Ibuprofen Aflofarm

Leaflet attached to the packaging: patient information

Ibuprofen Aflofarm, 200 mg, effervescent tablets

Ibuprofen

Read the 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 doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in case of fever and pain or 2 days in case of cold or flu there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 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 packaging and other information

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

Ibuprofen Aflofarm 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 Aflofarm

• mild to moderate pain: toothache, joint pain, muscle pain, painful menstruation, headache (including migraines);
• pain accompanying flu and cold;
• feverish conditions of various origins (including flu, cold, or other infectious diseases).

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), including acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced shortness of breath, asthma, runny nose, or hives 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 (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 ulcers;
• 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 (blood clotting disorder);
• 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, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
During the use of ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If any of these symptoms are noticed, the patient should stop taking Ibuprofen Aflofarm immediately and seek medical attention immediately.
Before taking 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, has had a bypass operation, has peripheral arterial disease (poor blood 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 stomach and/or intestinal diseases (such as chronic inflammatory bowel disease, ulcerative colitis, Crohn's disease), rectal and anal diseases, as the risk of gastrointestinal bleeding increases;
• if the patient has kidney or liver function disorders;
• if the patient has blood clotting disorders (ibuprofen may prolong bleeding time);
• if the patient has asthma or allergies (current or past), as taking the medicine may cause bronchospasm;
• if the patient is taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors;
• 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 lowest 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. Therefore, Ibuprofen Aflofarm may delay the use of appropriate infection treatment, which can 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 symptoms of the infection persist or worsen, they should consult their doctor immediately.
In elderly patients, the dose of the medicine can be reduced, using the smallest possible therapeutic dose for the shortest possible period, to reduce the risk of side effects.
Caution should be exercised when taking Ibuprofen Aflofarm and other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulant medicines like warfarin or antiplatelet agents like acetylsalicylic acid.
Concomitant, long-term use of different pain-relieving medicines may cause kidney damage, 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 symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Aflofarm immediately and seek medical attention.
Taking such medicines as Ibuprofen Aflofarm 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, do not take higher doses of the medicine and do not prolong the treatment period than recommended.

Children

Do not use the medicine 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.

Do not take Ibuprofen Aflofarm 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, among other things, asthma) - may increase the risk of side effects in the gastrointestinal tract;
• anticoagulant and antiplatelet medicines (such as 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;
• diuretic medicines (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;
• cyclosporin (a medicine used in patients after organ transplantation) - may increase the risk of kidney damage;
• zydovudine (a medicine used to treat HIV infection) - may prolong bleeding time;
• cardiac glycosides (medicines used to treat heart failure and heart rhythm disorders) - ibuprofen may enhance the symptoms of heart failure and increase the level of cardiac glycosides in the blood;
• 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 baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofen Aflofarm if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.
It may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong or delay labor. During the first 6 months of pregnancy, do not take Ibuprofen Aflofarm unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Aflofarm may cause the unborn baby 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 baby (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. Since there are no reports of a harmful effect of the medicine on infants, it is not necessary to stop breastfeeding during short-term use of ibuprofen in 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, do not drive or operate machinery.

Ibuprofen Aflofarm contains sucrose and sodium

Sucrose

The medicine contains 129.2 mg of sucrose in 1 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 0.35-0.42 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 Aflofarm

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

• 3 days in case of pain and fever;
• 2 days in case of cold or flu. The medicine is for oral use.

Recommended dose

Adults and adolescents over 12 years of age

Initial dose 1 to 2 tablets, then if necessary 1 to 2 tablets every 4 to 6 hours.
Tablets should be taken with water.
Do not take more than 6 tablets (1200 mg of ibuprofen) in 24 hours.

Use in children

Do not use in children under 12 years of age.
Elderly patients: no dose adjustment is required.
Use the lowest effective dose for the shortest period 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 Aflofarm than recommended

If the patient has taken a higher dose of Ibuprofen Aflofarm than recommended 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 to do in such a case.
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, dizziness, and confusion. It may also cause agitation, drowsiness, confusion, or coma. Rarely, patients may experience seizures. After taking large 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 have occurred. 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.

Missing a dose of Ibuprofen Aflofarm

Continue taking the medicine, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
In case of 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 medical attention immediately if the following occurs:

• 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, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell);

• red, scaly rash with thickening of 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;
• hives, itching;
• blurred vision, double vision, changes in color vision.

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

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

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

• stomach or duodenal ulcers;
• gastrointestinal bleeding (caused by a hole in the stomach or intestine wall), sometimes fatal, especially in elderly patients;
• 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 (sodium retention);
• depression, emotional disorders;
• tinnitus, hearing disorders;
• 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 mouth ulcers, 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, disorders of orientation (these are symptoms of aseptic meningitis);
• disorders 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.

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

• skin becomes sensitive to light.

Taking such medicines as Ibuprofen Aflofarm may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In case of any of the above symptoms, stop taking the medicine and consult a doctor.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, more information can be collected on the safety of the medicine.

5. How to store Ibuprofen Aflofarm

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 a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Aflofarm contains

• The active substance of the medicine is ibuprofen. 1 effervescent tablet contains 200 mg of ibuprofen (Ibuprofenum).
• Other ingredients are: hypromellose, sodium carboxymethylcellulose 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 available as effervescent tablets.
The packaging of the medicine is: 2 tablets in a sachet, 10, 20, 30, or 50 tablets packaged with a patient leaflet 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 leaflet: