Ibuprofen Afl

Leaflet accompanying the packaging: patient information

Ibuprofen AFL, 200 mg, effervescent tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, so you can read it again if you need to.
• -If you have any doubts, consult a doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• -If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Ibuprofen AFL is a pain-relieving, antipyretic, and anti-inflammatory medicine. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active substance ibuprofen.

Indications for use of Ibuprofen AFL

• mild or moderate pain: toothache, joint and muscle pain, headache (including migraine);
• painful menstruation;
• fever of various origins (including flu and cold);
• symptomatic treatment of rheumatoid arthritis and osteoarthritis;
• symptomatic treatment of juvenile rheumatoid arthritis.

2. Important information before taking Ibuprofen AFL

When not to take Ibuprofen AFL

• 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 shortness of breath, asthma, nasal congestion, or hives after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, as Ibuprofen AFL may cause similar side effects in these patients;
• if the patient has ever had a perforation (hole) in the stomach or intestine wall associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has or has had stomach or duodenal ulcers or bleeding in the digestive tract;
• 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).

Warnings and precautions

Taking pain-relieving/anti-inflammatory medicines, 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 treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If you notice any of these symptoms, stop taking Ibuprofen AFL immediately and contact a doctor or emergency medical services immediately.
Before taking Ibuprofen AFL, the patient should discuss it with a 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 artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had a 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 stomach and/or intestinal diseases (e.g., chronic enteritis, ulcerative colitis, Crohn's disease), rectal and anal diseases, as the risk of gastrointestinal bleeding increases;
• if the patient has kidney and/or liver function disorders;
• if the patient has bleeding disorders (ibuprofen may prolong bleeding time);
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient has asthma or allergies (current or past), as taking the medicine may cause bronchospasm;
• if the patient has gastrointestinal diseases, especially if over 65 years old, should inform the doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), especially during the initial treatment period. Such patients should use the lowest effective dose of the medicine;
• if the patient has an infection - see below, section entitled "Infections".

Infections
Ibuprofen AFL may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen AFL 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 is taking this medicine during an infection, and the infection symptoms persist or worsen, they should consult a doctor immediately.
Taking medicines like Ibuprofen AFL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Long-term use of high doses of the medicine increases the risk. Therefore, do not use higher doses of the medicine and longer treatment duration than recommended.
If symptoms persist, worsen, or do not improve within 3 days, or if new symptoms occur, consult a doctor.
In elderly patients, the dose of the medicine can be reduced, using the lowest possible therapeutic dose for the shortest possible duration, to reduce the risk of side effects.
Caution should be exercised when using Ibuprofen AFL in patients who are taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulant medicines like acenocoumarol or antiplatelet agents like acetylsalicylic acid.
Concomitant, long-term use of different pain-relieving medicines may cause kidney damage, and even kidney failure (analgesic nephropathy).
Skin reactions
Severe skin reactions have occurred with ibuprofen, including 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 AFL immediately and seek medical attention.

Children

Do not use the medicine in children under 12 years old.
It is not recommended to use in children with a body weight below 7 kg when taking the medicine for juvenile rheumatoid arthritis.

Ibuprofen AFL and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Ibuprofen AFL may affect the action of other medicines or other medicines may affect the action of Ibuprofen AFL.
Do not take Ibuprofen AFL at the same time as:

• 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, e.g., asthma) - may increase the risk of side effects in the digestive tract;
• anticoagulant and antiplatelet agents (e.g., warfarin, ticlopidine, acenocoumarol, acetylsalicylic acid) - ibuprofen may enhance the effect of these medicines and increase the risk of stomach and intestinal disorders or bleeding;
• lithium (a medicine used to treat depression) - ibuprofen may enhance the effect of lithium;
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis) - ibuprofen may enhance the effect of methotrexate;
• 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 used for abortion) - ibuprofen taken 8-12 days after mifepristone administration may reduce its effectiveness;
• cyclosporin (a medicine used in organ transplant patients) - may increase the risk of kidney damage;

and

• zydovudine (a medicine used to treat HIV infection) - may prolong bleeding time;
• cardiac glycosides (medicines used to treat heart failure and arrhythmias) - ibuprofen may enhance the symptoms of heart failure and increase the levels of cardiac glycosides in the blood;
• quinolone antibiotics - may increase the risk of seizures.

The patient should inform the doctor 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 a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofen AFL if the patient is in the last 3 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 increase the risk of bleeding in the patient and their child and cause prolongation or prolongation of labor. During the first 6 months of pregnancy, do not use Ibuprofen AFL unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible duration. From the 20th week of pregnancy, Ibuprofen AFL may cause the unborn child to have a narrowing of the arterial duct 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 than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. As there are no reports of harmful effects on infants, breastfeeding can be continued during short-term use of ibuprofen in doses used to treat pain and fever.
Fertility
Ibuprofen AFL may have a negative effect on female fertility; this effect is reversible and disappears after the end of treatment.

Driving and using machines

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

Ibuprofen AFL contains sucrose and sodium

Sucrose

The medicine contains 129.2 mg of sucrose in 1 tablet.
If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium

The medicine contains 0.35-0.42 mg of sodium in 1 tablet.
The medicine contains less than 1 mmol (23 mg) of sodium in 1 tablet, which means the medicine is considered "sodium-free".

3. How to take Ibuprofen AFL

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The medicine is for oral use.

Recommended dose

Adults and adolescents over 12 years old

The recommended daily dose is from 6 tablets (1200 mg) to 9 tablets (1800 mg) per day in divided doses.
In some patients, ibuprofen may be administered in a maintenance dose of 3 tablets (600 mg) to 6 tablets (1200 mg) per day.
In severe or acute conditions, it may be beneficial to increase the dose up to the disappearance of symptoms, not exceeding 12 tablets (2400 mg) per day.

Juvenile rheumatoid arthritis

The daily dose is usually 20 mg/kg body weight, up to 40 mg/kg body weight per day in divided doses. It is not recommended to use in children with a body weight below 7 kg.

Use in children

Do not use the medicine in children under 12 years old.
It is not recommended to use in children with a body weight below 7 kg when taking the medicine for juvenile rheumatoid arthritis.
Do not exceed the recommended dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Taking a higher dose of Ibuprofen AFL than recommended

If you have taken more than the recommended dose of Ibuprofen AFL, or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get advice on the possible risk to your health and the actions to be taken.
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, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur. Additionally, 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.

Missing a dose of Ibuprofen AFL

Continue taking the medicine; do not increase the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience:

• rash, severe swelling of the face, lips, tongue, or throat, difficulty breathing, speaking, or swallowing, low blood pressure, slow or fast heart rate, pallor, anxiety, sweating, dizziness, bronchospasm, loss of consciousness, and respiratory or cardiac arrest;
• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in the stool);
• chest pain, which may be a sign of a potentially serious 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 reactions 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, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• red, scaly rash with thickening of the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever 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);
• headache;
• hives, itching;
• vision disturbances (double, blurred vision, flashes, color vision disturbances).

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

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

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

• tinnitus, hearing disturbances;
• stomach and/or duodenal ulcers;
• gastrointestinal bleeding (caused by perforation of the stomach or intestine wall), sometimes fatal, especially in the elderly;
• 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 blood (leading to edema);
• increased sodium levels in the blood (causing edema);
• 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 oral mucosa ulceration, 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, headache, nausea, vomiting, fever, disturbances of orientation (these are symptoms of aseptic meningitis);

and

• disturbances of consciousness;
• severe hypersensitivity reactions: facial swelling, tongue and laryngeal edema making breathing, speaking, 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 AFL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If you experience any of the above symptoms, stop taking the medicine and consult a doctor.

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 medicine.

5. How to store Ibuprofen AFL

Keep the medicine out of the 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 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. 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 Ibuprofen AFL contains

• The active substance of the medicine is ibuprofen. 1 effervescent tablet contains 200 mg of ibuprofen (Ibuprofenum).
• Other ingredients: 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 AFL looks like and contents of the pack

Ibuprofen AFL is in the form of effervescent tablets.
The packaging of the medicine is: 60 tablets packaged with a patient leaflet in a cardboard box.

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 leaflet: