine) - increased risk of hematologic toxicity;
• flucloxacillin (an antibiotic) - due to the serious risk of blood and body fluid disorders (metabolic acidosis), which must be treated urgently (see section 2).

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

Metafen with food, drink, and alcohol

During treatment with Metafen, the patient should not consume alcohol, as there is a risk of toxic liver damage, especially in malnourished individuals who regularly drink alcohol.
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 baby, they should consult their doctor or pharmacist before using this medicine.
Metafen is contraindicated during the entire pregnancy and breastfeeding period.
The patient should not use Metafen 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 patient and their child and cause prolonged or delayed delivery.
Metafen used 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 (ductus arteriosus) in the child's heart.
Fertility effects - see "Warnings and precautions" section.

Driving and using machines

After taking the medicine, side effects such as dizziness, drowsiness, fatigue, and vision disturbances may occur. Patients who experience 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 advised by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
The medicine should be taken after a meal.
Recommended dose:
Adults: 1 or 2 coated tablets at a time.
If necessary, the dose can be repeated up to 3 times a day.
No more than 6 coated tablets should be taken per day.
Elderly patients: dose modification is not required. However, elderly patients are at increased risk of severe side effects, especially during long-term use. If the use of the medicine is necessary, the patient should take the lowest effective dose for the shortest possible time.
Children and adolescents
Adolescents over 12 years of age: 1 coated tablet at a time.
If necessary, the dose can be repeated up to 3 times a day.
No more than 3 coated tablets should be taken per day.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
For short-term use only.
The patient should consult their doctor if the symptoms persist or worsen, or if the medicine needs to be used for more than 3 days.

Using a higher than recommended dose of Metafen

In case of an overdose, symptoms may occur. Early symptoms of overdose are related to ibuprofen, while later symptoms are related to paracetamol.
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 get an opinion on the possible health risk and advice on what to do.

Missing a dose of Metafen

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

Stopping treatment with Metafen

In case of further doubts about the use of 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 (less than 1 in 10 patients):

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

Uncommon side effects (less than 1 in 100 patients):

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

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

• gastritis;
• edema.

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

• blood system disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia) - the first symptoms are fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and nosebleeds;
• hypersensitivity reactions, including anaphylaxis and angioedema; severe hypersensitivity reactions (anaphylaxis, angioedema) - symptoms include facial edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension - if these occur, the patient should seek medical attention immediately;
• confusion, depression, and hallucinations;
• paresthesia (numbness, tingling in the limbs), optic neuritis, and drowsiness, agitation, irritability;
• in patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), aseptic meningitis has been reported during ibuprofen treatment, with symptoms such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.
• depression, psychotic reactions, and tinnitus (reported in individual cases);
• vision disturbances;
• tinnitus and dizziness of labyrinthine origin;
• asthma, exacerbation of asthma, bronchospasm, and dyspnea (symptoms of respiratory hypersensitivity - see section 2);
• abnormal liver function, hepatitis, and jaundice, liver enlargement; acute liver failure, liver failure, liver necrosis, and liver damage (after paracetamol overdose);
• excessive sweating, purpura; very rare cases of severe skin reactions - exfoliative dermatitis; blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see "Warnings and precautions" section);
• nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure, dysuria, decreased urine output, increased urea levels in the serum, increased sodium levels in the serum (sodium retention);
• fatigue and malaise. With the use of NSAIDs in high doses, edema, hypertension, and heart failure have been reported. Clinical trials and epidemiological data suggest that taking ibuprofen, especially long-term and in high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke).

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

• severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome 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, mainly 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 stop taking Metafen and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light.
• a serious condition that can cause blood acidification (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Metafen

Do not store above 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 blister or carton after: EXP.
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 packaging and other information

What Metafen contains

• The active substances of the medicine are ibuprofen and paracetamol. Each coated tablet contains 200 mg of ibuprofen and 325 mg of paracetamol.
• Other ingredients are:
• maize starch, microcrystalline cellulose; povidone K-90; povidone K-29/32; magnesium stearate;
• coating: polyvinyl alcohol; titanium dioxide (E 171); macrogol 3350; talc.

What Metafen looks like and contents of the pack

The medicine is in the form of white or almost white coated tablets, oval, with the inscription "Metafen" on one side. The tablets are 18.2 mm ± 0.3 mm in length and 8.2 mm ± 0.3 mm in width.
The outer packaging - a cardboard box - contains:
2, 6, 10, 20, 60 coated tablets in PVC/Aluminum blisters.
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: