Ibuprofen aflofarm

Package leaflet: Information for the patient

Ibuprofen Aflofarm, 400 mg, coated tablets
Ibuprofenum
Please read this 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 the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for pain and fever, or after 2 days for cold or flu symptoms, or if you feel worse, you should consult a doctor.

Table of contents

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

Ibuprofen Aflofarm is an analgesic, 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 Aflofarm

• mild to moderate pain of various origins, including: headache, migraine, toothache, muscle pain, lumbosacral pain, bone and joint pain, neuralgia;
• painful menstruation;
• fever (e.g. associated with influenza, cold or other infectious diseases).

Ibuprofen Aflofarm is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, consult a doctor.

2. Important information before taking Ibuprofen Aflofarm

When not to take Ibuprofen Aflofarm

• 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 asthma, wheezing, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as Ibuprofen Aflofarm may cause similar adverse reactions in such patients;
• if the patient has ever experienced perforation (a hole) in 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 ulcer 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);
• in children under 12 years of age.

Warnings and precautions
Taking anti-inflammatory/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.
If any of these symptoms occur, Ibuprofen Aflofarm should be stopped immediately and medical help should be sought without delay.
Before using Ibuprofen Aflofarm, 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 artery bypass surgery, peripheral arterial disease (poor blood circulation in 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, high 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 stomach and/or intestinal disorders (e.g., chronic inflammatory bowel disease, ulcerative colitis, Crohn's disease presenting with chronic diarrhea), or disorders of the anus and rectum, as this increases the risk of gastrointestinal bleeding;
• if they have kidney or liver function disorders;
• if they have blood clotting disorders (ibuprofen may prolong bleeding time);
• if they have bronchial asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if they are taking other medicines (especially anticoagulants, diuretics, cardiac drugs, corticosteroids);
• if they are taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors;
• if they have chickenpox – use of the medicine is not recommended;
• if headaches occur during long-term use of high-dose painkillers – do not treat them by increasing the painkiller dose;
• if visual disturbances occur, the patient should consult an ophthalmologist;
• the medicine may mask (hide) symptoms of existing infection;
• if they have gastrointestinal disorders, especially if they are over 65 years old, they should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period. Ibuprofen Aflofarm may be used under medical supervision. These patients should use the lowest effective dose;
• if the patient has an infection – see below, section titled "Infections".

Infections
Ibuprofen Aflofarm may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Aflofarm may delay appropriate treatment of infection and consequently 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 existing infection and infection symptoms persist or worsen, immediate medical advice should be sought.
Caution is advised when using Ibuprofen Aflofarm 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
Serious skin reactions have occurred with the use of 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 any of the symptoms associated with these serious skin reactions described in section 4 occur, Ibuprofen Aflofarm should be discontinued immediately and medical help should be sought.
If the medicine is used long-term, the doctor may recommend regular monitoring of kidney and liver function and blood tests.
Ibuprofen use 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. Therefore, higher doses and longer treatment durations than recommended should not be used. If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms occur, medical advice should be sought.

Children
Do not use the medicine in children under 12 years of age.

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

Do not take Ibuprofen Aflofarm with:

• acetylsalicylic acid (a medicine used to relieve pain and reduce fever) – 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) – increases the risk of gastrointestinal adverse effects;
• selective serotonin reuptake inhibitors (medicines used to treat depression) – may increase the risk of gastrointestinal bleeding;
• anticoagulant and antiplatelet medicines (blood thinners/preventing blood clots, 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 (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;
• digoxin (a medicine used to treat heart failure) – ibuprofen may worsen symptoms of heart failure and increase digoxin blood levels;
• phenytoin (a medicine used to treat epilepsy) – ibuprofen may increase blood levels of phenytoin;
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, 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 (an abortion-inducing medicine) – ibuprofen taken 8–12 days after mifepristone may reduce its effectiveness;
• tacrolimus (a medicine used, among others, in atopic dermatitis treatment) – increases the risk of kidney damage;
• cyclosporine (a medicine used in organ transplant patients) – increases 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 ibuprofen elimination;
• sulfonylurea derivatives (medicines used to treat diabetes) – blood glucose monitoring is recommended during concomitant use;
• quinolone antibiotics – may increase the risk of seizures.

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

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

Pregnancy
Do not take Ibuprofen Aflofarm 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 6 months of pregnancy, Ibuprofen Aflofarm should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Ibuprofen Aflofarm may cause narrowing of a blood vessel (ductus arteriosus) in the unborn child's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (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 Aflofarm may adversely affect female fertility; this effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Ibuprofen Aflofarm has no or negligible influence on the ability to drive or operate machinery. However, if drowsiness, dizziness, or visual 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 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 0.7–0.84 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 Aflofarm

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not take Ibuprofen Aflofarm for longer than the following without consulting a doctor:

• 3 days for pain and fever;
• 2 days for cold or flu symptoms.

This medicine is intended for short-term use only. If symptoms persist or worsen, or if new symptoms occur, consult your doctor.
This 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.
Do not exceed a dose of 3 tablets per day (maximum daily dose 1200 mg ibuprofen in divided doses).
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Use in children
This medicine must not be given to children under 12 years of age.
If you take more Ibuprofen Aflofarm than recommended
If you have taken more than the recommended dose of Ibuprofen Aflofarm, or if a child has accidentally taken the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.
Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, confusion, or coma may also occur. Seizures have been reported occasionally. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially 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 also 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.
If you forget to take Ibuprofen Aflofarm
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 everybody gets them.
You should immediately contact your doctor or go to the nearest hospital if you experience:

• rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, paleness, restlessness, sweating, dizziness, bronchospasm, loss of consciousness, respiratory arrest or cardiac arrest;
• gastrointestinal bleeding (vomiting blood or material resembling coffee grounds, black stools or blood in stool);
• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome;
• red, flat, 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;
• visual disturbances such as scotoma, blurred vision, double vision, color vision disturbances;
• urticaria, itching.

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

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

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

• peptic ulcer of the stomach and/or duodenum;
• gastrointestinal bleeding (due to perforation of the stomach or intestinal wall), sometimes fatal, especially in elderly patients;
• local irritation of the anus;
• erosive ulceration of the oral mucosa;
• exacerbation of symptoms of inflammatory bowel disease 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);
• tinnitus, hearing disturbances;
• liver function disorders, especially during prolonged use of the medicine;
• significant reduction in the number of all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulcers 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, 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 such as 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 medicine should be discontinued and
medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet,
you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
at 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 provide more information on the safety of the medicine.

5. How to store Ibuprofen Aflofarm

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep 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 stated 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 package and other information

What Ibuprofen Aflofarm contains

• The active substance is ibuprofen. One coated tablet contains 400 mg of ibuprofen (Ibuprofenum).
• The other ingredients are: hypromellose, sodium carboxymethyl starch type A, corn starch, 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 coated tablet.
Pack contents: 10, 20 tablets in a cardboard box.
Not all pack sizes may be marketed.
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