Ibuprofen Catalent

Leaflet accompanying the packaging: information for the user

Metafen IBUPROFEN MAX

400 mg, soft capsules
Ibuprofen

You should carefully read the contents of the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days in the case of adolescents aged 12 to 18 years or after 3 days for fever and 4 days for pain in adults, no improvement occurs or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet

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

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

The active substance (which makes the medicine work) is ibuprofen.
Ibuprofen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs).
The action of NSAIDs is to change the body's response to pain, swelling, and high temperature.
Ibuprofen released from the soft capsule is easily absorbed by the body and provides relief for a period of up to 8 hours.
Metafen Ibuprofen Max is used in adolescents with a body weight of 40 kg (from 12 years of age and above) and in adults for short-term, symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, minor sprains and strains, fever, and pain associated with colds.

2. Important information before taking Metafen Ibuprofen Max

When not to take Metafen Ibuprofen Max:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (see section 6), aspirin or other painkillers;
• if you have or have had stomach ulcers, perforation, or bleeding in the stomach or intestines;
• if you have had an exacerbation of asthma, skin rash, itching nasal congestion, or facial swelling when taking ibuprofen, aspirin, or similar medicines in the past;
• if you have had bleeding or perforation in the gastrointestinal tract when taking NSAIDs (non-steroidal anti-inflammatory drugs) in the past;
• if you are taking other NSAIDs (non-steroidal anti-inflammatory drugs);
• if you have severe liver, heart, or kidney disease;
• if you have had bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
• if you have blood clotting disorders;
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if you are in the last 3 months of pregnancy;
• if you are under 12 years of age.

Warnings and precautions

Before taking Metafen Ibuprofen Max, you should talk to your doctor or pharmacist if:

• you have asthma;
• you have kidney, heart, liver, or intestinal disease;
• you have high cholesterol or have had a heart attack or stroke in the past;
• you have had intestinal diseases (Crohn's disease or ulcerative colitis), as this condition may worsen (see section 4, Possible side effects);
• you have systemic lupus erythematosus (an immune system disorder causing joint pain, skin changes, and disorders of other organs);
• you are taking other medicines that may increase the risk of stomach or intestinal disorders, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., warfarin), selective serotonin reuptake inhibitors (used for depression), or antiplatelet agents, such as aspirin (acetylsalicylic acid);
• you are taking ibuprofen or another NSAID (including COX-2 inhibitors, such as celecoxib or etoricoxib), as you should avoid taking these medicines at the same time;
• you are dehydrated;
• you have hereditary blood clotting disorders (such as acute intermittent porphyria);
• you have blood clotting disorders;
• you have recently undergone major surgery;
• you have an infection - see "Infections" below;
• you are a woman in the first 6 months of pregnancy, unless your doctor advises otherwise. If you need to take Metafen Ibuprofen Max for a longer period, you will need to have regular blood tests to check your blood count, liver, and kidney function. Painkillers and anti-inflammatory drugs, 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. During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain. If you notice any of these symptoms, you should stop taking Metafen Ibuprofen Max and contact your doctor or emergency medical services immediately.

Before taking Metafen Ibuprofen Max, you should discuss your treatment with your doctor or pharmacist if:

• you have had heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or have had any stroke (including "mini-stroke" or transient ischemic attack, TIA);
• you have high blood pressure, diabetes, high cholesterol, or have had heart disease or stroke in your family, or if you smoke.

Other warnings

• Chronic use of painkillers can lead to permanent kidney damage with a risk of kidney failure, especially when taking several painkillers at the same time.
• NSAIDs can mask symptoms of infection and fever.
• Long-term use of any painkillers for headaches can make them worse or increase their frequency. This is called medication-overuse headache (MOH).

In case of such a headache, you should stop taking Metafen Ibuprofen Max and consult your doctor.

• During the use of all NSAIDs, at any time during treatment, in patients with warning signs or without warning signs, or in the case of previous gastrointestinal events, there is a risk of gastrointestinal bleeding, ulcers, or perforation, which can be fatal.
• This risk increases with the dose of NSAIDs, in patients with a history of stomach ulcers, especially with bleeding and perforation (see section 2, Do not take Metafen Ibuprofen Max), in the elderly, and in patients taking low doses of aspirin (acetylsalicylic acid) or other medicines that may increase the risk of gastrointestinal disorders. In these patients, treatment should be started with the lowest available dose and consideration should be given to concomitant treatment with medicines that protect against these disorders (e.g., misoprostol or proton pump inhibitors).
• If symptoms of gastrointestinal bleeding, ulcers, or perforation occur (such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds), you should stop taking Metafen Ibuprofen Max and consult your doctor immediately.
• Ibuprofen has been associated with severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you experience any symptoms related to these severe skin reactions described in section 4, you should stop taking Metafen Ibuprofen Max and seek medical help immediately. Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.

Infections

Metafen Ibuprofen Max may mask symptoms of infection, such as fever and pain. Therefore, Metafen Ibuprofen Max may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in the course of pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately.

Elderly

In the elderly, the risk of side effects, especially those related to the stomach and intestines, is increased when taking NSAIDs. See section 4, Possible side effects.

Children and adolescents

In dehydrated children and adolescents, there is a risk of kidney function disorder. This medicine should not be given to adolescents with a body weight below 40 kg or under 12 years of age.

Metafen Ibuprofen Max and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

In case of any of the above interactions, you should consult your doctor or pharmacist. If you are not sure what types of medicines you are taking, you should show the medicine to your doctor or pharmacist.

Taking Metafen Ibuprofen Max with alcohol

Do not drink alcohol while taking Metafen Ibuprofen Max. Taking alcohol with Metafen Ibuprofen Max may increase the likelihood of certain side effects, such as those related to the gastrointestinal tract or central nervous system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you become pregnant while taking ibuprofen, you should inform your doctor.
Do not take this medicine during the last 3 months of pregnancy. It may cause problems with the baby's kidneys and heart. It may affect the mother's and baby's ability to clot and may prolong labor. You should avoid taking this medicine during the first 6 months of pregnancy, unless your doctor advises otherwise. If you need to take Metafen Ibuprofen Max for more than a few days during the period from the 20th week of pregnancy, Metafen Ibuprofen Max may cause problems with the baby's kidneys, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk.
Metafen Ibuprofen Max can be used during breastfeeding at the recommended dose and for the shortest possible duration.
Fertility
Metafen Ibuprofen Max belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

When used for a short period, this medicine has a minor or no effect on the ability to drive or use machines. However, after higher doses, side effects such as drowsiness, dizziness, or vision disturbances may occur, which can affect your reaction time when driving or using machines. These effects are more likely when the medicine is taken with alcohol.

Important information about some of the ingredients of this medicine:

This medicine contains:

• Carmoisine (E124), which may cause allergic reactions.
• Sorbitol (E420) - this medicine contains 93.8 mg of liquid, partially dehydrated sorbitol in each soft capsule.

3. How to take Metafen Ibuprofen Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are not sure, you should ask your doctor or pharmacist.
Metafen Ibuprofen Max is for oral use.
You should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection and the symptoms of the infection persist or worsen (see section 2), you should consult your doctor immediately.

Dosage

Adults, elderly, and adolescents with a body weight of 40 kg from 12 years of age and above:

Take 1 capsule up to 3 times a day as needed.
The capsules should be swallowed whole with a glass of water. There should be at least 4 hours between doses.
Do not take more than 3 Metafen Ibuprofen Max capsules (1200 mg) in 24 hours.
Do not give this medicine to children under 12 years of age.

Duration of treatment

For adolescents with a body weight of 40 kg, from 12 to 18 years of age:if the medicine needs to be taken for more than 3 days or if symptoms worsen, you should consult your doctor.
For adults:if the product needs to be taken for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, you should consult your doctor.
If you have taken more Metafen Ibuprofen Max than you should,or if a child has taken this medicine by mistake, you should always contact your doctor or the nearest hospital for advice on the risk and the actions to be taken.
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, confusion, or drowsiness. They may also include agitation, insomnia, irritability, or fatigue. Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, as well as blood in the urine and low potassium levels in the blood, feeling cold, and breathing difficulties 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. Additionally, low blood pressure and breathing difficulties may occur.

Missing a dose of Metafen Ibuprofen Max

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The risk of side effects can be minimized by taking the smallest effective dose for the shortest duration necessary to relieve symptoms.

In any of the following cases, you should STOP TAKINGthe medicine and seek medical help immediately:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of a rare but serious allergic reaction, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. These may occur even after the first dose of this medicine. If you experience any of these symptoms, you should contact your doctor immediately.
• Red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome).
• A red, scaly, widespread rash with bumps under the skin and blisters, with fever, usually appearing at the beginning of treatment (acute generalized exanthematous pustulosis).

If you experience any of the following side effects, their worsening, or side effects not listed below, you should TELL YOUR DOCTOR.

Gastrointestinal disorders, such as abdominal pain and nausea, indigestion, diarrhea, bloating (gas) and constipation, heartburn, and vomiting, as well as minor bleeding in the stomach and/or intestines, which in rare cases may cause anemia.

Not very common (may affect up to 1 in 100 people)

• Stomach ulcers, perforation, or bleeding, mouth ulcers, worsening of active intestinal disease (ulcerative colitis or Crohn's disease), stomach inflammation (gastritis).
• Headache, dizziness, insomnia, restlessness, or fatigue.
• Vision disturbances.
• Skin rashes and other skin reactions, such as itching.

Rare (may affect up to 1 in 1,000 people)

• Ringing in the ears (tinnitus), hearing loss.
• Kidney damage and increased uric acid levels in the blood (pain in the sides and/or abdomen and blood in the urine and fever may be signs of kidney damage).
• Decreased hemoglobin levels, leading to anemia.

Very rare (may affect up to 1 in 10,000 people)

• Pancreatitis or esophageal inflammation (inflammation of the gullet), the formation of narrowings in the small and large intestines.
• Heart failure, heart attack, and swelling of the face or hands (edema).
• Kidney failure, decreased urine output, and swelling (especially in patients with high blood pressure or reduced kidney function), kidney inflammation, which can lead to acute kidney failure. If you experience any of these symptoms or general malaise, you should stop taking Metafen Ibuprofen Max and consult your doctor immediately, as they may be the first signs of kidney damage or failure.
• Hair loss (alopecia).
• Psychotic reactions, depression.
• High blood pressure, blood vessel inflammation causing red or purple spots on the skin.
• Palpitations.
• Liver function disorders, liver damage (the first symptoms may be yellowing of the skin), liver failure, acute liver inflammation.
• Disorders of blood cell production - the first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, you should stop taking the medicine and consult your doctor immediately. Do not try to treat yourself with painkillers or antipyretics.
• Worsening of infection-related inflammation. If symptoms of infection worsen or persist, you should consult your doctor immediately, as antibiotic or other treatment may be necessary.
• During ibuprofen treatment, symptoms of aseptic meningitis (stiff neck, headache, nausea, vomiting, fever, or changes in consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be more prone to these symptoms. If you experience these symptoms, you should contact your doctor immediately.

Frequency not known:

• Respiratory system reactions, such as asthma, difficulty breathing, or shortness of breath.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increase in the number of a specific type of white blood cell.
• The skin becomes sensitive to light.
• A red, scaly, widespread rash with blisters under the skin and blisters, mainly in skin folds, on the trunk and upper limbs, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you experience such symptoms, you should stop taking Metafen Ibuprofen Max and consult your doctor immediately.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. NSAIDs, such as this medicine, may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. See section 2, Warnings and precautions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 medicine.

5. How to store Metafen Ibuprofen Max

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Metafen Ibuprofen Max contains

The active substance is ibuprofen.
Each capsule contains 400 mg of ibuprofen.
The other ingredients are: macrogol 600, potassium hydroxide (E525), purified water, gelatin, sorbitol, liquid, partially dehydrated (E420), carmoisine (E124), white ink (propylene glycol (E1520), titanium dioxide (E171), polyvinyl acetate phthalate, medium-chain triglycerides, lecithin (E322) (derived from soybeans).

What Metafen Ibuprofen Max looks like and contents of the pack

Oval capsule with a transparent red gelatin shell, with a logo printed in white ink, containing a transparent liquid filling.
Approximate length: 15.0 mm to 16.3 mm; approximate diameter: 9.9 mm to 10.7 mm.
Metafen Ibuprofen Max is available in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters of 10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, 96 soft capsules.
The PVC layer may be transparent or opaque. The blister strips are packaged in a carton box.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
69412 Eberbach
GERMANY
or
Catalent Germany Schorndorf GmbH
Steinbeisstr. 1 und 2
73614 Schorndorf
GERMANY

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: