Ibuprofen forte apteo med

Patient Information Leaflet

Ibuprofen FORTE APTEO MED, 400 mg, film-coated tablets
For adults and adolescents with body weight of 40 kg and above (aged 12 years and older)
Ibuprofenum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this 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 further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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 or 4 days of treatment for pain, or if you feel worse, consult your doctor.

Leaflet Contents

1. What Ibuprofen FORTE APTEO MED is and what it is used for
2. What you need to know before taking Ibuprofen FORTE APTEO MED
3. How to take Ibuprofen FORTE APTEO MED
4. Possible side effects
5. How to store Ibuprofen FORTE APTEO MED
6. Contents of the pack and other information

1. What Ibuprofen FORTE APTEO MED is and what it is used for

Ibuprofen FORTE APTEO MED contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that reduce pain and fever.
This medicine is used for short-term symptomatic treatment of mild to moderate pain such as headache, menstrual pain, toothache, and also for fever.
If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, consult your doctor.

2. Important information before taking Ibuprofen FORTE APTEO MED

When not to take Ibuprofen FORTE APTEO MED:

• if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has experienced difficulty in breathing, asthma, rhinitis, angioedema, or urticaria after taking acetylsalicylic acid (aspirin) or other similar pain-relieving medicines (NSAIDs),
• if the patient has a peptic ulcer (or has had two or more episodes of peptic ulcer disease) or gastrointestinal bleeding,
• if the patient has previously experienced gastrointestinal bleeding or perforation following the use of NSAIDs,
• if the patient has severe renal, cardiac, or hepatic insufficiency,
• if the patient has bleeding disorders, including intracranial bleeding (cerebral haemorrhage),
• if the patient has unexplained disorders of the haematopoietic system,
• in patients with significant dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
• in women during the third trimester of pregnancy.

Warnings and precautions
Special caution is required when using Ibuprofen FORTE APTEO MED:
The use of anti-inflammatory and/or analgesic medicines such as ibuprofen may be associated
with a small increased risk of myocardial infarction or stroke, particularly when used in high doses.
Do not exceed the recommended dose or duration of treatment.
Serious skin reactions 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) have occurred with the use of ibuprofen. If any of the
symptoms associated with these serious skin reactions described in section 4 occur, discontinue
Ibuprofen FORTE APTEO MED immediately and seek medical help.
Before starting Ibuprofen FORTE APTEO MED, discuss the following with your doctor or pharmacist:

• if any skin rash, mucosal changes, blisters, or other allergic symptoms appear, discontinue Ibuprofen FORTE APTEO MED immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. Serious skin reactions have been reported with the use of Ibuprofen FORTE APTEO MED. See section 4.
• Ibuprofen FORTE APTEO MED may mask objective signs of infection such as fever and pain. Therefore, Ibuprofen FORTE APTEO MED 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 varicella. If the patient takes this medicine during an existing infection and symptoms persist or worsen, consult a doctor immediately.
• if the patient has a hereditary disorder of the haematopoietic system (e.g. acute intermittent porphyria);
• if the patient is elderly, as they may be at higher risk of serious adverse effects associated with NSAID use, particularly gastrointestinal bleeding and perforation, which may be fatal.
• if the patient has asthma or allergic disease, as dyspnoea may occur;
• if the patient has fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. These may present as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria;
• if the patient has varicella (chickenpox), the use of Ibuprofen FORTE APTEO MED should be avoided;
• if the patient has impaired liver or kidney function;
• if the patient has recently undergone major surgery;
• if the patient has Crohn's disease or ulcerative colitis, as symptoms may worsen;
• if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease – autoimmune disorders;
• if the patient has heart disease such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
• if the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• during prolonged treatment with Ibuprofen FORTE APTEO MED, regular monitoring of liver and kidney function and blood counts is necessary;
• avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to increased risk of adverse effects (see section "Ibuprofen FORTE APTEO MED and other medicines").

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
Gastrointestinal bleeding, ulcers, or perforations, which may be fatal, have been reported during treatment with all NSAIDs, at any time during therapy, regardless of whether there were prior warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, or perforation increases with higher NSAID doses and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see "When not to take Ibuprofen FORTE APTEO MED" in section 2), and in elderly patients. In such patients, treatment should be initiated with the lowest effective doses. In these patients and in those requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients with a history of gastrointestinal adverse effects, particularly the elderly, should report any concerning abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Exercise caution in patients taking concomitant medications that increase the risk of ulceration or bleeding, such as corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or antiplatelet agents, e.g. acetylsalicylic acid (see "Ibuprofen FORTE APTEO MED and other medicines" in section 2).
Discontinue the medicine and contact a doctor immediately if gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen FORTE APTEO MED.
Severe and acute hypersensitivity reactions (e.g. anaphylactic shock) are very rare. If the first signs of severe hypersensitivity occur after taking Ibuprofen FORTE APTEO MED, discontinue the medicine immediately and contact a doctor without delay.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be carefully monitored during treatment.
Ibuprofen may mask symptoms of infection and fever.
Chronic use of analgesic medicines (of various types) may generally lead to permanent kidney damage. This risk may increase during physical exertion accompanied by salt loss and dehydration. Therefore, such practice should be avoided.
In dehydrated adolescents, there is a risk of impaired kidney function.
Long-term use of various types of analgesics for headache may worsen symptoms. If this situation occurs or is suspected, consult a doctor and discontinue the medicine. In patients with frequent or daily headaches, despite (or because of) regular use of headache medicines, medication-overuse headache should be suspected.
If any of the above situations apply to the patient, consult a doctor before using Ibuprofen FORTE APTEO MED.
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 FORTE APTEO MED immediately and contact a doctor or emergency medical services without delay.

Ibuprofen FORTE APTEO MED and other medicines
Ibuprofen FORTE APTEO MED may affect the action of other medicines, or other medicines may affect the action of Ibuprofen FORTE APTEO MED, e.g.:

• anticoagulant medicines (i.e. blood thinners or those preventing blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. Especially if the patient is taking:

Some other medicines may affect the action of Ibuprofen FORTE APTEO MED, or Ibuprofen FORTE APTEO MED may affect the action of other medicines. Therefore, always consult your doctor or pharmacist before using Ibuprofen FORTE APTEO MED with other medicines.

Ibuprofen FORTE APTEO MED and alcohol
The occurrence of certain adverse effects, such as those affecting the gastrointestinal system or central nervous system, may be more likely if Ibuprofen FORTE APTEO MED is taken together with alcohol.

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

Pregnancy
Ibuprofen FORTE APTEO MED must not be used during the last 3 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 affect bleeding tendency in both mother and child, and may result in delayed or prolonged labour. Ibuprofen FORTE APTEO MED should not be taken during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is needed during this period or when trying to become pregnant, the lowest possible dose should be used for the shortest possible time. Ibuprofen FORTE APTEO MED taken for longer than a few days after the 20th week of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is needed, your doctor may recommend additional monitoring.

Ibuprofen should be avoided in women who are planning pregnancy or who are pregnant. Use of this medicine at any stage of pregnancy should only occur on the advice of a doctor.

Breastfeeding
This medicine may be used during breastfeeding for up to 3 days (when treating fever) or 4 days (when treating pain), as only very small amounts of the medicine pass into breast milk.

Fertility
Ibuprofen FORTE APTEO MED belongs to the group of NSAIDs which may have an adverse effect on female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
When high doses of Ibuprofen FORTE APTEO MED are used, adverse effects on the central nervous system such as fatigue and dizziness may occur. In individual cases, reaction time may be prolonged and the ability to actively participate in traffic or operate machinery may be impaired. Concomitant alcohol consumption may intensify adverse effects.

Ibuprofen FORTE APTEO MED contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Ibuprofen FORTE APTEO MED contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ibuprofen FORTE APTEO MED

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.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration to relieve symptoms.
Use the lowest effective dose for the shortest necessary duration to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Oral administration. In individuals with a sensitive gastrointestinal tract, it is recommended to take the medicine
Ibuprofen FORTE APTEO MED with food.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more than the recommended dose of Ibuprofen FORTE APTEO MED
If you take more than the recommended dose of the medicine, or if a child accidentally ingests it, you must immediately contact a doctor or go to a hospital emergency department to obtain advice on the risks and actions to be taken.
Symptoms of taking more than the recommended dose may include: nausea, vomiting (possibly with blood), abdominal pain, diarrhoea, tinnitus, headache, confusion, nystagmus, gastrointestinal bleeding, restlessness, confusion, coma, prolonged prothrombin time/INR, acute renal failure, liver damage, hypotension, respiratory depression, cyanosis, and worsening of asthma in patients with asthma. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
Missing a dose of Ibuprofen FORTE APTEO MED
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The occurrence of adverse reactions can be minimized by using the lowest effective dose for the
shortest duration necessary to relieve symptoms. One of the known adverse reactions associated with NSAIDs (see below) may occur.
In such a case, or if in doubt, discontinue use of the medicine and consult a doctor as soon as possible. Elderly patients taking this medicine are at higher risk of experiencing adverse reactions.
If any of the following symptoms occur in a patient, ibuprofen use must be stopped immediately and medical help sought:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds;
• symptoms of a very rare but severe allergic reaction, such as swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These symptoms may occur even after the first dose of the medicine;
• red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome);
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If any adverse symptoms occur or worsen, or if any adverse symptoms not listed in this leaflet occur, consult a doctor.
Common (may occur in up to 1 in 10 patients)

• gastrointestinal disorders such as indigestion, heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhoea, constipation, and minor bleeding from the stomach and/or intestines, which may exceptionally lead to anaemia;
• rash.

Uncommon (may occur in up to 1 in 100 patients)

• rhinitis;
• allergic reactions with skin rash and itching, as well as bronchial asthma attacks (possibly with a drop in blood pressure), worsening of asthma, breathing difficulties (bronchospasm), dyspnoea. If any of the above symptoms occur, stop taking Ibuprofen FORTE APTEO MED and consult a doctor immediately;
• gastric and intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (oral ulcerative stomatitis), inflammation of the gastric mucosa, exacerbation of colitis and Crohn's disease;
• disorders of the central nervous system such as headache, dizziness, insomnia, restlessness, irritability or fatigue, paresthesia;
• visual disturbances;
• urticaria, itching, purpura.

Rare (may occur in up to 1 in 1,000 patients)

• optic neuritis;
• toxic optic neuropathy;
• hearing disturbances;
• tinnitus (ringing in the ears);
• dizziness;
• kidney damage (papillary necrosis) and increased blood uric acid levels.

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

• oesophagitis or pancreatitis, formation of membrane-like strictures in the small and large intestine (development of diaphragm-like intestinal strictures);
• vasculitis;
• severe skin infections and soft tissue complications occurring during varicella (varicella) virus infection;
• reduced urine output and oedema (particularly in patients with hypertension or impaired kidney function);
• cloudy urine (nephrotic syndrome), kidney inflammation (interstitial nephritis), which may be associated with acute kidney failure;
• psychotic reactions, anxiety, confusion, depression;
• worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) during concomitant use of non-steroidal anti-inflammatory drugs. If these symptoms occur or worsen, consult a doctor immediately. Investigations should be performed to determine whether antimicrobial and/or antibiotic therapy is indicated;
• hypertension, palpitations, heart failure, myocardial infarction;
• symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or disturbances in consciousness during ibuprofen use. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be at higher risk of this complication. Seek medical attention immediately if these symptoms occur;
• severe skin reactions such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia);
• severe generalized hypersensitivity reactions;
• blood cell production disorders (leukopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, anaemia, including aplastic and haemolytic anaemia), the first signs of which are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and medical advice sought. Do not self-medicate with painkillers or antipyretics;
• liver function disorders, liver damage, particularly during long-term treatment, liver failure, acute hepatitis, jaundice (yellowing of the skin or whites of the eyes).

Frequency not known (frequency cannot be determined from available data)

• red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Ibuprofen FORTE APTEO MED and seek medical help immediately. See also section 2;

• skin becomes sensitive to light;

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Taking medicines such as Ibuprofen FORTE APTEO MED may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Due to NSAID treatment, cases of oedema, hypertension and heart failure have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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.: 22 49 21 301, fax: 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 FORTE APTEO MED

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP:
The expiry date refers to the last day of the specified month.
Store blisters in the outer packaging to protect from light. No special
requirements for storage.
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 package and other information

What Ibuprofen FORTE APTEO MED contains

• The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, hypromellose, anhydrous colloidal silicon dioxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating Opadry White 03G28692: hypromellose, titanium dioxide (E 171), macrogol 6000,
macrogol 400.

What Ibuprofen FORTE APTEO MED looks like and contents of the pack
Coated tablets.
White, film-coated, cushion-shaped tablets, embossed with the number "236" on one side and smooth on the other side.
Pack sizes: 10, 12, 20, 24, 30, 48, 50, 60, 84, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Wave Pharma Limited
Ground floor, Cavendish House
369 Burnt Oak Broadway
Edgware, HA8 5AW,
United Kingdom
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Ascend Laboratories (UK) Ltd.
4 Floor, Cavendish House
369 Burnt Oak Broadway
Edgware HA8 5AW
United Kingdom
Ascend GmbH
Sebastian-Kneipp-Straße 41
60439 Frankfurt am Main,
Germany