Ibuprofen Analgesic antipyretic and anti-inflammatory 20 units

Dosage:
Adults and adolescents over 12 years of age: initial dose of 1 to 2 tablets, followed by 1 to 2 tablets every 4 to 6 hours as needed. Tablets should be sipped with water.
Do not use more than 6 tablets (1200 mg ibuprofen) per day. Do not use in children under 12 years of age.

The drug is intended for immediate use, use the smallest effective dose, for the shortest possible time. Ibuprofen Aflofarm drug should not be used without consulting a doctor for more than 3 days for fever and pain or 2 days for cold or flu.

Oral administration.
Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 63 mm. Width: 95 mm. Depth: 20 mm.
Packaging: box

1 tablet contains 200 mg of ibuprofen and excipients, including sucrose and sodium.

Aflofarm Farmacja Polska Sp. z o.o.

Responsible entity:
Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka street 133/151
95-200 Pabianice

Keep the drug out of sight and reach of children.

Number of units: 20

Recommended: 12 years/years/years

Read the leaflet carefully before taking the drug, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there has been no improvement after 3 days for fever and pain or 2 days for cold or flu, or if the patient feels worse, contact your doctor.

Table of contents of the leaflet
1 What is the drug Ibuprofen Aflofarm and what is it used for?
2. important information before taking Ibuprofen Aflofarm drug
3 How to take the drug Ibuprofen Aflofarm
4 Possible side effects
5. how to store the drug Ibuprofen Aflofarm
6. package contents and other information

1 What is the drug Ibuprofen Aflofarm and for what purpose it is used
Ibuprofen Aflofarm is an analgesic, antipyretic and anti-inflammatory drug. It belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). The drug contains the active substance ibuprofen.
Indications for use of the drug Ibuprofen Aflofarm
- Pain of moderate or weak intensity: toothache, joint pain, muscle pain, painful menstruation, headache (including migraine pain);
- pains accompanying flu and cold;
- febrile states of various origins, (including in the course of influenza, cold or other infectious diseases).

3 How to take the drug Ibuprofen Aflofarm
This drug should always be used exactly as described in the leaflet for the patient or according to the instructions of your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Without consulting your 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 drug for oral use.
Recommended dose
Adults and adolescents over 12 years of age
Initial dose of 1 to 2 tablets, followed by 1 to 2 tablets every 4 to 6 hours as needed. Tablets should be sipped with water. Do not use more than 6 tablets (1200 mg of ibuprofen) per day.
Use in children
Do not use in children under 12 years of age.
The elderly: no dose modification is required.
Taking more than the recommended dose of Ibuprofen Aflofarm.
If you have taken more than the recommended dose of Ibuprofen Aflofarm, or if your child has accidentally taken the drug, you should always ask your doctor or report to the nearest hospital for an opinion on the possible health risks and advice on what action to take in such a case. Symptoms may include nausea, stomach pain, vomiting (there may be traces of blood), headache, ringing in the ears, confusion and nystagmus. Drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems have occurred after taking a large dose.
Omission of taking the drug Ibuprofen Aflofarm
Continue taking the drug without increasing 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 drug, ask your doctor or pharmacist.

5 How to store the drug Ibuprofen Aflofarm
Store the drug out of sight and reach of children.
Store at a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiration date placed on the blister and on the box after EXP. The expiration date means the last day of the month stated.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use.
Doing so will help protect the environment.

4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone.
Notify your doctor immediately or go to the nearest hospital if you experience:
- rash, severe swelling of the face, mouth or throat making it difficult to breathe, speak or swallow, decreased blood pressure, slow or fast pulse, pallor, restlessness, sweating, dizziness, bronchospasm, loss of consciousness, respiratory and cardiac arrest;
- gastrointestinal bleeding (vomiting containing blood or fusiform content - similar to coffee grounds, black stool or blood in the stool).
The following side effects may occur
Uncommon (occur in 1 to 10 people per 1000):
- abdominal pain, nausea, indigestion (a crumpling sensation in the stomach, bloating, belching, heartburn, constipation);
- headache;
- urticaria, pruritus;
- gloom, blurred vision, double vision, color vision disturbances.
Rare (occurs in 1 to 10 people in 10,000):
- diarrhea, bloating, constipation, vomiting, gastritis;
- Dizziness, insomnia, fatigue;
- agitation, irritability;
- edema.
Very rare (occurs in less than 1 person in 10,000):
- peptic ulcer disease of the stomach and/or duodenum;
- gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall), sometimes with fatal outcome, especially in the elderly;
- ulcerative oral mucositis;
- exacerbation of the symptoms of 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 (sodium retention);
- depression, emotional disturbances;
- tinnitus, hearing impairment;
- liver dysfunction, especially during long-term use of the drug;
- significant reduction in the number of all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, nosebleeds or subcutaneous hemorrhages (e.g., bruising, purpura, petechiae);
- erythema multiforme (sino-red patches on the skin, sometimes with blisters);
- toxic necrotic separation of the epidermis, the occurrence of blisters on the skin and/or mucous membranes, which, when they burst, form painful wounds, often accompanied by fever, muscle and joint pain (this is the 1st Stevens-Johnson syndrome);
- peeling of large areas of the epidermis and its necrosis;
- systemic lupus erythematosus (a chronic disease caused by disorders of the immune system, involving multiple organs);
- mixed connective tissue disease;
- neck stiffness, headache, nausea, vomiting, fever, disorientation (these are symptoms of sterile meningitis);
- disturbance of consciousness;
- severe hypersensitivity reactions: swelling of the face, tongue and larynx making it difficult to breathe, speak or swallow, shortness of breath, accelerated heart rate, decreased blood pressure or shock, worsening of asthma symptoms.
Frequency unknown (frequency cannot be determined from available data):
- Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes and an increase in the number of eosinophils (a type of white blood cell).
- A red scaly rash with thickening under the skin and blisters, located mostly in skin folds, on the trunk and upper extremities, with fever occurring at the beginning of treatment (acute generalized pustular necrosis). If such symptoms occur, stop taking Ibuprofen Aflofarm and immediately seek medical help
medical attention. See also section 2.

Taking medications such as Ibuprofen Aflofarm may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

If you experience any of the symptoms listed above, discontinue the drug and contact your doctor.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 1810, 02-222 Warsaw
phone: +48 2249 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Adverse reactions can also be reported to the responsible entity.

6 Package contents and other information
What the drug Ibuprofen Aflofarm contains
- The active substance of the drug is ibuprofen.
1 irritated tablet contains 200 mg of ibuprofen.
- The other ingredients are: hypromellose, carboxymethyl sodium starch type A, corn starch, colloidal silica anhydrous, gum arabic, sucrose, talc, titanium dioxide (E 171), mixture of white beeswax and Carnauba wax (Capol 1295).
What the drug Ibuprofen Aflofarm looks like and what the package contains
The drug Ibuprofen Aflofarm has the form of irritated tablets.
The packaging of the product is: 2 tablets in a sachet, 10, 20, 30 or 50 tablets packed with a patient leaflet in a cardboard box.
Not all package sizes are necessarily on the market.
Responsible entity and manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka street 133/151
95-200 Pabianice
phone: (42) 22-53-100

2 Important information before taking the drug Ibuprofen Aflofarm
When not to take Ibuprofen Aflofarm drug:
- if the patient is allergic to ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid or any of the other ingredients of this drug (listed in section 6);
- if the patient has ever had shortness of breath, asthma, runny nose or hives after taking acetylsalicylic acid (such as aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs), 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 ever had gastric and/or duodenal ulcer disease or bleeding ulcer;
- if the patient has severe hepatic or renal insufficiency;
- 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 third trimester of pregnancy;
- if the patient has hemorrhagic diathesis (blood clotting disorder);
- in children under 12 years of age.
Warnings and precautions
Taking anti-inflammatory/pain medications such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment. Patients should discuss this with their doctor or pharmacist before taking Ibuprofen Aflofarm:
- if the patient has heart disease, such as heart failure, angina (chest pain), the patient has had a heart attack, bypass surgery, the patient has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of the arteries), or if the patient has undergone any stroke (including mini-stroke or transient ischemic attack - TIA);
- if the patient has hypertension, diabetes, has increased cholesterol, has a family history of heart disease or stroke, or if the patient smokes tobacco;
- if the patient has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
- if the patient has diseases of the stomach and/or intestines (such as, for example: chronic enteritis, ulcerative duodenitis, Crohn's disease manifested by chronic diarrhea, among others), diseases of the rectum and anus, as the risk of gastrointestinal bleeding is increased;
- if the patient has kidney and liver disorders;
- if the patient has blood clotting disorders (ibuprofen can prolong bleeding time);
- if the patient has bronchial asthma or allergies (present or past), as bronchospasm may occur after taking the drug;
- if the patient additionally takes other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors;
- if you have gastrointestinal disease, especially if you are over 65 years of age, you should tell your doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), especially during the initial period of treatment. Ibuprofen Aflofarm can be taken in consultation with the doctor.
These patients should use the lowest effective dose of the drug possible.

In elderly patients, the dose of the drug can be reduced, using the smallest possible therapeutic dose for the shortest possible period, in order to reduce the risk of side effects.

Caution should be exercised when using Ibuprofen Aflofarm concomitantly with other drugs that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like warfarin or antiaggregants like acetylsalicylic acid.

Simultaneous, long-term use of different painkillers can cause kidney damage and even kidney failure (postanalgesic nephropathy).

Skin reactions
Severe skin reactions associated with the use of Ibuprofen Aflofarm have been reported. If you develop: any rash on the skin, lesions on the mucous membranes, blisters or other symptoms of sensitization, stop taking Ibuprofen Aflofarm and seek medical help immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.

Taking medicines such as Ibuprofen Aflofarm may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. This risk is increased by long-term intake of large doses of the drug. Therefore, do not use higher doses of the drug and prolong treatment than recommended.
Children
Do not use the drug in children under 12 years of age.
Ibuprofen Aflofarm and other drugs
Tell your doctor or pharmacist about all medicines you are currently or recently taking, as well as medicines you plan to take.

Do not use the drugs listed below at the same time as Ibuprofen Aflofarm.

Ibuprofen Aflofarm drug may affect the effect of other drugs, or other drugs may affect the effect of Ibuprofen Aflofarm drug.
Patients should tell their doctor if they are taking any of the drugs listed below.
Drugs that can increase gastrointestinal bleeding:
- acetylsalicylic acid (used to relieve pain and lower fever, such as aspirin);
- other nonsteroidal anti-inflammatory drugs (NSAIDs);
- corticosteroids (drugs called steroids, used to treat bronchial asthma, among other conditions).
Ibuprofen Aflofarm may intensify the effects of:
- drugs with anticoagulant effects (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, tyclopidine);
- lithium (a drug used to treat depression);
- methotrexate (a drug used to treat certain cancers and rheumatoid arthritis).
Ibuprofen Aflofarm may reduce the effectiveness of:
- blood pressure-lowering drugs (ACE inhibitors such as captopril, beta-blockers such as drugs containing atenolol, drugs that are angiotensin II receptor antagonists such as losartan);
- diuretics (drugs that increase urine production);
- mifepristone (a drug with abortifacient effects).
Drugs that can cause kidney damage:
- cyclosporine (a drug used in organ transplant patients).
Do not use Ibuprofen Aflofarm at the same time:
- with zidovudine (a drug used to treat HIV infection), as bleeding time may be prolonged;
- with cardiac glycosides (used to treat heart failure and heart disorders), as ibuprofen may exacerbate symptoms of heart failure and increase the concentration of cardiac glycosides in the blood;
- quinolone antibiotics because it will increase the risk of seizures.

Also, some other drugs may affect or influence the treatment with Ibuprofen Aflofarm. Therefore, always consult your doctor or pharmacist before taking Ibuprofen Aflofarm with other medications.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should advise your doctor or pharmacist before taking this drug.
Do not use the drug Ibuprofen Aflofarm in the l and ll trimester of pregnancy.
Do not use this drug in the last trimester of pregnancy. The drug may increase the risk of complications in the mother and child in the perinatal period.

Ibuprofen penetrates into breast milk to a small extent. Since there are no reports of harmful effects of the drug on infants, discontinuation of breastfeeding is not necessary during short-term intake of ibuprofen, in doses used to treat pain and fever.

Ibuprofen Aflofarm may adversely affect fertility in women; this effect is transient and disappears after the end of treatment.
Driving and operating machinery
Ibuprofen Aflofarm has little or no effect on the ability to drive and operate machinery. If drowsiness, dizziness or visual disturbances occur, do not drive or operate machinery.
Ibuprofen Aflofarm contains sucrose and sodium
Sucrose
The drug contains 129.2 mg of sucrose in 1 tablet. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.
Sodium
The drug contains 0.35-0.42 mg of sodium in 1 tablet.
The drug contains less than 1 mmol (23 mg) of sodium in 1 tablet, that is, the drug is considered , "sodium free".

Ibuprofen Aflofarm
200 mg, irritated tablets
Ibuprofenum