Metafen ibuprofen max

Package leaflet: Information for the user

Metafen IBUPROFEN MAX
400 mg, soft capsules
Ibuprofenum
Please read the entire leaflet carefully 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 a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 3 days in adolescents aged 12 to 18 years, or after 3 days of treating fever and 4 days of treating pain in adults, or if the patient feels worse, consult a physician.

Leaflet contents

1. What Metafen Ibuprofen Max is and what it is 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 pack and other information

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

The active substance (the one responsible for the effect of this medicine) is ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by modifying the body's response to pain, swelling, and high temperature.
Ibuprofen released from the soft capsule is readily absorbed by the body and provides relief for up to 8 hours.
Metafen Ibuprofen Max is used in adolescents with a body weight of at least 40 kg (aged 12 years and above) and in adults for short-term, symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, minor joint pain and sprains, as well as fever and pain associated with colds.

2. Information before taking Metafen Ibuprofen Max

When not to take Metafen Ibuprofen Max:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (see section 6), aspirin, or other pain-relieving medicines;
• if the patient has or has previously had a stomach or intestinal ulcer, perforation, or gastrointestinal bleeding;
• if the patient has experienced worsening asthma, skin rash, allergic rhinitis with nasal itching, or facial swelling after previous use of ibuprofen, aspirin, or similar medicines;
• if the patient has experienced gastrointestinal bleeding or perforation during prior use of NSAIDs (non-steroidal anti-inflammatory drugs);
• if the patient is currently taking other NSAIDs;
• if the patient has severe liver, heart, or kidney disease;
• if the patient has intracranial bleeding (cerebrovascular haemorrhage) or any other active bleeding;
• if the patient has blood cell formation disorders;
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• if the patient is in the last three months of pregnancy;
• if the patient is under 12 years of age.

Warnings and precautions
Before starting to take Metafen Ibuprofen Max, talk to a doctor
or pharmacist if:

• the patient suffers or has suffered from asthma;
• the patient has kidney, heart, liver, or intestinal disease;
• the patient has high cholesterol or has previously had a heart attack or stroke;
• the patient has ever had intestinal diseases (Crohn’s disease or ulcerative colitis), as these conditions may worsen (see section 4, Possible side effects);
• the patient suffers from systemic lupus erythematosus (an autoimmune disorder causing joint pain, skin changes, and organ dysfunction);
• the patient is taking other medicines that may increase the risk of stomach or intestinal ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (used for depression), or antiplatelet medicines such as aspirin (acetylsalicylic acid);
• the patient is already taking ibuprofen or another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent use of these medicines should be avoided;
• the patient is dehydrated;
• the patient has hereditary blood formation disorders (such as acute intermittent porphyria);
• the patient has blood clotting disorders;
• the patient has recently undergone major surgery;
• the patient has an infection – see section “Infections” below;
• the patient is in the first 6 months of pregnancy, unless otherwise advised by a doctor.

If Metafen Ibuprofen Max is used long-term, regular blood tests are necessary to monitor blood counts, liver, and kidney function. Anti-inflammatory and 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. Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, discontinue Metafen Ibuprofen Max immediately and contact a doctor or emergency medical services without delay. Before starting treatment with Metafen Ibuprofen Max, discuss with a doctor or pharmacist if:

• the patient has or has had heart disease, including heart failure, angina (chest pain), previous heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or has had any stroke (including “mini-stroke” or transient ischaemic attack, TIA);
• the patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if the patient smokes.

Other warnings

• Regular use of painkillers may lead to permanent kidney damage and risk of kidney failure, especially when multiple painkillers are used simultaneously.
• NSAIDs may mask symptoms of infection and fever.
• Long-term use of any painkillers for headaches may worsen or increase the frequency of headaches. This is known as medication-overuse headache (MOH).

If such headache occurs or is suspected, stop using Metafen Ibuprofen Max and consult a doctor.

• During treatment with any NSAID, at any time, gastrointestinal bleeding, ulceration, or perforation may occur with or without warning symptoms, and may be fatal, especially in patients with prior gastrointestinal events.
• The risk increases with higher NSAID doses, in patients with a history of peptic ulcer disease (especially with bleeding or perforation – see section 2, Do not use Metafen Ibuprofen Max), in elderly patients, and in patients taking low-dose aspirin (acetylsalicylic acid) or other medicines that may increase gastrointestinal risk. In such patients, treatment should start with the lowest available dose, and gastroprotective co-therapy (e.g. misoprostol or proton pump inhibitors) should be considered.
• If any signs of gastrointestinal bleeding, ulceration, or perforation occur (such as severe upper abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds), immediately stop taking Metafen Ibuprofen Max and consult a doctor.
• Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If any of the symptoms associated with these serious skin reactions described in section 4 occur, immediately discontinue Metafen Ibuprofen Max and seek medical help. The risk of adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration to control symptoms.

Infections
Metafen Ibuprofen Max may mask symptoms of infection such as fever and pain. Therefore, treatment with Metafen Ibuprofen Max may delay appropriate treatment of infection, increasing 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 infection and symptoms persist or worsen, medical advice should be sought immediately.

Elderly patients
In elderly patients, the risk of adverse effects during NSAID use, particularly gastrointestinal, is increased. See section 4, Possible side effects.

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

Metafen Ibuprofen Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

If any of the above events occur, consult a doctor or
pharmacist. If the patient is unsure about which types of medicines they are taking, they should show the medicine to a
doctor or pharmacist.
Use of Metafen Ibuprofen Max with alcohol
Alcohol must not be consumed during treatment with Metafen Ibuprofen Max. Taking alcohol
together with Metafen Ibuprofen Max may increase the likelihood of certain adverse effects, for example, those affecting the gastrointestinal tract or central nervous system.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
If a patient becomes pregnant while taking ibuprofen, she should inform her doctor.
Do not use this medicine during the last three months of pregnancy. It may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both mother and child and may result in delayed or prolonged labour. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor. Prolonged use beyond a few days from week 20 of pregnancy may cause kidney problems in the unborn child, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasting longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk.
Metafen Ibuprofen Max may 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) which may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
When used short-term, this medicine has little or no influence on the ability to drive or operate machinery. However, at higher doses, adverse effects such as fatigue, dizziness or visual disturbances may occur, which could affect the ability to react while driving or operating machinery. These effects are more likely if the medicine is taken with alcohol.
Important information about certain ingredients of this medicine:
This medicine contains:

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

3. How to take Metafen Ibuprofen Max

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Metafen Ibuprofen Max is intended for oral use.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection and symptoms (such as fever and pain) persist or worsen (see section 2), contact a doctor immediately.
Dosage
Adults, elderly patients, and adolescents aged 12 years and older with body weight of at least 40 kg:
Take 1 capsule as needed, up to three times daily.
Swallow the capsules whole with a glass of water. Leave at least 4 hours between doses.
Do not exceed 3 capsules of Metafen Ibuprofen Max (1200 mg) in 24 hours.
Do not give this medicine to children under 12 years of age.
Duration of treatment
In adolescents aged 12 to 18 years with body weight of at least 40 kg: if treatment longer than 3 days is required, or if symptoms worsen, consult a doctor.
In adults: if the product needs to be used for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, consult a doctor.
If more Metafen Ibuprofen Max has been taken than recommended, or if children have accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risks and necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, dizziness, and nystagmus. Stimulation, drowsiness, disorientation, or coma may also occur. Seizures may occur occasionally in patients. After ingestion of large doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low blood potassium levels, cold sensation, and breathing difficulties. 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.
If a dose of Metafen Ibuprofen Max is missed
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The risk of adverse effects can be reduced by taking the lowest effective dose
for the shortest duration necessary to relieve symptoms.
In any of the following cases, STOP TAKING THE MEDICINE
and seek immediate medical help:

• Symptoms of gastrointestinal bleeding, such as: severe upper abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of a rare but serious allergic reaction, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These may occur even after the first dose of this medicine. If any of these symptoms occur, contact a doctor immediately.
• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mouth ulcers, and sores in the throat, nose, genital organs or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Extensive rash, high fever and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If any of the following adverse effects occur, worsen, or if any adverse effects not listed below appear, YOU SHOULD INFORM YOUR DOCTOR.
  Common (may affect up to 1 in 10 people)
• Gastrointestinal disturbances such as abdominal pain and nausea, indigestion, diarrhoea, bloating (wind) and constipation, heartburn, vomiting, and minor bleeding in the stomach and/or intestines, which in rare cases may lead to anaemia.
  Uncommon (may affect up to 1 in 100 people)
• Gastric and intestinal ulcers, perforation or bleeding, mouth ulcers, exacerbation of active inflammatory bowel disease (colitis or Crohn's disease), inflammation of the stomach (gastritis, inflammation of the gastric mucosa).
• Headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Visual 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 elevated uric acid levels in blood (pain in the sides and/or upper abdomen, blood in urine and fever may be symptoms of kidney damage).
• Decreased haemoglobin concentration, leading to anaemia.
  Very rare (may affect up to 1 in 10,000 people)
• Inflammation of the pancreas or oesophagus (gastrointestinal tract), development of diaphragm-like strictures in the small and large intestine.
• Heart failure, heart attack and facial or hand swelling (oedema).
• Passing less urine than usual and oedema (especially in patients with high blood pressure or reduced kidney function), oedema and cloudy urine; inflammatory kidney disease which may lead to acute kidney failure. If any of these symptoms or general malaise occur, stop taking Metafen Ibuprofen Max and consult a doctor immediately, as these may be early signs of kidney damage or kidney failure.
• Hair loss (alopecia).
• Psychotic reactions, depression.
• High blood pressure, inflammation of blood vessels causing red or purple spots on the skin.
• Palpitations.
• Liver function disorders, liver damage (early signs may include skin discolouration), especially during long-term treatment, liver failure, acute hepatitis.
• Problems with blood cell production – early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding, and unexplained bruising. In such cases, the medicine must be stopped immediately and medical advice sought. Do not attempt self-treatment with painkillers or antipyretics.
• Worsening of inflammatory conditions associated with infection. If signs of infection appear or worsen, seek medical advice promptly, as antibiotic treatment or other therapy may be required.
• During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or altered consciousness have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be at higher risk of developing these symptoms. If these symptoms occur, contact a doctor immediately.
  Frequency not known:
• Respiratory system reactions such as asthma, difficulty breathing or laboured breathing.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased number of a specific type of white blood cells.
• Skin becomes sensitive to light.
• Red, scaly, widespread rash with subcutaneous vesicles and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). If such symptoms occur, stop using Metafen Ibuprofen Max and contact a 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 of adverse effects
If any adverse effects occur in patients, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Metafen Ibuprofen Max

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

6. Contents of the pack 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), carmine red (E124), white ink (propylene glycol (E1520), titanium dioxide (E171), poly(vinyl)acetic acid phthalate, macrogol 400, ammonium hydroxide 28% (E527)), medium-chain triglycerides, lecithin (E322) (derived from soy).

What Metafen Ibuprofen Max looks like and contents of the pack
Oval capsule with a transparent red gelatin coating, printed with a logo in white ink, containing a transparent liquid filling.
Approximate length: from 15.0 mm to 16.3 mm; approximate diameter: from 9.9 mm to 10.7 mm.
Metafen Ibuprofen Max is available in blister packs made of PVC/PVDC/Aluminium or PVC/PE/PVDC/Aluminium, containing 10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, or 96 soft capsules.
The PVC layer may be transparent or opaque. Blister strips are packed into a cardboard box.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the European Economic Area countries under the following names: