Ibuprofen aflofarm

Package leaflet: Information for the patient

Ibuprofen Aflofarm, 200 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 doctor or pharmacist.

• Keep this leaflet, so 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 fever and pain, or after 2 days for cold or flu symptoms, or if you feel worse, consult your 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: toothache, joint pain, muscle pain, painful menstruation, headache (including migraine headache);
• Pain associated with influenza and colds;
• Fever of various origins (e.g. due to influenza, colds or other infectious diseases).

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), including acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced asthma, bronchospasm, rhinitis, or urticaria after taking acetylsalicylic acid or other NSAIDs, as Ibuprofen Aflofarm may cause similar adverse reactions in these patients;
• if the patient has ever experienced gastric or intestinal perforation (a hole in the stomach or intestinal wall) associated with 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 currently 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 discontinued immediately and the patient should seek immediate medical attention.
Before taking 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 the legs due to narrowed or blocked arteries), or have had any type of stroke (including mini-stroke or transient ischemic attack - TIA);
• they have high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if they smoke;
• they have certain skin conditions (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• they have gastrointestinal disorders (e.g., chronic inflammatory bowel disease, ulcerative colitis, Crohn's disease presenting with chronic diarrhea), or diseases of the anus and rectum, as this increases the risk of gastrointestinal bleeding;
• they have kidney or liver dysfunction;
• they have blood clotting disorders (ibuprofen may prolong bleeding time);
• they have bronchial asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• they are taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors;
• they have gastrointestinal disorders, particularly if they are 65 years of age or older, and should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding, pain), especially 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 under the section titled "Infections".

Infections
Ibuprofen Aflofarm may mask symptoms of infection such as fever and pain. Consequently, Ibuprofen Aflofarm may delay appropriate treatment of infection, potentially increasing 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 active infection and symptoms persist or worsen, immediate medical consultation is required.
In elderly patients, the dose of the medicine should be reduced, using the lowest effective therapeutic dose for the shortest possible duration to minimize the risk of adverse effects.
Caution is advised when using Ibuprofen Aflofarm concomitantly with other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like warfarin, or antiplatelet agents such as acetylsalicylic acid.
Long-term, simultaneous use of various painkillers may cause kidney damage and even kidney failure (analgesic nephropathy).

Skin reactions
Severe skin reactions have been reported 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 severe skin reactions described in section 4 occur, Ibuprofen Aflofarm should be discontinued immediately and medical help should be sought.
The use of medicines such 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. Therefore, do not exceed the recommended dose or extend the treatment duration beyond what is advised.

Children
Do not use this 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, or those planned to be taken.
Ibuprofen Aflofarm may affect the action of other medicines, and other medicines may affect the action of Ibuprofen Aflofarm.

Do not take Ibuprofen Aflofarm simultaneously 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) – increased risk of gastrointestinal adverse effects;
• anticoagulant medicines and antiplatelet agents (blood thinners that prevent 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 (a medicine used to treat depression) – ibuprofen may increase lithium levels;
• methotrexate (a medicine used in the treatment of certain cancers and rheumatoid arthritis) – ibuprofen may increase methotrexate levels;
• 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 that increase urine production) – ibuprofen may reduce the effectiveness of these medicines;
• mifepristone (a medicine with abortifacient action) – ibuprofen taken 8–12 days after mifepristone may reduce its effectiveness;
• cyclosporine (a medicine used in organ transplant patients) – increased risk of kidney damage;
• zidovudine (a medicine used in the treatment of HIV infection) – may prolong bleeding time;
• cardiac glycosides (medicines used in heart failure and cardiac rhythm disorders) – ibuprofen may worsen symptoms of heart failure and increase blood levels of cardiac glycosides;
• quinolone antibiotics – may increase the risk of seizures.

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

Pregnancy, breastfeeding, and 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 during 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, increase the risk of bleeding in both mother and child, and delay or prolong labor.
Ibuprofen Aflofarm should not be used during the first six months of pregnancy unless considered absolutely necessary by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Ibuprofen Aflofarm may cause constriction 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 more 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 to treat pain and fever.

Fertility
Ibuprofen Aflofarm may impair female fertility; this effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Ibuprofen Aflofarm has no effect or a negligible effect on the ability to drive and 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 129.2 mg of sucrose per tablet.
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their 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 Aflofarm

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

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

This medicine is for oral use only.

Recommended dose
Adults and adolescents aged 12 years and older
Initial dose: 1 to 2 tablets, then if needed, 1 to 2 tablets every 4 to 6 hours.
Tablets should be swallowed 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 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 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. There may also be restlessness, drowsiness, confusion, or coma. Seizures may occur rarely. 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. In addition, prothrombin time/INR may be prolonged, likely due to impaired function of circulating blood coagulation 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 develop.

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 scheduled, 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediately contact a doctor or go to the nearest hospital if any of the following occur:

• rash, severe swelling of the face, lips or throat causing difficulty breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pallor, 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 cell);
• 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 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 such as spots, blurred vision, double vision, color vision disturbances.

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

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

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

• 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;
• ulcerative inflammation of the oral mucosa;
• worsening of 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, reduced urine output, increased serum sodium concentration (sodium retention);
• depression, emotional disturbances;
• tinnitus, hearing disturbances;
• liver function disorders, particularly during long-term use;
• marked reduction in 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, purpura, petechiae);
• worsening of asthma symptoms and bronchospasm in patients with systemic lupus erythematosus (a chronic autoimmune disease 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 breathing, speaking or swallowing, shortness of breath, rapid heartbeat, low blood pressure or shock.

Frequency unknown (frequency cannot be estimated from 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 sought immediately.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to 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 the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must 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 Aflofarm contains

• The active substance is ibuprofen. One coated tablet contains 200 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.
The packaging contains: 2 tablets in a sachet, 10, 20, 30 or 50 tablets packed with the patient leaflet 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