Metafen Ibuprofen Caps

Package Leaflet: Information for the Patient

Metafen IBUPROFEN CAPS, 200 mg, Soft Capsules

Ibuprofen

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This medication should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

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

1. What is Metafen IBUPROFEN CAPS and what is it used for

The active substance of Metafen IBUPROFEN CAPS is ibuprofen, which belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The medication has analgesic, antipyretic, and anti-inflammatory effects.

The medication is intended for use in children from 6 years of age, adolescents, and adults in the following cases:

• Pain of various origins of mild to moderate severity:
• headaches (including migraines),
• toothaches,
• muscle, joint, and bone pain,
• post-traumatic pain,
• neuralgia,
• pain accompanying colds and flu,
• menstrual pain,
• ear pain occurring in middle ear infections.
• Febrile conditions of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking Metafen IBUPROFEN CAPS

When not to take Metafen IBUPROFEN CAPS:

• if the patient is hypersensitive to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medication (listed in section 6);
• if the patient has ever had symptoms of hypersensitivity such as rhinitis, urticaria, facial edema, tongue, lip, or pharyngeal edema, bronchospasm, or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had gastrointestinal bleeding or perforation after previous treatment with NSAIDs;
• if the patient has stomach or duodenal ulcers, or bleeding (or has had two or more confirmed episodes of ulcers or bleeding);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has unexplained blood disorders (e.g., thrombocytopenia);
• if the patient has had cerebral hemorrhage or other active bleeding;
• if the patient has significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• during the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Metafen IBUPROFEN CAPS, discuss it with your doctor or pharmacist.

During treatment with ibuprofen, symptoms of allergic reactions to this medication have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain.

If you notice any of these symptoms, stop taking Metafen IBUPROFEN CAPS immediately and seek medical attention or call emergency services.

Tell your pharmacist or doctor if you have an infection - see below, the section titled "Infections".

Taking the medication in the smallest effective dose for the shortest necessary period reduces the risk of side effects.

Elderly patients are more likely to experience side effects, especially gastrointestinal bleeding and perforation, which can be fatal.

Taking anti-inflammatory/pain-relieving medications like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.

Before taking Metafen IBUPROFEN CAPS, the patient should discuss 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, coronary artery bypass grafting, or has peripheral arterial 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);
• the patient has high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or smokes;
• the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease;
• the patient has gastrointestinal diseases and chronic bowel diseases (ulcerative colitis, Crohn's disease);
• the patient has kidney function disorders;
• the patient has liver function disorders;
• the patient has blood coagulation disorders;
• the patient has congenital porphyria metabolism disorders (e.g., acute intermittent porphyria);
• the patient has asthma (or has had asthma) or has experienced symptoms of allergic reactions (after taking the medication, bronchospasm may occur);
• the patient has had chickenpox - see below, the section titled "Infections".

Be cautious when taking the medication immediately after major surgery.

There is a risk of gastrointestinal bleeding, ulcers, or perforation, which can be life-threatening and not necessarily preceded by warning symptoms, or may occur in patients who have had such symptoms.

If gastrointestinal bleeding or ulcers occur, the medication should be stopped immediately.

Patients with gastrointestinal diseases, especially the elderly, should inform their doctor about the occurrence of any unusual gastrointestinal symptoms (especially bleeding), especially during the initial period of treatment.

Concomitant, prolonged use of different pain-relieving medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in the case of physical exertion resulting in salt loss and dehydration.

Therefore, concomitant, prolonged use of different pain-relieving medications should be avoided.

Avoid concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs, including medications called cyclooxygenase-2 inhibitors.

Severe skin reactions (SCAR - severe cutaneous adverse reactions)

Severe skin reactions (SCAR), 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), which can be life-threatening or fatal, have been reported in association with ibuprofen (see section 4.8). Most of these reactions occurred within the first month.

If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should stop taking Metafen IBUPROFEN CAPS and seek medical attention immediately.

Stop taking ibuprofen and seek medical attention immediately if any of the following symptoms occur (angioedema):

• facial, tongue, or throat edema,
• difficulty swallowing,
• hives and difficulty breathing.

In patients with systemic lupus erythematosus or mixed connective tissue disease, there may be an increased risk of aseptic meningitis.

Infections

Metafen IBUPROFEN CAPS may mask the symptoms of infection, such as fever and pain.

Therefore, Metafen IBUPROFEN CAPS may delay the use of appropriate infection treatment and, as a result, lead to increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.

If the patient is taking this medication during an infection and the symptoms of the infection persist or worsen, they should seek medical attention immediately.

Ibuprofen, the active substance of Metafen IBUPROFEN CAPS, may temporarily inhibit platelet aggregation (thrombocytes).

Patients with coagulation disorders should be closely monitored.

During long-term use of Metafen IBUPROFEN CAPS, regular monitoring of liver enzyme activity, kidney function, and blood morphology is necessary.

There is a risk of kidney failure in dehydrated children and adolescents.

Ibuprofen should not be used in patients with significant dehydration caused by vomiting, diarrhea, or insufficient fluid intake.

During long-term administration of pain-relieving medications, headaches may occur, which should not be treated by taking higher doses of the medication.

During treatment with ibuprofen, single cases of visual acuity impairment have been reported, so if any vision disturbances occur, the patient should consult a doctor.

Metafen IBUPROFEN CAPS and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Metafen IBUPROFEN CAPS may affect the action of other medications or other medications may affect the action of Metafen IBUPROFEN CAPS.

For example:

• anticoagulant medications (i.e., blood thinners that prevent clot formation, such as aspirin or acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• analgesics;
• other nonsteroidal anti-inflammatory drugs;
• diuretics;
• lithium, selective serotonin reuptake inhibitors (antidepressants);
• methotrexate - a medication used to treat cancer or rheumatoid arthritis;
• corticosteroids - used orally in inflammatory conditions;
• cyclosporine - used after organ transplants;
• digitalis glycosides (e.g., digoxin) - used in heart failure;
• tacrolimus - used after organ transplants;
• mifepristone - used in abortion procedures;
• zidovudine or ritonavir - used in HIV-positive patients or with AIDS;
• quinolone or aminoglycoside antibiotics - used in bacterial infections;
• voriconazole or fluconazole - used in fungal infections;
• probenecid or sulfinpyrazone - used in gout treatment;
• oral antidiabetic medications (sulfonylurea derivatives);
• cholestyramine - used to lower high cholesterol levels;
• phenytoin - used in epilepsy;
• baclofen - used in muscle spasms.

Also, some other medications may be affected or have an effect on treatment with Metafen IBUPROFEN CAPS.

Therefore, before taking Metafen IBUPROFEN CAPS with other medications, always consult your doctor or pharmacist.

Metafen IBUPROFEN CAPS with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.

Pregnancy

Do not take Metafen IBUPROFEN CAPS during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.

Taking Metafen IBUPROFEN CAPS may cause kidney and heart disorders in the unborn child.

This may affect the patient's and child's tendency to bleed and may cause delayed or prolonged labor.

Do not take Metafen IBUPROFEN CAPS during the first six months of pregnancy, unless absolutely necessary and advised by your doctor.

If treatment is necessary during this period or when trying to conceive, use the smallest effective dose for the shortest possible time.

Metafen IBUPROFEN CAPS taken for a period longer 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.

If longer treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts.

No cases of adverse reactions have been reported in infants breastfed by mothers taking ibuprofen.

It is not necessary to stop breastfeeding during short-term use of ibuprofen in doses used to treat pain and fever.

Fertility

The medication belongs to a group of nonsteroidal anti-inflammatory drugs, which may negatively affect female fertility.

This effect is temporary after the end of treatment.

Driving and using machines

Metafen IBUPROFEN CAPS may cause dizziness, fatigue, and vision disturbances.

If these occur, do not drive vehicles or operate machinery.

Do not perform any activities that require concentration.

Metafen IBUPROFEN CAPS contains sorbitol (E 420), maltitol liquid (E 965), potassium, and sodium

The medication contains 28.8 mg of sorbitol (E 420) per capsule.

The medication contains 15 mg of maltitol liquid (E 965) per capsule.

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

The medication contains 0.27 mmol (10.6 mg) of potassium per capsule, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

The blue dye in the medication (capsule shell) contains sodium.

The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means the medication is considered "sodium-free".

3. How to take Metafen IBUPROFEN CAPS

Always take this medication exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Take orally.

Take during meals or regardless of meals.

Swallow the capsules whole with a glass of water.

Do not chew, suck, or crush the capsules.

Use the smallest effective dose for the shortest necessary period to alleviate symptoms and reduce the risk of side effects.

If the symptoms of an infection (such as fever and pain) persist or worsen, seek medical attention immediately (see section 2).

Do not exceed the recommended dose.

The usual single dose of ibuprofen is 7 to 10 mg per kilogram of body weight, and the daily dose is 20 to 30 mg per kilogram of body weight.

Recommended dose

Do not use the medication in children under 6 years of age or with a body weight below 20 kg.

The medication is intended for short-term use.

If it is necessary to use this medication for more than 3 days or if symptoms worsen, consult your doctor.

Taking Metafen IBUPROFEN CAPS in patients with kidney and/or liver function disorders

In patients with mild and moderate kidney and/or liver function disorders, use the smallest possible doses.

Use in patients with severe kidney and/or liver function disorders is contraindicated.

Taking Metafen IBUPROFEN CAPS in elderly patients

No dose adjustment is required in elderly patients.

Overdose of Metafen IBUPROFEN CAPS

If you have taken more than the recommended dose of Metafen IBUPROFEN CAPS or if a child has accidentally taken the medication, always consult your doctor or go to the nearest hospital to assess potential health risks and for advice on what to do.

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, and disorientation.

They may also include agitation, drowsiness, disorientation, or coma.

Occasionally, patients experience seizures.

After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.

In addition, 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, worsening of asthma symptoms may occur.

Additionally, low blood pressure and difficulty breathing may occur.

Overdose cases are rare.

There is no specific antidote.

Treatment is symptomatic and supportive.

The doctor will consider administering activated charcoal if it has been less than one hour since the overdose.

Missed dose of Metafen IBUPROFEN CAPS

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Stop taking ibuprofen and seek medical attention immediately if you experience any of the following symptoms:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with nodules under the skin and blisters, accompanied by fever.

Metafen IBUPROFEN CAPS is generally well-tolerated, but during its use, side effects may occur.

During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed.

The most commonly observed side effects are related to the gastrointestinal tract.

Frequent(occurring in less than 1 in 10 patients):

• heartburn, abdominal pain, nausea, vomiting, bloating with gas, diarrhea, constipation, minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon(occurring in less than 1 in 100 patients):

• headache, dizziness, insomnia, drowsiness, agitation, irritability, fatigue.
• stomatitis;
• gastritis, exacerbation of ulcerative colitis and Crohn's disease, dyspepsia;
• vision disturbances (blurred vision);
• hypersensitivity reactions with rash and itching, as well as asthma attacks (may be associated with a drop in blood pressure), skin rashes of various types.

Rare(occurring in less than 1 in 1,000 patients):

• dizziness;
• ringing in the ears (tinnitus).

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

• esophagitis, pancreatitis, formation of intestinal strictures;
• gastric ulcer, perforation, or gastrointestinal bleeding, vomiting blood, black stools, sometimes with a fatal outcome, especially in elderly patients;
• kidney function disorders manifesting as decreased or increased urine output, cloudy urine, blood in urine, back pain, and swelling (especially of the legs).
• increased urea levels, kidney failure, nephrotic syndrome, interstitial nephritis, which can lead to acute kidney failure.
• liver function disorders, liver damage, and acute hepatitis, especially during long-term use, liver failure;
• blood disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a hematological disorder characterized by a deficiency of all blood elements: erythrocytes, leukocytes, and thrombocytes, agranulocytosis - decreased granulocyte count).

First symptoms are:

• fever, sore throat, mouth ulcers, flu-like symptoms, significant fatigue, bleeding (e.g., bruising, petechiae, and nosebleeds).

Frequency not known(frequency cannot be estimated from available data):

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

Taking medications like Metafen IBUPROFEN CAPS may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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

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, you can help provide more information on the safety of this medication.

5. How to store Metafen IBUPROFEN CAPS

Store the medication 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 medication after the expiration date stated on the blister pack and carton after EXP.

The expiration date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medications that are no longer needed.

This will help protect the environment.

6. Contents of the pack and other information

What Metafen IBUPROFEN CAPS contains

• The active substance of the medication is ibuprofen.
• Each capsule contains 200 mg of ibuprofen.
• Other ingredients are: macrogol 600, potassium hydroxide, purified water; Capsule shell: gelatin; sorbitol liquid, non-crystallizing (E 420); maltitol liquid (E 965); patent blue (E 131); purified water.

What Metafen IBUPROFEN CAPS looks like and contents of the pack

Metafen IBUPROFEN CAPS are soft blue gelatin capsules.

The pack contains: 6, 10, 20, 30, 50 capsules in PVDC/PVC/Aluminum blisters in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Medana Division in Sieradz

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: