Ibuprofen afl

Package leaflet: Information for the patient

Ibuprofen AFL, 200 mg, enteric-coated tablets
Ibuprofen
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

1. What Ibuprofen AFL is and what it is 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 pack and other information

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

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

• Mild to moderate pain: toothache, joint and muscle pain, headache (including migraine pain);
• Painful menstruation;
• Fever of various origins (e.g. in the course of influenza and common cold);
• Symptomatic treatment of rheumatoid arthritis and osteoarthritis;
• Symptomatic treatment of juvenile idiopathic arthritis.

2. Information before taking Ibuprofen AFL

When not to take Ibuprofen AFL

• if the patient is allergic to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine listed in section 6;
• if the patient has experienced breathlessness, asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as Ibuprofen AFL may cause similar adverse reactions in such patients;
• if the patient has ever experienced perforation of the stomach or intestinal wall related to the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient currently has or has previously had peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding;
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if the patient is concurrently taking other non-steroidal 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 anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a
slight increase in the 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 Ibuprofen AFL immediately and contact a doctor or
emergency medical services without delay.
Before using Ibuprofen AFL, the patient should consult a doctor or pharmacist:

• if they have heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA);
• if they have high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if they smoke;
• if they have certain skin conditions (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if they have gastrointestinal diseases (e.g., chronic intestinal inflammation, ulcerative colitis, Crohn's disease, characterized by chronic diarrhea), or disorders of the anus and rectum, as this increases the risk of gastrointestinal bleeding;
• if they have kidney or liver dysfunction;
• if they have blood clotting disorders (ibuprofen may prolong bleeding time);
• if they are taking other medications (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if they have bronchial asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if they have gastrointestinal disorders, particularly if they are over 65 years of age; they should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period. Such patients should use the lowest effective dose;
• if they have an infection – see below, section titled "Infections".

Infections
Ibuprofen AFL may mask symptoms of infection such as fever and pain. Consequently, Ibuprofen AFL
may delay appropriate treatment of infection and thereby increase 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 ongoing infection and symptoms persist or worsen, they should
consult a doctor immediately.
Use of medicines such as Ibuprofen AFL may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke. Long-term use of high doses increases this risk. Therefore, do not
use higher doses or longer treatment duration than recommended.
If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, contact a
doctor.
In elderly patients, the dose may be reduced by using the lowest possible therapeutic dose for the
shortest possible duration to minimize the risk of adverse effects.
Caution is advised when using Ibuprofen AFL concurrently with other medicines that may increase
the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like
acenocoumarol, or antiplatelet agents such as acetylsalicylic acid.
Concurrent, long-term use of various painkillers may cause kidney damage or even kidney failure
(post-analgesic nephropathy).
Skin reactions
Severe skin reactions have been reported with ibuprofen use, 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 develops any of the symptoms associated with these severe skin reactions
described in section 4, Ibuprofen AFL should be discontinued immediately and medical help sought.
The highest risk of severe reactions occurs early in treatment, mostly within the first month of use.

Children
Do not use this medicine in children under 12 years of age.
Its use is not recommended in children weighing less than 7 kg when treating juvenile
rheumatoid arthritis.

Ibuprofen AFL and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for
use.
Ibuprofen AFL may affect the action of other medicines, or other medicines may affect the action of
Ibuprofen AFL.

Do not use Ibuprofen AFL simultaneously with:

• acetylsalicylic acid (used for pain relief and fever reduction) – may increase the risk of adverse effects;

• other non-steroidal anti-inflammatory drugs (NSAIDs) – may increase the risk of gastrointestinal bleeding and ulcers;

• corticosteroids (steroid medicines used, among others, in asthma treatment) – increased risk of gastrointestinal adverse effects;

• anticoagulant medicines and platelet aggregation inhibitors (blood thinners/preventing clot formation, such as warfarin, ticlopidine, acenocoumarol, acetylsalicylic acid) – ibuprofen may enhance the effect of these medicines and increase the risk of gastrointestinal disorders or bleeding;

• lithium (used in depression treatment) – ibuprofen may enhance the effect of lithium;

• methotrexate (used in treatment of certain cancers and rheumatoid arthritis) – ibuprofen may enhance the effect of methotrexate;

• antihypertensive medicines (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 increasing urine production) – ibuprofen may reduce their effectiveness;

• mifepristone (an abortifacient) – ibuprofen taken 8–12 days after mifepristone administration may reduce its effectiveness;

• cyclosporine (used in organ transplant patients) – increased risk of
  kidney damage;

• zidovudine (used in HIV infection treatment) – may prolong bleeding time;

• cardiac glycosides (used in heart failure and cardiac rhythm disorders) – ibuprofen may worsen symptoms of heart failure and increase blood levels of cardiac glycosides;

• quinolone antibiotics – as this may increase the risk of seizures. The patient should inform the doctor if they are taking any of the above-mentioned medicines.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive,
she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ibuprofen AFL 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 increase the tendency to bleeding in both the mother and the child and may delay
or prolong labor. During the first six months of pregnancy, Ibuprofen AFL should not be used unless
the doctor considers it absolutely necessary. If treatment is required during this period or when trying
to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of
pregnancy, Ibuprofen AFL may cause narrowing of a blood vessel (ductus arteriosus) in the fetal heart
or kidney disorders, which may lead to low levels of amniotic fluid surrounding the fetus (oligohydramnios).
If treatment is required for longer 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, interruption of breastfeeding is not necessary during short-term use of ibuprofen at doses
used for pain and fever relief.

Fertility
Ibuprofen AFL may adversely affect fertility in women; this effect is reversible and resolves after
discontinuation of treatment.

Driving and operating machinery
Ibuprofen AFL has no effect or only a negligible effect on the ability to drive and operate machinery.
If drowsiness, dizziness, or visual disturbances occur, do not drive or operate machinery.

Ibuprofen AFL contains sucrose and sodium

Sucrose
The medicine contains 129.2 mg of sucrose per tablet.
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult
a doctor before taking this medicine.

Sodium
The medicine contains 0.35–0.42 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Ibuprofen AFL
This medicine should always be taken according to the doctor's instructions. If in doubt, consult a
doctor or pharmacist.
The medicine is for oral use.

Recommended dose
Adults and adolescents over 12 years of age
The recommended daily dose is 6 tablets (1200 mg) to 9 tablets (1800 mg) per day in divided doses.
In some patients, a maintenance dose of 3 tablets (600 mg) to 6 tablets (1200 mg) per day may be
administered.
In severe or acute conditions, increasing the dose up to symptom relief may be beneficial, 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
may be administered. Its use is not recommended in children weighing less than 7 kg.

Use in children
Do not use this medicine in children under 12 years of age.
Its use is not recommended in children weighing less than 7 kg when treating juvenile rheumatoid
arthritis.
Do not exceed the recommended dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms
of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Taking more Ibuprofen AFL than recommended
If the patient has taken more than the recommended dose of Ibuprofen AFL or if a child has
accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess
potential health risks and receive advice on necessary actions.
Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood), gastrointestinal
bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and nystagmus. Excitement,
drowsiness, confusion, or coma may also occur. Seizures may rarely occur. After large doses, drowsiness,
chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in
urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Additionally,
prothrombin time/INR may be prolonged, likely due to interference with circulating 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.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missed dose of Ibuprofen AFL
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately contact your doctor or go to the nearest hospital if you experience:

• skin rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing, decreased blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness, bronchospasm, loss of consciousness, respiratory arrest or cardiac arrest;
• gastrointestinal bleeding (vomiting blood or coffee-ground-like material, black stools or blood in the stool);
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• red, flat, non-raised, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs 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. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cells);
• red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

The following adverse effects may occur
Not very common (may occur in up to 1 in 100 people):

• abdominal pain, nausea, dyspepsia (feeling of pressure in the stomach, bloating, belching, heartburn, constipation);
• headache;
• urticaria, itching;
• visual disturbances (double vision, blurred vision, floaters, color vision disturbances).

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

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

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

• tinnitus, hearing disturbances;
• peptic ulcer disease of the stomach and/or duodenum;
• gastrointestinal bleeding (due to perforation of the stomach or intestinal wall), sometimes fatal, especially in elderly patients;
• erosive stomatitis;
• exacerbation of symptoms of ulcerative colitis and Crohn's disease;
• hypertension;
• heart failure;
• azotemia, hematuria, renal failure, including acute renal failure, renal papillary necrosis, decreased creatinine clearance, polyuria, decreased urine output, increased serum sodium concentration (sodium retention);
• increased blood sodium levels (causing edema);
• liver function disorders, particularly during long-term use of the medicine;
• marked decrease in all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, nosebleeds or subcutaneous hemorrhages (e.g. bruises, petechiae, purpura);
• worsening of asthma symptoms and bronchospasm in patients with systemic lupus erythematosus (a chronic disease caused by immune system disorders affecting multiple organs) and mixed connective tissue disease;
• neck stiffness, headache, nausea, vomiting, fever, disorientation (symptoms of aseptic meningitis);
• disturbances of consciousness;
• severe hypersensitivity reactions: facial, tongue and laryngeal swelling causing difficulty in breathing, speaking or swallowing, shortness of breath, rapid heartbeat, decreased blood pressure or shock;
• depression, emotional disturbances.

Frequency unknown (frequency cannot be determined from available data):

• skin becomes sensitive to light.

Taking medicines such as Ibuprofen AFL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the above symptoms occur, the medicine should be discontinued and a doctor contacted immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen AFL

Keep this medicine out of sight and reach of children.
Store below 25 ºC. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen AFL contains

• The active substance is ibuprofen. One film-coated tablet contains 200 mg of ibuprofen (Ibuprofenum).
• Other ingredients: hypromellose, sodium carboxymethyl starch type A, maize starch, colloidal anhydrous silica, arabic gum, sucrose, talc, titanium dioxide (E 171), mixture of white beeswax and carnauba wax (Capol 1295).

What Ibuprofen AFL looks like and contents of the pack
Ibuprofen AFL is available as film-coated tablets.
Pack size: 60 tablets packed together with the patient leaflet in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów