Ibuprofen Aflofarm

Package Leaflet: Information for the Patient

Ibuprofen Aflofarm, 400 mg, Chewable Tablets

Ibuprofen

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in the case of pain and fever or 2 days in the case of a cold or flu there is no improvement or the patient feels worse, they should contact a doctor.

Package Leaflet Contents

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

1. What is Ibuprofen Aflofarm and what is it used for

Ibuprofen Aflofarm is a pain reliever, antipyretic, and anti-inflammatory. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The active substance is ibuprofen.

Indications for use of Ibuprofen Aflofarm

• pains of various etiologies of mild to moderate severity, including: headaches, migraines, toothaches, muscle pains, lower back pains, bone and joint pains, neuralgias;
• painful menstruation;
• fever (including in the course of flu, colds, or other infectious diseases). Ibuprofen Aflofarm is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, a doctor should be consulted.

2. Important information before taking Ibuprofen Aflofarm

When not to take Ibuprofen Aflofarm

• if the patient is hypersensitive to ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced dyspnea, asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, as Ibuprofen Aflofarm may cause similar side effects in these patients;
• if the patient has ever had a perforation (perforation) of the stomach or intestinal wall associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has or has had stomach or duodenal ulcers or gastrointestinal bleeding;
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if the patient is taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors, such as celecoxib or etoricoxib;
• if the patient is in the last three months of pregnancy;
• if the patient has a bleeding disorder (coagulation disorders);
• in children under 12 years of age.

Warnings and precautions

Taking anti-inflammatory/pain-relieving medications, 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 duration of treatment should not be prolonged.
During the use of ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), chest pain.
If any of these symptoms are noticed, the patient should stop taking Ibuprofen Aflofarm immediately and contact a doctor or emergency medical services immediately.
Before using Ibuprofen Aflofarm, the patient should discuss it 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, has peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• if the patient has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if the patient has gastrointestinal diseases (such as chronic enteritis, ulcerative colitis, Crohn's disease), diseases of the anus and rectum, as the risk of gastrointestinal bleeding increases;
• if the patient has kidney or liver function disorders;
• if the patient has coagulation disorders (ibuprofen may prolong bleeding time);
• if the patient has asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient is taking other medications (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient is taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors;
• if the patient has chickenpox - the use of the medicine is not recommended;
• if during long-term use of high doses of painkillers, headaches occur - they should not be alleviated by increasing the dose of the painkiller;
• if vision disturbances occur, the patient should contact an ophthalmologist;
• the medicine may mask (hide) symptoms of an existing infection;
• if the patient has gastrointestinal diseases, especially if they are over 65 years old, they should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), especially during the initial treatment period. Ibuprofen Aflofarm can be taken in consultation with a doctor. These patients should use the smallest effective dose of the medicine;
• if the patient has an infection - see below, the section entitled "Infections".

Infections
Ibuprofen Aflofarm may mask the symptoms of an infection, such as fever and pain. As a result, Ibuprofen Aflofarm may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
Caution should be exercised when using Ibuprofen Aflofarm in patients who are also taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like acenocoumarol or antiplatelet agents like acetylsalicylic acid.
Concomitant, long-term use of different painkillers may cause kidney damage, and even kidney failure (analgesic nephropathy).
Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, 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 the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Aflofarm immediately and seek medical attention.
If the medicine is taken for a long time, the doctor will prescribe regular kidney and liver function tests and blood tests.
Taking ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Therefore, the medicine should not be used in higher doses or for longer than recommended. If symptoms persist or worsen, or if new symptoms occur, the patient should contact a doctor.

Children

The medicine should not be used in children under 12 years of age.

Ibuprofen Aflofarm 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.
Ibuprofen Aflofarm may affect the action of other medicines or other medicines may affect the action of Ibuprofen Aflofarm.

The following medicines should not be used at the same time as Ibuprofen Aflofarm:

• acetylsalicylic acid (a medicine used to relieve pain and reduce fever) - may increase the risk of side effects;
• other nonsteroidal anti-inflammatory drugs (NSAIDs) - may increase the risk of gastrointestinal bleeding and ulcers;
• corticosteroids (steroid medicines used to treat, among other things, asthma) - may increase the risk of side effects in the gastrointestinal tract;
• selective serotonin reuptake inhibitors (medicines used to treat depression) - may increase the risk of gastrointestinal bleeding;
• medicines with anticoagulant and antiplatelet effects (i.e., blood thinners/anti-clotting agents, such as warfarin, ticlopidine, acenocoumarol, acetylsalicylic acid) - ibuprofen may enhance the effects of these medicines and increase the risk of gastrointestinal disorders or bleeding;
• lithium (a medicine used to treat depression) - ibuprofen may enhance the effects of lithium;
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis) - ibuprofen may enhance the effects of methotrexate;
• digoxin (a medicine used to treat heart failure) - ibuprofen may increase the risk of heart failure and increase digoxin levels in the blood;
• phenytoin (a medicine used to treat epilepsy) - ibuprofen may increase phenytoin levels in the blood;
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan) - ibuprofen may reduce the effectiveness of these medicines;
• diuretics (medicines that increase urine production) - ibuprofen may reduce the effectiveness of these medicines;
• mifepristone (a medicine with abortive effects) - ibuprofen taken 8-12 days after mifepristone administration may reduce its effectiveness;
• tacrolimus (a medicine used to treat, among other things, atopic dermatitis) - may increase the risk of kidney damage;
• cyclosporin (a medicine used in patients after organ transplantation) - may increase the risk of kidney damage;
• zidovudine (a medicine used to treat HIV infection) - may prolong bleeding time;
• probenecid and sulfinpyrazone (medicines used to treat gout) - may delay the excretion of ibuprofen;
• sulfonylurea derivatives (medicines used to treat diabetes) - when used concomitantly with Ibuprofen Aflofarm, blood glucose levels should be monitored;
• quinolone antibiotics - may increase the risk of seizures.

The patient should inform their doctor or pharmacist if they are taking any of the above medicines.

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 taking this medicine.
Pregnancy
Ibuprofen Aflofarm should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and cause prolongation or prolongation of labor. During the first six months of pregnancy, Ibuprofen Aflofarm should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Aflofarm may cause the unborn child to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios).
If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. Since there are no reports of harmful effects on infants, breastfeeding does not need to be discontinued during short-term use of ibuprofen at doses used to treat pain and fever.
Fertility
Ibuprofen Aflofarm may have a negative effect on female fertility; this effect is temporary and disappears after the end of treatment.

Driving and using machines

Ibuprofen Aflofarm has no or negligible influence on the ability to drive and use machines.
If drowsiness, dizziness, or vision disturbances occur, the patient should not drive or operate machinery.

Ibuprofen Aflofarm contains sucrose and sodium

Sucrose

The medicine contains 420.5 mg of sucrose in one tablet.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

The medicine contains 0.7-0.84 mg of sodium in one tablet.
The medicine contains less than 1 mmol (23 mg) of sodium in one tablet, which means the medicine is considered "sodium-free".

3. How to take Ibuprofen Aflofarm

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Without consulting a doctor, the patient should not take Ibuprofen Aflofarm for longer than:

• 3 days in the case of pain and fever;
• 2 days in the case of a cold or flu.

The medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, the patient should consult a doctor.
The medicine is for oral use.

Recommended dose

Adults and adolescents over 12 years of age:1 tablet every 4 hours after meals.
Tablets should be taken with water.
The dose should not exceed 3 tablets per day (maximum daily dose of 1200 mg of ibuprofen in divided doses).
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 a doctor immediately (see section 2).

Use in children

The medicine should not be given to children under 12 years of age.

Overdose of Ibuprofen Aflofarm

If the patient has taken more than the recommended dose of Ibuprofen Aflofarm or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what actions to take.
Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors in the blood. 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.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missed dose of Ibuprofen Aflofarm

The patient should continue taking the medicine, without increasing the next dose.
A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• rash, severe swelling of the face, lips, or throat that makes breathing, talking, or swallowing difficult, low blood pressure, slow or fast heart rate, pallor, anxiety, sweating, dizziness, bronchospasm, loss of consciousness, and cessation of breathing and heart function;
• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in the stool);
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome;
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (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).

The following side effects may occur:

Uncommon(may affect up to 1 in 100 people):

• stomach pain, nausea, indigestion (feeling of bloating in the stomach, bloating, belching, heartburn, constipation);
• headaches;
• blurred vision, double vision, color vision disturbances;
• hives, itching.

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

• diarrhea, bloating, constipation, vomiting, gastritis;
• dizziness, insomnia, fatigue;
• agitation, irritability;
• edema.

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

• stomach or duodenal ulcers;
• gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall), sometimes fatal, especially in the elderly;
• local irritation of the anus;
• ulcerative stomatitis;
• worsening of symptoms of ulcerative colitis and Crohn's disease;
• high blood pressure;
• heart failure;
• azotemia, hematuria, kidney failure, including acute kidney failure, renal papillary necrosis, decreased creatinine clearance, polyuria, decreased urine output, increased sodium levels in the serum (sodium retention);
• tinnitus, hearing disturbances;
• liver function disorders, especially during long-term use of the medicine;
• significant decrease in the number of all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, or subcutaneous bleeding (e.g., bruising, petechiae, purpura);
• worsening of symptoms of asthma and bronchospasm in patients with systemic lupus erythematosus (a chronic disease caused by immune system disorders, affecting many organs) and mixed connective tissue disease;
• stiffness of the neck, headaches, nausea, vomiting, fever, disturbances of orientation (these are symptoms of aseptic meningitis);
• disturbances of consciousness;
• severe hypersensitivity reactions: facial swelling, tongue and throat swelling that makes breathing, talking, or swallowing difficult, shortness of breath, rapid heart rate, low blood pressure, or shock;
• depression, emotional disturbances.

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

• skin becomes sensitive to light.

Taking medicines like Ibuprofen Aflofarm may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the above symptoms occur, the patient should stop taking the medicine and contact their doctor.

Reporting side effects

If side effects occur, including those not listed in this package 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
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 to gather more information on the safety of the medicine.

5. How to store Ibuprofen Aflofarm

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister pack and 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 pack and other information

What Ibuprofen Aflofarm contains

• The active substance of the medicine is ibuprofen. One chewable tablet contains 400 mg of ibuprofen (Ibuprofenum).
• The other ingredients are: hypromellose, sodium carboxymethylcellulose type A, cornstarch, colloidal anhydrous silica, arabic gum, sucrose, talc, titanium dioxide (E 171), a mixture of white beeswax and carnauba wax (Capol 1295).

What Ibuprofen Aflofarm looks like and contents of the pack

Ibuprofen Aflofarm is a chewable tablet.
The pack contains: 10, 20 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the package leaflet: